Category: Science

The stigma encompassing marijuana has been steadily declining with states legalizing it for both medical and recreational use. On March 31st, New York became the 15th state to legalize cannabis. There are currently 18 states in the U.S. that legalized recreational cannabis and the number of states are only expected to increase with time. As cannabis continues to grow in popularity, it’s important to understand the potentially harmful consequences that come along with the drug.

According to Fiona Clement, a health-policy researcher at the University of Calgary’s Cummings School of Medicine, multiple studies have shown associations between marijuana and possible adverse effects. These side effects include the risk of impaired driving, increased chance of stroke and testicular cancer, brain development changes that may affect learning and memory, and mental illnesses involving psychosis.

After the legalization of marijuana in Colorado, cases of acute injuries and various illnesses linked to cannabis use began to rise. Research shows that cannabis-related visits to hospitals in Colorado increased around 40%, from 824 per 100,000 visits to 1,146 per 100,000, in the years between 2012 and 2014. Many of those cases were related to mental illnesses, which were found to be diagnosed in individuals who use cannabis five times more than those who choose to abstain.

Mental illnesses were not the only concerning cases related to cannabis use that the Colorado hospitals had to handle. Unfortunately, cases of marijuana use leading to cyclic vomiting syndrome also increased, with some hospitals doubling in these diagnoses. There have also been several occurrences where children, under the age of 10, were accidentally poisoned by cannabis. These incidents of marijuana-related visits to the children’s hospital nearly doubled after the legalization of cannabis, suggesting that there are real risks even to individuals who are not consuming the drug.

The potential adverse outcomes have evidently not abated the popularity of cannabis. However, the age restriction for the use of marijuana should be strictly adhered to. Minors are prone to sustaining long-term damage as their brains are still in the process of developing. THC binds to cannabinoid receptors in the brain, which play an important role in neurotransmitter release. These receptors should increase during adolescence, as they are vital for the genetic expression of neural (brain) development. Regular use of marijuana could significantly alter these neurodevelopmental systems, leading to poor cognitive and emotional outcomes in adulthood.

There are clear risks with cannabis use and it’s important to be transparent about these consequences. “Cannabis is not the root of all evil, nor is it the cure for all diseases,” Monte says. “You’ve got to understand what the good is and what the bad is, and then make a balanced decision.”

Johnson & Johnson’s COVID-19 vaccine helps prevent severe disease among those infected with the Delta variant, according to a trial involving almost 480,000 health workers in South Africa. The study, known as Sisonke, provides the first large-scale evidence that the J&J vaccine works against this dominant variant, according to trial co-lead Glenda Gray. It’s probably more protective against Delta than it was with the earlier beta strain, she said in a presentation Friday.

The single-dose shot was 71% effective against hospitalization and as much as 96% effective against death, she said. It also demonstrated durability of eight months. “These results show there is no need for a booster yet,” said Gray, who is president of the South African Medical Research Council.

While the J&J vaccine is a key element to South Africa’s vaccination plan, the country temporarily paused its use in April after the U.S. decided to suspend the shot because of its link to rare blood clots. Other data have raised questions about how well the shot holds up against the highly contagious strain that has driven renewed outbreaks in countries including the U.S. and China.

One U.S. study released last month showed the J&J shot produced relatively low levels of antibodies against Delta. J&J said that analysis, which hasn’t been published in a peer-reviewed journal, had examined only one aspect of protection and didn’t consider long-lasting responses among immune cells stimulated by the vaccine. The drugmaker’s researchers have said their own data indicated that the vaccine neutralizes the variant and that additional doses weren’t needed.

Africa’s Rollout

Earlier this year J&J agreed to supply as many as 400 million vaccines to the African Union through the end of 2022, delivering a boost to a continent trailing most of the world in the race to inoculate. The dose’s requirement for just a single shot is seen as beneficial for Africa, where vaccine distribution to more than 1 billion widely dispersed people is likely to present a challenge.

In the study, the vaccine was administered to the health workers at 120 sites in both urban and rural areas from Feb. 17 to May 17. Analysis of a third data set is expected in coming days. There were two cases of the rare clotting disorder thrombocytopenia thrombosis syndrome among participants, with both making a complete recovery, Gray said.

News wise — If you check the Centers for Disease Control and Prevention COVID-19 data tracker, which tracks cases in each state, much of the country is colored bright red, indicating a high rate of transmission of COVID.

A large chunk of the population is still unvaccinated against COVID-19, fewer people are wearing masks, and more people are getting together—all while the highly contagious Delta variant of the coronavirus continues to spread.

Last week, the CDC recommended that even vaccinated people wear masks indoors in areas with substantial or high rates of transmission to try to turn the tide and reduce cases. That recommendation was based in part on data gathered from a July 4th holiday COVID outbreak in Provincetown, MA that seemed to indicate that even vaccinated people could spread the virus. The news left many confused and concerned about just how well they are protected.

There is danger in reading too much into this case, however, said Adam Lauring, M.D. Ph.D., an infectious disease specialist at Michigan Medicine.  “While this is clearly something to pay attention to, in the CDC report, they are pretty clear in the discussion about the limitations and what they are saying and not saying. Of course, not everyone made it that far,” noted Lauring. For example, as more people are vaccinated, it follows that more cases detected will be in vaccinated individuals.

Lauring also noted that a nasal swab COVID test measures how much viral RNA is present in a person’s nose but can’t measure how much of that virus is infectious. “The amount of genome present is a marker, but it is not the same thing as saying these people are equally as infectious,” said Lauring.

Another important point is that a swab is taken at one moment in time. “You could picture a situation where vaccinated people with Delta have a really steep rise and then a really steep fall in the amount of virus shed, whereas an unvaccinated person would have a steep rise that would remain high for longer.”

Even with all the unknowns, what was true before Delta is true now: the majority of cases will be in unvaccinated people. But, he added, “the big change is before, we were thinking vaccinated people would not transmit that often, whereas it appears that vaccinated people with the Delta variant will transmit more often than with other variants,” said Lauring.

What does this mean practically? This means that it will take additional measures, like wearing masks in certain situations—such as indoor spaces with a lot of local cases—in addition to vaccines to stop the spread of COVID.

Early data show that the vaccines are still more than 80% effective at preventing severe illness and death and are still reducing transmission. As far as boosters go, said Lauring, “I’m more concerned about people who have not been vaccinated at all.” And in the U.S., case counts continue to be highest in areas with low vaccination rates, evidence that the vaccines are working against all variants.

What about kids under 12 who don’t yet have an approved COVID vaccine?

Lauring noted that the risk of severe illness and death is low for children and that hasn’t changed, even with Delta. But as more adults become vaccinated, more of any future cases will be in unvaccinated people, including kids.

“The more transmissible the virus is, the higher the percentage of immune people you’ll need to shut down transmission.”

The best thing to do to protect kids, immunocompromised individuals and to reduce the chance for the emergence of even more transmissible variants remains to get as many people vaccinated against COVID-19 as possible to safely approach herd immunity.

Lauring noted that COVID is probably here to stay.

“My sense is people are coming to grips with what that means. From a policy level, we’ll have to figure out what level of circulation and hospitalization we are comfortable with,” he said.

The Food and Drug Administration (FDA) has begun accelerating the process to fully approve the Pfizer-BioNTech COVID-19 vaccine, facing pressure to add resources from those who believe the lack of full approval is hampering efforts to get more Americans vaccinated.

“We recognize that for some, the FDA approval of COVID-19 vaccines may bring additional confidence and encourage them to get vaccinated,” Abigail Capobianco, a spokeswoman at the FDA, said in a statement on Aug. 4. “Acknowledging the urgency related to the current state of the pandemic, we have taken an all-hands-on-deck approach, including identifying additional resources such as personnel and technological resources from across the agency and opportunities to reprioritize other activities, in order to complete our review to help combat this pandemic surge.”

President Joe Biden said last week he expects a fully approved vaccine by the early fall, but the FDA would not comment on the time frame.

Data show that being vaccinated dramatically reduces the risk of hospitalization or death following a COVID-19 infection. More than 192 million Americans have gotten at least one dose of the three vaccines that have been given emergency use authorization (EUA) in the U.S., made by Pfizer-BioNTech, Moderna and Janssen/Johnson & Johnson, without widespread side effects, data show. But now the number of Americans fully vaccinated against COVID-19 has begun to stall with about 92 million people over age 12 still unvaccinated, according to U.S. Centers for Disease Control and Prevention (CDC) data. Meanwhile, the more contagious Delta variant of the virus is spreading rapidly among the unvaccinated population.

The spike in COVID-19 cases in states that have low vaccination rates has threatened to claw the U.S. back into the worst of the pandemic, and it creates a looming political liability for Biden. On Aug. 3, Biden gave a sober speech from the East Room of the White House, saying the country’s “best line of defense” against the virus “is the vaccine.” “It’s as simple as that. Period. The vaccine,” he said.

But as Biden attempts to mount more aggressive vaccination efforts to stave off the spread of the highly transmissible Delta variant, the fact that the FDA has yet to fully approve any of the vaccines is threatening to slow progress. About 30% of unvaccinated people say they would be more likely to get a shot with full FDA approval, according to recent polls from the Kaiser Family Foundation. While the pollsters warn that may be a “proxy for more general concerns,” some doctors and public health experts in areas with low vaccination rates also say they frequently hear the FDA’s emergency authorization cited as a reason people remain hesitant to get the shot.

The Biden Administration has said all civilian federal employees must be vaccinated against COVID-19 or submit to regular testing, and many hospital systems and universities, as well as a number of large private employers like Walmart, Google, and Disney, have begun to follow suit.

The Justice Department’s Office of Legal Counsel recently released an opinion saying federal law does not prohibit companies from requiring vaccines even if they are under emergency authorization, and courts have generally upheld vaccine mandates.

But some employers and organizations have been reluctant to make similar requirements while the vaccines are still under emergency authorization. A number of public educational institutions—including the State University of New York and Colorado State University systems—have said they will mandate vaccination for students once a vaccine is fully approved. In other parts of the country, Republican politicians have used the lack of full approval to block vaccine requirements from being put into place. In Texas, for example, Republican Gov. Greg Abbott signed an executive order on July 29 preventing any organization that receives state funds, including public universities, from requiring vaccines under emergency use authorization.

Health systems have also taken a mixed approach. Mass General Brigham, which employs 80,000 workers in Massachusetts, said it will require employees to get vaccinated once the FDA issues its full approval for at least one of the vaccines, as did Beaumont Health, the largest health care system in Michigan. Other large health systems like Cleveland Clinic, Intermountain Health, and Christus Health have not put in place vaccine requirements and say they are still monitoring the situation.

“We need to see a full approval before we’ll do another evaluation of thinking about a requirement in the future,” says Dr. Sam Bagchi, executive vice president and chief clinical officer at Christus. He notes that the health system is already facing “unprecedented staffing challenges” due to many health care workers quitting or taking early retirement during the pandemic. If his hospitals required workers to get vaccinated now, he fears it would push workers away at a time when they need more staff due to rising COVID-19 cases.

Long-term care facilities are in a particularly precarious position. LeadingAge, the national trade group for non-profit nursing homes and other aging services, recently called for its members to require employees to get vaccinated against COVID-19 as vaccination efforts have stalled in places where the virus devastated residents and staff last year. But Katie Smith Sloan, the group’s president and CEO, says she knows many of her member facilities can’t afford to lose staff who aren’t ready to get vaccinated. “We’re already facing acute shortages, particularly nursing assistants and nurses in long-term care, home health, nursing homes, and assisted living,” she says. She hopes that an FDA approval will make more workers volunteer to get vaccinated and encourage more facilities to require it.

Even the U.S. military is still weighing what to do. It has not yet required that its 1.3 million active duty personnel be vaccinated, and senior military medical officials are watching the FDA approval process closely. Secretary of Defense Lloyd Austin is consulting with medical experts and still weighing whether to request approval from Biden to require vaccines, Pentagon spokesman John Kirby said on Aug. 3.

The FDA typically completes a priority review, like it is conducting for Pfizer, in six to eight months. Pfizer says it submitted a rolling application in May and Moderna—which manufactures one of the other approved COVID-19 vaccines—says it submitted a rolling application in June, meaning both companies could turn in portions of their applications while continuing to collect data. The process is “moving forward as rapidly as possible in keeping with the high-quality complete assessment that the public expects from the FDA,” said FDA spokeswoman Capobianco.

The COVID-19 pandemic was the first time that the FDA granted emergency use authorization to a vaccine for widespread use. The EUA designation was developed after the Sept. 11 attacks and originally intended for potentially lifesaving medicines or other products during an emergency like a terrorist attack or a more acute disease outbreak. To get an EUA for the COVID-19 vaccines, manufacturers had to follow special guidelines that included submitting two months of clinical trial data, along with information about the quality and consistency of the vaccines—and the FDA had to establish that the “potential benefits outweigh the known and potential risks” of the vaccine.

For full approval, the FDA must review significantly more data and make a larger determination that a vaccine is ready to be licensed, according to Dr. Jesse Goodman, former chief scientist at the FDA and a professor at Georgetown University. This involves analyzing hundreds of thousands of pages of material about the clinical trials, manufacturing processes and how the vaccines have functioned in the real world since the agency authorized it for emergency use. Regulators will check the vaccine manufacturer’s data and perform their own analyses to verify the vaccine’s efficacy, how that efficacy might decline over time and any evidence of potential side effects. They will also inspect manufacturing plants to ensure high levels of quality control—a particularly complex job given that these vaccines used new technology, Goodman says. He notes the FDA “has historically been under-resourced” and that there are a limited number of people with the appropriate expertise to review these new vaccines.

While all that can take time, public health experts are calling for more transparency from the agency as the U.S. struggles to convince a significant portion of its population to take the lifesaving shot. “It’s been a black box,” says Dr. William Schaffner, an infectious disease professor at Vanderbilt University Medical Center. “Particularly since we’re dealing with a pandemic and the taxpayers of the United States are paying for this vaccine, I think having the leadership of the FDA be more explicit about what the process is, and why it’s taking so long, would be at the very least instructive.”

But some worry hastening the approval process could backfire. Peter Marks, director of the Center for Biologics Evaluation and Research at the FDA, warned in a letter to the New York Times last month that “any vaccine approval without completion of the high-quality review and evaluation that Americans expect the agency to perform would undermine the F.D.A.’s statutory responsibilities, affect public trust in the agency and do little to help combat vaccine hesitancy.”

Dr. Arnold Monto, a professor of epidemiology at University of Michigan who chairs the committee of outside experts that advises the FDA on vaccines, including for COVID-19, agrees. “They’re trying as hard as they can,” he says, “given the constraints that they’re working under.”

The U.S. government’s top infectious disease expert, Dr. Anthony Fauci, said last week that he was hopeful the Food and Drug Administration will give full approval to the coronavirus vaccine by month’s end and predicted the potential move will spur a wave of vaccine mandates in the private sector as well as schools and universities.

Moderna said its COVID-19 vaccine remained 93% effective through six months after the second shot, as it reported second-quarter earnings and revenue that beat expectations. A final analysis of the company’s late-stage study, described in a statement on Thursday, suggests the vaccine’s protection remains stable for long after recipients complete the standard two-dose regimen. The 93% effectiveness level is just short of the shot’s initial efficacy of 94%.

Concern that the effectiveness of COVID-19 vaccines could wane has stoked talk of booster shots, and some countries have begun to offer vulnerable people third doses. However, World Health Organization Director-General Tedros Adhanom Ghebreyesus called for a moratorium on such measures on Wednesday until more people in the developing world are inoculated. The recommendation could limit the reach of Moderna’s shot, called Spikevax.

The shares fell 2.9% as of 8:28 a.m. before U.S. markets opened Thursday. COVID-19 vaccine-maker Pfizer lost 0.6%, while its partner BioNTech shed 3.8%.

Moderna’s latest efficacy data hasn’t been published in a medical journal and further details weren’t released. Despite the apparent endurance of its vaccine, Moderna is exploring options for supplemental shots that could fend off emerging strains of the virus.

All three of the company’s booster candidates produced “robust antibody responses” against delta and other variants of concern in a phase 2 human study, Moderna said in its statement. The boosters are being tested at a 50 microgram dose, or half what is used in the current shot. That data has been submitted to a journal for publication, the company said.

Seeking Approval

Cambridge, Massachusetts-based Moderna also said it expected to complete its submission for full Food and Drug Administration approval for its vaccine this month.

The agency is already reviewing the submission for a rival messenger RNA vaccine from Pfizer Inc. and BioNTech SE, and is under growing pressure to complete the process quickly. With the delta variant sparking a new wave of cases, advocates say an approval could help convince more people to get a shot.

Moderna, which reported its first profit earlier this year, had net income of almost $2.8 billion in the quarter ending June 30 on revenue of $4.4 billion, almost all of which is from its COVID-19 shot. Diluted earnings per share of $6.46 easily beat analysts expectations, according to a survey of analysts by Bloomberg, while revenue only slightly exceeded expectations.

The company said in the release it has signed $20 billion worth of COVID-19 vaccine purchase agreements for 2021, up from the $19.2 billion it announced in May. For 2022, it already has signed agreements for $12 billion in vaccine sales with options for $8 billion more. Moderna didn’t increase its forecast that it will produce 800 million to 1 billion COVID vaccine doses this year.

Seeking Deals

Moderna’s views for total sales of its COVID-19 vaccine pale in comparison to the Pfizer-BioNTech partnership, which has a higher manufacturing capacity for its shot. Last month, Pfizer boosted its vaccine sales forecast for 2021 to $33.5 billion.

Moderna’s shares have quadrupled since the beginning of the year, and the company hit $100 billion in market value for the first time July 14. The stock was made part of the S&P 500 last month and is the index’s best performer this calendar year.

As the biotech seeks to grow further, it will look opportunities to acquire or license technologies that could enhance its platform. Moderna, which has more than $12 billion in cash and investments, will focus on nucleic acid technologies, such as mRNA, gene editing, and gene therapy, the company said in a presentation.

Moderna has also built out its suite of leaders to double down on its commercial franchise. In the last quarter, the company hired Paul Burton, a former Johnson & Johnson executive, to serve as chief medical officer, and Ogilvy’s Kate Cronin as chief brand officer.

In late May, The US Food and Drug Administration (FDA) allowed for Emergency Use Authorization (EUA) to combat the COVID-19 pandemic, resulting in the investigational monoclonal antibody therapy sotrovimab. This new therapeutic weapon allows for the treatment of mild-to-moderate COVID-19 in patients over 12 years of age with positive outcomes. Its widespread use includes patients who are at a higher risk of more severe symptoms of COVID-19 such as individuals who are over 65 years old or those with certain medical conditions.

With a lead over the first-generation monoclonal antibody (mAb) therapies for COVID-19, Sotrovimab is reportedly referred to as super-antibodies due to their broad neutralization capacity when encountered with viral pathogen variants.

Sequencing each version of the virus the patients are suffering from would not only be overly meticulous but also equally painstaking. Therefore, Sotrovimab’s large range in capabilities is enticing to physicians as stated by analysts and researchers.

When a person is infected with COVID-19, antibodies are typically produced to fight against the invading disease. These antibodies are unique to each individual, meaning that some antibodies are better than others at combating the virus. Thus, pharmaceutical companies study thousands of these antibodies to take advantage of the most effective ones with the highest barrier to resistance.

Out of these pharmaceutical companies, Vir Biotechnology and GlaxoSmithKline derived the monoclonal antibody sotrovimab from patients who had SARS in 2003, which targets parts of the COVID-19 virus that it shares with the original SARS virus. By targeting these areas, it lowers the chance for the virus to mutate and should allow for the antibody to work against new variants.

According to data from clinical trials, sotrovimab showed positive results with a 79% reduction in risk of hospitalization or death, appearing to yield activity against the currently known problematic variants of COVID-19.

Sales for these antibody therapies were expected to diminish as vaccination rates continuously rose, however, analysts predict that the market for COVID-19 mAbs will endure to assist in treatments for those who are unable to receive their vaccination shots for medical reasons.

A full course of two of the most widely available coronavirus vaccines is about as effective against the more contagious delta variant as it was against a previously dominant version of the virus, according to a study published in the New England Journal of Medicine.

Two doses of the Pfizer-BioNTech vaccine offer 88 percent protection against symptomatic disease caused by the delta variant, compared to 94 percent against the alpha variant that was first discovered in Britain and became dominant across the globe earlier this year, the study said.

A double dose of the Oxford-AstraZeneca vaccine was 67 percent effective against delta, according to the British researchers, down slightly from an efficacy rate of 75 percent against the alpha variant.

Here are some significant developments:

• China said Thursday that it will not accept the World Health Organization’s suggested plan for the second phase of investigation into the origins of the coronavirus. A senior Chinese health official criticized the agency’s proposal to include the lab-leak hypothesis as a research priority.
• Officials announced that some 200 million people or more than half of all adults in the European Union have now been fully vaccinated.
• The United States has extended restrictions on nonessential travel at the borders with Canada and Mexico until Aug. 21. The Department of Homeland Security said the decision was made because of the “continued transmission and spread of [the virus] within the United States and globally.”
• Australia’s most populous state Thursday reported its highest number of new, locally transmitted cases for the year, even as much of the country remained under lockdown to stem an outbreak of the more contagious delta variant. New South Wales, which includes Sydney, recorded 124 new infections, health authorities said.
• Tunisia’s president has ordered the military to oversee the country’s coronavirus response as the North African nation battles its worst outbreak of the pandemic. Earlier this week, the health minister was fired for bungling Tunisia’s vaccine rollout as the virus spread.
• The Tokyo 2020 Organizing Committee announced 12 new coronavirus cases among accreditation holders, including two unnamed athletes who were living in the Olympic Village. Eight athletes have tested positive since arriving in Tokyo for the Games.

The authors of the new study said a single dose of either the Pfizer-BioNTech or the Oxford-AstraZeneca vaccine was significantly less effective against the delta variant than two doses. One dose of the vaccine developed by U.S. firm Pfizer with German partner BioNTech was just 36 percent effective, the study found, while a single shot of the vaccine from Oxford University and British-Swedish company AstraZeneca offered 30 percent protection.

“Absolute differences in vaccine effectiveness were more marked after the receipt of the first dose,” the authors wrote. The research confirmed earlier data released by Public Health England that suggested the two vaccines offered similar levels of protection against the delta variant when administered as a full course. It also offered some hope to those nations struggling to beat back outbreaks caused by the delta variant, which the World Health Organization says has reached at least 124 countries.

The study stood in contrast to preliminary data made public by Israel’s Health Ministry earlier this month that said the Pfizer-BioNTech vaccine was only 64 percent effective in preventing symptomatic infection caused by the delta variant. Some public health experts warned that the data from Israel was observational and not the result of a controlled study.

Newswise — Australian scientists researching how our immune system responds to COVID-19 have revealed that those infected by early variants in 2020 produced sustained antibodies, however, these antibodies are not as effective against contemporary variants of the virus.

The research is one of the world’s most comprehensive studies of the immune response against COVID-19 infection. It suggests vaccination is more effective than the body’s natural immune response following infection and shows the need to invest in new vaccine designs to keep pace with emerging COVID variants.  Published today in PLOS Medicine, the study was made possible by a partnership between the University of Sydney, Kids Research, Sydney Children’s Hospitals Network, the Kirby Institute at UNSW Sydney, Australian Red Cross Lifeblood, St Vincent’s Hospital and NSW Health Pathology, as well as other local and international collaborators.

The team analysed the serum of 233 individuals diagnosed with COVID-19 over 7 months and uncovered that the level of immunity over time is dependent on disease severity and the viral variant. They show that antibodies developed during the first wave had reduced effectiveness against six variants, ranging from those observed in the second wave in Australia through to three variants of concern that have driven the global pandemic in the UK, Brazil and South Africa.

How do we study the immune response?

The serum of COVID-19 infected individuals was of interest as it is the part of our blood that contains crucial information about our immune system. Analysis of the serum made it possible to create a detailed timeline of the level of ‘neutralising antibodies’ produced against COVID-19 infection, and so to see if there was long-term immunity. 

Neutralising antibodies are part of our immune system’s frontline arsenal that is triggered during infection and vaccination. Their job is to shield cells that are usually the target of a pathogen (such as the SARS-CoV-2 virus which causes the COVID-19 disease) from being infected. The level of neutralising antibody response can be a defining feature of how effectively our body fights off illness.

Interestingly, a rare group of ‘super responders’ was also identified as an exception.  This group of ‘super responders’ had a stable and robust level of antibodies across all COVID-19 variants. The researchers say this group could prove useful for investigating the potential of convalescent plasma (using blood from people who have recovered to treat others) which has so far proven ineffective against severe COVID-19 illness. In addition, key donors could be looked at closely and their antibodies cloned for future therapeutic use.

Why it is important?

Co-senior author Associate Professor FabienneBrilot of the University of Sydney and Kids Research, Sydney Children’s Hospitals Network, and her research team led the analysis branch of the study, using highly sensitive tools they developed to study the antibodies in detail.

“We can learn a great deal from these people who were infected in the first wave in Australia as they were infected with the same variant that our current vaccines are based on,” said Associate Professor Brilot.  “While the approved vaccines are showing good responses, our study highlights the importance of continued vaccine development, especially taking into account the differences in variants.” Co-senior author Associate Professor Stuart Turville of the Kirby Institute said the study was conducted to investigate the level, breadth and longevity of the immunity generated from COVID-19 infection and whether mutation of the virus compromises immunity.

“What this work has shown us is that current observations about vaccines show they offer a much broader protection against COVID-19 and its variants than the body’s natural immune response following infection, which is usually only protective against the variant of the virus that the person was infected with. We, therefore, should not rely on the body’s natural immune response to control this pandemic, but rather the broadly protective vaccines that are available.”

Key findings 

• SARS-CoV-2 antibody responses are sustained for up to seven months post-infection.
• The immune response remained stable in some individuals, and while it decreased in others, no individual showed a negative response during the seven-month period.
• Levels of virus-neutralising antibodies were associated with COVID-19 severity.
• Antibodies generated after early infection displayed a significantly reduced antibody binding and neutralisation potency to globally emerging viral variants.

Research shows that a previous coronavirus infection plus one dose of vaccine provides powerful protection — but concerns linger. Many people who’ve been infected with the coronavirus might be able to safely skip the second jab of any two-dose vaccine regimen, a growing number of studies suggest. These results could help to stretch scarce vaccine supplies and are already influencing vaccination policies in some countries. But questions remain about whether the findings hold for all individuals and all vaccines — and therefore how policymakers should respond to the findings.

Studies show that people with previous exposure to SARS-CoV-2 tend to mount powerful immune responses to single shots, and gain little added benefit from another injection^1,2,3. What’s more, for people with immunity gained through infection, one dose typically boosts antibody numbers to levels that are equal to, or often greater than, those found in individuals who have not been infected and have received double doses⁴.

France, Germany and Italy, among other countries, now advise only one dose of vaccine for people with a healthy immune system and a confirmed previous diagnosis. Many scientists who have studied immune responses to vaccination say such policies are a sensible way to make the most of limited supplies in countries that are racing to inoculate their populations. “To follow the current two-dose vaccination schedule in previously infected individuals, when there are millions of people waiting for their first dose, simply does not make sense,” says Jordi Ochando, an immunologist at the Icahn School of Medicine at Mount Sinai in New York City, who has advised the Spanish government on vaccination guidelines.

But scientists still don’t know whether one-jab programmes for the previously infected could leave some individuals with suboptimal protection. Nor is it clear that such programmes would be effective for all types of vaccine. “If you have been infected before, then probably one dose is sufficient,” says Giuliana Magri, an immunologist at the Hospital del Mar Research Institute in Barcelona, Spain. But putting that knowledge into practice? “It’s complicated,” she concedes.

Just one jab

There’s ample laboratory-based evidence that people who’ve been infected by SARS-CoV-2 benefit from vaccination, prompting the World Health Organization and other public-health agencies to recommend that such individuals still get vaccinated. There’s less clarity, however, on whether they need to roll up their sleeves twice. A paper published in Nature on 14 June provides some of the most recent evidence that one shot could be all that’s necessary for people who’ve had COVID-19⁵. A team of researchers at the Rockefeller University in New York City and elsewhere studied 26 people who had contracted the virus early in the course of the pandemic. All of them subsequently received at least one dose of either the Pfizer–BioNTech or the Moderna vaccine, both of which are based on messenger RNA.

The researchers analysed participants’ levels of ‘neutralizing’ antibodies, potent immune molecules that can block the virus from entering cells. At the moment, the quantity and vigour of a person’s neutralizing antibodies are the best markers for assessing whether that person is protected from infection and illness — although scientists are still working to confirm that antibody levels can serve as a realistic stand-in for immune protection. The team also assessed participants’ levels of memory B cells, which remember pathogens and can quickly crank out targeted antibodies if they encounter an infectious agent that they’ve seen before. Within a month or two of vaccination, study participants’ levels of memory B cells had risen, on average, nearly 10-fold and their ‘titres’, or levels, of neutralizing antibodies had shot up around 50-fold. Those gains were apparent in previously infected participants whether they’d received one shot or two.

In fact, just one dose of vaccine generated titres equal to — or higher than — than those produced by two doses of vaccine in people without previous infections. “It’s really amazing,” says virologist Theodora Hatziioannou, who co-led the study. “I wish everyone’s titres were like this.”

Memory booster

The findings from Hatziioannou and her colleagues also hint at the biological underpinnings of one jab’s effectiveness in exposed people. In the 12 months after participants were infected, their memory B cells had not been static. Instead, those cells spent the entire year evolving, which left them able to craft antibodies even more potent and versatile than those that they produced immediately after infection. Other studies corroborate that thinking, with some showing that one shot can spur the growth of antibodies and infection-fighting T cells alike^6,7. “We’re all seeing pretty much the same thing,” says John Wherry, an immunologist at the University of Pennsylvania Perelman School of Medicine in Philadelphia. For people who have recovered from COVID-19, “the second shot doesn’t seem to do a whole lot”.

And although most research on the topic so far has focused on mRNA vaccines, preliminary evidence from studies done in the United Kingdom and India suggests that single-dose strategies could succeed if they rely on using the shot from Oxford-AstraZeneca, which uses an engineered adenovirus to stimulate an immune response against SARS-CoV-2^8,9. A study published last month, for example, showed that one dose of the AstraZeneca jab produced a much more powerful immune response in health-care workers who’d been infected than in colleagues who’d escaped infection. The results “support a single-dose vaccination strategy for previously infected individuals to increase coverage and protect a larger number of populations”, the authors write⁹.

A one-jab policy for those who’ve been infected might even help to overcome vaccine apathy, says Stacy Wood of North Carolina State University in Raleigh, a marketing expert who has studied vaccine messaging. She argues that rather than sowing confusion, outreach that accounts for individual characteristics can help convince people who feel that their own circumstances, including infection history, make them unique. Cutting down the number of shots — and all the attendant side effects, anxiety, and time involved — can also be an attractive proposition to some who are on the fence about getting immunized.“The more tailored approach is probably better at this point,” Wood says.

Stretching vaccine doses

The accumulating evidence has been enough to convince many scientists that second doses of precious vaccine should not be allotted to people who’ve been infected. Providing only one dose to those who’ve had COVID-19 “would free up many urgently needed vaccine doses. With the additional available vaccines, there would be no need to delay the second vaccine dose for naïve individuals”, argues a letter published in May in EBioMedicine and signed by eight COVID-19 scientists¹⁰. And increasingly, countries and regions that are short of vaccine are following the scientists’ lead, at least for younger adults who do not have compromised immune systems.

But not all governments are on board with this approach. In the United States, for instance, where vaccine is relatively plentiful, officials still recommend two doses for all. Determining prior infection history “is not recommended for the purposes of vaccine decision-making”, says Kate Grusich, a spokesperson for the US Centers for Disease Control and Prevention in Atlanta, Georgia. Scientists also point out that some people who become infected with SARS-CoV-2 mount a relatively weak immune response. Such a response is especially common in people who don’t develop COVID-19 symptoms. “There’s a huge range of antibody generation and durability in those individuals,” notes Wherry. “Making decisions based on previous PCR-confirmed infections might miss some people.” That’s where diagnostic antibody testing could help.

Screening for antibodies to the hepatitis B virus is already routine in some settings to guide vaccination strategies against that infectious agent — and the same could be done with antibodies to the SARS-CoV-2 spike protein, a marker of both natural and vaccine-induced immunity, says Viviana Simon, an infectious disease specialist at Mount Sinai and a signatory to the EBioMedicine letter.“When in doubt, I’m all for a second dose,” she says. “But I personally hope that we can move eventually to more personalized schedules and recommendations.”

We’re not going to vaccinate our way completely out of this pandemic. With epidemiologists around the world increasingly accepting the reality that SARS-CoV-2 and its variants will become endemic viruses—like the seasonal flu—the push is on to develop antiviral medications that can be taken at home to prevent infections from leading to hospitalization and death. Today, the Department of Health and Human Services announced that the Biden Administration has authorized $3.2 billion to accelerate the development of antivirals already in the R&D pipeline, with the hope that at least one will be ready for release before the end of the year.

“The remarkable and rapid development of vaccines and testing technology has shown how agile scientific discovery can be,” said Dr. Francis S. Collins, director of the National Institutes of Health (NIH), in an HHS statement. “We will leverage these same strengths as we construct a platform for the discovery and development of effective antivirals.” The plan will focus on 19 drugs currently being investigated for their antiviral potential, with a goal of accelerating their development to Phase 2 clinical trials. Last week, the Administration already placed a major bet on one of the 19, announcing that it will purchase up to 1.7 million doses of an antiviral being produced by Merck, pending emergency use authorization or full approval by the U.S. Food and Drug Administration.

Of the $3.2 billion being allocated, $1.2 billion is going to fund the creation of what the HHS calls “collaborative drug discovery groups,” hoping that the push to create a COVID-19 treatment will also create a developmental infrastructure for other antivirals to treat other diseases.

The new drugs could not only fill the breach left by the vaccine-hesitant who are slowing the push in the U.S. and around the world to reach herd immunity, they could also serve as a backstop against breakthrough infections—cases of COVID-19 that occur even among the vaccinated. Late last month, for example, the CDC reported more than 10,000 breakthrough vaccinations in 46 states as of the end of April, at a time when just over 100 million vaccines had been administered in the U.S. In Massachusetts alone, there have currently been a total of 4,000 breakthrough infections recorded, reported the Boston Herald today. That’s still a relatively small number—representing just 0.1% of vaccinated people—but does make the new drugs attractive.

“New antivirals that prevent serious COVID-19 illness and death, especially oral drugs that could be taken at home early in the course of disease, would be powerful tools for battling the pandemic and saving lives,” said Dr. Anthony Fauci, head of the National Institute for Allergy and Infectious Diseases, in the HHS announcement.

Newswise — June 18, 2021 – An experimental artificial heart includes an autoregulation control mechanism, or Auto-Mode, that can adjust to the changing needs of patients treated for end-stage heart failure. Outcomes in the first series of patients managed with the new heart replacement pump in Auto-Mode are presented in the ASAIO Journal, official journal of the American Society for Artificial Internal Organs. The journal is published in the Lippincott portfolio by Wolters Kluwer.

The study reports on the response to “pressure sensor-based autoregulation of blood flow” in ten patients for up to two years after implantation of the Carmat Total Artificial Heart (C‑TAH). “The C‑TAH Auto-Mode with built-in pressure sensors effectively produces appropriate physiological responses reflective of changing patients’ daily needs and thus provides almost physiological heart replacement therapy,” according to the new research. The lead author is Ivan Netuka, MD, of the Institute for Clinical and Experimental Medicine, Prague. Auto-Mode may increase independence and quality of life in severe heart failure

Heart replacement pumps can restore cardiac output in patients with end-stage, biventricular heart failure (affecting both sides of the heart) whose only other option is heart transplantation. However, to enable patients to go home from the hospital and return to their usual activities, the pump should emulate normal heart function, with minimal need for adjustment. To meet that goal, the C‑TAH incorporates an Auto-Mode that automatically adapts the pumping action of the right and left ventricles in response to pressure sensors located inside the device, based on parameters set by the physician. The goal is to mimic normal physiological responses to changing needs – particularly physical activity.

Dr. Netuka and colleagues analyzed the Auto-Mode’s performance in the first 10 patients undergoing C‑TAH implantation in early European clinical experience. The patients were all men, average age 60 years. The C‑TAH was used as a bridge to heart transplantation in six patients and as a permanently implanted device in four. In all patients, the artificial heart was successfully switched from manual control to Auto-Mode in the operating room. Auto-Mode led to “an immediate appropriate cardiac output response” to the targeted settings. Hemodynamic data recorded by the C‑TAH showed expected variations in pumping output of the left and right ventricles, in response to changes in pressures and heart rate. Heart rate averaged 78 to 128 beats per minute; blood pressure was normal as well.

Over almost five years of aggregate follow-up, medical teams made changes in the Auto-Mode settings just 20 times. Most adjustments were performed during the first 30 days after device placement. Only four were done after the patient went home from the hospital: a rate of about 1 change per 11 months. “The reduced need for device management changes may contribute to greater autonomy for patients outside of the hospital environment and improvement in their quality of life,” Dr. Netukaand coauthors write. They acknowledge that their study is an initial experience in a relatively small number of patients.

“Nevertheless,” they add, “it represents a significant leap towards the next stage more physiological heart replacement therapy. The overall experience of more than four years of device performance represents a positive and promising outcome for the patients while requiring only minimal intervention from the clinicians.” The researchers plan further refinements based on the preliminary results; future studies will provide data on response to exercise and hospital readmission rates. A US clinical trial of the C‑TAH is scheduled to begin soon.

Click here to read “First Clinical Experience With the Pressure Sensor–Based Autoregulation of Blood Flow in an Artificial Heart.”

The first new treatment for Alzheimer’s disease for nearly 20 years has been approved by regulators in the United States, paving the way for its use in the UK. Aducanumab targets the underlying cause of Alzheimer’s, the most common form of dementia, rather than its symptoms.Charities have welcomed the news of a new therapy for the condition. But scientists are divided over its potential impact because of uncertainty over the trial results. At least 100,000 people in the UK with a mild form of the disease could be suitable for the drug if it were to be approved by the UK regulator. The US Food and Drug Administration (FDA) said there was “substantial evidence that aducanumab reduces amyloid beta plaques in the brain” and that this “is reasonably likely to predict important benefits to patients”.

Controversial trial

In March 2019, late-stage international trials of aducanumab, involving about 3,000 patients, were halted when analysis showed the drug, given as a monthly infusion, was not better at slowing the deterioration of memory and thinking problems than a dummy drug.But later that year, the US manufacturer Biogen analysed more data and concluded the drug did work, as long as it was given in higher doses. The company also said it significantly slowed cognitive decline.Aducanumab targets amyloid, a protein that forms abnormal clumps in the brains of people with Alzheimer’s that can damage cells and trigger dementia, including:

Aldo Ceresa, who took part in the trial, first noticed problems differentiating between left and right 10 years ago.After his diagnosis, the 68-year-old, who is originally from Glasgow and now lives in Oxfordshire, close to his family, had to give up his job as a surgeon.MrCeresa took aducanumab for two years before the trial was halted – and then had to wait almost as long for another trial, at the National Hospital for Neurology and Neurosurgery, in London, to begin.

“I’m quite happy to volunteer,” he says. “I really, really enjoy this journey that I’m going through – and obviously the benefits I’m getting from it, which I’m very, very grateful for.”He is convinced the drug has helped him. “I feel like I’m not quite as confused. Although it’s still there, it’s not quite as bad.  “And I’m just getting that bit more confident now.”MrCeresa says his family has noticed improvements too. “Before, if I was going to get something, I couldn’t remember, you know, where to find things in the kitchen.  “That has become less of a problem,” he says. “I haven’t caught up to the level that I was before – but I’m heading in the right direction.”More than 30 million people around the world are thought to have Alzheimer’s, with most aged over 65. For around 500,000 people affected in the UK, those eligible for aducanumab will be mostly in their 60s or 70s and at an early stage of the disease.

This is not a miracle drug, nor a cure for Alzheimer’s but it is the first treatment which tackles the destructive mechanism in the brain that drives the destruction of neurons.And that makes this a landmark moment. But scientific opinion both here and the United States is divided. While some have welcomed approval, calling it a milestone for millions living with Alzheimer’s, others believe the drug will only have marginal benefits.

Alzheimer’s charities say they will be pressing for an early decision in the UK – but that could take another year. Lastly, we don’t know how much aducanumab will cost – it could be tens of thousands of pounds per patient each year. And if approved, access will be limited to those who’ve had specialist brain scans to confirm their diagnosis.Despite all the caveats, this is moment for very cautious celebration.  Prof Bart De Strooper, director of the UK Dementia Research Institute, said the decision to approve aducanumab marked “a hugely significant milestone” in the search for treatments for Alzheimer’s disease.

In the past decade, more than 100 potential Alzheimer’s treatments have flopped.  But while he hoped it would prove a turning point for millions of people with the condition, he said there were “still many barriers to overcome”.Prof John Hardy, professor of neuroscience at University College London, said: “We have to be clear that, at best, this is a drug with marginal benefit which will help only very carefully selected patients.”And Prof Robert Howard, professor of old age psychiatry at UCL, went further calling the drug’s approval “a grave error” that could derail the ongoing search for meaningful dementia treatments “for a decade”.  He said the FDA had ignored data from the trial which showed no slowing of decline in cognition or function.

However, Alzheimer’s Society said the drug was “promising” but added it was “just the beginning of the road to new treatments for Alzheimer’s disease”.Another charity, Alzheimer’s Research UK, said it had written to the Health Secretary Matt Hancock asking the government to priorities the fast-track approval process for the drug in the UK. Chief executive Hilary Evans, said: “People with dementia and their families have been waiting far too long for life-changing new treatments.”It is now essential that regulatory authorities assess the evidence to decide whether they believe the drug is safe and effective for use in the UK.”Although many doctors are doubtful of aducanumab’s benefits, its US approval could be a huge boost to dementia research, which is traditionally underfunded compared with cancer or heart disease.

Newswise — A massive genome-wide association study (GWAS) of genetic and health records of 1.2 million people from four separate data banks has identified 178 gene variants linked to major depression, a disorder that will affect one of every five people during their lifetimes.

The results of the study, led by the U.S. Department of Veterans Affairs (V.A.) researchers at Yale University School of Medicine and University of California-San Diego (UCSD), may one day help identify people most at risk of depression and related psychiatric disorders and help doctors prescribe drugs best suited to treat the disorder.The study was published May 27 in the journal Nature Neuroscience.

For the study, the research team analyzed medical records and genomes collected from more than 300,000 participants in the V.A.’s Million Veteran Program (MVP), one of the largest and most diverse databanks of genetic and medical information in the world.These new data were combined in a meta-analysis with genetic and health records from the UK Biobank, FinnGen (a Finland-based biobank), and results from the consumer genetics company 23andMe. This part of the study included 1.2 million participants. The researchers crosschecked their findings from that analysis with an entirely separate sample of 1.3 million volunteers from 23andMe customers.

When the two sets of data from the different sources were compared, genetic variants linked to depression replicated with statistical significance for most of the markers tested.”What is most heartening is we could replicate our findings in independent data sets,” said Daniel Levey, an associate research scientist in the Yale Department of Psychiatry and co-lead author. “Replication is a hallmark of good science, and this paper points to just how reliable and stable results from GWAS studies are becoming.”

Like many mental health disorders, depression is genetically complex and is characterized by combinations of many different genetic variants, the researchers say.”That’s why we weren’t surprised by how many variants we found,” said Joel Gelernter, the Foundations Fund Professor of Psychiatry at Yale, professor of genetics and of neuroscience, and co-senior author of the study. “And we don’t know how many more there are left to discover — hundreds? Maybe even thousands?”

The size of the new GWAS study will help clinicians to develop polygenic risk scores to pinpoint those most at risk of developing major depression and other related psychiatric disorders such as anxiety or post-traumatic stress disorder, the authors say.The study also provides deep insights into the underlying biology of genetic disorders. For instance, one gene variant implicated in depression, NEGR1, is a neural growth regulator active in the hypothalamus, an area of the brain previously linked to depression. That confirms research done by the late Yale neuroscientist Ronald Duman on the role of neurotrophic factors in depression, Levey said.

“It’s really striking when completely different kinds of research converge on similar biology, and that’s what’s happening here,” he said.Insights into the functions of the variants can also help identify many drugs that hold promise in the treatment of depression, the researchers say. For instance, the drug riluzole, which is approved for the treatment of amyotrophic lateral sclerosis (ALS), modulates glutamate transmission in brain. Several gene variants linked by the new study to depression affect the glutamate system, which is actively being studied for depression treatments.

“One of the real goals of the research is bringing forward new ways to treat people suffering from depression,” added co-senior author Dr. Murray Stein, staff psychiatrist at the V.A. San Diego Healthcare System and Distinguished Professor of Psychiatry and Public Health at UCSD. Research was primarily funded by the U.S. Department of Veterans Affairs, including the Million Veteran Program and the Cooperative Studies Program. Levey also received support from a NARSAD Young Investigator Award from the Brain & Behavior Research Foundation.

The darkness descends slowly for people with retinitis pigmentosa (RP), a degenerative eye disease that affects 2 million people worldwide. The condition is typically diagnosed in childhood or adolescence, but it can take until middle age before a person’s vision has deteriorated severely enough that they are fully or effectively blind. When the lights finally do go out, however, they stay out.

Or that’s the way things used to be. In a breakthrough study published today in Nature Medicine, investigators report a relatively simple yet remarkably effective way to restore partial vision to RP patients—one that, with further study, may soon have wide application.

The key lies in the rod-shaped photoreceptors that principally govern peripheral vision and the cone-shaped receptors that give us our central view of the world. In people with RP, mutations in more than 70 genes cause slow deterioration of the rods, leading to tunnel vision, and later the cones, leading to blindness. Light still streams into the eye through the unaffected lens, and that light could still make its way to the brain via the optic nerve. But the retina, which lies between the two, no longer works.

A team of researchers, led by Dr. José-Alain Sahel, professor of ophthalmology at Sorbonne University and the University of Pittsburgh, however, thought they might have a way to bring the retina back into the game: ChrimsonR, a protein that opens electrical channels in neurons and makes them reactive to light. The trick was finding a way to deliver the protein—and the answer was to genetically manipulate a harmless adenovirus so that it carried ChrimsonR; the virus was then injected into the fluid-filled portion of the eye behind the lens.

“The ChrimsonR sparks electrical activity,” says Sahel. “It transforms the cells and makes them able to absorb light, though it takes a while—about four months—for the cells to take up the virus and the protein with it.”

Nonhuman primate studies showed that the technique did not harm the eye, and also helped the researchers establish the proper dose of Chrimson4 to sensitize the retinal cells. For the human trial, Sahel and his team worked with a 58-year-old man who had been diagnosed with RP 40 years earlier and whose vision was limited to rudimentary light perception. They treated the poorer functioning of his two eyes—in order to spare the marginally healthier one if anything went wrong with the experiment—and injected it with a single dose of the altered virus.

Assuming the experiment worked, the next steps would not be nearly so simple as waiting the required four months or so until the man’s vision simply returned in the treated eye. ChrimsonR is not remotely sufficient to restore the exquisitely complex interplay of rods and cones that give healthy eyes their rich, colorful, three-dimensional view of the world. Rather, it sensitizes cells mostly in the amber spectrum, making shapes and shadows discernible at that color frequency. What’s more, a healthy retina reacts in real time to the amount and intensity of light striking it, becoming more reactive in low-light conditions and less reactive in bright light, to prevent damage to retinal cells. To see at all through the treated eye, the patient needs to wear a pair of goggles that shifts incoming light to the amber spectrum and regulates it to a safe intensity.

“The eye needs a lot of light, but there is the danger that it could be a toxic level,” says Sahel. “Without the goggles it could be like the patient looking directly into the sun.”

While waiting for the ChrimsonR to take effect, members of Sahel’s team worked with the patient, training him with the goggles and running tests to see if he could distinguish objects placed on a table, point to them, count them, and pick them up. Over repeated trials, there were no results—until finally, as Sahel recalls it, he got a call from one of his team members with a simple message: “He sees.”

At right around the four-month mark, the subject began achieving remarkable results on all of the lab tests. And in the months since that breakthrough, he has become able to navigate his world in new ways: he can detect the crosswalk at an intersection and count the number of white stripes demarcating it; perceive objects like a plate, a mug and a phone; spot a piece of furniture in a room and see a door in a corridor. “He can also,” adds Sahel, “detect where people are.”

Sahel believes the results will be long-lasting, or even close to permanent. “We think this could last at least 10 years or it could be for a lifetime,” he says. “If not, we can always go back and re-inject.”

As to whether the treatment is ready for practical application beyond the one patient, Sahel says the answer is “a small yes and a big no.” The small yes is that the work was merely a feasibility study (but by any measure, it succeeded spectacularly). The big no is that a great deal more research must be conducted to learn more about dosing levels, to improve both the goggles and the training patients go through to use them, and to figure out when in the course of a person’s RP is the right time to begin the treatment—Sahel notes that for now, at least the procedure is only for people with very advanced disease. “People with RP can retain central vision for many years,” he says. “You always have to weigh the benefit versus the risk.”

A minimum ratio of one nurse to four patients for day shifts can successfully improve patient care, with a 7 per cent drop in the chance of death and readmission, and 3 per cent reduction in length of stay for every one less patient a nurse has on their workload, according to a study across 55 hospitals in Queensland, Australia.

In 2016, 27 public hospitals in Queensland were required to instate a minimum of one dedicated nurse for every four patients during day shifts and one for every seven patients for night shifts on medical-surgical wards.The study, published in The Lancet, examined more than 400,000 patients and 17,000 nurses in 27 hospitals that implemented the policy and compared with 28 hospitals that did not. The comparison hospitals had no change in staffing, with six patients per nurse in 2016 and the same ratio (1:6) in the follow-up period in 2018.

The findings showed that the chance of death rose between 2016 and 2018 by 7 per cent in hospitals that did not implement the policy, and fell by 11 per cent in hospitals that did implement the policy.The chances of being re-admitted increased by 6 per cent in the comparison hospitals over time, but stayed the same in hospitals that implemented the policy. Between 2016 and 2018, the length of stay fell by 5 per cent in the hospitals that did not implement the policy, and by 9 per cent in hospitals that did.

Further analyses found that when nurse workloads improved by one less patient per nurse, the chance of death and readmissions fell by 7 per cent, and the length of hospital stay dropped by 3 per cent.“Our findings plug a crucial data gap that has delayed a widespread roll-out of nurse staffing mandates. Opponents of these policies often raise concerns that there is no clear evaluation of policy, so we hope that our data convinces people of the need for minimum nurse-to-patient ratios by clearly demonstrating that quality nursing is vital to patient safety and care,” said lead author, Matthew McHugh from the University of Pennsylvania School of Nursing, US. (IANS)

US-based pharmaceutical major Pfizer’s Chief Executive Officer Albert Bourla said that the company’s Covid-19 oral antiviral pill, which is in early-stage trials, could be ready by the end of the year, the media reported.

According to CNBC, the company, which developed the first authorised Covid-19 vaccine in the US with German drugmaker BioNTech, began an early-stage clinical trial for testing a new antiviral therapy for Covid-19 in March.

The drug is part of a class of medicines called protease inhibitors and works by inhibiting an enzyme that the virus needs to replicate in human cells.

“If clinical trials go well and the Food and Drug Administration (FDA) approves it, the drug could be distributed across the US by the end of the year,” Bourla told CNBC.

Protease inhibitors are used to treat other viral pathogens such as HIV and hepatitis C, the report said.

Last month, the pharmaceutical giant asked the US Food and Drug Administration (FDA) to expand the Emergency Use Authorisation (EUA) for its Covid-19 vaccine to include children ages 12 to 15.

The request to expand emergency use comes just days after Pfizer released data demonstrating its vaccine was 100 per cent effective and well-tolerated by the younger group.

Pfizer is also working on its vaccine for 6-month to 11-year-old children.

A recent study, published in the journal Science, showed that a single dose of Pfizer-BioNTech vaccines against Covid may boost immunity against the Covid-19 variants, only in people who were previously infected with the deadly virus.

In people who have not previously been infected and have so far only received one dose of vaccine, the immune response to variants of concern may be insufficient, the study indicated. (IANS)

COVID-19 vaccines teach our immune systems how to recognize and fight the virus that causes COVID-19. It typically takes two weeks after vaccination for the body to build protection (immunity) against the virus that causes COVID-19. That means it is possible a person could still get COVID-19 before or just after vaccination and then get sick because the vaccine did not have enough time to provide protection.  People are considered fully protected two weeks after their second dose of the Pfizer-BioNTech or Moderna COVID-19 vaccine, or two weeks after the single-dose Johnson & Johnson’s Janssen COVID-19 vaccine, CDC has stated.

Studies have shown that several vaccines are highly effective in preventing people getting seriously ill from Covid-19. Now, early results from a survey in the UK suggest two commonly used vaccines — the Pfizer-BioNTech and AstraZeneca shots — can significantly reduce infections.

Twenty-one days after the first vaccine, odds of a new Covid-19 infection were reduced by 65%, according to results from the COVID-19 Infection Survey, coordinated by the University of Oxford, the Office of National Statistics and the Department for Health and Social Care. The largest reductions in odds were seen after a second dose, it said.

The numbers appeared more promising for the prevention of symptomatic infections. The odds of testing positive and self-reporting symptoms were reduced by 90% after the second dose. And vaccination was just as effective in the vulnerable over-75 age group as it was in younger people.

Two studies highlighting the results were posted as pre-prints and have not been peer-reviewed. They analysed 1.6 million test results from nose and throat swabs taken from more than 373,000 people between December and the start of April.

But experts advise people to continue with Covid prevention measures, as some infections will still be transmitted, particularly when large numbers of the population have had just one dose in a two-dose regimen or haven’t been vaccinated at all. Although infections are at a record high, lives are being saved in countries with effective immunization programs.

Although COVID-19 vaccines are effective at keeping you from getting sick, scientists are still learning how well vaccines prevent you from spreading the virus that causes COVID-19 to others, even if you do not have symptoms. Early data show the vaccines do help keep people with no symptoms from spreading COVID-19, but we are learning more as more people get vaccinated.

We’re also still learning how long COVID-19 vaccines protect people. For these reasons, people who have been fully vaccinated against COVID-19 should keep taking precautions in public places, until we know more, like wearing a mask, staying 6 feet apart from others, avoiding crowds and poorly ventilated spaces, and washing your hands often.

A committee of the U.S. Centers for Disease Control (CDC) has decided to lift the temporary hold on using the COVID-19 vaccine made by Johnson & Johnson/Janssen as of April 23rd. The U.S. Food and Drug Administration (FDA) and CDC had temporarily halted vaccination with the J&J shot on April 13 after six reports of unusual blood clots in the brain occurred among nearly 7 million people vaccinated with the shot in the U.S.

Within hours, CDC director Dr. Rochelle Walensky accepted the panel’s recommendation and FDA officials said vaccinations could resume immediately. “The American public should feel reassured by the safety protocols we have in place for COVID-19 vaccines,” said Walensky at a briefing following the committee’s decision.

The panel of 15 independent experts was under some pressure to make a decision about the safety of the vaccine, which is the only single-shot vaccine for COVID-19 currently authorized in the U.S. But after an initial meeting on April 14, the group decided it needed more information.

Over the past week, an additional nine cases of unusual blood clots, called cerebral venous sinus thrombosis (CVST) were reported, bringing the total so far to 15 cases. All 15 have occurred in women, and most were in their 30s. However, since that’s still among several million people who had recently been vaccinated with the shot, CDC vaccine-safety experts still felt the overall risk is very small.

To put those 15 cases in context, Dr. Sara Oliver, from the CDC’s National Center for Immunization and Respiratory Diseases, and her team presented data from models they constructed to estimate how the 11-day pause in using the J&J vaccine affected COVID-19 cases, hospitalizations and death. The models showed that if the vaccine were reinstated for all adults over age 18 years, there would be 26 to 45 additional cases of the rare blood clots side effects over the next six months, but 800 to 3,500 fewer admissions to the ICU and anywhere from 600 to 1,400 fewer deaths. If officials restricted the vaccine only to people over age 50—which might make sense given that younger people are more at risk of the clotting side effect— they would expect two to three additional cases of clotting compared to 300 to 1,000 fewer ICU admissions and 40 to 250 fewer deaths.

J&J representatives at the meeting reiterated that the vaccine starts protecting people against disease within days of administration, and that data from the company’s clinical trials showed it was 85% efficacious in protecting people from severe COVID-19, including against new variants of the virus. The company favored adding a warning label about the risk of clotting, similar to the way the risk of anaphylaxis is now included in the label for the mRNA vaccines from Pfizer-BioNTech and Moderna.

Nearly 286.1 million doses of the COVID-19 vaccine have been shipped to various U.S. states as of this afternoon, of which 222.3 million doses have been administered thus far, according to TIME’s vaccine tracker. About 27.5% of Americans have been completely vaccinated. A single dose of either the AstraZeneca-Oxford University or Pfizer-BioNTech vaccine may provide protection against COVID-19 for at least 10 weeks, Oxford researchers reported during a press briefing.

U.S. Surgeon General Vivek Murthy has said the U.S. was increasing funding to areas that had been hit disproportionately by COVID-19, including $4 billion in funding to the Indian Health System. Though the IHS has impressively distributed 1 million vaccines in Indian Country, recent data showed that American Indians and Alaska Natives suffered devastating loss when the pandemic was at its worst.

According to a recent CDC report, they were 3.5 times more likely to get COVID than white people and more than four times as likely to be hospitalized as a result of COVID-19.

Murthy said the steady increase in cases over the last month had him more concerned than the J&J pause, which was put into place on Tuesday after the CDC and FDA found that out of the nearly 7 million people who got the J&J shot, at least 6 patients suffered blood clots roughly 6-13 days afterward.

The pause could last at least a few more weeks, according to an independent CDC advisory panel that on Wednesday decided to wait and see if more patients developed symptoms before recommending next steps on the vaccine.

“As much attention as the J&J news has received though, what I’m most concerned about, the numbers which are most on my mind are the rising cases and hospitalizations among those who are not vaccinated,” Murthy said.

He underscored the positive news, however, which is that the U.S. is one of the few countries in the world with three vaccine options and hundreds of millions of doses.

“We’re really fortunate to have highly effective vaccines and a system that’s working day and night to keep us safe. It gives me faith that we will make it through this pandemic together,” Murthy said.

All Americans age 16 and up can now get a Covid-19 vaccine. But the challenge is getting enough people to roll up their sleeves so we can finally quash this pandemic.  “The vaccine is the most important pathway to ending this pandemic. That means we’ve got to get everyone in our country vaccinated,” US Surgeon General Dr. Vivek Murthy said Monday.

“Now what we’ve got to do is No. 1: Get the vaccine. No. 2: Turn around and look at our family and friends and ask if they’re going to get vaccinated. If they need help, that’s what we’ve got to do.”

About 40% of the US population — more than 132 million people — have received at least one dose of the Covid-19 vaccine and about 26% of the population — more than 85 million — are fully vaccinated, according to the Centers for Disease Control and Prevention.

Nearly 212 million doses have been administered in the US, with an average of 3 million shots per day, the CDC said. It’s critical for those age 16 and up to get vaccinated before new, more contagious strains emerge — just like the B.1.1.7 variant did.

Over the last year, several drugs have either been developed or tested to treat coronavirus. Now there’s another that’s showing some promise.  Molnupiravir is an antiviral drug in clinical trials.

In an interview with molecular epidemiologist Dr. Jill Roberts says the way that it works is it messes up viral replication. It’s shown some use against other viruses such as SARS and MERS.

Dr. Roberts says during an animal study on ferrets, they tried to get coronavirus to spread, and it wouldn’t. So while it’s a treatment designed to prevent hospitalizations and deaths, it also seems to prevent transmission.

While there is no timetable about when this would be available, it could be promising for future viruses or pandemics.  “This is a great tool to have to be able to know for future viruses maybe if we get a mutant that actually circumvents the vaccines, this drug will still work.”

Dr. Roberts says now that Merck is behind it, it has the resources to do a big enough trial to send to the FDA to get Emergency Use Authorization or even full authorization.

A couple of other positives she pointed out with this drug: it can also be used for people who do not want to get a vaccine or don’t have the resources to get shots. And, this is a pill, unlike other treatments right now that are IVs and have to be given at a treatment center.

It would be a pill, exquisitely calibrated to target SARS-CoV-2, with tolerable side effects and a low price tag. And it would work just as well as those antibody treatments that require an hourlong intravenous infusion, but it would come in a handy packet patients could take home.

“We’re looking for something I could give everyone in an urgent care setting who comes in with exposure or a positive test,” said Nathaniel Erdmann, an infectious disease specialist at the University of Alabama at Birmingham Hospital who treats Covid-19. “An easy, oral, safe drug.”

NIH Director Francis Collins called his “dream”: a highly effective pill that can be given immediately after diagnosis.“It’s just a damn long pathway,” Collins said in an interview. First scientists have to find molecular vulnerability in a virus, and then comes the process of screening hundreds of thousands of would-be drugs to find the few that latch onto that target. Then medicinal chemists get to work on honing a Goldilocks molecule that balances power, specificity, and safety, and if everything goes well in the Petri dish, there’s still months of animal testing to do before a single human being can take a pill in a clinical trial.

“But I will tell you that this is an extremely high priority for Tony Fauci and Francis Collins and the Biden administration, to work with these companies to try to make sure that we speed this up,” Collins said. “Because this pandemic is going to be with us — even with great vaccines — and people are going to get sick.”

There is hope, even in the short term. Any day now, Merck is expected to present pivotal data on an oral treatment akin to remdesivir. Behind that is a treatment from Atea Pharmaceuticals, first developed for hepatitis C virus, which could have pivotal results in the coming months. Neither is purpose-built for the virus that causes Covid-19, but experts said the treatments could still tick many of the boxes of a hoped-for antiviral.

Perhaps most promising is a novel antiviral from Pfizer, a drug engineered specifically for the virus SARS-CoV-2 that entered its first clinical trial last month.

New Jersey-based Merck acquired the drug, MK-7110, through its $425 million acquisition of privately held biopharmaceutical company OncoImmune late last year. An interim analysis of clinical trial data suggested the drug improved the chances of recovery for the sickest patients with Covid-19 and reduced the risk of death or respiratory failure.

A team of US scientists, led by an Indian-origin researcher at Sanford Burnham Prebys have identified a set of human genes that fight SARS-CoV-2 infection, the virus that causes COVID-19. Knowing which genes help control viral infection can greatly assist researchers’ understanding of factors that affect disease severity and also suggest possible therapeutic options. The genes in question are related to interferons, the body’s frontline virus fighters. The study was published in the journal Molecular Cell

According to Sumit K. Chanda, professor and director of the Immunity and Pathogenesis Programme at Sanford Burnham Prebys Medical Discovery Institute, the scientists have gained new insights into how the virus exploits the human cells it invades.  “We are still searching for its Achille’s Heel so that we can develop optimal antivirals,” Chanda said in a paper published in the journal Molecular Cell.

Knowing which genes help control viral infection can greatly assist researchers’ understanding of factors that affect disease severity and also suggest possible therapeutic options.  The genes in question are related to interferons, the body’s frontline virus fighters.

“We wanted to gain a better understanding of the cellular response to SARS-CoV-2, including what drives a strong or weak response to infection,” says Sumit K. Chanda, Ph.D., professor and director of the Immunity and Pathogenesis Program at Sanford Burnham Prebys and lead author of the study. “We’ve gained new insights into how the virus exploits the human cells it invades, but we are still searching for its Achille’s heel so that we can develop optimal antivirals.”

Soon after the start of the pandemic, clinicians found that a weak interferon response to SARS-CoV-2 infection resulted in some of the more severe cases of COVID-19. This knowledge led Chanda and his collaborators to search for the human genes that are triggered by interferons, known as interferon-stimulated genes (ISGs), which act to limit SARS-CoV-2 infection.

Based on knowledge gleaned from SARS-CoV-1, the virus that caused a deadly, but relatively brief, outbreak of disease from 2002 to 2004, and knowing that it was similar to SARS-CoV-2, the investigators were able to develop laboratory experiments to identify the ISGs that control viral replication in COVID-19.

“We found that 65 ISGs controlled SARS-CoV-2 infection, including some that inhibited the virus’ ability to enter cells, some that suppressed manufacture of the RNA that is the virus’s lifeblood, and a cluster of genes that inhibited assembly of the virus,” says Chanda. “What was also of great interest was the fact that some of the ISGs exhibited control across unrelated viruses, such as seasonal flu, West Nile and HIV, which leads to AIDS.”

“We identified eight ISGs that inhibited both SARS-CoV-1 and CoV-2 replication in the subcellular compartment responsible for protein packaging, suggesting this vulnerable site could be exploited to clear viral infection,” says Laura Martin-Sancho, Ph.D., a senior postdoctoral associate in the Chanda lab and first author of this study. “This is important information, but we still need to learn more about the biology of the virus and investigate if genetic variability within these ISGs correlates with COVID-19 severity.”

This knowledge led Chanda and his collaborators to search for the human genes that are triggered by interferons, known as interferon-stimulated genes (ISGs), which act to limit SARS-CoV-2 infection.

“We found that 65 ISGs controlled SARS-CoV-2 infection, including some that inhibited the virus’ ability to enter cells, some that suppressed manufacture of the RNA that is the virus’s lifeblood, and a cluster of genes that inhibited assembly of the virus,” Chanda explained.

“What was also of great interest was the fact that some of the ISGs exhibited control across unrelated viruses, such as seasonal flu, West Nile and HIV, which leads to AIDS”.

The team also identified eight ISGs that inhibited both SARS-CoV-1 and CoV-2 replication in the subcellular compartment responsible for protein packaging, suggesting this vulnerable site could be exploited to clear viral infection.

“This is important information, but we still need to learn more about the biology of the virus and investigate if genetic variability within these ISGs correlates with Covid-19 severity,” said Laura Martin-Sancho, a senior postdoctoral associate in the Chanda lab.  As a next step, the researchers will look at the biology of SARS-CoV-2 variants that continue to evolve and threaten vaccine efficacy.

In a first, a new study has pointed out that those taking the Moderna vaccine have reported more side effects than people who get the Pfizer/BioNTech jabs. The study, published in the journal JAMA, analysed reports collected via a Centers for Disease Control and Prevention (CDC) programme called v-safe that tracks side effects in vaccine recipients. A total of 3,643,918 people were enrolled in v-safe and completed at least one health survey within seven days following their first vaccine dose before February 21, and 1,920,872 v-safe participants reported receiving a second vaccine dose and completed at least one daily health survey within seven days following the second dose. Nearly 70 per cent of those said they had some kind of injection site reaction, like pain or swelling, and half had generalised reaction like fatigue or chills.

“A greater percentage of participants who received the Moderna vaccine, compared with the Pfizer-BioNTech vaccine, reported reactogenicity; this pattern was more pronounced after the second dose,” the researchers noted. Reactogenicity refers to a subset of reactions that occur soon after vaccination. People who got a Moderna shot were more likely to have a side effect — 73 per cent had an injection site reaction, compared with 65 per cent of people who had a Pfizer/BioNTech dose.

Nearly 51 per cent of Moderna recipients had full-body symptoms, compared with 48 per cent of people who got the Pfizer/BioNTech shot. The gap widened after the second dose. Almost 82 per cent of people getting their second Moderna shot had injection site pain versus just under 69 per cent of people with Pfizer/BioNTech, reports The Verge. “Overall, 74 per cent of people said they had general reactions after their Moderna shot, compared with 64 per cent of people getting Pfizer/BioNTech,” the report said on Tuesday.

People over 65 were also less likely to have side effects than people under 65, regardless of which vaccine they received. “Data from millions of v-safe participants indicate that injection site pain is common after both the first and second doses of either mRNA-based vaccine,” the study noted. Systemic reactions, including fatigue, headache, myalgia, chills, fever, and joint pain, occurred in participants after the first dose, although they were more frequently reported after the second dose among both Pfizer-BioNTech and Moderna vaccine recipients. (IANS)

Newswise — SAN FRANCISCO – For more than a decade, ophthalmologists have treated wet age-related macular degeneration (AMD) with eye injections given every month or two, and dry AMD with antioxidant vitamins. These treatments were groundbreaking when introduced, offering hope for the first time that this sight-threatening disease could be slowed, and in some cases stopped or even reversed. As we mark February as AMD Awareness Month, the American Academy of Ophthalmology is highlighting what the next decade may hold for the 11 million Americans suffering from AMD.

The good news is that AMD treatment continues to evolve to the benefit of patients. Ophthalmologists expect to soon have more effective options to protect people from going legally blind from AMD.

“While our current treatments have made a huge difference in the lives of hundreds of thousands of people, new treatments offer hope to patients whose AMD previously could not be treated,” said Sunir J. Garg, MD, FACS, a retina specialist and clinical spokesperson for the American Academy of Ophthalmology. “New treatments will also help patients receive beneficial treatment more conveniently than ever before.”

The following is a review of the most promising research.

Dry AMD

Dry AMD can be divided into three forms: early, intermediate, and late. For those with intermediate disease, a formulation of antioxidant vitamins called the AREDS2 formula can help many patients reduce their risk of vision loss. But for those with late-stage disease, also called geographic atrophy, there is no treatment available. However, there are several promising clinical trials underway.

• Targeting the immune system A part of the immune system called the “complement cascade” has long been identified as a culprit in AMD. Two new drugs that target the complement cascade and stop it from attacking the retina have recently advanced to late-stage clinical trials. One (pegcetacoplan, APL-2) targets a complement protein called C3, the other drug candidate (Zimura, avacincaptad pegol) targets a different protein in the cascade, C5. Like currently available treatments for wet AMD, these drugs are injected directly into the patient’s eye. Already proven safe in people, researchers are now investigating whether they can substantially improve vision. Results are expected in about a year.
• Replacing vision cells Another concept under investigation is the possibility of replacing some cells that begin to die in late dry AMD. These retinal pigment epithelial cells can be produced from stem cells and then placed under the retina during a surgical procedure. Trials have shown that cell replacement did not have unexpected side effects. Additional trials are now evaluating whether it can actually improve vision. Even though intriguing investigations are progressing, stem cell treatments still have a long way to go before approval.

Wet AMD

Before anti-VEGF treatments were introduced about 15 years ago, people with wet AMD were almost certain to develop severe vision loss or blindness. While clinical trials show that anti-VEGF injections have allowed more than 90 percent of patients to keep their vision, in the real world the percentage is closer to 50 percent. That’s because people aren’t being treated as regularly as they should. The problem is most people need an injection every four to eight weeks to keep their vision. This can be a difficult schedule to maintain for many elderly patients struggling with other maladies and reliant on others to get them to their ophthalmology visits.

Some of the most exciting research today is looking at better alternatives to frequent injections. It’s not just about convenience; the hope is that a more consistent treatment will also help people keep more of their vision.

• New delivery methods One promising approach that could be available soon is a refillable drug reservoir. The device, about the size of a grain of rice, is surgically implanted in the eye, just under the eyelid. After the device is filled with a concentrated version of the anti-VEGF drug Lucentis, it delivers drug to the back of the eye over time. Instead of an injection every six to eight weeks, patients might get a fill up once or twice a year at the doctor’s office. The device can be refilled using a special needle. The latest studies show many people treated this way were able to go 15 months in between treatments.
• Gene therapy Gene therapy offers the hope of a potential “one-and-done” treatment. Researchers are using already proven gene therapy methods to deliver a treatment that enables the eye to make its own anti-VEGF medicine. Two different methods are under investigation: One injects the gene therapy underneath the retina in a surgical procedure; the other injects it into the eye just like a routine anti-VEGF treatment is done in the doctor’s office. There are four different drug candidates under investigation for wet AMD and one for dry AMD. Despite the promise of gene therapy, the long-term effectiveness remains to be seen. Among the challenges it faces is the likely sky-high cost of such a treatment.
• New targets Anti-VEGF treatments are effective because they target one key factor that contributes to wet AMD, vascular endothelial growth factor (VEGF). But what if a drug could target two key contributing factors to the development of AMD? That’s the idea behind the drug faricimab. It targets both VEGF and the protein angiopoietin-2. It’s injected into the eye like a standard anti-VEGF treatment, but it lasts longer. The latest research shows patients could go up to four months in between treatments. However, this data is so new that it has not yet been published in a peer-reviewed journal.

“This is an exciting time for clinical research for age-related macular degeneration that gives hope to many of our patients,” said Rahul N. Khurana, a retina specialist and clinical spokesperson for the American Academy of Ophthalmology. “For dry AMD patients suffering from vision loss, there may be treatments on the horizon. For wet AMD, there are new delivery options with longer duration of action and new molecular targets that may lead to more effective therapies.”

The American Academy of Ophthalmology is the world’s largest association of eye physicians and surgeons. A global community of 32,000 medical doctors, we protect sight and empower lives by setting the standards for ophthalmic education and advocating for our patients and the public. We innovate to advance our profession and to ensure the delivery of the highest-quality eye care. Our EyeSmart^® program provides the public with the most trusted information about eye health. For more information, visit aao.org.