Author: Staff Reporter

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.