On Oct. 22, the Food and Drug Administration (FDA) approved the first drug for treating COVID-19. Remdesivir, an antiviral medication given intravenously, is now approved for anyone hospitalized with COVID-19. It works by blocking the virus’s ability to make more copies of itself. Earlier this year, the drug had received emergency use authorization (EUA), which falls short of approval but is granted during a public health crisis if there is encouraging data supporting its potential benefits. Approval means the drug’s maker, Gilead, provided more information to the FDA on the medication’s effectiveness and safety than was used to issue the EUA.
“This decision by the FDA is a milestone in the treatment of hospitalized patients with COVID-19,” says Dr. Andre Kalil, professor of internal medicine at University of Nebraska Medical Center who was among the first to treat patients from the Diamond Princess Cruise ship with remdesivir and runs one of the drug’s clinical trials. “Remdesivir shortens the recovery time by 5-7 days, provides 50% faster clinical improvement, prevents patients’ progression to mechanical ventilation, and is associated with a 45% mortality reduction in the first two weeks of disease. These are real and meaningful benefits to our patients.”
The FDA decision is based on three randomized controlled trials that found that people receiving remdesivir shortened their recovery time. While the data did not find a statistically significant benefit in reducing mortality, doctors involved in one of the studies, published in the New England Journal of Medicine (NEJM), reported a trend toward reduced mortality after about a month, especially among people who received the drug early in their infection, as Kalil notes. Patients receiving the drug also needed less additional oxygen and were less likely to progress to severe disease compared to those receiving placebo. The NEJM study was placebo-controlled and supported by the U.S. National Institute of Allergy and Infectious Diseases.
The other two studies, sponsored by Gilead, did not include placebo controls, but compared patients receiving the drug and standard of care to those getting standard of care alone. The drug was effective, and those receiving five days of remdesivir treatment improved as much as those receiving a 10-day course.
The National Institutes of Health now includes remdesivir as part of its recommended treatment strategy for hospitalized COVID-19 patients, and doctors treating patients have said that the drug is one of the reasons that death rates from the disease may have started to drop since the beginning of the pandemic. Other medications and treatment strategies, such as anti-inflammatories and keeping patients on their stomachs to prevent worsening respiratory symptoms, are other likely contributors to the decline in death rates.
The FDA approval comes days after a study from the World Health Organization found no benefit of the drug in reducing early death or in preventing progression to serious disease among nearly 3000 COVID-19 patients. That study, however, did not include a placebo control and compared outcomes to standard of care. It’s also not clear how sick the patients in that study were and therefore how meaningful the results are.
The NEJM study included hints that people who receive the drug earlier in their disease may benefit more, and doctors are already studying whether people with mild symptoms but who don’t need to be hospitalized can be treated with remdesivir on an outpatient basis.
Cyber Attack on Vaccines
Indian drugmaker Dr Reddy’s, which is to run clinical trials of Russia’s Sputnik V Covid-19 vaccine, said it has isolated all its data centres in the wake of a cyber-attack. “We are anticipating all services to be up within 24 hours and we do not foresee any major impact on our operations due to this incident,” the company said in a statement.
Business news channel ET Now, citing sources, said the company has shut all key plants across the globe due to the data breach. The plants in the UK, US, Brazil, India and Russia have been impacted due to the breach.
It is not yet known if the attack was related to Dr Reddy’s work on Covid-19. Beside the trial of the Russian vaccine, the drugmaker also has tie-ups with global firms to sell coronavirus treatments remdesivir and favipiravir in India.
Cyber-attacks to steal proprietary information is not rare. Early in July, security agencies of the United States, United Kingdom and Canada said a Russia-linked hacking group is targeting universities involved in the Covid-19 vaccine research. The same month, the Indian Computer Emergency Response Team (CERT-In), India’s nodal cybersecurity agency, said Indian healthcare services and educational institutions have faced increased cyber-attacks from China and Pakistan since the nationwide lockdown in mid-march.
COVID Vaccination Best for the Older Adults
The Covid-19 vaccine candidate developed by the Oxford University and AstraZeneca has prompted a robust immune response in elderly people, the Financial Times reported, citing people familiar with the findings. The observations are from the so-called immunogenicity blood tests done on a subset of older participants of the trial. Oxford has not officially commented on the report.
A safe and effective vaccine for the elderly is crucial to beat the pandemic as they are among the most at-risk population. But the fact that the immune system weakens with age, raises fears that the very group that most needs the protection may generate the least effective response against a vaccine.
“If what they have is data which shows that the vaccine generates good immunity, as measured in the laboratory, in the overage group — plus 55-year-old — and that also includes good responses in people who are even older than that, I think that’s a promising sign,” Jonathan Ball, professor of virology at the University of Nottingham, said.
Another candidate to have shown promise among the elderly is the mRNA vaccine developed by Moderna, though that too is a preliminary finding. Russia’s Gamaleya Institute has also claimed that its Sputnik V is effective on the elderly but the claim has not been independently reviewed.
The FT report comes shortly after Oxford-AstraZeneca received clearance from the US FDA to restart its trial in the country after pausing it due to potential safety concern — a volunteer in the UK trial had fallen ill.
“The restart of clinical trials across the world is great news as it allows us to continue our efforts to develop this vaccine to help defeat this terrible pandemic,” Pascal Soriot, AstraZeneca’s CEO, said in a statement. The US trial of the vaccine candidate developed by Johnson & Johnson, too, is set to resume after a brief pause.
You can come to India for family or business, but not for pleasure The Ministry of Home Affairs (MHA) on Thursday came out with a notification permitting “all OCI and PIO card holders and all other foreign nationals intending to visit India for any purpose, except on a tourist visa“.
Announcing the “graded relaxation”, the MHA will “restore with immediate effect all existing visas (except electronic visa, Tourist Visa and Medical Visa)” — for visas that may have expired, fresh visas will be issued while for medical visa, foreign nationals need to apply afresh.
The Centre had on March 11 suspended all visas, with relaxation being granted in June for “foreign businessmen coming to India on a Business visa” and those coming for purposes of work.
It may be recalled that hotels were allowed to reopen only in August while tourist sites like the Taj Mahal were reopened last month. Though foreign tourists constitute just 0.5% of all tourists — India received 10.89 million foreign tourists in 2019 — the country earned almost Rs 2.11 lakh crore as forex from them last year.