Solving COVID: December 2, 2020
1.
Britain's medicine and health-care regulator, the MHRA, gave emergency approval Wednesday for the COVID-19 vaccine made by Pfizer and BioNTech, making the U.K. the first country to green-light the promising vaccine for mass rollout. Britain has already ordered 40 million doses of the vaccine, or enough to inoculate 20 million people, and the first doses should arrive in the coming days. "Help is on its way," Health Secretary Matt Hancock tweeted: "The NHS stands ready to start vaccinating early next week." Pfizer and Moderna have both reported a 95 percent effectiveness rate for their vaccines from large human clinical trials. The U.S. Food and Drug Administration is expected to grant such authorization for both vaccines in the next two or three weeks. [BBC, Axios]
2.
All but 11 of the 196 Moderna COVID-19 vaccine trial participants who contracted the virus were in the placebo group, good for a 94 percent efficacy rate. But, perhaps even more crucially, none of the people who received the vaccine developed a severe infection, the company said. There were 30 severe cases — including one death — in the trial, but all of those occurred in the placebo group. Experts have previously highlighted the importance of companies separating out the worst cases in vaccine trials, arguing that a candidate's true efficacy should be determined by its ability to protect against severe infections. It appears Moderna has done just that. [The Associated Press, The New York Times]
3.
The Food and Drug Administration approved a "new generation" of COVID-19 antibody test designed to detect how well people are protected against subsequent infection. Most antibody tests are able to tell whether a person has contracted the virus or not, and some can estimate the level of neutralizing antibodies someone has, CNBC notes. But the newly-authorized COVID-SeroKlir developed by Kantaro BioSciences measures specific levels. The catch is that scientists aren't sure if high levels of antibodies guarantee COVID-19 immunity, so the test won't necessarily serve as proof that someone is protected against re-infection. What it will do, however, is allow researchers to gain a better understanding of the correlation between antibody levels and immunity, which will come in handy both for people who have been exposed to the virus already and for vaccine development. [CNBC]
4.
The Centers for Disease Control and Prevention will advise that health-care workers and long-term care facility residents receive COVID-19 vaccinations first, if and when Food and Drug Administration approval is granted. The decision was reached by the Advisory Committee on Immunization Practices, which is advising the CDC on vaccine distribution practices. As vaccine approval for emergency use becomes increasingly likely in the coming weeks, the panel voted 13-1 in favor of a motion elevating two groups to the front of the line. Health-care workers are frequently exposed to the virus and are essential to keeping hospitals running throughout the pandemic, while nursing homes have faced some of the deadliest COVID-19 outbreaks across the country. [CNN]
5.
Thomas Cueni, the director-general of the International Federation of Pharmaceutical Manufacturers and Associations, said that as many as 10 COVID-19 vaccines could be available by the middle of next year, as long as they are granted approval by regulatory agencies. Cueni noted that the vaccine developers that have already released info from late-stage trials — Pfizer and BioNTech, Moderna, and the University of Oxford and AstraZeneca — have all showed promising results (although the latter is amending its trial after confusing results), and he expects similar data from Johnson & Johnson, Novavax, Sanofi Pasteur, GSK, and Merck. "But all of them need to be submitted by rigorous scientific scrutiny by the regulators," he said. [Reuters]
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