The feds are reportedly slated to release detailed data about Moderna’s coronavirus vaccine on Tuesday ahead of a key vote to clear a second shot for emergency use.
The Food and Drug Administration is expected to publish its analysis of the Massachusetts biotech firm’s vaccine a day after the first shots from Pfizer and BioNTech were jabbed into Americans’ arms.
The FDA’s analysis could shore up Moderna’s findings that the vaccine was about 94 percent effective and posed no safety concerns, just as the review of Pfizer’s shot confirmed the company’s finding that it was 95 percent effective.
The agency will also publish Moderna’s own review of its 30,000-person clinical trial of the vaccine, The Wall Street Journal reported. The data will be reviewed Thursday by the FDA’s Vaccines and Related Biological Products Advisory Committee, a panel of experts that could recommend the vaccine for an emergency use authorization.
The FDA will likely move quickly to grant the emergency approval for Moderna’s vaccine just as it did for Pfizer’s, which received the clearance a day after the vaccine panel recommended it, according to the Journal.
If the published analyses of Moderna’s vaccine are similar to those of Pfizer, they’ll provide insight into how well the shot works across various age, racial and ethnic groups along with its performance in people with underlying medical issues that put them at risk for severe COVID-19 infections.
The FDA’s vaccine panel will also likely pore over the data for signs of severe allergic reactions, like those that some people in the UK suffered after receiving Pfizer’s shot. Both vaccines use so-called messenger RNA, genetic material that provokes an immune response to the virus by directing the body to create a tiny amount of coronavirus spike proteins.
Moderna says it will have about 20 million vaccine doses available in the US by the end of the year, enough to inoculate roughly 10 million people with two doses apiece. Pfizer, meanwhile, expects to have about 50 million doses on hand globally this year, with about half allocated to the US.
The feds expect that 20 million Americans will be able to get their first shots by the end of the month, followed by another 30 million in January.
Moderna shares were down about 0.8 percent in premarket trading Tuesday at $153.90 as of 6:54 a.m.
With Post Wires