Advisers to the Food and Drug Administration voted 20-0 to recommend that the agency authorize Moderna's vaccine for emergency use during the pandemic. There was a single abstention.
Despite being founded a decade ago, Moderna has never had a product make it to market. And the company registered its first factory with the Food and Drug Administration just this week.
The Food and Drug Administration says is advising health workers to use "every full dose obtainable" to help speed up the nationwide immunization campaign.
Two days before a panel of experts is set to review Moderna's COVID-19 vaccine and advise the Food and Drug Administration, documents show the vaccine is 94% effective and well-tolerated.
States are starting to administer their first doses of Pfizer's newly FDA-authorized COVID-19 vaccine. It marks a new phase in the pandemic, but what's that mean for you?
As FDA emergency use authorization of Pfizer and Moderna vaccines nears, airlines, FedEx and UPS prepare to transport millions of vials of life saving shots.
The Food and Drug Administration's authorization of a COVID-19 vaccine could come in a day or two, a member of an FDA expert panel says. But he says it may be late 2021 before normalcy returns.
The Food and Drug Administration finds "no specific safety concerns" that would stand in the way of authorization of the vaccine for emergency use. Effectiveness is 95% after two doses.
The experimental cocktail from the biotech company Regeneron is the same drug President Trump got when he was battling the coronavirus this year. It is designed for mild to moderate cases.
The vaccine was found to be 95% effective in an updated study analysis. Safety data required by the Food and Drug Administration showed no serious concerns, the company said.
Eli Lilly's monoclonal antibody will be available to people 65 or older or those with underlying health conditions. Supplies will be short, and allocating the medicine will be a challenge.
A panel of doctor and scientists raised questions about the expedited regulatory path the Food and Drug Administration is considering for COVID-19 vaccines.
Pfizer Chairman and CEO Albert Bourla said in a public statement Friday that the company won't have data showing that the vaccine is safe before the third week of November at the earliest.
The requirements laid out by the Food and Drug Administration in advice for drugmakers underscore why it's unlikely a vaccine could clear the agency before Election Day.
