FDA

A nurse prepares to administer the Pfizer-BioNTech COVID-19 vaccine at a hospital in London on Tuesday. The Food and Drug Administration is considering a recommendation to authorize the vaccine in the United States.

FDA Adviser: Vaccine To Be OK'd In Days, But 'Normal' May Not Return Until Next Fall

12:47pm December 11, 2020

by Noel King

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.

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The authorization under consideration for the Pfizer/BioNTech vaccine would be for "individuals 16 years of age and older."

Health & Safety

FDA Analysis Of Pfizer COVID-19 Vaccine Finds It Effective And Safe

10:14am December 08, 2020

by Scott Hensley

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.

Dr. Deborah Birx, the White House's coronavirus response coordinator, speaks during a briefing with the coronavirus task force at the White House on Thursday. The Food and Drug Administration has granted emergency use authorization for a second antibody t

FDA Grants Emergency Authorization For A 2nd COVID-19 Antibody Treatment

3:43pm November 22, 2020

by Matthew S. Schwartz

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.

Pfizer plans to file within days with the Food and Drug Administration to allow emergency use of its COVID-19 vaccine.

Health & Safety

Pfizer To Seek FDA OK For COVID-19 Vaccine 'Within Days'

9:47am November 18, 2020

by Joe Palca

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.

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The Food and Drug Administration has authorized Eli Lilly's antibody-based drug bamlanivimab for emergency use as a treatment for COVID-19.

Health & Safety

FDA OKs Eli Lilly COVID-19 Drug, But Supplies Will Be Limited

1:46pm November 10, 2020

by Richard Harris

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 advisers to the Food And Drug Administration has raised questions about some aspects of the agency's approach to reviewing COVID-19 vaccines.

Health & Safety

Will FDA Heed Its Outside Experts' Advice On COVID-19 Vaccines?

5:50pm October 23, 2020

by Sydney Lupkin

A panel of doctor and scientists raised questions about the expedited regulatory path the Food and Drug Administration is considering for COVID-19 vaccines.

The first patient enrolled in Pfizer's COVID-19 vaccine clinical trial at the University of Maryland School of Medicine in Baltimore receives an injection in May.

Health & Safety

Pfizer COVID-19 Vaccine Won't Be Ready By Election Day

1:29pm October 16, 2020

by Richard Harris

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.

A volunteer in a clinical trial for an experimental COVID-19 vaccine receives an injection last month at Research Centers of America in Hollywood, Fla.

Health & Safety

FDA Releases Long-Awaited COVID-19 Vaccine Guidance

7:43pm October 06, 2020

by Sydney Lupkin

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.

An NPR investigation has identified more than 30 medical practices in more than a dozen states promoting unproven claims that the drug thymosin alpha-1, which is administered via injection, can prevent or treat COVID-19.

Health & Safety

Web Of 'Wellness' Doctors Promote Injections Of Unproven Coronavirus Treatment

5:00am October 01, 2020

by Tom Dreisbach

An NPR investigation has identified a web of more than 30 medical practices and compounding pharmacies across more than a dozen states promoting injections of an unproven treatment for COVID-19.

As we get closer to a COVID-19 vaccine, it's exciting to imagine a day when the virus is gone. But a vaccine will not be a magic bullet. In fact, it may be only about 50% effective.

A COVID-19 Vaccine May Be Only 50% Effective. Is That Good Enough?

12:30pm September 12, 2020

by Allison Aubrey

Scientists are racing to develop a vaccine that proves "safe and effective." It may not prevent infection in everyone who gets it, but it still could eventually stop the pandemic. Here's how.