FDA

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.

Queue Listen Now

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.

Some of the world's largest vaccine-makers hope to bolster public confidence in a yet-to-arrive COVID-19 vaccine, pledging to follow strict safety protocols in the rush to respond to the pandemic. Here, a nurse practitioner administers a dose of flu vacci

9 Drugmakers Sign Safety Pledge In Rush To Develop Coronavirus Vaccine

2:12pm September 08, 2020

by Bill Chappell

The pledge comes one month after a survey found that only 2 in 5 Americans said they planned to get vaccinated against COVID-19.

A scientist at work on a COVID-19 vaccine candidate at Bogazici University in Istanbul in August.

How Can You Tell If A COVID-19 Vaccine Is Working?

1:21pm September 07, 2020

by Joe Palca

Several COVID-19 vaccine candidates are being tested now. But why does it take 30,000 volunteers to know if one is safe and effective? And what does it mean to say a vaccine candidate is working?

Queue Listen Now

The U.S. Food and Drug Administration headquarters in White Oak, Md. The agency this week has removed a top communications official in the wake of misleading claims it made about a treatment for COVID-19.

FDA Removes Top Spokesperson After Blood Plasma Blunder

8:27pm August 28, 2020

by Joe Neel

Emily Miller was central in defending the FDA commissioner, Dr. Stephen Hahn, after he falsely said that blood plasma could lower the death rate from COVID-19 by more than a third.