facebook linkedin twitter

Pfizer Asking FDA to Approve COVID-19 Booster Shots for All Adults

November 9, 2021 by Dan McCue
Vials of the Pfizer-BioNTech COVID-19 vaccine sit in a cooler before being thawed at a pop-up COVID-19 vaccination site in the Bronx borough of New York on Tuesday, Jan. 26, 2021. (AP Photo/Mary Altaffer, File)

WASHINGTON — Pfizer and BioNTech SE asked the Food and Drug Administration Tuesday to allow boosters of its COVID-19 vaccine for anyone 18 or older.

Currently, COVID-19 booster shots are only available to older Americans and those with underlying health conditions that make them particularly vulnerable to the virus.

In September, the FDA’s scientific advisors rejected a request to recommend extra doses of the Pfizer-BioNTech vaccine for everyone, saying it wasn’t convinced healthy young people needed one, especially when much of the world’s population remains unvaccinated.

At the same time, the agency said it would quickly expand booster shots to other adults if warranted.

In a press release, the two companies said the amendment request is based on results from a phase 3 randomized controlled trial evaluating the efficacy and safety of a 30-µg booster dose of the vaccine.

More than 10,000 people participated in the trial, which was carried out when the Delta variant was the prevalent strain of the virus.

In October, the companies announced positive top-line results from the trial showing that a booster dose administered to individuals who previously received the Pfizer-BioNTech primary two-dose series demonstrated a relative vaccine efficacy of 95% when compared to those who did not receive a booster. 

Side effects were similar to those seen with the company’s first two shots.

“Thus far, these are the first and only efficacy data disclosed from any randomized controlled COVID-19 vaccine booster trial. The adverse event profile was generally consistent with other clinical safety data for the vaccine, with no new safety concerns identified,” the companies said.

A median of 11 months after their last Pfizer vaccination, trial participants were given either a third dose or a dummy shot. 

Researchers tracked any infections that occurred at least a week later, and so far have counted five cases of symptomatic COVID-19 among booster recipients compared to 109 cases among people who got dummy shots.

Dan can be reached at [email protected] and at https://twitter.com/DanMcCue

A+
a-

Health

December 1, 2021
by Alexa Hornbeck
White House to Release Plan for Fighting COVID-19 Variants

WASHINGTON — President Joe Biden said he will unveil plans this week on how his administration will work to slow... Read More

WASHINGTON — President Joe Biden said he will unveil plans this week on how his administration will work to slow the spread of the new COVID-19 variant, known as omicron, which emerged in South Africa and has been classified by the World Health Organization as a... Read More

Omicron Keeps World Jittery as More Information Drips Out

TOKYO (AP) — The omicron variant kept a jittery world off kilter Wednesday as Japan further tightened travel restrictions, infections... Read More

TOKYO (AP) — The omicron variant kept a jittery world off kilter Wednesday as Japan further tightened travel restrictions, infections linked to the new version of the coronavirus popped up in more places and new evidence made clear the mutant strain was circulating weeks earlier than... Read More

World Shares, US Futures Slip on Worries Over Omicron Risks

NEW YORK (AP) — Global shares mostly slipped Tuesday as investors cautiously weighed how much damage the new omicron coronavirus... Read More

NEW YORK (AP) — Global shares mostly slipped Tuesday as investors cautiously weighed how much damage the new omicron coronavirus variant may unleash on the global economy. Germany's DAX lost 1.1% to 15,106.35 in afternoon trading. France’s CAC 40 slipped 0.9%, while Britain's FTSE 100 shed... Read More

November 29, 2021
by Dan McCue
Biden Tells Americans New COVID Variant ‘Not Cause for Panic’

WASHINGTON — President Joe Biden addressed the nation Monday, calling the new omicron variant of the coronavirus a cause for... Read More

WASHINGTON — President Joe Biden addressed the nation Monday, calling the new omicron variant of the coronavirus a cause for concern “but not a cause for panic.” Speaking in the Roosevelt Room of the White House, as Dr. Anthony Fauci, director of the National Institute of... Read More

Biden Pushes Shots, Not More Restrictions as Variant Spreads

WASHINGTON (AP) — President Joe Biden will urge Americans to get vaccinated and to receive a booster shot as he... Read More

WASHINGTON (AP) — President Joe Biden will urge Americans to get vaccinated and to receive a booster shot as he seeks to quell concerns Monday over the new COVID-19 variant omicron, but won't immediately push for more restrictions to stop its spread, his chief medical adviser said.... Read More

Supreme Court Set to Take Up All-or-Nothing Abortion Fight

WASHINGTON (AP) — Both sides are telling the Supreme Court there's no middle ground in Wednesday's showdown over abortion. The justices can... Read More

WASHINGTON (AP) — Both sides are telling the Supreme Court there's no middle ground in Wednesday's showdown over abortion. The justices can either reaffirm the constitutional right to an abortion or wipe it away altogether. Roe v. Wade, the landmark 1973 ruling that declared a nationwide right to abortion, is... Read More

News From The Well
scroll top