Regulators could OK Pfizer boosters for older Americans this week

A vial labelled with the Pfizer-BioNTech coronavirus disease (COVID-19) vaccine is seen in this illustration picture taken March 19, 2021. REUTERS/Dado Ruvic/Illustration

Sept 20 (Reuters) - U.S. regulators could authorize a booster shot of the Pfizer Inc (PFE.N)/BioNTech SE COVID-19 vaccine for older and some high-risk Americans early this week in time for the government to roll them out by Friday.

The Food and Drug Administration is expected to give the nod to the third shots for at least this group before advisers to the U.S. Centers for Disease Control and Prevention are due to meet on Wednesday. The CDC panel will discuss more precise recommendations for how to administer the shots.

On Friday, an FDA advisory committee voted to recommend emergency authorization of the additional Pfizer shots for Americans 65 and older and those at high risk of severe illness. The initial Pfizer vaccinations consisted of two doses.

The panel decided against recommending broader approval, citing a lack of evidence to support broad use, and they wanted to see more safety data, especially about any risk of heart inflammation in younger people after vaccination. read more

President Joe Biden has pushed for the additional shots in the face of surging hospitalizations and deaths caused by the highly contagious Delta variant, mostly among the unvaccinated, and rising cases of breakthrough infections among fully vaccinated Americans.

The FDA is not bound to follow the panel's recommendation but usually does. The rollout of boosters can begin as soon as the FDA authorizes the shots and the head of the CDC signs off on how they will be administered.

The FDA could later widen access to the booster shots. Top FDA members have been split on the necessity of the boosters, with interim head Janet Woodcock backing them and some of the agency's top scientists arguing they are not needed yet.

Woodcock said on former Biden administration official Andy Slavitt's podcast on Monday that boosters could be an important tool to contain the pandemic in the United States by reducing transmission.

"If people are acquiring the virus and spreading it, you want to stop that as much as possible. Of course we're using mitigation measures like masking and so forth, but vaccination is important," she said.

Despite the narrow scope of the proposed authorization, the panel's recommendation would cover most Americans who got their shots in the earliest stages of the U.S. vaccination campaign and whose immunity may be waning.

Norman Baylor, chief executive of Biologics Consulting and former director of FDA’s Office of Vaccines Research and Review, said the decision gives the FDA additional time to understand what data is required to approve booster shots broadly.

"It does give them some space," Baylor said.

Health officials signaled they expect boosters will ultimately be recommended for a broad swath of the population, but advised Americans not to seek booster doses until they have the nod from the FDA.

Biden's chief medical adviser, Dr. Anthony Fauci, told CNN on Sunday that the data needed to determine the advisability of booster shots of the Moderna Inc (MRNA.O) and Johnson & Johnson (JNJ.N) COVID-19 vaccines is weeks away. read more

Some countries, including Israel and Britain, have begun COVID-19 booster campaigns. The United States authorized extra shots for people with compromised immune systems last month and some 2 million people had already received a third shot, according to the CDC.

Reporting by Michael Erman; Editing by Stephen Coates

Our Standards: The Thomson Reuters Trust Principles.