Covid-19: Regulators could okay Pfizer boosters for older Americans this week

Reuters file photo
Reuters file photo

It would cover most people who got their shots in the earliest stages of the US vaccination campaign

By Reuters

Published: Mon 20 Sep 2021, 9:03 PM

Last updated: Mon 20 Sep 2021, 9:19 PM

US regulators could authorise a booster shot of the Pfizer-BioNTech 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 (FDA) is expected to give the nod to the third shots for at least this group before advisers to the US Centres 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 authorisation 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.

In Dubai, a third dose of the vaccine is already being administered to certain residents with compromised immune systems.

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

The CDC 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.

ALSO READ: Pfizer, BioNTech say data shows vaccine safe, protective in kids

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 authorises the shots and the head of the CDC signs off on how they will be administered.

The authority 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 US 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 authorisation, the panel’s recommendation would cover most Americans who got their shots in the earliest stages of the US 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 signalled 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 and Johnson & Johnson Covid-19 vaccines is weeks away.

Some countries, including the UAE, Israel and Britain, have begun Covid-19 booster campaigns. The US authorised extra shots for people with compromised immune systems last month and some two million people had already received a third shot, according to the CDC.

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