The decision represents a rebuke for President Joe Biden’s administration
Washington:
Prominent US medical experts advising the government voted against recommending a booster dose of Pfizer’s COVID-19 vaccine for everyone aged 16 and older, citing concerns about potential side effects in younger age groups. did.
After a day of data presentations and debate, a panel of vaccinologists, infectious disease researchers and epidemiologists voted 16 to 2 against the measure, but left the door open for older people to agree to a third shot.
Paul Offit, of The Children’s Hospital in Philadelphia, said, “Although I probably support the three-dose recommendation for people over 60 or 65, I really have trouble supporting it, as opposed to those over 16 or so. Equal is written for someone.”
The decision represents a rebuke to the administration of President Joe Biden, which announced plans to begin the rollout of booster shots this month before consulting its scientific agencies.
But amid concerns over global disparity and a potentially increased risk of rare side effects, including myocarditis (inflammation of the heart) seen especially in younger men, many experts expressed reservations about whether they are needed.
The Food and Drug Administration (FDA) said in a cautious tone in documents released ahead of Friday’s meeting, where an independent panel has been convened.
“Overall, the data indicates that currently US-licensed or authorized COVID-19 vaccines still provide protection against serious COVID-19 illness and death in the United States,” the FDA said in its briefing document.
Peter Marks, a senior FDA scientist who initiated the meeting, called on participants to “focus our discussions on the science … and not on operational issues related to the booster campaign or issues related to global vaccine equity.”
After the vote, the panel’s chairman said they would formulate a new question about approving the vaccine among an older group, for example those over 65, where the risk-benefit profile differs greatly.
It will then turn to another committee convened by the Centers for Disease Control and Prevention (CDC) on September 22-23 to decide how to proceed with the rollout.
Consistent efficacy against hospitalization
At the meeting, Pfizer officials cited studies that demonstrated weakened immunity against infections over several months from the first two doses.
“The safety and effectiveness of third-dose support for adding a booster dose to the vaccination program has been demonstrated,” said Donna Boyce, Pfizer’s senior vice president of global regulatory affairs.
But a growing body of US research – including a dataset presented by Pfizer at Friday’s meeting – has shown that the two doses offer high protection against serious consequences, and this was highlighted by several panelists.
Pfizer also presented data showing increased antibody levels in the booster against the delta variant.
Sharon Alroy Preis, an official with Israel’s health ministry, presented data from her country that conducted a booster campaign after experiencing a delta wave, and approved boosters for everyone 12 years of age and older.
“Administration of booster doses helped Israel reduce severe cases in the fourth wave,” she said.
For its part, the FDA said in its briefing document that not all studies are reliable and believes that US-based research “may most accurately represent vaccine effectiveness in the US population.”
(Except for the title, this story has not been edited by NDTV staff and is published from a syndicated feed.)
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