WASHINGTON: The panel of leading medical experts that show the government voted for the authorization of the Pfizer coronavirus vaccine booster for all people aged 65 and rise, as well as high-risk people affected by severe covid.
But the same committee rejected the initial proposal, which was delivered by Pfizer and was supported by President Joe Biden’s government, to fully approve a booster to everyone aged 16 years and over.
The decision came after a daily meeting full of data presentations and sometimes collecting the debate organized by Food and Drug Administration (FDA).
Tens of millions of Americans will soon be eligible for the third shot.
“I think this must show the public that members of this committee are independent of the FDA, and that in fact we brought our voices to the table,” said Archana Chatterjee, the Dean of the Chicago Medical School.
The panel – which includes vaccines, infectious disease researchers, and epidemiologists – concludes that the balance of risks of different benefits for younger people, especially men who are at risk for myocarditis.
Clinical trials for Booster are involved more than 300 people, which they feel too small to be able to draw strong conclusions about safety.
The panel voted 16-2 by providing full third dose consent.
They are then served with new movements, and vote 18-0 to provide emergency authorization for people over the age of 65 and those who are at high risk.
They agreed this must extend to health care workers and people who are at high risk of work exposure.
Now this problem turned to another committee, this time organized by the Disease Control and Prevention Center (CDC) on September 22-23 to define who further meets the requirements and decides launch.
Pfizer will work with the FDA to address Committee questions as “We continue to believe in the benefits of a booster dose for a wider population,” Kathrin Jansen, head of the vaccine research and development in the company, said in a statement.
Even before the meeting, the administration of food and medicine (FDA) has printed a careful note.
In his direction document, the FDA stated: “Data shows that currently the Covid-19 vaccine licensed or inherited by the US is still able to protect against severe diseases and deaths.” Two senior FDA officials signed a point of view in Lancet this week against the booster for the general population, in what was seen as a rebuke of the White House for making a decision before consulting with its scientific agent, effectively placing the train in front of the horse.
At the meeting, Pfizer officials quoted studies that showed immunity fading against infections several months of the first two doses.
“Safety and the effectiveness of the third dose shown to increase the dose of booster for vaccination schedules,” said Donna Boyce, Senior Vice President of the Pfizer of Global Regulatory.
But the Body of the US research is developing – including the dataset presented by Pfizer itself at the Friday meeting – has shown two doses continuously providing high protection against severe results, even though the elderly level is slightly reduced.
Pfizer also presented data that showed booster increasing the level of antibodies to the Delta variant, but a FDA scientist against that this lab study could not translate directly to the estimated efficacy.
Sharon Alroy Preis, an official with the Israeli Ministry of Health, presented data from his country who run a booster campaign after experiencing a delta wave, and has agreed to a booster for everyone aged 12 years and over.
Jay Portnoy, a pediatrician with a children’s Mercy Hospital in Kansas City, said the experience of Israel must function as a warning flare and that the United States must follow its leadership.
But most panels do not see both countries as very analogous.
Because the US has a much lower overall vaccination rate, which is not vaccinated is the main driver of deployment, than the breakthrough case between vaccinated.
The US panel recommends covid boosters for people 65 and older
