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Pfizer: US Panel recommends Covid boosters for people over 65

Washington: A committee of leading U.S. medical professionals advising the government has decided to allow all people over the age of 65 and those at high risk of developing severe Covid to receive a booster dose of Pfizer’s coronavirus vaccine. I voted for it.
However, the same committee rejected the first proposal submitted by Pfizer and endorsed by President Joe Biden’s administration to fully approve the booster for everyone over the age of 16.
The decision was made after a one-day meeting full of data presentations, sometimes with discussions convened by the Food and Drug Administration (FDA). Tens of millions of Americans will soon be the target of the third shot.
“I think this should generally show that the members of this committee are independent of the FDA, and that they actually express our opinion,” said Archana Chatterjee, Dean of the Chicago Medical College. Stated.
A panel of vaccinologists, infectious disease researchers, and epidemiologists concluded that the balance between benefit and risk is different in younger people, especially men at risk of myocarditis.
Over 300 people participated in the booster clinical trial, but I felt it was too small to draw a firm conclusion about safety.
The panel voted 16-2 in opposition to giving full approval for the third dose.
They were then presented with a new motion and voted 18-0 to give emergency permits to people over the age of 65 and those at high risk. They agreed that this should extend to health care workers and those at high risk of occupational exposure.
Now the issue moves to another committee. This time, it will be convened by the US Centers for Disease Control and Prevention (CDC) on September 22-23 to further define who is eligible and determine deployment.
In a statement, Pfizer’s Head of Vaccine Research and Development, Kathrin Jansen, said in a statement that Pfizer worked with the FDA to answer the Commission’s question, “We continue to believe in the benefits of booster immunity for more people.” Said.
Even before the meeting, the Food and Drug Administration (FDA) was paying close attention.
In the briefing document, the FDA states: “Data show that the Covid-19 vaccine currently licensed or licensed in the United States still provides protection against severe Covid-19 disease and death.”
Meanwhile, two FDA officials co-signed a view against civilian boosters at Lancet this week. This was seen as a blame for the White House making a decision before consulting a scientific institution and effectively placing the cart in front of the horse. ..
At the meeting, Pfizer officials cited a study showing that the immune system was weakened against infection months after the first two doses.
Donna Voice, Pfizer’s Senior Vice President of Global Regulation, said:
However, the increase in US studies, including the dataset presented by Pfizer himself at the Friday meeting, continues to provide high protection against serious consequences, although the level of older people has declined slightly. Is shown.
Pfizer also provided data showing that boosters increased antibody levels against delta variants, but FDA scientists argued that studies in these laboratories could not be directly translated into efficacy estimates. Did.
Sharon Alroy Preis, an employee of the Israeli Ministry of Health, presented data from her country that ran a booster campaign after experiencing the delta wave and approved the booster for everyone over the age of 12.
Jay Portnoy, a pediatrician at Children’s Mercy Hospital in Kansas City, said the Israeli experience served as a warning sign and the United States should follow its lead.
However, most of the panels did not consider the two countries to be closely similar. The United States has a much lower overall vaccination rate, so unvaccinated people are not a breakthrough case among vaccinated people, but a major driver of dissemination.



Pfizer: US Panel recommends Covid boosters for people over 65

Source link Pfizer: US Panel recommends Covid boosters for people over 65

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