U.S. recommends Covid boosters for people 65 and older-News

A group of leading American medical experts who advise the government voted to authorize Pfizer’s coronavirus vaccine booster for everyone 65 years and older, as well as people at high risk of developing severe Covid.

However, the same committee rejected a preliminary proposal submitted by Pfizer and supported by President Joe Biden’s government, which fully approved the provision of boosters to everyone 16 years and older.

These decisions were made after a one-day meeting, which was full of data presentations and was sometimes convened by the US Food and Drug Administration (FDA) for heated debates. Tens of millions of Americans will soon be eligible for the third shot.

Archana Chatterjee, dean of the Chicago Medical School, said: “I think this should show the public that the members of this committee are independent of the FDA, and in fact we did put forward our own opinions.”

The team-including vaccinologists, infectious disease researchers, and epidemiologists-concluded that young people have a different balance of benefits and risks, especially men at risk of developing myocarditis.

The clinical trial of Booster only involves more than 300 people, who believe that the scale is too small to draw definitive conclusions about safety.

The panel voted 16 to 2 against giving full approval to the third dose.

Subsequently, they received a new motion and approved an emergency authorization for people over 65 and at high risk with an 18-0 vote. They agreed that this should be extended to health care workers and occupational exposure high-risk groups.

The question now turns to another committee, this time convened by the Centers for Disease Control and Prevention (CDC) from September 22 to 23 to further determine who is eligible and decide to launch.

Katherine Jensen, Pfizer’s head of vaccine development, said in a statement that Pfizer will work with the FDA to resolve the committee’s issues because “we continue to believe in the benefits of enhanced doses for a wider population”.

Even before the meeting, the U.S. Food and Drug Administration (FDA) issued a cautious warning.

The FDA stated in its briefing document: “Data shows that the current Covid-19 vaccine licensed or authorized in the United States can still provide protection against severe Covid-19 disease and death.”

At the same time, two senior FDA officials co-signed on the Lancet this week an opinion opposing the provision of boosters for the general public, which is seen as a decision made by the White House before consulting its scientific agency The condemnation is actually putting the trolley in front of the horse.

At the meeting, Pfizer officials cited some studies that showed that the immunity to infection is weakening within a few months after the first two vaccinations.

Donna Boyce, senior vice president of global regulatory affairs at Pfizer, said: “The proven safety and effectiveness of the third dose supports the addition of booster doses to the vaccination program.”

But a growing number of US studies — including a data set presented by Pfizer at Friday’s meeting — indicate that both doses continue to provide a high degree of protection against serious consequences, albeit with a slight decline in the level for the elderly.

Pfizer also provided data showing that the enhancer increased the level of antibodies against the Delta variant, but an FDA scientist countered that these laboratory studies cannot be directly translated into efficacy estimates.

Sharon Alroy Preis, an official from the Israeli Ministry of Health, introduced the data of her country/region, which has launched a booster campaign after experiencing the delta wave and has approved it as Boosters are provided for everyone 12 years and older.

Jay Portnoy, a pediatrician at the Kansas City Children’s Charity Hospital, said the Israeli experience should be a warning light and the United States should follow suit.

But most expert groups do not think the two countries are very similar. Since the overall vaccination rate in the United States is much lower, unvaccinated is the main driver of transmission, not vaccinated breakthrough cases.

© AFP