FDA Advisors Recommend COVID Boosters for People 65 and Over After Rejecting Broad Approval

Sept. 17 (Reuters) – U.S. Food and Drug Administration advisers voted on Friday to recommend booster shots of the COVID-19 vaccine for Americans 65 and older and those at high risk of serious illness, after overwhelmingly rejecting a call for broader approval.

The panel also recommended that the FDA include healthcare workers and others at high risk of occupational exposure to the virus that causes COVID-19, such as teachers.

Despite the reduced scope of the proposed authorization, the panel’s recommendation would cover most Americans who were vaccinated in the early stages of the US vaccination campaign.

“Today was an important step forward in providing better protection to Americans against COVID-19,” White House spokesman Kevin Munoz said. “We are ready to provide booster shots to eligible Americans once the process is completed at the end of next week,” he said.

The FDA is expected to make its decision on the third round of shooting soon. He is not bound by the panel’s recommendation but will take it into account.

Dr Paul Offit, an infectious disease expert at the University of Pennsylvania and a member of the panel, said the recommendation was “a step backwards” from the Biden administration’s recommendation to generalize recalls to from September 20.

“That’s not it. It’s, ‘We’re going to test the water, one foot at a time,'” said Offit, who voted “no” on the original question of the widespread use of boosters and “yes” on the smaller offer of vaccines for those most at risk.

By a 16-2 vote, members of the FDA’s Vaccines and Related Biologics Advisory Committee declined to recommend a third dose of Pfizer (PFE.N) / BioNTech vaccine to anyone 16 years of age and older who received his second injection at least six months earlier.

Panelists suggested that the evidence supporting broad endorsement was inadequate, and they wanted to see more safety data, especially regarding the risk of heart inflammation in young people after vaccination.

Sister Barbara Sullivan, 84, receives a vaccine against coronavirus disease (COVID-19) during a vaccination campaign for retired nuns at the Independent Living Center of the Sisters of Saint-Joseph de Carondelet in Los Angeles, California, USA, March 3, 2021. REUTERS / Lucy Nicholson

Panel members then unanimously endorsed the recommendation of a third shot for older, high-risk Americans, convinced by evidence showing they were at higher risk for severe COVID-19 and may be more susceptible. to have waning immunity after the first shots.

Advisors from the U.S. Centers for Disease Control and Prevention (CDC) are due to meet on September 22 and 23 to discuss new recommendations on who is eligible for injections.

“We’re wondering how much of this restriction can be managed in the real world or how to stop people, but the point is it will be available to those who need it,” said Michael Yee, analyst at Jefferies.

Pfizer could always come back with more data to support a broader clearance or approval.

The drugmaker said it “will work with the FDA after today’s meeting to answer questions from the committee as we continue to believe in the benefits of a booster dose to a wider population.”

Pfizer shares closed down 1.3%, while US-traded shares of BioNTech ended the day down 3.6%.

Some countries, including Israel and the UK, have already started COVID-19 recall campaigns. The United States authorized additional injections for people with weakened immune systems last month and some 2 million people had already received a third injection, according to the CDC.

President Joe Biden has called for additional injections amid rising hospitalizations and deaths from the highly contagious Delta variant of the coronavirus, mostly among the unvaccinated, and increasing cases of infections among fully vaccinated Americans.

Recent polls have shown that most Americans who get vaccinated want a booster to boost their immunity.

Reporting by Manojna Maddipatla and Ankur Banerjee in Bengaluru, Mike Erman in New York and Julie Steenhuysen in Chicago; Editing by Caroline Humer, Bill Berkrot and Sonya Hepinstall

Our Standards: The Thomson Reuters Trust Principles.

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