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U.S. approval of COVID-19 shots could boost vaccination numbers, Fauci says By Reuters 


© Reuters. Signs guide the public at a large vaccination and testing site as people with preexisting health conditions are granted access to a vaccination during the outbreak of the coronavirus disease (COVID-19) in Inglewood, California, U.S., March 15, 2021. REUT


By Michael Erman and Carl O’Donnell

(Reuters) -Top U.S. infectious disease expert Dr. Anthony Fauci said on Friday he hopes regulators as soon as next month could start granting full approval for the COVID-19 vaccines, a move he said could spur unvaccinated Americans to get the shots.

The Pfizer/BioNTech and Moderna (NASDAQ:) two-dose vaccines and Johnson & Johnson (NYSE:)’s one-dose shot are currently being administered under emergency use authorization by the U.S. Food and Drug Administration.

Full approval by the FDA could push more Americans to get the COVID-19 vaccine as it might reduce their fears about the safety of the shot and make local officials more comfortable about implementing vaccine mandates, Fauci, director of the National Institute of Allergy and Infectious Diseases and chief medical adviser to the White House, said in an interview with Reuters.

In addition, formal FDA approval would give physicians the ability to prescribe a third dose of the vaccine to people with weakened immune systems on an off-label basis, Fauci said.

Pfizer Inc (NYSE:) and BioNTech SE (NASDAQ:) as well as Moderna Inc have filed with the FDA to ask for full approval for their vaccines. Johnson & Johnson Inc has not yet requested full approval for its COVID-19 shot.

“Given what we’ve been through now and the number of months that have gone by since the (emergency use authorization), I would hope that within the very reasonable period of time in the future we’ll see that. I hope as we get into the middle of August that we’re almost there,” Fauci said.

The FDA said in a statement on Friday that the agency is moving as rapidly as possible on the Pfizer-BioNTech application. The FDA said it had moved personnel and technological resources and prioritized its activities to complete its review given the surge in cases. STAT reported the FDA move earlier on Friday.

More than 163 million people in the United States, or nearly half of the population, have been fully vaccinated against the virus, according to the Centers for Disease Control and Prevention. But vaccination rates remain stubbornly low in some parts of the country, partly because large numbers of people are hesitant to receive the vaccine, CDC data shows.

The spread of the highly contagious coronavirus Delta variant has fueled a new surge in infections, with the CDC reporting rising numbers of cases in nearly 90% of U.S. jurisdictions.

More than 611,000 people have died from COVID-19 in the United States.

“If we get that 100 million people in this country who are eligible to be vaccinated who have not yet gotten vaccinated, that is the answer to the problem,” Fauci said. “If we don’t get those people vaccinated, you are going to continue to see an acceleration of cases.”

The Pfizer/BioNTech vaccine is currently the only one authorized in the U.S. for adolescents between the ages of 12 and 18. Fauci said he expects to start seeing data on how well the vaccines work in kids aged 11 and under “as we get into the fall.”

The FDA may require vaccine makers to expand access to the COVID-19 shots to younger kids through the full approval process, rather than the faster emergency use authorization (EUA) process that was used to get the shots cleared in teens and adults, Fauci said.

Pfizer said earlier this week it expects to have data from its clinical trials to potentially support an EUA for kids aged 5 to 11 by the end of September. However, data to support a full approval will take longer and is expected by the end of the year.

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