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

By Michael Erman and Carl O'Donnell

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

Use of the Pfizer/BioNTech and Moderna (NASDAQ:MRNA) two-dose vaccines and Johnson & Johnson (NYSE:JNJ)'s one-dose shot are currently authorized on an emergency use basis by the U.S. Food and Drug Administration.

Formal approval by the FDA 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 during an interview with Reuters.

Pfizer Inc (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) 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.

Fauci, the director of the National Institute of Allergy and Infectious Diseases and chief medical adviser to the White House, said 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.

"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," he said.

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 Delta coronavirus 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 country 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 five 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.