UPDATE 2-U.S. approval of COVID-19 shots could boost vaccination numbers, Fauci says

(Adds FDA comment on approval efforts)
By Michael Erman and Carl O'Donnell
July 30 (Reuters) - Leading U.S. infectious disease expert Dr. Anthony Fauci said Friday he hoped regulators could give full approval of the COVID-19 vaccines as early as next month, a move that could encourage unvaccinated Americans to get the vaccinations.
The two-dose vaccines from Pfizer / BioNTech and Moderna, as well as the one-dose shot from Johnson & Johnson, are currently being administered under emergency approval by the US Food and Drug Administration.
Full FDA approval could attract more Americans to get the COVID-19 vaccine as it could reduce their concerns about the safety of the vaccine and make it easier for local officials to implement vaccine mandates, Fauci, director of the National Institute of Allergy and others Infectious diseases and chief medical officer of the White House said in an interview with Reuters.
In addition, the formal FDA approval would allow doctors to prescribe a third dose of the vaccine on an off-label basis for people with compromised immune systems, Fauci said.
Pfizer Inc and BioNTech SE and Moderna Inc have filed with the FDA for full approval of their vaccines. Johnson & Johnson Inc has not yet applied for full approval for its COVID-19 syringe.
"Given what we've been through now and the number of months that have passed since (emergency clearance), I would hope that we will see that in a very reasonable period of time in the future. I hope how we are in mid-August we're almost there, "said Fauci.
The FDA said in a statement Friday that the agency is dealing with the Pfizer BioNTech application as soon as possible. The FDA said it had shifted human and technological resources and prioritized its activities to complete its review in light of the increase in cases. STAT reported the move to the FDA the previous Friday.
More than 163 million people in the United States, or nearly half the population, have been fully vaccinated against the virus, according to the Centers for Disease Control and Prevention. But vaccination rates remain persistently low in some parts of the country, in part because many people are reluctant to get the vaccine, CDC data show.
The spread of the highly contagious coronavirus delta variant has sparked a new surge in infections, with the CDC reporting rising case numbers in nearly 90% of U.S. jurisdictions.
More than 611,000 people have died from COVID-19 in the United States.
"If we get to vaccinating 100 million people in this country who have not yet been vaccinated, that is the solution to the problem," said Fauci. "If we don't vaccinate these people, you will continue to see cases accelerating."
The Pfizer / BioNTech vaccine is currently the only one approved in the US for adolescents between the ages of 12 and 18. "
The FDA may require vaccine manufacturers to expand access to the COVID-19 syringes to younger children through the full approval process, rather than the faster emergency approval process (EEA) used to clear the vaccinations in adolescents and adults, Fauci said.
Pfizer said earlier this week that it expects to have data from its clinical trials by the end of September to potentially support an EEA for children ages 5-11. However, the data to support full approval will take longer and is expected by the end of the year. (Reporting by Michael Erman in New Jersey and Carl O'Donnell in New York Editing by Paul Simao and Leslie Adler)
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