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19Nov21

The FDA authorizes COVID booster shots for all U.S. adults

The Food and Drug Administration has given its OK for fully vaccinated Americans who are age 18 and older to receive a COVID-19 booster shot.

The FDA on Friday granted emergency use authorization for a third dose of the Pfizer-BioNTech and Moderna vaccines, which had already been available to people 65 and older and to anyone 18 years and older who is at elevated risk of contracting COVID-19.

"The FDA has determined that the currently available data support expanding the eligibility of a single booster dose of the Moderna and Pfizer-BioNTech COVID-19 vaccines to individuals 18 years of age and older," said Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research. "Streamlining the eligibility criteria and making booster doses available to all individuals 18 years of age and older will also help to eliminate confusion about who may receive a booster dose and ensure booster doses are available to all who may need one."

People who got the Pfizer or Moderna immunizations to start would be eligible for a booster six months after their second shot, the FDA said. People who got the Johnson & Johnson vaccine would be eligible for a booster two months after their first shot.

A Centers for Disease Control and Prevention committee of independent experts is scheduled to meet Friday afternoon to take up the matter. If the panel approves and CDC Director Rochelle Walensky concurs, the booster shots could become widely available right away.

Both Pfizer and Moderna have shown data that an additional shot improves the efficacy of their vaccines in adults. Pfizer and Moderna first made their request for boosters in September, but advisers to the FDA were cool to the idea of boosters for all adults. The FDA narrowed the authorization to groups of people at elevated risk. Earlier this month, Pfizer and Moderna renewed their requests for broader use of their boosters.

Even so, several states — including California, Kansas, Maine, Rhode Island and Louisiana — have moved ahead of federal health authorities in recent days and independently authorized booster shots for their adult residents.

The latest FDA authorization comes nearly two months after the agency first gave the green light to booster shots for Americans 65 and older and for others considered at high risk for COVID-19. In September, the agency granted its initial authorization for the additional shot to Pfizer, and a month later it followed suit with the Moderna and Johnson & Johnson vaccines.

The vast majority of hospitalizations and deaths due to COVID-19 are among unvaccinated individuals. But protection against coronavirus infection among the fully vaccinated has also been waning, partly due to the more infectious delta variant of the virus.

[Source: By Scott Neuman, NPR, Washington, 19Nov21]
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