A review issued Wednesday by the U.S. Food and Drug Administration says a third dose of Pfizer’s two-dose COVID-19 vaccine boosts a person’s immunity against the virus, but said the current regimen still provides enough protection against severe illness.
The FDA is considering Pfizer’s request to offer a third shot of its vaccine, which the drugmaker says is needed as its effectiveness wears off between six to eight months after the second dose. Pfizer submitted a preliminary study to the FDA that suggested a third dose of the vaccine given to more than 300 people boosted their immunity levels three to five times higher than after the earlier shots.
Pfizer also cited a study from Israel, published Wednesday in the New England Journal of Medicine, that showed infection rates were 11 times lower among people age 60 and older who received a third dose of the vaccine. About 1 million people took part in the study.
Pfizer has applied for permission to offer a third dose as the highly contagious delta variant of COVID-19 has triggered a dramatic new surge of infections, hospitalizations and deaths around the world.
But the FDA said in its review that recent studies “indicate that currently US-licensed or authorized COVID-19 vaccines still afford protection against severe COVID-19 disease and death in the United States.”
The U.S. government drug regulator’s vaccine advisory committee will meet Friday to discuss whether the agency should approve Pfizer’s request. The committee’s recommendation is non-binding, meaning the FDA could approve the third Pfizer dose even if the committee recommends against it.
Both the FDA and the Centers for Disease Control and Prevention last month recommended a third shot of the Pfizer or the Moderna vaccine for some people with weakened immune systems.
The FDA meeting will be held days after an international group of vaccine experts published an essay in The Lancet medical journal in opposition to providing booster shots of current vaccines to the general population.
Experts say recent studies show the current vaccines in use around the world continue to provide strong protection against the virus, including the delta variant, especially against severe illness and hospitalization.
The authors include two key officials in the FDA’s vaccine review office who are leaving their posts before the end of the year. The New York Times recently reported that Dr. Marian Gruber and Dr. Philip Krause are upset over the Biden administration’s recent announcement that booster shots would be offered for some Americans beginning next month, well before the FDA had time to properly review the data.
The authors suggest that modifying the vaccines to match the specific COVID-19 variants is a better approach than providing extra doses of the original vaccine.
Tedros Adhanom Ghebreyesus, the director-general of the World Health Organization, has called on wealthy nations to forgo COVID-19 vaccine booster shots for the rest of the year to ensure that low- and middle-income countries have more access to the vaccine.
Some information for this report came from the Associated Press and Reuters.
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