COVID-19 vaccine boosters not widely needed, top FDA and WHO scientists say

Additional COVID-19 vaccine booster shots are not yet needed for the general population, according to a new medical journal article from leading international scientists, including some from the U.S. Food and Drug Administration (FDA) and the World Health Organization (WHO).

Writing in the Lancet medical journal, the scientists said “efficacy against severe disease remains high,” with more evidence needed to justify broad use of boosters.

That view goes against U.S. government plans to begin offering another round of shots to many fully vaccinated Americans as soon as next week, contingent on approval from health regulators.

“Any decisions about the need for boosting or timing of boosting should be based on careful analyzes of adequately controlled clinical or epidemiological data, or both, indicating a persistent and meaningful reduction in severe disease,” the Lancet article reads.

As COVID-19 cases caused by the delta variant of the virus rise, U.S. President Joe Biden’s administration is concerned that infections among those already vaccinated are a sign that their protection is waning and has pushed boosters as a way to rebuild immunity, despite an argument by WHO officials that the vaccines are still needed for first doses around the globe. 

There is a growing body of evidence showing vaccines dramatically reduce the risk of serious illness or death

The risk-benefit evaluation should consider the number of severe COVID-19 cases that booster shots would be expected to prevent, and whether it is safe and effective against the current variants, they said.

WATCH | WHO calls for halt on COVID-19 booster shots: 

WHO calls for temporary halt on COVID-19 vaccine booster shots

Saying the priority should be on immunizing health-care workers in low- and middle-income countries, WHO director general Tedros Adhanom Ghebreyesus called for a temporary moratorium on COVID-19 vaccine boosters. 1:44

Some countries pursue broad booster campaigns

Some countries have begun COVID-19 booster campaigns, including Israel, providing some of the data on which the Biden administration has made its case for additional shots.

The article’s authors included the FDA Office of Vaccines Research and Review Director Marion Gruber and Deputy Director Phil Krause, both of whom plan to leave the agency in the next several months.

They acknowledged that some individuals, such as those who are immunocompromised, could benefit from an additional dose.

That’s the approach recommended here in Canada, with the country’s National Advisory Committee on Immunization (NACI) recently saying that third doses of COVID-19 vaccines should be given to certain immunocompromised individuals — though the advisory body still hasn’t reached a decision on whether to provide additional shots to the broader population.

Broader use of boosters may be needed in the future if there is waning immunity to the primary vaccination or if new variants evolve so that the vaccines no longer protect against the virus, the scientists behind the Lancet paper wrote.

But those additional shots could also prove risky if introduced too soon or too frequently, the authors said.

A panel of experts that advises the FDA on vaccines plans to meet on Sept. 17 to discuss additional doses of the Pfizer-BioNTech shot, the first step in a wider booster roll-out.

The article’s authors included WHO top scientists Soumya Swaminathan, Ana-Maria Henao-Restrepo and Mike Ryan.

“Current vaccine supplies could save more lives if used in previously unvaccinated populations,” they wrote.

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