FDA Experts Among Group Opposing COVID Booster Shots

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Healthcare worker fills a syringe with the Pfizer COVID-19 vaccine.
The group of scientists concluded the vaccines are working well and none of the studies they examined proved the need for booster shots yet.

The average person doesn’t need a COVID-19 booster yet, an international group of scientists — including two top U.S. regulators — wrote Monday in a scientific journal.

The experts reviewed studies of the vaccines' performance and concluded the shots are working well despite the extra-contagious delta variant, especially against severe disease.

“Even in populations with fairly high vaccination rates, the unvaccinated are still the major drivers of transmission" at this stage of the pandemic, they concluded.

The opinion piece, published in The Lancet, illustrates the intense scientific debate about who needs booster doses and when, a decision the U.S. and other countries are grappling with.

President Joe Biden has promised to “follow the science.” But the review raises the question of whether his administration is moving faster than the experts.

The authors include two leading vaccine reviewers at the Food and Drug Administration, Drs. Phil Krause and Marion Gruber, who recently announced they will be stepping down this fall. Among the other 16 authors are leading vaccine researchers in the U.S., Britain, France, South Africa and India, plus scientists with the World Health Organization, which already has urged a moratorium on boosters until poor countries are better vaccinated.

In the U.S., the White House has begun planning for boosters later this month, if both the FDA and Centers for Disease Control and Prevention agree. Advisers to the FDA will weigh evidence about an extra Pfizer shot Friday at a key public meeting. 

The U.S. already offers an extra dose of the Pfizer or Moderna vaccines to people with severely weakened immune systems.

For the general population, the debate is boiling down to whether boosters should be given even though the vaccines are still offering high protection against severe disease — possibly in hopes of blocking milder “breakthrough” infections among the fully vaccinated.

The writers of Monday's commentary reported reviewing worldwide studies since delta began surging, mostly of U.S. and European vaccines. The team concluded “none of these studies has provided credible evidence of substantially declining protection against severe disease.”

The more the virus spreads, the more opportunity it has to evolve into strains that could escape current vaccines. The Lancet reviewers suggest there could be bigger gains from creating booster doses that better match circulating variants, much like flu vaccine is regularly updated, than from just giving extra doses of the original vaccine.

Additional reporting by the Associated Press.