Last month, CDC and NIH health officials said the U.S. was ready to start offering COVID-19 vaccine booster shots to Americans beginning Sept. 20, pending FDA review.
Though the Biden administration wanted to move forward, “Slow the horses” wrote two FDA advisors who reportedly are stepping down from their posts over a disagreement with the White House on the administration of booster shots.
Marion Gruber, director of the FDA’s Office of Vaccines Research and Review, and her deputy director, Phil Krause, set to leave in October and November, published a viewpoint in The Lancet on Monday along with other experts from the World Health Organization (WHO).
The conclusion comes just a week before the Biden administration says it plans to begin offering the shots to the general public.
In the article, they effectively explain that the COVID-19 vaccines remain effective in preventing severe disease, including against the highly transmissible and dominant delta variant. Additional COVID-19 vaccine booster shots are not needed for the general population.
The scientists said more evidence was needed to justify boosters.
“Careful and public scrutiny of the evolving data will be needed to assure that decisions about boosting are informed by reliable science more than by politics,” authors wrote, adding in part: “Widespread boosting should be undertaken only if there is clear evidence that it is appropriate.”
The comments come after Dr. Janet Woodcock, acting commissioner of the FDA, and Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention, recently advised the White House that regulators need more time to review necessary data before approving a COVID-19 booster shot plan.
The guidance from the FDA and CDC is that both agencies have so far only accumulated enough data to suggest that some individuals who received the Pfizer vaccine should get a booster shot.
Gruber, Krause, and other authors urged caution overdrawing conclusions about vaccine efficacy from preliminary observational studies possibly affected by “confounding and selective reporting” to inform the country’s booster shot rollout. In addition, they added, “Vaccine supply should instead be allocated to unvaccinated populations to best reduce the risk of serious illness and emerging variants”.
Hopefully, this is a turning point in the Biden administration’s bull rush over everyone and everything in their pursuit to patronize the radical left-wing of the Democratic party.
Fortunately, this team of health professionals was able to force more reviews of the booster shots, and I am sure countless lives will be saved by them doing so.
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