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The available evidence does not yet point to the need for COVID-19 booster vaccines in the general population, an international group of scientists said on Monday, including two senior FDA officials who have reportedly resigned from their posts due to a disagreement with the White House on the administration of booster injections.
Marion Gruber, director of the FDA’s Office of Vaccine Research and Review, and her deputy director Phil Krause, who are scheduled to leave in October and November, posted a viewpoint in The Lancet with others on Monday. experts around the world, claiming that COVID-19 vaccines remain effective in preventing serious disease, including against the dominant and highly transmissible delta variant.
SENIOR FDA OFFICIALS RELAX WITH WHITE HOUSE ON BOOSTER SHOTS
“Careful and public scrutiny of the evolving data will be necessary to ensure that decisions about reinforcement are informed by reliable science rather than policy,” the authors wrote, adding in part: “Widespread reinforcement should not be undertaken. only if there is clear evidence that it is appropriate. “
The comments come after acting FDA commissioner Dr Janet Woodcock and Centers for Disease Control and Prevention director Dr Rochelle Walensky recently informed the White House that regulators need more time to review the The data before approving a COVID-19[female[feminine booster shooting plan. According to guidelines from the FDA and CDC, the two agencies have so far only accumulated enough data to suggest that some people who have received the Pfizer vaccine should receive a booster.
RESIGNATIONS FROM THE FDA ON THE ORIENTATION OF THE SHOT BOOSTER OF THE WHITE HOUSE A “MESS FOR THE ADMINISTRATION”
Last month, the country’s top health officials said the United States was ready to start offering COVID-19[female[feminine vaccine booster shots to Americans starting Sept. 20, pending FDA review. This statement, attributed to Walensky, Woodcock, US Surgeon General Dr Vivek Murthy, Director of NIH, Dr Francis Collins, Chief Medical Advisor to President Biden, Dr Anthony Fauci and others, had stated that available data indicated that protection began to wane over time, and “may decline in the coming months, especially in those at higher risk or who were vaccinated in the early stages of the vaccination rollout.” ”
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Gruber, Krause, and others have urged caution before drawing conclusions about vaccine efficacy from preliminary observational studies possibly affected by “confusing and selective reports” to inform vaccine deployment of. recall in the country. Rather, the vaccine supply should be allocated to unvaccinated populations in order to best reduce the risk of severe disease and emerging variants, they said.
Fox News’ Peter Aitken contributed to this report.
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