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The White House and federal health officials are upholding the decision to announce COVID-19 recall plans for many Americans in August ahead of approval from the Food and Drug Administration (FDA) and the Center for Disease Control and Prevention (CDC) for additional doses.
The announcement released by eight top government doctors on August 18 notes clear evidence that the effectiveness of the COVID-19 vaccine is waning over time and reveals a plan to roll out booster shots in response. The Biden administration then presented plans to start giving booster shots to more Americans from September 20.
The FDA’s Vaccines and Related Biologics Advisory Committee (VRBPAC) met on Friday morning to discuss the possibility of recommending booster doses. He voted 16 to 3 against providing the booster for most people, but recommended it for people over 65 and those at high risk. The CDC’s Advisory Committee on Immunization Practices (ACIP) will hold a two-day meeting next week to make its recommendation.
The decision to make the announcement in August raised questions as to whether the White House and the Department of Health and Human Services (HHS) put undue pressure on regulators to approve boosters in publicizing the potential need for a third dose.
US Surgeon General Dr Vivek Murthy said on Friday the announcement was made for two reasons: transparency and planning.
“If we saw a signal that told us that protection was starting to wane and that more shots might be needed, that we would be transparent and open to the public about it,” Vivek said, adding: “You want to deploy the hit booster. You can’t flip a switch and make it happen overnight. There is important planning that has to take place.
The White House also backed the August announcement this week when press secretary Jen Psaki told reporters, “Our goal is to be prepared if this whole process is to go forward. It has always been pending ACIP and FDA approval.
The recent resignation of senior vaccine officials from the FDA seems to suggest a glaring disagreement within the regulatory agency over the plan to roll out the booster injections. Dr Marion Gruber, director of the FDA’s Office of Vaccine Research and Review, and her deputy, Dr Philip Krause, announced late last month their intention to leave the FDA in October and November.
The two were co-authors of an article published this week in the scientific journal The Lancet saying that booster injections may only be appropriate for certain populations at risk.
The article reads: “While the benefits of primary COVID-19 vaccination clearly outweigh the risks, there could be risks if boosters are widely introduced too early or too frequently, particularly with vaccines that may have immune-mediated side effects… If unnecessary stimulation causes significant adverse effects, there could be implications for vaccine acceptance that go beyond COVID-19 vaccines. Thus, generalized reinforcement should only be undertaken if there is clear evidence that it is appropriate. “
Officials say there are a lot of boosters if they are approved.
To follow
Nick Ciolino covers the White House.
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