International scientists argue that the data are not there, push for more initial doses worldwide

Booster doses of the Covid-19 vaccines may not be needed right now given the efficacy of the initial vaccine doses, even with the continuing surge of the Delta variant, according to a Viewpoint article published in The Lancet.

Philip R. Krause, MD, from the Office of Vaccines Research and Review at the FDA, and 18 international colleagues, including scientists from the FDA and WHO, argued that the data are not there to support rolling out booster shots at this time and the decision to do so should “consider the benefits and risks for individuals and society.”

Krause and Marion F. Gruber, MD, also from the FDA, tendered their resignations in August and noted that they are leaving the agency “at least in part because they disagreed with the Biden administration’s push for boosters 8 months after the initial shots before federal scientists could review the evidence and make recommendations,” The New York Times reported.

At issue in the Viewpoint article is whether the benefit of giving booster doses to those already fully vaccinated outweighs providing more vaccine doses worldwide, especially when research so far has not “provided credible evidence of substantially declining protection against severe disease, even when there appear to be declines over time in vaccine efficacy against symptomatic disease,” the editorialists wrote.

“The vaccines that are currently available are safe, effective, and save lives. The limited supply of these vaccines will save the most lives if made available to people who are at appreciable risk of serious disease and have not yet received any vaccine,” Krause and colleagues wrote. “Even if some gain can ultimately be obtained from boosting, it will not outweigh the benefits of providing initial protection to the unvaccinated.

“If vaccines are deployed where they would do the most good, they could hasten the end of the pandemic by inhibiting further evolution of variants. Indeed, WHO has called for a moratorium on boosting until the benefits of primary vaccination have been made available to more people around the world. This is a compelling issue, particularly as the currently available evidence does not show the need for widespread use of booster vaccination in populations that have received an effective primary vaccination regimen.”

Another point Krause and colleagues brought up is that with the emergence of new variants, “boosting against the main variants now circulating and against even newer variants could be greater and longer lived if the booster vaccine antigen is devised to match the main circulating variants,” they wrote.

They also noted that the chatter about the need for booster doses could “undermine messaging about the value of primary vaccination. Public health authorities should also carefully consider the consequences for primary vaccination campaigns of endorsing boosters only for selected vaccines,” as such programs might be “difficult to implement—so it will be important to base recommendations on complete data about all vaccines available in a country, to consider the logistics of vaccination, and to develop clear public health messaging before boosting is widely recommended.”

According to The New York Times, the FDA will be meeting on Friday, Sept. 17 to review data and decide on the need for boosters.

Candace Hoffmann, Managing Editor, BreakingMED™

Cat ID: 190

Topic ID: 79,190,730,933,190,926,192,927,151,928,925,934