FDA and WHO Vaccine Experts Argue Against COVID-10 Boosters for the General Public

Two outgoing vaccine experts at the FDA as well as experts from the World Health Organization (WHO) are arguing that providing COVID-19 booster shots to the general public isn’t warranted at this time.

The FDA’s Marion Gruber and Phil Krause, the two lead authors on a paper in The Lancet, contend along with many co-authors that while the evidence about boosters is still accumulating, it makes more sense to ensure that unvaccinated populations get vaccinated than to provide boosters to those who have already had their shots.

The authors write that most of the observational studies that show that COVID-19 vaccines continue to be effective against severe disease are preliminary and “difficult to interpret precisely due to potential confounding and selective reporting.”

“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,” they wrote.

The FDA’s Gruber, director of the agency’s Office of Vaccines Research & Review (OVRR), and Krause, deputy director of OVRR, both announced their resignation in recent weeks, hinting at internal conflict over vaccines (DID, Sept. 1).

The paper’s sentiments are in sharp contrast to the Biden Administration’s stance on the matter. The administration has said it plans to begin rolling out booster shots to the general population as early as Monday, Sept. 20 (DID, Aug. 24).

But the paper’s authors argue that the evidence isn’t in yet.

“Current evidence does not … appear to show a need for boosting in the general population, in which efficacy against severe disease remains high,” said the authors.

Reductions in neutralizing antibody titre do not necessarily predict reductions in vaccine efficacy over time, and reductions in vaccine efficacy against mild disease do not necessarily predict reductions in the (typically higher) efficacy against severe disease, wrote the authors.

Additionally, the authors said that if the U.S. offers boosters to general populations too soon, it could backfire.

“The message that boosting might soon be needed, if not justified by robust data and analysis, could adversely affect confidence in vaccines and undermine messaging about the value of primary vaccination,” they wrote.

The authors also said public health authorities should be careful about endorsing boosters only for selected vaccines as booster programs that affect some but not all vaccines may be difficult to implement.

“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,” they concluded.

Read the full paper here: bit.ly/3hsLorF. — Suz Redfearn