WHO and FDA ‘not on same page’ about future COVID-19 vaccine boosters

The World Health Organization and the United States Food and Drug Administration have found themselves on opposite sides of a debate on how to move forward with COVID-19 vaccine boosters given the rapidly changing variants.

The Food and Drug Administration (FDA) met last week to discuss the best course forward for vaccine boosters in the United States. The official decision was announced the following day, to roll out new vaccine boosters in or around the fall, which would include not just the BA.1 omicron subvariant boosters, but also BA.5 and BA.6, which the FDA believes will be dominant strains of COVID-19 in the near future.

The decision to roll out a bivalent vaccine (one that targets more than one strain of the virus) directly contradicts a recommendation by the World Health Organization (WHO) on the same matter. The WHO’s Technical Advisory Group on COVID-19 Vaccine Composition (TAG-CO-VAC) met in the middle of last month and decided to recommend rolling out a monovalent vaccine booster that targets the BA.1 subvariant of omicron. 

The FDA has already ordered US vaccine manufacturers to begin producing the bivalent booster in time for an approximate September rollout, but the vaccine manufacturers face several questions about how to proceed based on the WHO’s contradicting advice. It remains unclear what will happen to any doses of the BA.1 monovalent booster that have already been manufactured, or whether they will still be needed. 

Pfizer and Moderna had already begun producing BA.1 vaccines for the fall rollout, and the change in the FDA guidance may lead to delays in vaccine distribution in the fall. Jerry Weir, director of viral products at Center for Biologics Evaluation and Research (CBER) at the FDA says more global coordination will be needed in order to make the right decisions about vaccine production.

“I will remind you that the parallel track of influenza strain selection, which works very well, was a process that was honed over many, many years,” said Weir. “This is a very different virus, so we probably have a lot of work to do on this strain selection process for COVID vaccines.”