Monkeypox vaccine maker raises concerns on doses

The CEO of the company that makes the only vaccine approved by the Food and Drug Administration (FDA) to prevent monkeypox told Biden administration health officials he was concerned about a new strategy to split doses and change the way the vaccine is injected.

In a letter shared with The Hill, Bavarian Nordic CEO Paul Chaplin said the company has “some reservations” about the new approach, “due to the very limited safety data available,” as well as the fact that more people experienced adverse reactions after vaccination.

Chaplin said the company fully supports approaches to conserve limited supply, but “it would have been prudent” to roll out the new strategy with much more comprehensive guidance that would allow additional safety data to be collected.

 

Flashback: The letter was dated Aug. 9, the day the administration announced a major change to its monkeypox vaccination strategy.

 

The new method splits up the doses and uses one-fifth as much vaccine per shot. The partial dose of the vaccine is injected into the upper layer of skin, rather than the full dose into the underlying fat, which is how shots are typically administered.

 

Public health officials confused: Chaplin said the company has been “inundated with calls from U.S. state government officials with questions and concerns” since last Thursday regarding the new vaccination plan.