After the Biden administration announced plans to stretch the nation’s limited supply by splitting doses and changing how they are administered, the monkeypox vaccine manufacturer voiced its concerns.
In a letter to Health and Human Services Secretary Xavier Becerra and Food and Drug Administration Commissioner Robert M. Califf, Bavarian Nordic CEO Paul Chaplin expressed “reservations” about the dose-sparing approach “due to the very limited safety data available” for the Jynneos vaccine.
The Washington Post has obtained a letter written by Chaplin, in which he states that conducting studies on the strategy that could provide more safety information “would have been prudent.”
U.S. state government officials have been calling with “questions and concerns” about the ID administration, he wrote. Of course, we’ll coordinate our responses with the CDC, but we think it would have been better if we’d done so before the announcement was made.
Becerra responded to the criticisms on Wednesday, reassuring people that the Biden administration is fully confident in its vaccine strategy.
Becerra claimed that the FDA “has had conversations with them about this.” We wouldn’t have gone forward unless we were confident in its safety and efficacy, and the FDA would have had to double-check all of our work.
On Tuesday, the Biden administration announced the plan, saying that the emergency declaration would allow providers to inject one-fifth of the current dose of the Jynneos vaccine into the skin rather than the full dose into the underlying fat. Last week, Califf mentioned that intradermal injection was something the FDA was considering.
Dr. Daniel Griffin, an infectious disease specialist from Columbia University, told CNN that intradermal vaccination only requires a “small dose” because the vaccine “stays in the skin; you’re not going through the skin.”
Dendritic cells in the skin are responsible for the immune response, which is why this technique was previously used for flu and rabies vaccines. Epidemiologist Dr. Jay Varma said, “The skin has special cells that are very good at helping a vaccine stimulate the body’s immune system.”
“They live in the skin, and they’re better at teaching the immune system what they need to respond to,” he added.
Two subcutaneous injections are required for protection against Jynneos monkeypox. The Washington Post reports that if the expected level of protection is not discovered using the new approach, people may need to take more than one dose. Local health officials may need more training to give the shots correctly.
More than 600,000 doses of the monkeypox vaccine have left the United States since Monday. There have been over 10,300 confirmed cases of monkeypox in the US, according to the CDC.
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