2 months ago

Monkeypox Vaccine Maker Expresses Concern Over Dose-Splitting Plan

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Monkeypox
Vaccine Maker , Expresses Concern , Over Dose-Splitting Plan.
Bavarian Nordic makes the only monkeypox vaccine currently authorized by the Food and Drug Administration (FDA).
The CEO of the company recently expressed concern about the Biden administration's plans to mitigate a vaccine shortage by splitting doses.
CEO Paul Chaplin expressed his concerns in a letter recently sent to Health and Human Services Secretary (HHS) Xavier Becerra.
We do have some reservations … due to the very limited safety data available, Paul Chaplin, Bavarian Nordic CEO,
via 'The Washington Post'.
According to Chaplin's letter, more studies to determine the efficacy of a split vaccine "would have been prudent.".
His letter also states that the company has received numerous "calls from U.S. state government officials
with questions and concerns.”.
Responding to news of the vaccine maker's concerns, HHS Secretary Xavier Becerra expressed confidence with the Biden administration's plan.
We’ve had conversations with them about this, and so has FDA, Xavier Becerra, HHS Secretary, via 'The Washington Post'.
We wouldn’t have moved forward unless we thought it was safe and effective, and if FDA hadn’t dotted its I’s and crossed its T’s, Xavier Becerra, HHS Secretary, via 'The Washington Post'.
Biden administration officials have speculated that Bavarian Nordic could be primarily concerned with a loss of profit.
... though Bavarian Nordic officials are adamant that the concerns of the company are safety focused.
Officials connected to the U.S. monkeypox vaccine plan call it a "game changer.".
It’s safe, it’s effective, and it will significantly scale the volume of vaccine doses available, Robert J. Fenton Jr., U.S. Monkeypox Response Co-Ordinator, via 'The Washington Post'

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