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Immunogenicity Data Drove Monkeypox Dose-Sparring Decision…It Also Drove Initial Approval

 
• By Sarah Karlin-Smith

Comfort with the initial approval based on inferred effectiveness may have made the current EUA process more palatable to US FDA officials but means there is a bigger gap in what’s known about the vaccine’s effectiveness overall.

white house monkeypox press briefing Aug. 9, 2022
Biden administration officials discuss Jynneos EUA or dose-sparing vaccine strategy 9 August. • Source: White House Press Briefing

 The US Food and Drug Administration relied on a 2015 immunogenicity study to grant Bavarian Nordic A/S’ monkeypox vaccine Jynneos an emergency use authorization for administration by intradermal injection, a strategy that will increase the total number of doses available by up to five fold. (Also see "Monkeypox Vaccine: US FDA Eyes Dose-Sparing Strategy For Jynneos" - Pink Sheet, 4 August, 2022.)

One reason the agency may have been comfortable using immunogenicity data to grant the EUA for adults at high-risk of monkeypox is that unlike for most vaccines, the initial Jynneos...

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