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

Executive Summary

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.

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EU, UK & Brazil Take Steps To Boost Access To Monkeypox Vaccines

Regulators in the EU and the UK are exploring the intradermal use of monkeypox vaccine as a dose-sparing measure to stretch out scarce supplies, while Brazil is to waive the registration requirements for imported vaccines and therapeutics for monkeypox.

US NIH Testing Strategy To Stretch Monkeypox Vaccine Supply Even Further

The National Institutes of Health is gearing up to launch a trial that would test a smaller intradermal dose of Jynneos than was recently given an emergency use authorization, which could double vaccine supplies relative to currently available intradermal dosing. The trial still will leave the efficacy question unanswered. 

US Encouraging Monkeypox Vaccine Maker To Work With Large Pharma To Up Supply

The US FDA's Peter Marks also says the intradermal dose-sparing plan was motivated by concern over city and state one-dose strategies. 

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