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# Smallpox/Mpox Vaccine OK’d Despite CBER Turmoil
- URL: https://www.fdaweb.com/smallpox-mpox-vaccine-okd-despite-cber-turmoil/
- Published: 2025-03-31T12:00:00.000Z
- Updated: 2026-09-14T14:56:33.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5158926

In a move that may assuage vaccine makers regarding HHS’s potential interference in vaccine reviews and approvals, Bavarian Nordic just gained FDA approval 3/31 for its freeze-dried formulation of Jynneos (smallpox and mpox vaccine, live, non-replicating) for preventing smallpox and mpox \[monkeypox\] disease in adults 18 years of age and older. “This approval will provide additional flexibility for stockpiling against a smallpox event or mpox outbreak,” the company says.

Vaccine and biologic makers have been reeling over CBER director **Peter Marks**’ departure from the agency which was announced late 3/28 ([see story](https://fdaweb.com/login.php?sa=v&aid=D5158918&cate=&stid=%241%24BH%2F.04..%24aHjchEF2m6M563X4zQLA3.&ref=fdaweb.com)). The unexpected resignation triggered a selloff in biotech stocks on Monday (3/31), with shares of Moderna and Sarepta dropping significantly. Some are speculating that HHS secretary **Robert F. Kennedy Jr.**, a well-known vaccine skeptic, will now be motivated to move more aggressively against vaccine makers with Marks out of the way.

Federal vaccine advisory committee meetings have been canceled or postponed under Kennedy’s leadership. Additionally, the [National Institutes of Health has halted research ](https://www.npr.org/2025/03/12/nx-s1-5325863/nih-trump-vaccine-hesitancy-mrna-research?ref=fdaweb.com)on vaccines and Kennedy was behind the hiring of a known conspiracy theorist, **David Geier**, to run a planned study which will investigate the thoroughly disproven idea of a link between childhood vaccinations and autism ([see earlier story](https://www.fdaweb.com/advocates-blast-hiring-quack-for-autism-study/)).

Bavarian Nordic’s approval followed a standard review of a supplemental BLA submitted 5/2024\. The submission was primarily based on clinical data that showed comparability in terms of the immune responses and safety between the freeze-dried and liquid-frozen formulations, as well as other non-clinical and manufacturing data, the company says. “The current liquid-frozen formulation of Jynneos, approved by the FDA in 9/2019, has specific cold-chain requirements, while the freeze-dried formulation provides advantages in terms of transportation, storage conditions and shelf life, all of which are important factors for long-term stockpiling.”