Monkeypox: Bavarian Nordic’s Jynneos Vaccine Should Be Given Only As A Two-Dose Series, US FDA Says
Despite limited vaccine supplies and a growing number of cases, public health officials nix the idea of giving only one dose of Jynneos to individuals exposed or at high risk, saying that two doses one month apart are required for full protection; FDA says it is working to expedite the availability by late July of an additional 786,000 doses made in Denmark.
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Switching method of administration from subcutaneous to intradermal would increase by five-fold the number of doses of Bavarian Nordic’s vaccine available to combat the outbreak; an EUA declaration would be needed to make this change, FDA commissioner Robert Califf said.
Providers will have to look up the expiration date for vials of the protein-based vaccine on a website because it is not printed on the carton or packaging; omission sparks ACIP members’ frustrations with FDA and manufacturers about inadequate packaging for some other recently authorized vaccines.
Rather than holding half of all vaccines produced to ensure administration of the second dose, only a portion would be held to cover for manufacturing or other problems.