Bavarian Nordic AS (BVNRY)

[OGINVU]

https://www.barrons.com/articles/monkeypox-covid-supply-chain-vaccines-51660928179


So far, the U.S. federal agencies have demonstrated once again their lack of urgency and agency by insisting on the dosing schedule specified on the label. In an unexpected development, instead of stretching the time interval between two 0.5-milliliter doses, the Biden administration asked the FDA to authorize so-called intradermal injection, which would involve injecting a 0.1-milliliter dose into the skin instead of a full 0.5-milliliter dose into the underlying fat. The FDA did so on Aug. 9. But some experts have expressed concerns because the efficacy of this intradermal method with only one-fifth of the full dose is unknown. This method is also complicated for vaccinators, who need to guide a needle into a skin-deep space. It requires additional training, posing challenges to an already overstretched healthcare workforce.


The Biden administration’s proposed solution quickly backfired, drawing strong opposition from Bavarian Nordic, the manufacturer of Jynneos, as the Washington Post reported. Its CEO has apparently threatened to revoke upcoming orders from the U.S., jeopardizing the fight against monkeypox. The “first dose first” approach, in contrast, is supported by solid data and has the support of the manufacturer as well as state and local public health organizations.

We urge the CDC, FDA, and the recently elevated Administration for Strategic Preparedness and Response to seriously factor in the ongoing severe shortage when developing a national monkeypox vaccine distribution strategy. Pretending that there are no supply shortages will not make the problem go away.