January 27, 2023

“To help close this gap, we are considering a current-dose Jynneos approach that allows healthcare providers to use an existing single-dose vial of the vaccine to deliver up to five separate doses in total,” FDA Commissioner Robert Califf told reporters. week in a briefing, referring to the monkeypox vaccine.

The two government officials, who granted anonymity to speak freely about the government’s thinking, said the National Institute of Allergy and Infectious Diseases is conducting a dose-saving study of the Jynneos vaccine, but it could take months to complete. In the meantime, the FDA relies on the seven-year-old study showing that the vaccine can be administered intradermally – between the layers of skin – with a smaller amount of a typical dose and still remain effective. Intradermal use of the vaccine could increase the number of doses available “fivefold,” the study said.

The FDA did not immediately respond to a request for comment.

News of the potential dose-saving recommendations prompted some congressional officials to question federal health officials, including from the CDC and the Department of Health and Human Services, in a briefing Friday about whether the move could affect the shot’s efficacy.

“They didn’t seem to have any good answers for us other than denying that it would affect things. But they didn’t present any data,” one person in the briefing told POLITICO.

Speaking to reporters, Califf said the “overall safety and efficacy profile” [of Jynneos] will not be sacrificed” with a dose-saving approach, which Anthony Fauci, the president’s chief physician, has touted as a promising solution to the vaccine shortage, the two officials said.

See also  Biden Signs Expansive Health, Climate and Tax Law

A dose-saving decision could help free up potentially millions of doses for Americans at a time when monkeypox cases continue to rise. The Biden administration has struggled to obtain the additional vaccine doses needed to contain the spread.

Last week the government declared monkey pox a public health emergency, but it’s not clear yet how that will change things in the short term. The administration is in talks with lawmakers on Capitol Hill about the possible approval of about $7 billion in emergency funding — but Congress is in recess for weeks.