Monkeypox dose sparing? Biden admin looks to NIH-funded study for clues.
The Biden administration’s embrace of dose-sparing, an approach intended to stretch the limited supply of monkeypox vaccine doses, is partly based on a 2015 study funded by the National Institutes of Health, according to two senior administration officials.
The Food and Drug Administration said Friday it is considering dose-sparing as the administration grapples with how to contain the increasing spread of the monkeypox virus across the country. More than 7,500 Americans have been infected as of Friday, according to the Centers for Disease Control and Prevention.
The U.S. is running low on vaccine and dose sparing could offer public health officials a way to control the spread of the virus while the federal government finds solutions for obtaining additional shots.
“To help close this gap, we're considering an approach for the current doses of Jynneos that would allow health care providers to use an existing one-dose vial of the vaccine to administer a total of up to five separate doses,” FDA Commissioner Robert Califf told reporters in a briefing last week, referring to the monkeypox vaccine.
The two administration officials, granted anonymity to speak freely about the administration’s thinking, said the National Institute of Allergy and Infectious Diseases is conducting a dose-sparing study of the Jynneos vaccine but that it could take months to complete. In the meantime, the FDA is relying on the seven-year-old study that shows the vaccine could be administered intradermally – between the layers of the skin – with a smaller amount of a typical dose and still remain effective. Using the vaccine intradermally could increase the number of doses available “5-fold,” the study said.
The FDA did not immediately respond to a request for comment.
The news of the potential dose sparing recommendations prompted some congressional staff to question federal health officials, including from the CDC and the Department of Health and Human Services, in a Friday briefing about whether the move could impact the efficacy of the shot.
“They seemed to have no good answers for us, other than denying that it would impact things. But they didn’t present any data,” one individual in the briefing told POLITICO.
On the call with reporters, Califf said the “overall safety and efficacy profile [of Jynneos] will not be sacrificed” with a dose sparing approach, which Anthony Fauci, the president’s chief medical officer, has touted as a promising solution to the vaccine shortage, the two officials said.
A decision on dose sparing could help free up potentially millions of doses for Americans at a time when monkeypox case numbers continue to increase. The Biden administration has struggled to obtain the additional vaccine doses it needs to help contain the spread.
Last week, the administration declared monkeypox a public health emergency, but it is not yet clear how that will change things in the short-term. The administration is in conversations with lawmakers on Capitol Hill about the potential approval of about $7 billion in emergency funding – but Congress is on recess for weeks.
