Bottling of monkeypox vaccine could take until early 2023

The Biden administration is in talks with several companies about bottling millions of new doses of the monkeypox vaccine, but it could be three to six months before they are ready for distribution, according to two senior administration officials. management and two other people with knowledge of the matter. .

The administration recommended Tuesday that providers administer the monkeypox vaccine at a fifth of the normal amount intradermally, between the layers of the skin, to try to stretch the supply without sacrificing efficacy.

“This will increase the total number of doses available five times,” Robert Califf, commissioner of the Food and Drug Administration (FDA, for its acronym in English) told reporters.

However, officials aren’t sure how long that strategy will work, particularly if cases rise sharply in the coming weeks and if the virus spreads outside the community of men who have sex with men.

Nearly 9,500 monkeypox infections have been reported, According to the Centers for Disease Control and Prevention, up 50 percent in the last week. Almost all of the cases were reported in men, and CDC Director Rochelle Walensky urged men who have sex with men, including those who are vaccinated, to avoid skin-to-skin contact with infected people.

The administration is trying to shore up more vaccine by striking deals with companies, including Grand River Aseptic Manufacturing in Michigan, to bottle doses, a process known as “fill and finish.” in Denmark, officials said. There are up to 12 million doses available in that stockpile, the two people with knowledge of the matter said.

Once the deals are finalized and the vaccines are bottled, U.S. regulators will likely have to inspect the doses before distributing them. Depending on what deals the Biden administration reaches, the process could stretch into 2023, one of the senior administration officials said.

That timeline also depends on how many doses the US draws from the stockpile in Denmark to fill and finish.

An HHS official said the administration is “exploring multiple avenues to accelerate production and distribution” of the vaccine. Despite comments made by health officials during Tuesday’s briefing, the HHS official said the administration made a dose-sparing decision “regardless of [its]efforts … to acquire and produce additional vaccines.

The CDC is collecting case information from states, but the agency is still working to set up a system to track transmission of the virus and model how it might change over the course of the next few months, one of the people with knowledge of the matter said. . The CDC did not respond to questions about its monkeypox model.

So far, the administration has obtained just over 1 million doses from Bavarian Nordic, a Danish vaccine company. The US needs about 3.2 million doses in total to fully vaccinate the more than 1.6 million Americans at risk. More than 600,000 doses have reached the public and thousands more will be rolled out in the coming weeks.

While the dose-sparing strategy announced Tuesday received broad support from top health officials, data on this approach is limited to one 2015 study: first reported by POLITICO. There is no clinical trial or real-world efficacy data available to support the administration’s recommendation. The NIH is developing a study. The CDC is also working to collect efficacy data from states.

The administration could again recommend providers administer the full dose of the vaccine normally subcutaneously, under the fatty tissue of the skin, one of the top officials said.

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