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Bottling the monkeypox vaccine could take until early 2023

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Officials don’t know how long that strategy will work, though, especially if cases spike in the coming weeks and whether the virus spreads beyond the community of men who have sex with men.

Nearly 9,500 monkeypox infections have been reported, According to the CDC, an increase of about 50 percent in the past week. Nearly all cases have been reported in men, and CDC Director Rochelle Walensky has urged men who have sex with men, including those who have been vaccinated, to avoid skin-to-skin contact with infected people.

The government is trying to support more vaccines by making deals with companies — including Grand River Aseptic Manufacturing in Michigan — to bottle doses, a process known as “fill and finish.” The vaccine to be bottled is currently being stocked by Bavarian Nordic in Denmark, officials said. As many as 12 million doses are available in that supply, 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 agreements reached by the Biden administration, the process could extend to 2023, one of the government’s senior officials said.

That timeline also depends on how many doses the US pulls from stock in Denmark for filling and finishing.

The CDC is collecting case information from states, but the agency is still working to set up a system to track the transmission of the virus and to model how it could change over the coming months, one of the people with knowledge of said the case. The CDC did not respond to questions about monkey pox modeling.

The Department of Health and Human Services did not immediately respond to a request for comment.

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

While the dose-saving strategy announced Tuesday received widespread support from top health officials, data on this approach is limited to one 2015 study — first reported by POLITICO. There is no clinical study or field-based efficacy information available to support the administration’s recommendation. The NIH is developing an investigation. The CDC is also working to collect state efficacy data.

The administration could return to recommending providers normally administer the full dose of the vaccine via subcutaneous administration – under the fatty tissue of the skin, one of the senior officials said.

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