Bottling monkeypox vaccine could take until early 2023

However, officials do not know how long this strategy will work, particularly if cases rise sharply in the coming weeks and the virus spreads outside the community of men who have sex with men.

Nearly 9,500 monkeypox infections have been reported, according to the CDC, up about 50% in the past week. Almost all of the cases have been 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 bolster more vaccines by striking 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 stored by Bavarian Nordic 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 bottled, U.S. regulators will likely need to inspect the doses before they are distributed. According to the agreements reached by the Biden administration, the process could extend until 2023, said one of the senior administration officials.

This timeframe also depends on how many doses the United States pulls from stock in Denmark for fill and finish.

An HHS official said the administration was “exploring multiple avenues to expedite production and distribution” of the vaccine. Despite comments from health officials during Tuesday’s briefing, the HHS official said the administration had made a decision on dose sparing “regardless of [its]efforts … to procure and produce additional vaccines.

The CDC is collecting case information from states, but the agency is still working on setting up a system to track transmission of the virus and model how it might change over the next few months, one of the people knowing says the case. The CDC did not respond to questions about its modeling of monkeypox.

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

While the dose-saving strategy announced on Tuesday has received broad support from senior 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 information available that supports the administration’s recommendation. The NIH is developing a study. The CDC is also working to collect efficacy data from states.

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


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