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U.S. to release 786K monkeypox vaccine doses amid shortage, disease spread

An artist's rendering of the monkeypox virus. Image by <a href="https://pixabay.com/users/samuelfrancisjohnson-1207793/?utm_source=link-attribution&amp;utm_medium=referral&amp;utm_campaign=image&amp;utm_content=7229283" target="_blank">Samuel F. Johanns</a>/<a href="https://pixabay.com/?utm_source=link-attribution&amp;utm_medium=referral&amp;utm_campaign=image&amp;utm_content=7229283" target="_blank">Pixabay</a>
An artist's rendering of the monkeypox virus. Image by Samuel F. Johanns/Pixabay

July 27 (UPI) -- The Biden administration released an additional 786,000 doses of the monkeypox vaccine on Wednesday as states combat a shortfall in the drug amid surging cases.

Health and Human Services Secretary Xavier Becerra announced in a statement that the hundreds of thousands of doses will be made available to states "as soon as possible" with allocations to be announced Thursday.

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The country has been hit with an outbreak of the monkeypox virus that began mid-May, and which has grown to more than 4,600 cases as of 2 p.m. Wednesday, according to stats from the U.S. Centers for Disease Control and Prevention.

Amid the outbreak, the Biden administration has announced measures to mitigate the spread, but supplies of the two-dose Jynneos monkeypox vaccine have been limited, forcing states and jurisdictions hardest hit to find ways to deal. Earlier this week, health officials in Washington, D.C., shifted their vaccine strategy due to the dearth in doses to prioritize the high-risk unvaccinated, resulting in the temporary postponement of those scheduled to receive their second dose in order to ensure as many people in the district as possible are inoculated.

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The Biden administration has ordered more than 7 million doses of the Jynneos vaccine, though they will be delivered in batches throughout the year and into mid-2023. As of Friday, HHS said it has delivered 310,385 vaccine doses to states and jurisdictions.

The release of the new vaccines was due to the U.S. Food and Drug Administration okaying a new Bavarian Nordic fill-and-finish facility in Denmark that now allows doses produced at the plant to be delivered to the United States. Bavarian Nordic is the manufacturer of the Jynneos vaccine.

The FDA said the inspection of the facility was expedited earlier this month and it determined that the vaccine "meets its quality standards."

In anticipation of the approval, the FDA said it had doses manufactured at the plant already shipped to the United States "so that they would be ready to be distributed once the manufacturing changes were approved."

"With this supplemental approval, those manufactured doses may now be further distributed and administered," the FDA said. "Additional doses manufactured at this plant can help address the need for this vaccine moving forward."

The Biden administration has come under criticism, even from its own Democratic Party, for its response to the outbreak, which has been disproportionately affecting the LGBTQ+ community, in particular men who have sex with other men.

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Reps. Mondaire Jones and Jerry Nadler, both New York Democrats, sent a letter dated July 21 to Biden to hurry the delivery to the United States of 1.1 million Jynneos doses sitting in Danish storage and awaiting the FDA approval.

"We also encourage the Administration to declare a public health emergency and use those authorities to accelerate the federal response," they said.

Bavarian Nordic said the expedited inspection began on July 1, which the House representatives said they were "unclear why the FDA delayed inspection."

"This omission has cost valuable time in the U.S. response to monkeypox," they said.

The Danish company also said Wednesday that its facility has received approval for European Union regulators following its application submitted in June.

It also comes days after the World Health Organization declared the international spread of monkeypox a global health emergency.

According to the CDC, there have been more than 20,000 infections recorded in 77 countries since the outbreak began in June.

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