Biden Officials Accelerate Monkeypox Vaccine Effort with 1.8 Million More Doses and Other Milestones


This includes increasing supply with an additional 1.8 million doses of the Jynneos Monkeypox Vaccine, accelerating the U.S. Department of Health and Human Services’ vaccine distribution schedule. HHS is also launching a new program to make vaccines available and engage with at-risk communities at major events that appeal to LGBTQ communities. And the administration pre-positions doses of an antiviral treatment for people who test positive.

The details, compiled in a White House fact sheet, were first shared with CNN.

The announcements come as latest data from the US Centers for Disease Control and Prevention says more than 13,500 cases of monkeypox have been reported in the United States, with more than 39,000 cases reported worldwide as of Wednesday evening. There have been no deaths in the United States. Most cases of monkeypox in the current outbreak have been linked to sexual activity. According to CDC guidelines, “monkey pox can be spread to anyone” through close contact, which is often skin-to-skin, as well as intimate contact which includes sex, cuddling, massaging and kissing. . Men who have sex with men are at high risk of contracting the virus.

During a Thursday morning briefing alongside HHS Secretary Xavier Becerra and CDC Director Dr. Rochelle Walensky, White House monkeypox response coordinator Bob Fenton announced, “We have accelerated phase four of our national immunization strategy. Starting Monday, an additional 1.8 million doses of the vaccine will be made available to jurisdictions for ordering. » This accelerated allocation phase will give states and jurisdictions more visibility into how much vaccine to expect when they plan to distribute it.

The Biden administration is also providing more resources to local jurisdictions to help transition to the new type of injection to expand vaccine supply. The administration is encouraging states to supply the Jynneos vaccine intradermally — or between layers of the skin — rather than subcutaneously or under the skin, which would allow providers to expand supply in a vial to standard dose. Los Angeles County in California and Fulton County in Georgia have both transitioned completely to the intradermal vaccine, a White House official told CNN, as the administration “provides technical assistance, support and resources to jurisdictions in the process of adopting and expanding intradermal delivery”. .”

Officials also unveiled a new program aimed at reaching populations most at risk — gay and bisexual men – which have made up the majority of confirmed cases so far.

“HHS is launching a pilot program that will provide up to 50,000 doses from the national stockpile to be made available for Pride and other events that will have a high turnout of gay and bisexual men,” Fenton said Thursday, calling him a ‘important’ and ‘innovative’ way to strengthen local efforts to mitigate the spread.

One of the upcoming events is the Charlotte Pride Festival and Parade this weekend in North Carolina. Officials acknowledge that this effort will not prevent the spread around these events since the vaccine does not provide full immunity until two weeks after the second dose. But it’s an effort to raise awareness and meet people where they are.

The CDC also “offers assistance and support to jurisdictions in preparing for these major events, including helping to develop vaccine and testing strategies to be put in place during and around these events, developing data collection tools information to event attendees and providing messaging and communications resources about vaccines, testing, and strategies to reduce the risk of contracting the virus,” the White House fact sheet reads.

And officials described new efforts to make the monkeypox treatmentTpoxx, easier to access.

“Next week, HHS will pre-position 50,000 courses of Tpoxx across the country. That’s nearly five times as many treatment courses as confirmed cases in the United States. These courses will be made available to jurisdictions where the outbreak is most severe so individuals can get treatment more quickly from their healthcare providers,” Fenton said.

Dawn O’Connell, HHS assistant secretary for preparedness and response, said the new effort reflects that “this is not a static response. We continue to assess where we are, to assess what we need and make improvements in real time”. The Biden administration has been criticized for being slow to respond to the evolving outbreak.

The allocation will be based on a formula based 75% on the number of cases in a jurisdiction and 25% on the number of people at risk.

“It’s important that we all take monkeypox seriously, and it’s critical that we do everything we can to prevent this dangerous virus from spreading here,” Becerra told reporters Thursday, adding that there was ” more work to do.”

Federal health officials in the United States have also said the alternative method of giving smaller doses of the Jynneos monkeypox vaccine by intradermal injection would offer some protection as the country continues to battle the virus.

Still, on the exact efficacy numbers, Walensky said, “We don’t know yet how well this vaccine will work in this outbreak.”

CNN reported that Jynneos was approved for emergency use based on studies of immune responses, not clinical outcomes, because there were no large enough outbreaks of smallpox or monkeypox. to test it.

The U.S. Food and Drug Administration last week issued an emergency use authorization to inject the Jynneos monkeypox vaccine into the skin, a change that may stretch the vaccine supply as it would require a fifth of a dose used for subcutaneous injection. The FDA said it based the approval on a 2015 clinical study of intradermal versus subcutaneous injection, finding they produced similar results.

“So when the intradermal dosing strategy, which we believe will work as well as subcutaneous dosing, we again met closely with health services,” Walensky said. “It has been smooth, but we have been in close contact with our national and local health departments providing them with all the data and information we have when we have it.”

Dr. Peter Marks, director of the FDA’s Center for Biologics and Evaluation Research, said the switch to intradermal injection was done “very carefully” and “with great thought”.

“We’re working very actively to make sure the community has the information we’ve looked at and can see the thought process we’re using to come to the conclusion that giving this intradermally provided the same kind of protection as giving it. subcutaneously,” said Marc.

Dr Demetre Daskalakis, deputy White House monkeypox response coordinator, said: “It’s safe, it’s just as effective, and it also allows us to scale up the vaccine so we can maximize protection in the community.”

This story has been updated with additional reaction.

CNN’s Deidre McPhillips contributed to this report.

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