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Men eligible for the monkeypox vaccine who did not receive one were roughly 14 times more likely to catch the virus, early real-world effectiveness from the CDC showed.

During the week of August 28, for example, incidence of monkeypox was 230 per 100,000 for those who did not get vaccinated, as compared to 15 per 100,000 in those who received at least a single dose of the Jynneos vaccine, according to findings highlighted by the White House Monkeypox Response Team on Wednesday.

Vaccine protection was seen as early as 2 weeks after the first dose, said CDC Director Rochelle Walensky, MD, MPH, who noted that real-world effectiveness data for the two-dose vaccine had been limited.

The analysis was restricted to males ages 18 to 49, and matched preliminary vaccine data with monkeypox case data from July 31 to September 3 across 32 states (representing 54% of the U.S. population). Limitations included that the analysis could not account for potential differences between the vaccinated and unvaccinated groups when it came to testing or behavior.

"These early findings and similar results from studies in other countries suggest that even one dose of the monkeypox vaccine offers at least some initial protection against infection," Walensky said.

However, laboratory studies of the Jynneos vaccine have shown that immune protection is highest 2 weeks after the second dose of vaccine, said Walensky, and stressed the importance of eligible individuals receiving the complete two-dose regimen 28 days apart, "to ensure durable, lasting immune protection against monkeypox."

Although the agency has yet to stratify the data by intradermal as opposed to subcutaneous injection, such an analysis is possible with more time and more cases. And the agency is continuing to collect data to determine the impact of a second dose of vaccine, which will be shared as soon as the data are available, she noted.

As of Tuesday, approximately 25,300 monkeypox cases have been reported in the U.S., and 800,000 vaccine doses have been administered. While the number of nationally reported daily cases continues to decline, the CDC is continuing to keep a careful eye on trends in individual states, Walensky said.

In addition to sharing the latest efficacy data, she announced that the administration is expanding eligibility for the vaccine and shifting to a a pre-exposure prophylaxis strategy to help stop the virus's spread.

"We're looking to ensure those at the highest risk for monkeypox receive the vaccine before exposure and that vaccines continue to be made available equitably to those who need them," she said.

The CDC is updating its to include more information on expanded vaccine eligibility and to expand the locations on the body the vaccine can be delivered intradermally.

Demetre Daskalakis, MD, MPH, the team's deputy response coordinator, explained that the administration's new approach both expands eligibility for vaccines to more people and calls on vaccine providers to "minimize the risk assessment" of those requesting it.

"Fear of disclosing sexuality and gender identity must not be a barrier to vaccination," he said.

"This new strategy means that more people who might be at present or future risk for monkeypox now qualify for the vaccine, Daskalakis said. "That includes gay, bisexual, and other men who have sex with men; transgender or gender-diverse people who have had more than one sex partner in the last 6 months, had sex in a place associated with higher monkeypox risk, or have had a sexually transmitted infection diagnosed over that same time period."

In addition the pre-exposure prophylaxis strategy extends vaccine eligibility to sexual partners of anyone with the risks noted above, including commercial sex workers, he said.

The new strategy also expands where on the body the vaccines can be administered.

Advocates have said that some individuals have declined to get a vaccine because of the "visible but temporary mark" vaccines can leave on a person's forearm. For that reason, the CDC will now allow recipients to receive their shot on their shoulder or upper back, Daskalakis said.

Another barrier to vaccination is the anxiety individuals feel about the virus, Daskalakis said. In response, the Substance Abuse and Mental Health Services Administration has published to help address those concerns.

Walensky stressed that even vaccinated individuals should continue to protect themselves from infection by avoiding "close skin-to-skin contact" with anyone who has monkeypox as well as to "consider ."

She also urged providers to proactively offer vaccines to newly eligible individuals and to remind anyone who has received a first dose when it's time to get a second dose.

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