U.S. to provide 50,000 monkeypox vaccines for Pride and other events with high attendance by gay men

The U.S. will provide 50,000 monkeypox vaccine doses specifically for large events with high attendance by gay and bisexual men in an effort to better reach the community most at risk right now, health officials said Thursday.

Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention, said communities hosting Pride and other events can order additional shots to offer vaccinations on-site. The CDC is asking jurisdictions that order more vaccine for these events to provide a plan on how they will educate attendees about the risk factors associated with monkeypox, Walensky said.

The education outreach includes tips on safer sex, including temporarily limiting sexual partners during the current outbreak, according to the CDC director. Monkeypox is primarily spreading through close contact during sex right now.

“I want to emphasize that while we are offering the vaccine at these events to those at high risk, this is a two-dose vaccine series and receiving the vaccine at these events will not provide protection at the event itself,” Walensky said. It’s particularly important to avoid behavior that increases the risk of infection between the first and second dose of the vaccine, she said.

The U.S. is deploying the Jynneos vaccine, made by the Danish biotech company Bavarian Nordic, to immunize people against monkeypox. The vaccine is administered in two doses given 28 days apart. It takes two weeks after the second dose to produce the maximum immune response to protect against the virus.

The U.S. has delivered more than 1 million doses of the monkeypox vaccine across the country since the outbreak started in May, according to the Health and Human Services Department. The federal government will make another 1.8 million doses available for states and other local jurisdictions to order on Monday.

The U.S. has also delivered 22,000 courses of the antiviral treatment tecovirimat so far and will make another 50,000 courses available for state and local jurisdictions to order next week, according to HHS.

The U.S. has reported more than 13,500 cases of monkeypox across 49 states, Washington D.C., and Puerto Rico, according to the CDC. The overwhelming majority of infections, 98%, are in men and 93% of patients who provided their gender and recent sexual history were men who have sex with men. The median age of patients is 35 years old.

The outbreak is disproportionately impacting Black and Hispanic communities. Nearly 35% of monkeypox patients are white, 33% are Hispanic and 28% are Black, according to CDC data. Whites make up about 59% of the U.S. population while Blacks and Hispanics account for 13% and 19%, respectively. Public health officials are tailoring outreach for upcoming events attended primarily by Black and Hispanic individuals, said Demetre Daskalakis, the White House deputy monkeypox response coordinator.

Walensky said the CDC is working closely with local officials ahead of Atlanta Black Pride, which begins Aug. 31, and Southern Decadence in New Orleans, which starts Sept. 1.

“Specifically we’re asking for plans for how the education will happen, how we can do more outreach in some cases, whether we can make testing available, how we can make vaccine available,” Walensky said.

The Food and Drug Administration last week authorized administering the Jynneos vaccine through intradermal injection, or between the layers of the skin. The vaccine was originally approved for subcutaneous injection, or beneath the skin.

The decision to allow intradermal injections has significantly expanded the limited vaccine supply because this method of administration uses a fifth of the normal dose volume. That means five doses can now be extracted from each vaccine vial, according to Robert Fenton, the White House monkeypox response coordinator.

Bavarian Nordic, the manufacturer, has expressed some concerns about intradermal injections. CEO Paul Chaplin told HHS Secretary Xavier Becerra and FDA Commissioner Dr. Robert Califf in a letter last week that Bavarian Nordic was worried about limited safety data on the method. The letter was first reported by The Washington Post.

Califf and Dr. Peter Marks, head of the FDA’s vaccine division, said intradermal injections produced a similar immune response to the subcutaneous method in a study sponsored by the U.S. government. The intradermal method did result in more redness, itchiness and swelling at the injection site, but the side effects were manageable and people actually had less pain from the shot, the FDA officials told Bavarian Nordic in a letter.

There is limited data on the vaccine’s real-world effectiveness. WHO officials said earlier this week there are reports of breakthrough cases in which people who received the shots after exposure to the virus are still falling ill as well as individuals becoming infected after receiving the vaccine as a preventative measure.

“We have known from the beginning that this vaccine would not be a silver bullet, that it would not meet all the expectations that are being put on it, and that we don’t have firm efficacy data or effectiveness data in this context,” Dr. Rosamund Lewis, the WHO’s lead monkeypox expert, told reporters Wednesday.

The monkeypox vaccine can be administered after exposure to reduce the risk of severe disease or before exposure to reduce the risk of infection.

Walensky said last week that the CDC is launching studies to monitor the shots real-world effectiveness at preventing disease. She said Thursday the CDC expects the shots will provide protection with vaccine most effective two weeks after the second dose.