The U.S. will provide 50,000 monkeypox vaccine doses specifically for large-scale, high-attendance events of gay and bisexual men to better reach the currently most vulnerable community, 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 supplemental shots to provide on-site immunizations. The CDC is asking jurisdictions ordering more vaccines for these events to come up with a plan for how they will educate attendees about the risk factors associated with monkeypox, Walensky said.
According to the CDC director, the educational work includes tips on safer sex, including temporarily restricting sexual partners during the current outbreak. Monkeypox is currently spread primarily through close contact during sex.
“I want to emphasize that while we are offering the vaccine at these events to high-risk patients, this is a two-dose vaccine series and receiving the vaccine at these events does not provide protection at the event itself,” Walensky said. It’s especially important to avoid behaviors that increase the risk of infection between the first and second doses of the vaccine, she said.
The United States is using Danish biotech company Bavarian Nordic’s Jynneos vaccine to immunize people against monkeypox. The vaccine is given in two doses 28 days apart. After the second dose, it takes two weeks to reach the maximum immune response to protect against the virus.
The U.S. has shipped more than 1 million doses of the monkeypox vaccine nationwide since the outbreak began in May, according to the Department of Health. The federal government will make an additional 1.8 million doses available for states and other local jurisdictions to order Monday.
The U.S. has also shipped 22,000 courses of the antiviral treatment Tecovirimat so far and will make an additional 50,000 courses available for state and local jurisdictions to order next week, according to HHS.
The US has reported more than 13,500 cases of monkeypox in 49 states, Washington DC and Puerto Rico, according to the CDC. The overwhelming majority of infections, 98%, occur in men, and 93% of patients who provided their gender and recent sexual history were men who had sex with men. The average age of the patients is 35 years.
The outbreak is disproportionately impacting black and Hispanic communities. According to CDC data, nearly 35% of monkeypox patients are white, 33% are Hispanic, and 28% are black. Whites make up about 59% of the US population, while Blacks and Hispanics make up 13% and 19%, respectively. Public health officials are adjusting the range for upcoming events that are primarily attended by Black and Hispanic people, said Demetre Daskalakis, the deputy coordinator for the White House monkeypox response.
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 begins Sept. 1.
“Specifically, we’re asking about plans for how education will work, how we can do more outreach in some cases, if we can provide testing, how we can provide vaccines,” Walensky said.
The Food and Drug Administration last week approved the administration of the Jynneos vaccine by intradermal injection, or between the layers of the skin. The vaccine was originally approved for subcutaneous injection, or under the skin.
The decision to allow intradermal injections has greatly expanded the limited vaccine offering, as this method of administration uses one-fifth the normal dose volume. According to Robert Fenton, the White House coordinator for monkeypox control, five doses can now be extracted from each vaccine vial.
Bavarian Nordic, the manufacturer, has raised concerns about intradermal injections. CEO Paul Chaplin shared HHS Secretary Xavier Becerra and FDA Commissioner Dr. Robert Califf wrote in a letter last week that Bavarian Nordic was concerned about limited safety data on the method. The letter was first reported by the Washington Post.
Calif and Dr. Peter Marks, chief of the FDA’s vaccines division, said in a US government-sponsored study that intradermal injections elicit an immune response similar to the subcutaneous method. While the intradermal method resulted in more redness, itching, and swelling at the injection site, side effects were manageable and people actually experienced less pain from the injection, FDA officials told Bavarian Nordic in a letter.
There is limited data on the effectiveness of the vaccine in practice. WHO officials said earlier this week there were reports of groundbreaking cases where people who had received the vaccinations after exposure to the virus are still getting sick, as well as people contracting the disease after receiving the vaccine as a preventative measure.
“We knew from the start that this vaccine wasn’t going to be a silver bullet, that it wasn’t going to live up to all the expectations that were placed on it, and that we don’t have any clear efficacy data or efficacy data around that.” Rosamund Lewis, the WHO’s top monkeypox expert, told reporters on Wednesday.
The monkeypox vaccine can be given after exposure to reduce the risk of serious illness, or before exposure to reduce the risk of infection.
Walensky said last week that the CDC is starting studies to monitor the shots’ real-world effectiveness in preventing disease. She said Thursday the CDC expects the shots to be most effective two weeks after the second dose of the vaccine.