U.S. to release 786,000 additional monkeypox vaccine doses as outbreak spreads

The U.S. will make 786,000 additional monkeypox vaccine doses available to local health departments “as soon as possible” after the Food and Drug Administration approved the shots for distribution, the nation’s top health official said on Wednesday.

Health and Human Services Secretary Xavier Beccerra said the federal government will announce more allocations of the two-dose vaccine, called Jynneos, for local health departments on Thursday. The U.S. vaccination campaign against monkeypox has faced major hurdles as demand for the shots has outstripped supply, leading to long lines at clinics and protests in some cities.

The U.S. has reported more than 3,500 cases of monkeypox across 46 states, Washington D.C., and Puerto Rico, according to the Centers for Disease Control and Prevention. The U.S. has the second highest number of monkeypox cases in the world after Spain.

The Jynneos vaccine is made by the Danish biotech company Bavarian Nordic. The FDA had to inspect and sign off on a Bavarian Nordic plant in Denmark to ensure the shots met quality standards. Doses were shipped to the U.S. while the FDA conducted its review this month and can now be distributed to local authorities for use.

House Democrats, in a letter to the White House last week, criticized the pace of the FDA inspection and called on President Joe Biden to use his executive authority to speed up delivery. The FDA began to inspect the facility in early July, two months after the global monkeypox outbreak began.

“It is unclear why the FDA delayed inspection of a stockpile needed for biodefense, and this omission has cost valuable time in the U.S. response to monkeypox. Bureaucratic delays should not prevent us from getting the vaccine doses we need now,” Reps. Mondaire Jones and Jerrold Nadler, both of New York, wrote in the letter signed by 48 other members of Congress.

The FDA’s top vaccine official, Dr. Peter Marks, told reporters during a call earlier this month that the FDA and HHS worked to expedite approval of the Bavarian Nordic facility soon after the first confirmed monkeypox case in the U.S.  The doses were originally scheduled for release in the fall, Marks said.

The House Democrats also called on the Biden administration to declare a public health emergency and work with Congress to secure additional funding to respond to the outbreak.

The U.S. has shipped more than 300,000 doses of the Jynneos doses to state and local health authorities since May, according to the Biden administration. HHS has also secured an additional 5 million doses for the U.S. that will ship through the middle of 2023.

The FDA approved the Jynneos vaccine in 2019 for people ages 18 and older who are at a high risk of exposure to monkeypox or smallpox. The viruses are in the same family, though monkeypox causes milder disease. There is no data on how effectively the vaccines will prevent disease in the current outbreak, according to the CDC.

Monkeypox is primarily spreading through close physical contact during sex, and men who have sex with men are the highest risk of infection right now. About 99% of monkeypox patients in the U.S. are men, and 98% of the 309 patients who provided demographic information identified as men who have sex with men, according to the CDC.

Vaccination with Jynneos should begin within 4 days of exposure to monkeypox to have the best chance of preventing disease onset, according to the CDC. The two doses are administered 28 days apart. If the vaccine is administered between 4 and 14 days after exposure, the shots may not prevent disease but could reduce symptoms, according to the CDC.

The CDC is recommending vaccination for people with confirmed or presumed monkeypox exposures as well as people at high risk of infection. The U.S also has more than 100 million doses of an older generation smallpox vaccine called ACAM2000 that is likely effective at preventing monkeypox, but ACAM2000 can have serious side effects. It’s not recommended for those with weak immune systems such people who are HIV positive, pregnant women, and people with eczema and similar skin conditions.