A person holds doses of the Imvanex vaccine, used to protect against monkeypox virus, at the Edison municipal vaccination center in Paris, France, on July 27, 2022.
Alain Jokar | Pole | Reuters
The U.S. will provide 786,000 additional doses of monkeypox vaccine to local health departments “as soon as possible” after the Food and Drug Administration approved the shots for distribution, the country’s top health official said Wednesday.
Health and Human Services Minister Xavier Becerra said Thursday the federal government will announce additional allocations of a two-dose vaccine called Jynneos to local health departments. The monkeypox vaccination campaign in the US has been hit hard as demand for vaccines has outstripped supply, leading to long lines at clinics and protests in some cities.
More than 3,500 cases of monkeypox have been reported in the United States in 46 states, Washington, and Puerto Rico, according to the Centers for Disease Control and Prevention. The United States has the second highest number of monkeypox cases in the world after Spain.
The Jynneos vaccine is manufactured by the Danish biotech company Bavarian Nordic. The FDA had to check and sign off the Bavarian Nordic plant in Denmark to make sure the vaccines met quality standards. The doses were shipped to the US while the FDA was conducting their review this month and can now be turned over to local authorities for use.
House Democrats, in a letter to the White House last week, criticized the pace of the FDA review and urged President Joe Biden to use his executive powers to expedite delivery. The FDA began inspecting the facility in early July, two months after the start of the global monkeypox outbreak.
“It is not clear why the FDA delayed reviewing stockpiles needed for biosecurity, and this omission has cost precious time in the US response to monkeypox. Bureaucratic delays should not prevent us from getting the vaccine doses we need now,” the representatives said. Mondar Jones and Jerrold Nadler, both from New York, wrote in a letter signed by 48 other members of Congress.
A senior FDA vaccine official, Dr. Peter Marks, told reporters during a call earlier this month that the agency and HHS were working to speed up approval of the Bavarian Scandinavian facility shortly after the first confirmed case of monkeypox in the US. Initially, the doses were to be released in the fall, Marks said.
House Democrats also urged the White House to declare a public health emergency and work with Congress to secure additional funding for the outbreak response.
Since May, the US has sent more than 300,000 doses of the Jynneos vaccine to state and local health authorities, according to the Biden administration. HHS has also secured an additional 5 million doses for the US, to be shipped by mid-2023.
The FDA approved the Jynneos vaccine in 2019 for people aged 18 and older who are at high risk of contracting monkeypox or smallpox. Viruses belong to the same family, although monkeypox causes milder disease. According to the CDC, there is no data on how effectively vaccines will prevent the disease in the current outbreak.
Monkeypox is mainly spread through close physical contact during sex, and men who have sex with men are currently at the greatest risk of infection. About 99% of monkeypox patients in the US are men, according to the CDC, and 98% of the 309 patients who provided demographic information identified as men who had sex with men.
According to the CDC, Jynneos vaccination should begin within four days of exposure to monkeypox for the best chance of preventing the onset of the disease. Two doses are administered 28 days apart. If the vaccine is given between 4 and 14 days after exposure, vaccinations may not prevent the disease, but may reduce symptoms.
The CDC recommends vaccination of people with confirmed or suspected exposure to monkeypox, as well as people at high risk of infection. There are also over 100 million doses of an old-generation smallpox vaccine in the US called ACAM2000, which is likely effective in preventing monkeypox, but ACAM2000 can have serious side effects. Not recommended for people with weak immune systems, including HIV positive, pregnant women, people with eczema and similar skin conditions.