The United States will make an additional 786,000 doses of monkeypox vaccine available to local health departments “as soon as possible” after the Food and Drug Administration approves the vaccines for distribution, the top official said Wednesday. of the country’s health.
Health and Human Services Secretary Xavier Becerra said the federal government would announce more allocations of the two-dose vaccine, called Jynneos, to local health departments on Thursday. The US monkeypox vaccination campaign has encountered major hurdles as demand for vaccines has exceeded supply, leading to long lines at clinics and protests in some cities.
The United States has reported more than 3,500 cases of monkeypox in 46 states, Washington, DC 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 behind Spain.
The Jynneos vaccine is made by Danish biotech company Bavarian Nordic. The FDA had to inspect and approve a Nordic Bavarian factory in Denmark to ensure the shots met quality standards. The doses were shipped to the United States 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 FDA inspection and called on President Joe Biden to use his executive authority to expedite delivery. The FDA began inspecting the facility in early July, two months after the global monkeypox outbreak began.
“It is unclear why the FDA delayed inspection of a stock needed for biodefense, and this oversight cost valuable time in the US response to monkeypox. Bureaucratic delays should not prevent us from getting the doses. vaccine we need now,” Mondaire Jones said. 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 on a call earlier this month that the agency and HHS worked to expedite approval of the northern Bavarian facility soon after. the first confirmed case of monkeypox in the United States. The doses were initially to be released. in the fall, Marks said.
House Democrats also called on the White House to declare a public health emergency and work with Congress to secure additional funding to respond to the outbreak.
The United States has shipped more than 300,000 doses of the Jynneos vaccine to state and local health authorities since May, according to the Biden administration. HHS has also secured an additional 5 million doses for the United States that will ship through mid-2023.
The FDA approved the Jynneos vaccine in 2019 for people ages 18 and older who are at high risk of exposure to monkeypox or smallpox. The viruses belong to the same family, although monkeypox causes milder disease. There are no data on how effectively vaccines will prevent the disease in the current outbreak, according to the CDC.
Monkeypox is mainly spread through close physical contact during sex, and currently men who have sex with men are most at risk of infection. About 99% of monkeypox patients in the United States are male, and 98% of the 309 patients who provided demographic information were identified as men who have had sex with men, according to the CDC.
Vaccination with Jynneos should begin within four days of exposure to monkeypox to have the best chance of preventing disease onset, according to the CDC. The two doses are given 28 days apart. If the vaccine is given between four and 14 days after exposure, the injections may not prevent disease, but may reduce symptoms.
The CDC recommends vaccination for people with confirmed or suspected exposures to monkeypox as well as people at high risk of infection. The US also has over 100 million doses of an older generation smallpox vaccine called ACAM2000 which is likely effective in preventing monkeypox, but ACAM2000 can have serious side effects. It is not recommended for people with weakened immune systems, including people with HIV, pregnant women and people with eczema and similar skin conditions.