US releases 786,000 additional vaccine doses of monkey pox

The US will make 786,000 additional monkeypox vaccine doses available to local health departments “as soon as possible after the Food and Drug Administration approves the injections for distribution, the country’s top health official said Wednesday.

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

The US 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 US has the second highest number of monkey pox cases in the world after Spain.

The Jynneos vaccine was created by the Danish biotech company Bavarian Nordic. The FDA had to inspect and sign a Bavarian Scandinavian factory in Denmark to make sure the shots met quality standards. Doses were shipped to the US as the FDA conducted its review this month and can now be distributed to local authorities for use.

In a letter to the White House last week, House Democrats criticized the pace of the FDA inspection and called on President Joe Biden to use his executive power 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 has delayed inspection of a stockpile needed for biodefense, and this omission has cost precious time in the US response to monkeypox. Bureaucratic delays should not prevent us from getting the vaccine doses that we need. we need now,” Representatives 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, on a phone call earlier this month, told reporters that the agency and HHS were working to expedite approval of the Bavarian Scandinavian facility shortly after the first confirmed case of monkeypox in the US. The doses were originally scheduled for release in the fall, Marks said.

The 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.

According to the Biden administration, the US has shipped more than 300,000 doses of the Jynneos vaccine to state and local health authorities since May. HHS has also secured an additional 5 million doses for the US to ship through mid-2023.

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

Monkeypox mainly spreads 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 U.S. are men, and 98% of the 309 patients who provided demographic information identified as having had sex with men, according to the CDC.

Vaccination with Jynneos, according to the CDC, should begin within four days of monkeypox exposure to have the best chance of preventing the onset of the disease. 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 monkeypox exposure and for those at high risk of infection. The US also has more than 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 weak immune systems, including those who are HIV positive, pregnant women, and those with eczema and similar skin conditions.

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