US releases 786,000 more doses of monkeypox vaccine as outbreak spreads – CNBC

A person carries doses of the Imvanex vaccine used to protect against monkeypox virus at the Edison Municipal Vaccination Center in Paris, France, July 27, 2022.

Alan Joquard | pool | Reuters

The United States will make an additional 786,000 doses of the monkeypox vaccine available to local health departments “as soon as possible” after the Food and Drug Administration approved the injections for distribution, the top US health official said on Wednesday.

Health and Human Services Secretary 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 faced significant hurdles as demand for injections outpaced supply, leading to long queues at clinics and protests in some cities.

The United States has reported more than 3,500 cases of monkeypox in 46 states, Washington, D.C., 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 produced by the Danish biotechnology company Bavarian Nordic. The Food and Drug Administration (FDA) had to inspect and sign off on a Bavarian factory in the North in Denmark to ensure that the shots met quality standards. The doses were shipped to the United States while the Food and Drug Administration conducted their 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 Food and Drug Administration’s inspections and called on President Joe Biden to use his executive power to speed up delivery. The US Food and Drug Administration (FDA) began inspecting the facility in early July, two months after the start of a global outbreak of monkeypox.

“It is unclear why the US Food and Drug Administration has been so late in examining the stockpile needed for biodefense, and this omission has cost valuable time in the US response to monkeypox. Bureaucratic delays should not prevent us from getting the vaccine doses we need now,” reps. Mondir Jones and Jerrold Nadler, both from New York, wrote in the letter signed by 48 other members of Congress.

The FDA’s chief vaccine officer, Dr. Peter Marks, told reporters during a call earlier this month that the agency and HHS worked to expedite approval of the northern Bavarian facility shortly after the first confirmed case of monkeypox in the United States. Marx said in the fall.

Democratic members of the House of Representatives 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 to the United States that will be shipped through mid-2023.

The FDA approved the Jynneos vaccine in 2019 for people 18 years of age or older who are at high risk of exposure to monkeypox or smallpox. Viruses are from the same family, although monkeypox causes milder disease. There is no data on how effective vaccines will be in preventing disease in the current outbreak, according to the CDC.

Monkeypox is spread primarily through close physical contact during sex, and currently men who have sex with men are more likely to contract the infection. About 99% of monkeypox patients in the United States are men, and 98% of 309 patients who provided demographic information identified as men who had sex with men, according to the CDC.

Vaccination with Jynneos should begin within four days of exposure to monkeypox for the best chance of preventing the onset of the disease, 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 injection may not prevent disease but may reduce symptoms.

The Centers for Disease Control and Prevention recommends vaccination for people with confirmed or presumptive cases of monkeypox as well as for people at risk of infection. The United States also has more than 100 million doses of an older generation smallpox vaccine called ACAM2000 that is potentially effective in preventing monkeypox, but ACAM2000 can have serious side effects. Not recommended for those with compromised immune systems including people with HIV, pregnant women, and people with eczema and similar skin conditions.

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