HHS Statement on FDA Approval of Bavarian Nordic Monkeypox Vaccine

On Saturday, July 23, 2022, the director-general of the WHO declared monkeypox a public health crisis. Public health organizations have encouraged vaccination for at-risk populations to minimize the spread of the disease. On July 27, HHS secretary Xavier Becerra made a statement on the FDA approval of the Bavarian Nordic Monkeypox Vaccine.

Based on data from the New England Journal of Medicine, monkeypox is a zoonotic virus. The publication also states that between April 27 and June 24, 2022, there were 528 infections of monkeypox reported.

Researchers in the publication state, “transmission of monkeypox virus occurs through large respiratory droplets, close or direct contact with skin lesions, and possibly through contaminated fomites. There is no clear evidence of sexual transmission through seminal or vaginal fluids. Vertical transmission and fetal deaths have been described.”

The CDC states that rash, fever, headache, muscle ache, swollen lymph nodes, chills, and fatigue are potential symptoms of monkeypox.

According to the CDC monkeypox global outbreak map, as of August 1, 2022, there have been 22,485 confirmed cases of monkeypox during this recent outbreak.

These cases have not been contained to areas previously having monkeypox. Instead, 22,141 cases have been in countries without a history of monkeypox and only 344 have been in countries that have a history of the virus.

Recommendations from the WHO have included vaccinations for at-risk populations.

The California Department of Public Health states that the JYNNEOS vaccine, manufactured by Bavarian Nordic, is given in a two-dose series, four weeks apart.

While the monkeypox vaccine is deemed safe, the most common side effects are pain, redness, swelling, firmness, or itching at the injection site. Uncommon symptoms such as mild muscle pain, headaches, nausea, chills, or fatigue may also occur.

“This action by the FDA is a critical step forward in our plans to strengthen and accelerate our monkeypox response, which includes distributing a safe and effective vaccine to those at highest risk of exposure to monkeypox. The expedited inspection and approval by the FDA of Bavarian Nordic’s fill-and-finish capabilities means that an additional 786,000 doses of vaccine are now available for use in the US. HHS is working to make these doses available to states and jurisdictions as soon as possible to fulfill their needs and will announce allocations tomorrow,” said Becerra in a press release.

Becerra and other public health officials hope that increased vaccine doses will widen access to preventative measures and minimize the further spread of the virus. Individuals are urged to find a vaccination site or contact their healthcare provider to discuss their risk and vaccination status further.