US to distribute 786,000 additional monkeypox vaccine doses obtained from Danish plant

Biden government has come under criticism for delayed response to monkeypox outbreak

The US government has announced that it will make 786,000 additional monkeypox vaccine doses available to local health departments “as soon as possible”.

More than 3,500 cases of monkeypox have been recorded across 46 states, Washington, DC, and Puerto Rico, according to the Centers for Disease Control and Prevention (CDC). The US has the second-highest number of monkeypox cases in the world, only behind Spain.

On Wednesday, the Food and Drug Administration (FDA) said that it had finished certifications of the Jynneos vaccine at Bavarian Nordic’s facility in Denmark.

“Given the emerging public health need, FDA previously facilitated the shipment of manufactured doses to the US so that they would be ready to be distributed once the manufacturing changes were approved,” it said.

“With this supplement approval, those manufactured doses may now be further distributed and administered. Additional doses manufactured at this plant can help address the need for this vaccine moving forward.”

Last week the pace of the FDA inspection was criticised by House Democrats, who wrote to president Joe Biden to expedite the delivery, CNBC reported.

“It is unclear why the FDA delayed inspection of a 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,” representatives Mondaire Jones and Jerrold Nadler, both from New York, wrote in the letter to the president, signed by 48 other members of Congress.

The agency which requires inspections of all vaccine manufacturing plants to assure safety, sterility and consistency of production, began its checks at the facility only earlier this month, two months after the beginning of the global monkeypox outbreak.

While officials had announced orders for five million more doses this month, most of the shipments are not expected to arrive until next year.

“There’s not enough doses,” Dr Perry Halkitis of Rutgers University said. “I think with some quicker action on part of federal government we might not be in the situation we are now.”

Officials have recommended the vaccines to those who know or suspect they were exposed to monkeypox in the last two weeks.

The virus spreads through close contact and tends to cause flu-like symptoms and pus-filled skin lesions. Its more commonly known symptoms are a high temperature, headache, muscle aches, backache, swollen glands, shivering and exhaustion, according to the NHS website.

Last week, the World Health Organisation (WHO) declared the monkeypox outbreak in more than 70 countries a “global health emergency”. The WHO label is set to trigger a coordinated international response and could unlock funding for countries to collaborate on sharing vaccines and treatments.

Cases of monkeypox emerged in early May from countries where the disease is not endemic, and continue to be reported in several endemic countries, the WHO said.

According to the CDC, more than 16,000 cases of monkeypox have been reported in 74 countries since May.

Additional reporting by agencies