Nearly 800,000 doses of monkeypox vaccine may be in U.S. by end of July

Nearly 800,000 more doses of monkeypox vaccine could be ready for distribution in the United States by the end of July following a Food and Drug Administration inspection of a Danish vaccine plant and the expected authorization of the facility, part of an effort to control a record U.S. outbreak of the disease, according to the federal government.

About 780,000 doses are at the supplier in Denmark, according to the Department of Health and Human Services, which oversees the national stockpile where the vaccines are maintained. The shots have been stored in Denmark awaiting the completion of the FDA on-the-ground inspection and authorization.

We are working diligently and as fast as we can, and we are aspiring to have that process completed by the end of July, Peter Marks, who oversees vaccines at the Food and Drug Administration, said in an interview Wednesday.

The inspection is finished, but even with authorization pending, the FDA is allowing the Jynneos vaccine, the only one specifically approved by the agency to prevent monkeypox, to be flown to the United States on special planes from Bavarian Nordic, the vaccine’s manufacturer in Denmark, Marks said.

We have to fly those doses from Europe, he said. “They have to come on special planes [to maintain needed cold temperatures]. . . . They can only load 150,000 to 160,000 doses at a time.”

The update on the vaccine supply comes amid heated criticism leveled at the FDA and other federal health agencies over the response to the monkeypox outbreak. In New York City, where demand for vaccines far outstrips supply, the city’s monkeypox vaccine appointment website crashed Tuesday “due to overwhelming traffic,” the city said.

City and state officials in New York have complained for days to the White House that they have not received enough vaccines, arguing that they are dealing with the nation’s largest monkeypox outbreak and should be apportioned more doses. New York had 158 cases, as of Tuesday, according to federal health data. New York Mayor Eric Adams, D, held a call with Biden administration officials Tuesday in which he again raised concerns that the administration needed to send more doses to the city.

Monkeypox cases have climbed steadily since they were first reported in May, with 929 cases in 41 states, the District and Puerto Rico, according to the Centers for Disease Control and Prevention. Because of difficulties accessing testing, experts say the actual case count is much higher.

White House coronavirus coordinator Ashish Jha tried to allay concerns Wednesday on CNN, saying a shipment of vaccines is expected from Denmark this week and that there will be more doses arriving “in the days and weeks ahead.”

Jha, noting that gay and bisexual men have been disproportionately affected by the virus, urged anyone who develops a fever and rash to get tested and treated. “This is not some novel virus,” Jha said. “We have tests, therapies, we have vaccines. . . . We are going to get our arms around this thing.”

The United States maintains doses of two vaccines effective against monkeypox. Of the two, Jynneos, a two-shot vaccine, is in high global demand. The other, ACAM2000, is older and was approved to prevent smallpox. While that vaccine is effective against monkeypox, it can cause serious side effects and cannot be used for people with severely weakened immune systems or eczema, according to the CDC.

More than 10,000 cases of monkeypox have been reported in more than 60 countries. The World Health Organization is expected to hold an emergency meeting – its second – next week to decide whether to declare monkeypox a global health emergency.

Because of the limited supply of the Jynneos vaccine, the U.S. government is allocating doses based on the number of individuals at risk for monkeypox who also have preexisting conditions, such as HIV.

As monkeypox has spread, health advocates, especially those representing the gay, bisexual and trans communities, have pressed the federal government to sharply step up its response. In a letter last month to top health officials, two nonprofits – Prep4All and Partners in Health – complained that “members of at risk communities are being turned away from monkeypox vaccination because these vaccines are not available in sufficient quantity in the U.S., but instead sitting in freezers in Denmark.” They said one of the holdups was a delay in the FDA inspection of the facility.

But Marks defended the agency, saying that when the monkeypox outbreak occurred, the FDA moved to accelerate the plant inspection, which had been planned for this fall. He said the FDA’s policy is to inspect new manufacturing operations to ensure that vaccines are being made “in a way that is consistent with the quality we expect . . . which is directly related to safety and effectiveness. This was not the place to skimp on that.”

The agency inspected the facilities that make the vaccine in 2019, when it approved the vaccine. But Bavarian Nordic recently started using its own “fill-finish facility,” where the vaccine is put in a vial and tested to ensure the material is stable to store. That facility required an agency inspection, Marks said.

Since the first U.S. cases of monkeypox were reported in May, U.S. officials have distributed more than 135,000 doses of Jynneos from the Strategic National Stockpile, according to HHS.

New York City has received 21,821 doses, according to HHS.

In early July, the Biomedical Advanced Research and Development Authority, the HHS office responsible for protecting Americans from biological threats, ordered an additional 2.5 million doses of the Jynneos vaccine in response to the current outbreak and future episodes. Deliveries from that order will begin arriving at the stockpile later this year and continue through early next year.