Nearly 800,000 doses of the monkeypox vaccine could be in the US by the 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 after a Food and Drug Administration inspection of a Danish vaccine factory and the facility’s expected approval, part of an effort to set a record in the United States control the outbreak of the disease, according to the federal government.

About 780,000 doses are with the supplier in Denmark, according to the Ministry of Health and Human Services, which oversees the national stockpile where the vaccines are kept. The shots have been stored in Denmark awaiting completion of FDA inspection and approval on site.

“We are working diligently and as quickly as possible and are aiming to have this process complete by the end of July,” Peter Marks, the FDA’s vaccine director, said in an interview on Wednesday.

The inspection is complete, but still with approval from the FDA allows the Jynneos vaccine, the only one specifically approved by the agency to prevent monkeypox, to be flown to the United States on special aircraft owned by Bavarian Nordic, the vaccine’s maker in Denmark, Marks said.

“We have to fly in these cans from Europe,” he said. “They have to come with special planes [to maintain needed cold temperatures]. …You can only load 150,000 to 160,000 cans at a time.”

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

US response to monkeypox mirrors early missteps of coronavirus, experts say

city ​​and state Officials in New York have been complaining to the White House for days that they haven’t received enough vaccine, arguing that they are dealing with the country’s largest monkeypox outbreak and more doses should be allocated. New York had 158 cases as of Tuesday, according to federal health data. New York City Mayor Eric Adams (D) held a phone call with officials in the Biden administration on Tuesday, in which he again expressed concerns that the administration would need to send more cans to the city.

Monkeypox cases have been rising steadily since they were first reported in May, with 929 cases in 41 states, DC and Puerto Rico, according to the Centers for Disease Control and Prevention. Due to difficulties in accessing testing, experts say the real caseload is much higher.

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

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

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

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 next week – its second – to decide whether to declare monkeypox a global health emergency.

Due to the limited supply of For the Jynneos vaccine, the US government allocates doses based on the number of people at risk of monkeypox who also have pre-existing conditions such as HIV.

With the spread of monkeypox, health advocates, particularly those representing the gay, bisexual, and transgender communities, have urged the federal government to significantly step up its response. In a letter to top health officials last month, two nonprofits — Prep4All and Partners in Health — complained that “members of vulnerable communities are being turned away from monkeypox vaccines because these vaccines are under-available in the US but are sitting in Freezers in Denmark.” They said one of the raids was a delay in FDA inspection of the facility.

But Marks defended the agency, saying the FDA moved there after the monkeypox outbreak speed up plant inspection, planned for this fall. He said FDA policy is to inspect new manufacturing facilities to ensure vaccines are “made in a manner that is consistent with the quality we expect…which is directly related to safety and efficacy.” This was not the place to skimp on.”

The agency inspected the facilities that make the vaccine in 2019 when it approved the vaccine. But Bavarian Nordic has recently started using its own ‘fill finish’ facility, where the vaccine is filled into a vial and tested to ensure the material is shelf stable. That facility required regulatory inspection, Marks said.

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

According to HHS, New York City received 21,821 cans.

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 this order will arrive at the warehouse later this year and continue until early next year.

Dan Diamond contributed to this report.

Comments are closed.