US to distribute 800,000 doses of monkeypox vaccine after weeks of delay

After weeks of delays, nearly 800,000 doses of the monkeypox vaccine will soon be available for distribution, US health regulators said on Wednesday.

Also on Wednesday, it was reported that the US Centers for Disease Control and Prevention (CDC) plans to make the rapidly spreading disease a nationally notifiable condition, a move that would streamline reporting of cases.

Through the designation, which will probably take effect on 1 August, the agency will direct all states to share surveillance data, including case numbers, Politico said, citing people with knowledge of the matter and a letter sent to state epidemiologists on Monday.

States will be required to report confirmed or probable monkeypox cases within 24 hours, Politico said. State health departments are not yet required to provide the federal government with standardized data on monkeypox.

More than 3,500 monkeypox cases were reported in the US as of Tuesday, according to the CDC.

The announcement that more doses of vaccine are on the way came amid growing criticism that authorities have been too slow in deploying the vaccine, potentially missing the window to contain what could become an entrenched infectious disease.

Nearly two weeks ago, the Food and Drug Administration (FDA) said it had finished inspections at Bavarian Nordic’s facility in Denmark, where the company fills vials of the vaccine.

The FDA said on Wednesday the certification had been finalized. The doses are already in the US “so that they would be ready to be distributed once the manufacturing changes were approved”, the agency said.

The US has sent more than 310,000 doses of the Jynneos vaccine to state and local health departments. But clinics in San Francisco, New York and other large cities say they don’t have enough shots.

The head of the US Department of Health and Human Services said on Wednesday officials would announce more allocations on Thursday.

Monkeypox mainly spreads through skin-on-skin contact but it can also transmit through touching linens used by someone with the infection. The vast majority of cases reported have been in men who have sex with men, though health officials have stressed that anyone can catch the virus.

People with monkeypox may experience fever, body aches, chills and fatigue. Many in the outbreak have developed zit-like bumps on many parts of the body.

The sluggish federal response has drawn comparisons to the initial days of the Covid outbreak. Experts had pointed out that the US had one huge advantage: more than 1m doses of vaccine in the strategic national stockpile.

But it turned out US officials had only about 2,000 doses on hand when the outbreak was identified in May. Shipping and regulatory delays have meant only a portion of the rest were deployed.

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

The doses previously shipped came from a separate facility in Denmark that had FDA clearance. Another 786,000 doses made at a newly opened Bavarian Nordic facility were awaiting the US certification announced on Wednesday.

The FDA requires inspections of all vaccine manufacturing plants to assure safety, sterility and consistency of production.

US officials announced orders this month for 5m more doses, though most of those are not expected to arrive until next year.

Officials have recommended the shots be given to people who know or suspect they were exposed to monkeypox in the previous two weeks.

The Jynneos vaccine has never been widely used in response to an outbreak like this, and the government will track how well it’s working.

The Guardian