NEW INJECTION METHOD APPROVED FOR MONKEYPOX SHOTS

Intradermal delivery designed to extend limited vaccine supply

The Biden administration has decided to stretch out its limited supply of monkeypox vaccine by allowing a different method of injection that uses one-fifth as much per shot, according to senior administration officials familiar with the planning.

In order for the Food and Drug Administration to authorize socalled intradermal injection, which would involve injecting one-fifth of the current dose into the skin instead of a full dose into underlying fat, the Department of Health and Human Services will need to issue a new emergency declaration allowing regulators to invoke the FDA’s emergency-use powers. That declaration is expected as early as this afternoon.

The move would help alleviate a shortage of vaccine that has turned into a growing political and public health problem for the administration.

The administration has faced a barrage of criticism that it was too slow to ship vaccine that was ready for use to the United States from Denmark, where it was manufactured, and too slow to order that bulk vaccine stocks be processed into vials after the disease first surfaced in the U.S. in mid-May.

In less than three months, more than 8,900 monkeypox cases have been reported. The disease spreads primarily through skin-to-skin contact during sex among men who have sex with men. Federal officials are concerned about both the current infection rate and the risk of further spread.

Even though it invested more than $1 billion in developing the two-dose vaccine known as Jynneos that works against both monkeypox and smallpox, the government has only 1.1 million shots on hand. It needs about three times as many doses to cover the 1.6 million to 1.7 million Americans who, according to the Centers for Disease Control and Prevention, are at high risk of contracting monkeypox.

Federal health officials said last week that so far, they have distributed about 600,000 doses of the vaccine.

The Department of Health and Human Services last week also issued a broader public-emergency declaration that allowed the federal government to more easily allot money and other resources to fight the virus.

Research on intradermal injection of the monkeypox vaccine is essentially limited to one study. It showed that when the vaccine was injected between skin layers, it induced an immune response comparable to that from a standard injection into the fat underneath the skin. Federal officials have consulted with a variety of outside groups about switching to the intradermal injection approach, according to people familiar with the talks.

Some outside experts have criticized the data backing up the method for monkeypox as too thin and narrowly focused. The government’s decision to go with it is heavily based on a 2015 study that was sponsored by the National Institutes of Health.

Dr. John Beigel, an NIH associate director of clinical research who has briefed federal health officials and the World Health Organization, said that switching to the intradermal method was a better option for preserving vaccine than administering just one of the two recommended doses. One shot does not prompt nearly as strong an immune response as two, he said.

“The upside is you can stretch out doses,” said John Moore, a virus expert at Weill Cornell Medicine. “The downside is if you cut it too far or take too many liberties, you reduce the efficacy. And how are you going to know that? It’s educated guesswork.”