NYC will use a one-dose monkeypox vaccine strategy to stretch supplies, despite FDA, CDC warnings against the move

New York City’s Health Department announced Friday it will speed up the delivery of first doses of monkeypox vaccine to people in the city at high risk of contracting the disease. The move, it warned, may delay the city’s ability to dole out second doses to those who’ve been vaccinated — which would run counter to advice from the Food and Drug Administration and the Centers for Disease Control and Prevention.

“New York City is the epicenter of the monkeypox outbreak in the U.S. and yet does not have sufficient vaccine supply to reach the number of people who need it protect themselves,” the department said in a late afternoon press release. “Given the rapid increase in cases, the Health Department has decided that providing first doses to offer protection to more at-risk New Yorkers is the best strategy until we receive adequate vaccine supply.”

“Until there is sufficient supply in the city, all vaccine doses will be treated as first doses, and we will only begin scheduling second dose appointments once we have enough vaccine to do so. The department will communicate to people who have received first doses about when second doses are available and how to receive them.”

This approach is being used in the United Kingdom and in Canada, where decisions were made to focus on getting first doses of the vaccine into people at high risk of contracting monkeypox and worry later about catching up those people’s second doses. A similar strategy was employed by some countries — though not the United States — in the early days of the Covid-19 vaccine rollout.

The vaccine in question, Jynneos, is meant to be given in two doses, with the second jab administered 28 days after the first. And Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, stressed on Friday that is the way the agency believes the vaccine should be given.

“We do not recommend to go off of the recommended schedule here,” Marks said during a press conference organized by the Department of Health and Human Services to update the media on the administration’s monkeypox response.

“A single dose of this vaccine will not provide the kind of protection over time that is necessary if people continue this risky behavior,” Marks said. “So the two-dose regimen is the best that we can do to make sure that we actually have people get the protection that the vaccine is intended to provide.”

Vaccine is currently being offered both to people who are known contacts of monkeypox cases and men who have sex with men who are at high risk because they have multiple sex partners or partake in anonymous sex. For that latter group, the risk of contracting monkeypox is ongoing and one dose of vaccine will not offer enough protection, CDC Director Rochelle Walensky explained.

“You just need a higher level of protection than one dose will give you. That’s really why we’re advocating for two doses,” Walensky told STAT in an interview.

Though the New York health department release raised the specter that second doses may have to be delayed because of the decision to prioritize the delivery of first doses, Walensky said the administration hopes to have enough vaccine by the end of the month to enable New York to give second doses on schedule.

“There’s going to be another allocation for New York that they’ll hear about today,” Walensky told STAT in an interview. “And we have a lot more doses coming, likely by the end of the month. And so we actually anticipate that we will have enough to cover their second doses when those doses come in.

“So we’re not asking New York — or anybody — to hold back doses right now because … we’re pretty confident that what’s going to come in is going to be able to cover those second doses,” she said.

New York City had been holding back 1,000 doses for second vaccinations, but will instead use them to expand the pool of people who can get a first shot, the health department said.

Demand for the vaccine has been high in the city, with vaccination appointments snapped up quickly whenever they become available. A block of appointments opened up online at 6 p.m. Friday for 9,200 doses that will administered in clinics in all five boroughs over the weekend. They were filled by 6:07 p.m.

As of Friday afternoon, the city had detected 461 cases of monkeypox — nearly a third of the cases in the entire country. As of Thursday, 43 states, the District of Columbia and Puerto Rico had reported 1,814 cases.

Walensky said that with the U.S. taking delivery of more vaccine, distribution allocation will start to focus on states with the highest number of cases.  “We are going to be allocating based on cases pretty heavily in this next round and so I anticipate that there will be a lot more supply for … New York.”

So far the administration has distributed 156,000 doses of monkeypox vaccines. It announced Friday that an additional 131,000 doses of the Jynneos vaccine — made by Bavarian Nordic, a Danish company — had arrived in the U.S. and would be shipped to states and territories immediately.

A further 780,000 doses are in the process of being approved for release and may arrive before the end of July.