A One-Dose Monkeypox Vaccine Strategy Could Help Extend Scarce Supplies As U.S. Outbreak Grows

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Topline

Health officials in New York City, Canada and the U.K. are stretching scarce monkeypox vaccine supplies by focusing on delivering as many first doses to high-risk groups as possible, a strategy opposed by key federal regulators amid a sluggish vaccine rollout marred by technical mishaps, a severe shot shortage that could last months and a growing outbreak experts warn may be difficult to contain.

Key Facts

Monkeypox vaccine is being offered to men who have sex with men at high risk of contracting the disease, as well as contacts of known cases.

Demand for the shots is fierce and supplies severely limited, hampering efforts to tackle the growing outbreak and risking monkeypox becoming a permanent fixture in the U.S.

Jynneos, the only vaccine specifically approved to prevent monkeypox, is supposed to be given in two doses delivered 28 days apart but the urgent situation has experts and health officials wondering whether a better approach would be to focus on getting as many first doses into high-risk people as quickly as possible.

The strategy is already used in Canada and in the U.K., and on Friday health officials in New York City, the epicenter of the U.S. outbreak, announced that they would also prioritize administering first doses.

The decision was made in light of the “accelerating outbreak,” is rooted in “available scientific evidence” and should not affect the immune response to the second dose, despite a longer interval between doses, the city’s health department said.

Rolf Sass Sørensen, vice president of investor relations at Bavarian Nordic, the Danish biotech that makes Jynneos, told Forbes the matter is “basically a regulatory issue” and said there is unpublished data that shows the second dose can wait up to two years and “still provide the same long-term boosting effect.”

Contra

The decision to prioritize first doses clashes with advice from the Centers for Disease Control and Prevention and the Food and Drug Administration. Both regulators endorse the dosing and schedule for which the vaccine was approved and is listed on the label. At a press conference on Friday, Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, acknowledged the “desire to get out as many doses as possible” but advised against departing from the recommended schedule. As the agency that approved the vaccine, Marks said the FDA is very familiar with the data supporting its use and believes that one dose does not provide sufficient protection over time if people continue with risky behaviors. “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.” CDC Director Rochelle Walensky echoed this reasoning in an interview with STAT News, saying people “need a higher level of protection than one dose will give.” The federal agencies both said the request to adhere to the vaccine’s approved schedule does not amount to asking states to “hold back doses”—second doses are often held in reserve if supplies are limited—and reiterated optimistic assertions that more shots are on the way. Officials have not provided key specific details, such as dates or numbers, of future vaccine shipments.

News Peg

The federal government expanded the scope of its monkeypox vaccine drive in June to include people most at risk of catching the disease. As cases have been identified almost exclusively among men who have sex with men and transmission is being driven by sexual contact—which is distinct from the virus being sexually transmitted—most cities and states are offering shots to members of this group who have multiple sexual partners or anonymous sex, as well as transgender and gender non-conforming people who have sex with men who do the same. Many are also offering shots to healthcare and lab workers involved in managing the outbreak. The scarcity of the vaccines, distributed according to the number of monkeypox cases and vulnerable people states have, alongside a series of technological and logical mishaps means many eligible Americans have been unable to get a shot. The U.S. has ordered nearly 7 million doses but most will not arrive for months. There have been 14,511 cases of monkeypox as of Tuesday, according to the CDC, the vast majority in countries that have not historically reported monkeypox and 2,108 in the U.S. Cases are likely significantly higher given inadequate or absent testing.

Crucial Quote

Dr. Peter Chin-Hong, an infectious disease expert at the University of California, San Francisco, told Forbes the strategy of providing one dose to as many people as possible would have been a “much better” approach for the U.S. than the current two-dose regimen. “The goal is as much individual protection as breaking the chain of transmission,” he explained. The longer we wait the harder it will be to contain the outbreak and the more likely it is that the virus “will spill over into the general population,” Chin-Hong added. Dr. Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security, agreed that prioritizing first doses is the best strategy right now. “There’s nothing magical about spacing vaccines the way they’re spaced on the label…you can catch people back up with their second doses later,” he added.

Further Reading

Struggling To Find A Monkeypox Shot? Severe Shortages And Technical Mishaps Are Slowing Down Rollouts (Forbes)

With monkeypox spreading globally, many experts believe the virus can’t be contained (STAT News)

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