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Monkeypox vaccine maker raises concerns about plan to split doses

The CEO of the company that makes the only vaccine approved by the Food and Drug Administration (FDA) to prevent monkeypox told Biden administration health officials he was concerned about a new strategy to split doses and change the way the vaccine is injected. In a letter shared with The Hill, Bavarian Nordic CEO Paul…

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The CEO of the business that creates the sole vaccine authorized by the Food and Drug Administration (FDA) to prevent monkeypox expressed his concern about a new plan to split dosages and alter the injection technique for the vaccine to Biden administration health officials.

The company has “some misgivings” about the new strategy, according to Bavarian Nordic CEO Paul Chaplin in a letter obtained by The Hill, “because to the very limited safety data available,” as well as the fact that more persons had negative reactions following vaccination.

According to Chaplin, this “may have a detrimental effect on vaccine uptake and coverage.”

The Washington Post was the first to report on the letter to Xavier Becerra, secretary of health and human services, and FDA commissioner Robert Califf.

Although the corporation fully supports strategies to conserve limited supply, according to Chaplin, “it would have been sensible” to introduce the new policy with much more thorough advice that would have allowed for the collection of extra safety data.

The letter was dated August 9, the day the government made a significant adjustment to its vaccination program for monkeypox. The new approach uses one-fifth less vaccination per shot and divides the doses into smaller portions. Instead of administering the complete amount of the vaccine into the underlying fat as is customary with shots, only a portion of it is injected into the top layer of skin.

The new method, known as an intradermal injection, makes use of a smaller needle and probably calls for more training for those administering the shot. Not the company, but the National Institutes of Health, requested a change in the immunization procedure.

Since last Thursday, according to Chaplin, the company has received “a deluge of calls from U.S. state government officials with questions and concerns” about the new immunization program.

In order to ensure the optimal rollout, Chaplin stated, “We will of course coordinate our answers with those of our CDC colleagues. However, we think that coordination would have been better served prior to any announcement.”

The new approach aims to stretch the Jynneos vaccination from Bavarian Nordic’s limited supply in the United States. The number of verified cases of monkeypox in the nation is above 10,000, and there is a severe shortage of the vaccine.

According to an estimate by Peter Marks, the FDA’s senior vaccine expert, 1.6 to 1.7 million Americans are thought to be at a higher risk of monkeypox and may benefit from vaccination.

Given that Jynneos needs two doses, the nation need 3.2 to 3.4 million doses. But according to current estimates, only approximately half of that number will be made available before the end of 2022, according to Marks.

Other strategies for preserving or extending dosages, such as delaying second doses of Jynneos or utilizing an older smallpox vaccine, were taken into consideration, according to Marks, but the intradermal approach was the only one judged suitable.

The nation’s remaining 441,000 dosages might be divided among 2.2 million shots under the new strategy.

The extra doses of vaccine that will be made available “may also help to significantly improve public health by assisting in containment efforts in the current situation of a monkeypox outbreak that is spreading in the context of a restricted number of vaccine doses,” Marks wrote.

In order to vaccinate more people with a first dosage, Chaplin said Bavarian Nordic was open to delaying second doses, a practice used by other cities as well as the UK.

However, Marks said that there was no proof that a single dose offered sufficient protection, despite the fact that a clinical trial had demonstrated the efficacy of intradermal delivery.

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