Vaccine maker Monkeypox concerned about dose-splitting plan

The CEO of the company that makes the only Food and Drug Administration (FDA)-approved vaccine to prevent monkeypox has told Biden administration health officials he’s concerned about a new strategy aimed at dividing doses and changing the way the vaccine is injected.

In a letter shared with The Hill, Bavarian Nordic CEO Paul Chaplin said the company had “some reservations” about the new approach, “due to the very limited safety data available”, as well as the fact that more people experienced adverse effects after vaccination. .

“This can negatively impact vaccine uptake and coverage,” Chaplin wrote.

The letter to FDA Commissioner Robert Califf and Secretary of Health and Human Services Xavier Becerra was ffirst reported by the Washington Post.

Chaplin said the company fully supports approaches to keep supply limited, but “it would have been prudent” to roll out the new strategy with much more comprehensive guidance that would allow additional safety data to be collected.

The letter was dated Aug. 9, the day the administration announced a major shift in its monkeypox vaccination strategy. The new method splits the doses and uses one-fifth the amount of vaccine per injection. The partial dose of the vaccine is injected into the top layer of the skin, rather than the full dose into the underlying fat, which is how injections are usually given.

The new approach, called intradermal injection, uses a smaller needle and will likely require additional training for people giving the shot. The request for the vaccine method change was made by the National Institutes of Health, not the manufacturer.

Chaplin said the company has been “inundated with calls from US state government officials with questions and concerns” since last Thursday about the new vaccine plan.

“We will of course align our responses with our CDC colleagues, but we believe that this alignment would have been better served prior to any announcement to ensure the best deployment,” Chaplin wrote.

The new strategy is an attempt to stretch the United States’ limited supply of Bavarian Nordic’s Jynneos vaccine. There are more than 10,000 confirmed cases of monkeypox in the country and demand for the vaccine far exceeds supply.

Peter Marks, the FDA’s top vaccine official, wrote in a memo on Tuesday that about 1.6 to 1.7 million people are currently estimated to be at high risk for monkeypox in the United States and may need to be vaccinated.

Since Jynneos requires two doses, that means the country needs 3.2 million to 3.4 million doses. However, Marks said only around half of that number will currently be available before the end of 2022.

Marks said other methods of conserving or stretching doses were being considered, including postponing second doses of Jynneos or using an older smallpox vaccine, but the intradermal method was the only one deemed acceptable.

Under the new plan, the country’s remaining 441,000 doses could be stretched to give 2.2 million injections.

“In the current context of a monkeypox epidemic that continues to spread in the context of a limited number of doses of vaccine, the additional doses of vaccine that will be made available can also contribute to a measurable benefit to health. public by contributing to containment efforts,” Marc wrote.

Chaplin said Bavarian Nordic was willing to delay second doses in order to vaccinate more people with a first dose, a strategy employed by several cities as well as the UK.

But Marks said there was no evidence that a single dose provided enough protection, while a clinical trial had shown intradermal delivery to be effective.

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