Vaccine maker Monkeypox voices concerns over US plan to split doses

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The maker of the only vaccine approved by the Food and Drug Administration to protect against monkeypox has privately warned top Biden health officials of plans to split doses and change how injections are given.

“We have some reservations…due to the very limited safety data available,” Bavarian Nordic CEO Paul Chaplin wrote to Health and Human Services Secretary Xavier Becerra and Food and Drug Administration Commissioner. , Robert M. Califf, in a letter sent on Tuesday and obtained by the Washington Post.

“It would have been prudent” to conduct more studies before revising the national monkeypox vaccination strategy, Chaplin said, adding that his company had been “inundated with calls from U.S. government officials with questions and concerns” about how to implement the new plan.

In interviews on Wednesday, Biden administration officials acknowledged the concerns of the Bavarian Nordic countries, but said they would not affect their vaccine strategy.

“We’ve had conversations with them about this, as has the FDA,” Becerra said. “We wouldn’t have moved forward if we didn’t think it was safe and effective, and if the FDA hadn’t dotted the I’s and crossed out the T’s.”

Some Biden officials also believe Bavarian Nordic’s concerns stem from a potential loss of profits if the United States and other countries were able to stretch their existing vaccine supplies and reduce the need for future orders. according to three officials who were not authorized to comment. A Bavarian Nordic representative who spoke on condition of anonymity because he was not authorized to comment stressed that the company’s concerns were driven by safety.

Becerra and other officials on Tuesday announced a strategy to stretch the country’s limited supply of monkeypox vaccine, saying the plan would turn several hundred thousand doses of Bavarian Nordic’s Jynneos vaccine into millions of potential vaccines. . About 9,500 cases of monkeypox have been confirmed in the United States, mostly among gay and bisexual men, and local officials have pressed the White House to provide more vaccine doses amid growing demand.

The plan is a “game changer,” Robert J. Fenton Jr., national monkeypox response coordinator, told reporters on Tuesday. “It’s safe, it’s effective and it will significantly increase the volume of vaccine doses available.”

Under the new approach, healthcare providers would divide each single-dose vial of Jynneos into five doses. Rather than injecting the injections subcutaneously, a traditional way of delivering vaccines into fatty tissue under the skin, the doses would be injected under the top layer of the skin. This approach, known as intradermal injection, uses a thinner needle and less vaccine but results in a small bubble forming on the surface of the skin.

Calif, who authorized the new approach Tuesday cited a 2015 study of the two-dose vaccine that he said showed the strategy would be effective. Chaplin, the Nordic Bavarian CEO, was one of the authors of the study.

“The results of this study demonstrate that intradermal administration elicits a similar immune response to subcutaneous administration,” Califf said Tuesday. The FDA commissioner first publicly announced the dose-splitting strategy last week.

Peter Marks, the FDA’s top vaccine official, released a note which reviewed data from the new approach and addressed the need to increase existing vaccine stocks.

“It is currently estimated that approximately 1.6 to 1.7 million people are at high risk for monkeypox in the United States and may need vaccination,” Marks wrote in his memo. “Therefore, 3.2 to 3.4 million doses of JYNNEOS would be needed to immunize this population. However, it is currently estimated that only about half of this number of doses will be available before the end [of] 2022,” before the United States adjusted its strategy as it did on Tuesday.

But Bavarian Nordic noted on Wednesday that the FDA had approved its vaccines only to be administered subcutaneously and called for further study, according to the company representative.

Outside experts have also raised concerns about whether the Biden administration is rushing to adjust its vaccine strategy, amid criticism that the country does not have enough monkeypox vaccine to meet demand.

“No effort to protect people’s health should come without proper due diligence and research,” David Harvey, executive director of the National Coalition of STD Directors, said in a statement. “We are very concerned about the limited amount of research that has been done on this dose and method of administration.”

Michael T. Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, and other public health experts also said changing the Jynneos vaccination strategy will require more healthcare providers to be trained. to the new approach.

But Biden officials argue the shift in vaccine strategy is necessary, given growing demand and limited alternatives.

“We really need to look at what we have now as countermeasures, and we realized that, unfortunately, we just didn’t have enough doses of the Nordic Bavarian vaccine,” said a senior FDA official who spoke. on condition of anonymity because they were not authorized to comment publicly said in an interview Wednesday evening.

Nordic Bavarian officials have signaled they are open to other strategies to stretch limited vaccine supplies, such as delay the second dose of the vaccine, as have officials in New York, the UK and other monkeypox hotspots. Nordic Bavarian scientists are examining doses of Jynneos that were previously purchased by the United States but have passed their shelf life to see if they remain viable and can be deployed during the outbreak.

Meanwhile, Nordic Bavarian officials had ‘limited notice’ before Califf and other officials touted their potential plan to split doses last Thursday, according to two people with knowledge of the communications who spoke on condition of anonymity. because they were not authorized to comment publicly. .

The Biden administration said it still plans to procure more than 5 million additional single-dose vials from Bavarian Nordic by next year.

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