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The maker of the only vaccine approved by the Food and Drug Administration to protect against monkeypox privately warned top Biden health officials about its plan to split the doses and change the form in what vaccinations are administered.
“We have some reservations … due to the very limited safety data available,” Nordic Bavaria CEO Paul Chaplin wrote to Health and Human Services Secretary Xavier Becerra and the Commissioner of the Administration of Food and Drug Administration, Robert M. Califf, in a letter sent Tuesday and obtained by The Washington Post.
“It would have been prudent” to conduct additional studies before revising the national monkeypox vaccine strategy, Chaplin said, adding that his company had been “inundated with calls from US state government officials with questions and concerns” about how to implement the new plan.
In interviews Wednesday, Biden administration officials acknowledged Bavarian Nordic’s concerns but said they would not affect its vaccination strategy.
“We’ve had conversations with them about it, and so has the FDA,” Becerra said. “We wouldn’t have moved forward unless we thought it was safe and effective, and if the FDA hadn’t dotted their I’s and crossed their T’s.”
Some Biden officials also believe Bavarian Nordic’s concerns stem from a possible loss of profits if the U.S. and other countries could expand their existing vaccine supplies and reduce the need for future orders, according to three officials who were not authorized to do so. to comment A Bavarian Nordic representative who spoke on condition of anonymity because they were not authorized to comment stressed that the company’s concerns were motivated by safety.
Becerra and other officials on Tuesday announced a strategy to stretch the nation’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 vaccinations. 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 doses of the vaccine amid growing demand.
The plan is “a game changer,” Robert J. Fenton Jr., the nation’s monkeypox response coordinator, told reporters 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. Instead of injecting the injections subcutaneously, a traditional way of administering vaccines into the fatty tissue under the skin, the doses will be injected under the top layer of skin. This approach, known as an intradermal injection, uses a thinner needle and less vaccine, but causes a small bubble to form on the surface of the skin.
Califf, who authorized the new approach on Tuesday, cited a 2015 study of the two-dose vaccine that he said showed the strategy would be effective. Chaplin, the CEO of Nordic Bavaria, was one of the authors of the study.
“The results of this study demonstrate that intradermal administration produces an immune response similar to subcutaneous administration,” Califf said Tuesday. The FDA commissioner first publicly presented the split-dose strategy last week.
Peter Marks, the FDA’s top vaccine official, released a memo that reviewed data from the new approach and addressed the need to stretch existing vaccine supplies.
“There are currently an estimated 1.6 to 1.7 million people in the US who are at high risk for monkeypox and may need vaccination,” Marks wrote in his memo. “Therefore, between 3.2 and 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 are available before the end [of] 2022,” before the United States adjusted its strategy as it did on Tuesday.
But Bavarian Nordic noted Wednesday that the FDA had approved its injections only to be delivered subcutaneously and requested further study, according to the company representative.
Outside experts have also raised concerns about whether the Biden administration is rushing to adjust its vaccination strategy, amid criticism that the nation does not have enough monkeypox vaccine to meet demand.
“No effort to protect people’s health should come without due diligence and research,” David Harvey, executive director of the National Coalition of STD Directors, said in a statement. “We have serious concerns 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 have also said that changing Jynneos’ vaccination strategy will require more health care providers to be trained in the new approach
But Biden officials maintain that the change in vaccine strategy is necessary, given the increased demand and limited alternatives.
“We really have to look at what we have as countermeasures now, 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 weren’t. authorized to comment, he said publicly in an interview Wednesday night.
Nordic officials in Bavaria have indicated they are open to other strategies to stretch the limited vaccine supply, such as delaying the second dose of the vaccine, as officials in New York, the United Kingdom and other hot spots in the monkey pox Nordic scientists in Bavaria are reviewing doses of Jynneos that were previously purchased by the United States but have passed their useful life to see if they are still viable and can be deployed in the outbreak.
Meanwhile, Nordic Bavarian officials had “limited notice” before Califf and other officials touted their potential plan to split the doses last Thursday, according to two people with knowledge of the communications who spoke on condition of anonymity because they did not were authorized to comment publicly. .
The Biden administration has said it still plans to acquire more than 5 million additional single-dose vials from Bavarian Nordic next year.