The manufacturer of the only vaccine approved by the Food and Drug Administration to protect against monkeypox privately warned senior Biden health officials about their plan to split doses and change how the shots are delivered.
“We do 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 Tuesday and obtained by The Washington Post. “It would have been prudent” to conduct further studies before overhauling the nation’s monkeypox vaccine strategy, Chaplin said, adding that his company had been “inundated with calls from U.S. 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 their vaccine strategy.
“We’ve had conversations with them about this, and so has FDA,” Becerra said. “We wouldn’t have moved forward unless we thought it was safe and effective, and if FDA hadn’t dotted its I’s and crossed its T’s.” Some Biden officials also believe Bavarian Nordic’s concerns stem from a potential loss in profits should the United States and other countries be 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 representative for Bavarian Nordic who spoke on the condition of anonymity because they were not authorized to comment stressed that the company’s concerns were driven by safety. Becerra and other officials Tuesday announced a strategy to stretch the nation’s limited supply of monkeypox vaccine, saying the plan would transform several hundred-thousand doses of Bavarian Nordic’s Jynneos vaccine into millions of potential shots. About 9,500 cases of monkeypox have been confirmed in the United States, overwhelmingly among gay and bisexual men, and local officials have pressed the White House to deliver more vaccine doses amid surging demand.
The plan is “a game changer,” Robert J. Fenton Jr., coordinator of the nation’s monkeypox response, told reporters Tuesday. “It’s safe, it’s effective, and it will significantly scale the volume of vaccine doses available.” Under the new approach, health-care providers would split each single-dose vial of Jynneos into five doses. Rather than injecting the shots subcutaneously, a traditional way of delivering vaccines into the fatty tissue under the skin, the doses would be injected under the top layer of the skin. This approach, known as an intradermal injection, uses a thinner needle and less vaccine but leads to a small bubble forming on the surface of the skin.
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