Before monkeypox outbreak, U.S. officials knew for years they didn't have enough of key shot

Top U.S. health officials have known for years that the country's Strategic National Stockpile did not have enough doses of a smallpox vaccine that is now key to the monkeypox fight, according to three former senior officials and a current official working on the monkeypox response.

The U.S. has stockpiled Jynneos, the vaccine by Bavarian Nordic, which is also being used to combat monkeypox.

The U.S. never had the money to purchase the millions of doses that experts felt were necessary, the officials said. Now, that shortfall is hampering efforts to contain the growing monkeypox outbreak, one in which the Biden administration has come under fire for failing to deliver enough vaccine for the millions of people at risk.

“Every time I meet a member of Congress, I let them know what the need is,” said Dawn O’Connell, head of the Administration for Strategic Preparedness and Response, in an interview. “The SNS … has been chronically underfunded. We need to get this SNS fully funded and stocked against what we think the next threats are.”

The Strategic National Stockpile was supposed to have about 120 million Jynneos doses, enough for 60 million people, said the officials who were granted anonymity to discuss sensitive government matters. Jynneos was stockpiled as an alternative to ACAM 2000, a different vaccine that is not suitable for people who are immunocompromised. Prior to 2019, the U.S. had just 20 million doses. In 2020, the U.S. purchased just over 1 million doses to replenish expired vaccine.

Paul Chaplin, CEO of Bavarian Nordic, told POLITICO on Thursday that after the vaccine received approval from the Food and Drug Administration in 2019, the U.S. stockpile requirement called for the protection of 66 million at-risk Americans. That meant about 132 million doses of the Jynneos shot were needed for people who cannot receive ACAM 2000 in the event of a smallpox outbreak.

“That's people [who] are vulnerable who shouldn't really receive first and second generation vaccines,” Chaplin said.

An official at the Department of Health and Human Services suggested the 120 million dose figure was higher than the government threshold but did not dispute that the Jynneos stockpile level was below what it should have been, and declined to provide what the SNS requirements actually say.

The senior officials who spoke to POLITICO said the requirements for the stockpile — levels set in part by HHS — often shift and are, at times, outdated. For example, one former senior official said the department kept two numbers on hand — the number of doses the stockpile could afford to purchase and the number of doses that were actually needed to distribute to a certain population. The number of Jynneos doses the government could afford as of 2019, that official said, was around 40 million. But money for Jynneos shots competed with funding for more pressing priorities and threats the administration perceived as more likely.

“That's not preparedness,” said the former senior health official. “It's like telling the military … you have a requirement for 100 airplanes, but we're only gonna give you 10 because that's all we can afford. And then we have to fight. Good luck.”

Since the Biden administration assumed office, there have been ongoing discussions within the ASPR about adjusting the requirement levels and about how to get additional funding to help ramp up supply of critical medicines and shots.

In November 2021, senior officials from HHS and the Centers for Disease Control and Prevention held a meeting to discuss responses to a potential smallpox outbreak. Officials there spoke about the Jynneos shot and noted many doses had previously expired. They planned to ask Congress for additional funding to shore up supply, according to one of the former officials who attended the meeting.

“There was a push after that to get hard, concrete numbers and budget numbers because they didn't want to report … this huge gap [in supply] back to the White House,” one of the officials said.

In May of 2021, POLITICO reported that the Biden administration rerouted $2 billion from the SNS to help handle the surge of unaccompanied migrants at the border. In its most recent budget request, ASPR asked for $975 million in funds for the stockpile, about $130 million more than was enacted in 2022.

“We all saw what happened in 2020 when the PPE we expected to be there wasn't there. I think Congress felt that acutely as well when their constituents were searching for things,” O’Connell said. “So it is really important for me to use that as a critical example of why we need to move forward and make sure the SNS is well funded against the current material threats.”