Biden administration weighs saving monkeypox doses for potential smallpox outbreak

Top health officials in the Biden administration are weighing whether to save vaccine doses that could be used to fight monkeypox for a potential future smallpox outbreak, according to two people with knowledge of the matter and a senior administration official.

The U.S. has purchased at least 11 million vials of the Jynneos vaccine which is FDA-approved for both smallpox and monkeypox to combat the current monkeypox outbreak. Manufacturer Bavarian Nordic, a pharmaceutical company based in Denmark, is now bottling 5.5 million of those vials.

Some of that vaccine — plus an additional 5.5 million vials stored in Denmark — may be saved if the administration determines the monkeypox outbreak is leveling off, the people familiar with the matter and the official said.

It’s a delicate balance to strike: The administration must secure enough doses for future spikes in monkeypox infections while replenishing its stockpile for a potential smallpox outbreak. Too few doses earmarked for the monkeypox response could set the administration back further in its fight to contain the outbreak if cases increase.

The Biden administration has faced criticism from state health officials and LGBTQ advocates for failing to move fast enough to ensure it had enough vaccines to combat the early stages of the outbreak, which has mainly affected men who have sex with men — a misstep that frustrated public health experts and activists.

Now, some administration officials worry that holding off on bottling the rest of its supply could put them at risk of being caught shorthanded once again. Others believe that there are already sufficient doses to fight the disease, especially as its spread has slowed, and that the government needs to maintain its defenses against the prospect of a major bioterror attack.

Naturally occurring smallpox was declared eradicated worldwide in 1980. But the U.S. has continued to stockpile drugs and vaccines to guard against the possibility the disease could be used for bioterrorism.

“We are evaluating a number of options to further strengthen our monkeypox response, including if and when to fill and finish the approximately 11 million vials of government-owned bulk substance,” an HHS spokesperson said. “In making this decision, we are considering a number of factors including the state of the outbreak, funding, shelf life implications, and overall smallpox preparedness.”

The debate inside the administration comes as monkeypox cases begin to slightly decline in major U.S. cities. Rochelle Walensky, the Centers for Disease Control and Prevention director, told reporters last week that she is cautiously optimistic the outbreak is slowing. However, Texas on Monday reported the death of a severely immunocompromised person diagnosed with monkeypox, increasing fear within the administration that the outbreak could take a new, more dangerous turn.

White House aides, including monkeypox coordinator Robert Fenton, have backed manufacturing more doses to fight the current outbreak, arguing the administration needs to be prepared if the disease begins to spread more widely.

Monkeypox is currently circulating almost exclusively within the community of men who have sex with men. But there remains some concern the outbreak could spill into the broader population, sending case counts soaring and the administration in need of more supply.

Manufacturing the entire stockpile – at least 11 million vials – would cost roughly $350 million, a price tag that HHS has warned it can't afford unless Congress appropriates more funding, according to a senior official familiar with the internal discussions.

The administration plans to seek that funding in the coming days as part of a broader request for more congressional money to combat Covid and monkeypox, the official said.

In the first several weeks of the outbreak, the Biden administration struggled to get doses out to at-risk Americans, in large part because it needed to find other manufacturers to help scale what’s known as the “fill and finish” process — or the bottling of the doses. For weeks, the Biden team has worked to identify additional facilities in the U.S. to help, and last week finalized a deal with Michigan’s Grand River Aseptic Manufacturing.

About 2.5 million of the 11 million available vials are going to be bottled at the Michigan facility. Bavarian Nordic will ready the rest of the 3 million. It’s unclear which company will take on the fill and finish process for the rest of the Jynneos vials.

Dawn O’Connell, the head of the Administration for Strategic Preparedness and Response at HHS, told reporters on Aug. 18 that the administration is trying to find a way to work with a larger pharmaceutical company to expand the manufacturing capacity of the Jynneos vials.

The health official confirmed to POLITICO the administration is still looking for other options to help bottle the leftover bulk substance in Denmark.

The question for officials now is how many of those vials will be shipped to states to help contain monkeypox and how many will be held in the Strategic National Stockpile — overseen by HHS — for a potential future smallpox outbreak.

The federal government has stockpiled Jynneos to help combat smallpox. But due to budget constraints at HHS, the U.S. has over the last several years struggled to purchase enough to meet the requirements of the Strategic National Stockpile, POLITICO has reported.

Now, having used millions of its stockpile for monkeypox, the Biden administration is trying to replenish its stockpile of the Jynneos vaccine – an alternative to ACAM 2000, a different vaccine that is not suitable for people who are immunocompromised.

CLARIFICATION: An earlier version of this report misstated the number of Jynneos vaccine vials and doses purchased by the U.S. government for the smallpox stockpile.