HHS lines up nearly $700M in supply deals to combat monkeypox and stock up on a smallpox treatment
The Department of Health and Human Services is doubling down on efforts to secure more doses of Bavarian Nordic’s monkeypox vaccine and Chimerix’s smallpox treatment as the CDC reveals that few people have completed their full vaccine series.
BARDA announced on Monday that it’s shelling out $11 million to Michigan-based Grand River Aseptic Manufacturing, which agreed earlier this month to perform fill and finish services for Bavarian Nordic’s monkeypox vaccine Jynneos.
Jynneos remains the only vaccine that’s specifically approved by the FDA to prevent monkeypox — and though it’s a two-dose vaccine, CDC director Rochelle Walensky said in a White House briefing on Friday that 97% of shots that have been delivered so far have been first doses.
“While we are encouraged by the scale-up, there are many people eligible for second doses, and very few of the doses administered so far are recorded [as] second doses,” she said during the briefing. “I’d like to take this moment to emphasize that this is a two-dose vaccine and it is important to receive the second dose in the series.”
As part of BARDA’s July contract for 5 million vials of Jynneos, Bavarian Nordic agreed to allow a US-based manufacturer to fill and finish 2.5 million vials.
“We continue to build on our efforts to secure and make safe and effective vaccines readily available,” HHS Secretary Xavier Becerra said in a statement. “This new agreement solidifies a domestic manufacturing capability that will bring us more vaccine sooner to end this outbreak.”
Meanwhile, BARDA struck a deal with Chimerix for up to 1.7 million doses of its smallpox treatment Tembexa. An initial $115 million will grant the US government 319,000 doses, but the 10-year contract has additional options worth another $551 million, plus post-marketing activities worth $13 million. Overall, the contract is worth up to $680 million.
Back in May, Chimerix agreed to sell its Tembexa rights to Emergent BioSolutions, which has offered $225 million upfront and milestones that could reach $100 million.
However, the closing of that deal is dependent on “BARDA’s approval of a pre-novation agreement between Chimerix and EBS,” according to a news release.
“Our collaboration with BARDA for the development of TEMBEXA has provided the United States government with a second therapeutic option to ensure the federal government’s readiness for a potential smallpox emergency,” Chimerix CEO Mike Sherman said.
While there’s no treatment approved for monkeypox in the US, antivirals such as Tembexa and Siga’s Tpoxx may be used, according to the NIH.
The US is also ramping up shipments of Siga’s Tpoxx treatment which was shown to clear 10 of 25 monkeypox patients’ lesions by day 7, and 23 patients’ lesions by day 21, according to data published by JAMA.
In the hopes of stretching the US supply of Jynneos, the FDA a couple of weeks ago cleared most people for intradermal injections, which are more difficult to administer correctly but require much less vaccine. While officials claimed the new route of administration would expand supply by five-fold, vaccine clinics have reportedly struggled to squeeze a full five doses out of each vial.
During the press briefing, White House monkeypox response coordinator Robert Fenton said clinics are extracting between 4.5 to 5 doses per vial.
So far, 1.1 million vials of vaccine have been made available, and 75% of jurisdictions are administering doses intradermally while about 20% are working to get there, Fenton said. As of Aug, 23, 207,000 doses had been administered.
This story has been updated to clarify that the Chimerix deal is intended to prepare for a potential smallpox emergency.