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Monkeypox Shot Contract With Jynneos Maker Grows by $1 Billion (1)

Aug. 15, 2022, 9:58 PMUpdated: Aug. 16, 2022, 2:46 PM

An extra $1 billion worth of monkeypox vaccines could make its way to US shores under an increase to the federal contract with Jynneos maker Bavarian Nordic A/S.

The Health and Human Services Administration for Strategic Preparedness and Response Aug. 12 raised the contract ceiling “for the additional procurement of the Smallpox/Monkeypox vaccine JYNNEOS© in the amount of one billion dollars.” The previous cap was $871 million.

The agency has spent $675 million so far in vaccines but demand for the monkeypox vaccine continues to far outstrip supply. The HHS said Monday it’s making up to 442,000 more doses of Jynneos available for states and jurisdictions to order. Those doses initially weren’t supposed to be available until later this month, but the health department said it accelerated its timetable in light of new dosing authorities and guidelines.

HHS is seeking “the flexibility, if needed, to procure” more Jynneos for monkeypox “and restore U.S. preparedness to address smallpox moving forward,” the agency said Tuesday in an emailed statement. “Raising the ceiling is an administrative change to the contract and does not guarantee additional doses will be purchased but provides the flexibility to do so.”

The revised purchasing limits come a little more than a week after HHS Secretary Xavier Becerra declared monkeypox a public health emergency and days after US health leaders said they’ll stretch the vaccine supply with a new administration technique. Data from a 2015 study indicate a smaller dose in the skin offers similar protection to the original vaccination route but it’s drawn concerns both from state officials and Bavarian Nordic.

The change would increase the maximum dollar value the US government could spend on the Danish-based biotechnology company’s contract, which was signed in 2017.

“Under a Project BioShield contract that was awarded in 2017, Bavarian Nordic has achieved the JYNNEOS© vaccine and it has been procured by the government,” according to a synopsis of the increase. “However more vaccine is needed to assist in the fight against the current outbreak and public health emergency regarding Monkeypox.”

US health officials estimated last week that there are nearly 1.7 million people at highest risk but only about 400,000 doses left in the US stockpile.

Bavarian Nordic A/S, the only company with an approved vaccine specifically for monkeypox, will supply 2.5 million doses of Jynneos to US authorities in the last quarter of the year and in 2023. A company spokesperson told Bloomberg News last month that under the previous contract, the US government has access to about 15 million doses, based on bulk orders that can be filled upon request.

Bavarian Nordic said in an email Tuesday that it didn’t have additional details about the new contract but pointed to previously manufactured bulk vaccine stocks for the HHS’s Biomedical Advanced Research and Development Authority (BARDA).

“One could speculate that the additional funds are for filling more bulk (we estimate that the current inventory of bulk represents approx. 13 million final doses, including the 5.5 million already ordered in June and July), but could also fund manufacturing of additional bulk,” Bavarian said.

Many people seeking vaccination against monkeypox have called three to four sites before finally securing an appointment, Kevin Ard, director of the Massachusetts General Hospital Sexual Health Clinic, said during an Infectious Diseases Society of America press briefing last week.

“In the current outbreak, the supply of the Jynneos vaccine administering post-exposure Prophylaxis has not been commensurate with need or demand,” Ard, who’s also the medical director of the National LGBTQIA+ Health Education Center at the Fenway Institute, said.

“The experience of our clinic offering vaccination has been seen across the country. Demand for vaccination is immense,” he said.

—With assistance from Shira Stein of Bloomberg Law; Madison Muller of Bloomberg News

(Updates Aug. 15 story with comment from HHS and Bavarian in the fourth and 10th paragraphs.)

To contact the reporters on this story: Jeannie Baumann in Washington at jbaumann@bloombergindustry.com; Paul Murphy in Washington at pmurphy@bloombergindustry.com

To contact the editors responsible for this story: Alexis Kramer at akramer@bloomberglaw.com; Cheryl Saenz at csaenz@bloombergindustry.com; Amanda H. Allen at aallen@bloombergindustry.com