Mpox Vaccine Manufacturing Capacity Expands in India

Bavarian Nordic A/S today announced an agreement with Serum Institute of India Pvt. Ltd. ("SII") for its MVA-BN® mpox vaccine.

Under the agreement revealed on December 16, 2024, the companies will undertake a technology transfer of the current manufacturing process for MVA-BN (JYNNEOS®) to SII to enable the supply of the mpox vaccine for the Indian market. Furthermore, upon the relevant regulatory approvals, SII will perform contract manufacturing of MVA-BN, ensuring global access even during outbreaks of mpox.

SII's multifunctional production and one of the most extensive facilities in Pune, India, has an annual capacity of 4 billion doses.

In a press release, SII's CEO Adar Poonawalla said, "The recent mpox outbreak underscores the critical need for a swift and coordinated response. Partnering with Bavarian Nordic on the MVA-BN mpox vaccine reflects our shared commitment to protect millions at risk. Leveraging our manufacturing strength and rapid response capabilities, we aim to enhance epidemic preparedness and expand access to life-saving vaccines, safeguarding vulnerable populations and easing the global burden of mpox."

Bavarian Nordic continues to explore additional opportunities to establish partnerships, including with local African manufacturers, to ensure equitable access to MVA-BN.

Local media recently reported that since 2022, 33 confirmed cases of Mpox have been reported in India. And a Surveillance Program has been recently instructed to intensify surveillance of Mpox patients at airports. India confirmed its first case of the clade Ib mpox strain in late September 2024.

Since it was approved to protect people from smallpox in 2019, the JYNNEOS brand is now commercially available at many clinics and pharmacies.

From an efficacy perspective, U.S. CDC research published in the journal Emerging Infectious Diseases, Volume 30, Number 10—October 2024, concluded the estimated effectiveness of the 2-dose JYNNEOS vaccine was about 80% against clade 2.

A study announced in March 2024 showed that JYNNEOS antibodies waned within a year.

Vaccine efficacy data against clade I mpox is pending.