Smallpox (vaccinia) vaccine, live(Sanofi)

Bavarian Nordic demonstrated non-inferiority between the freeze-dried and liquid-frozen formulations. Image credit: Shutterstock/ davide bonaldo. The US Food and Drug Administration (FDA) has approved the freeze-dried formulation of Bavarian Nordic’s smallpox and mpox vaccine in a move expected to provide flexibility in stockpiling the jab. Marketed as Jynneos in the US, the vaccine currently exists in a liquid-frozen formulation. These products require a temperature-controlled supply chain that keeps them frozen between production up until being used on a patient. Freeze-dried formulations have fewer supply chain limitations, conferring advantages such as easier transportation, storage conditions, and extended shelf life. Freeze drying is a dehydration process to extend its shelf life and molecular stability. The FDA approved Bavarian Nordic’s new formulation after the vaccine maker demonstrated comparability to the old formulation in terms of immune responses. The freeze-dried formulation is approved for the prevention of smallpox and mpox disease in adults aged 18 years and older. This included a Phase II trial in 651 healthy volunteers who were given two doses of either the liquid-frozen vaccine or the freeze-dried counterpart. No statistical differences were observed between the groups in immune responses and no serious adverse events were recorded, although the freeze-dried group did have slightly higher local reactions. Bavarian Nordic also supplied non-clinical and manufacturing to the FDA as part of the supplemental biologics licence application (sBLA) submitted in May 2024. The US Government has been working closely with Bavarian Nordic to ensure a stockpile of the vaccines is available in the event of a mpox outbreak. The country has been stockpiling since 2010 and ramped up efforts after the 2022-2023 outbreak, where the disease had spread to all 50 states. Bavarian Nordic is working closely with the US Biomedical Advanced Research and Development Authority (BARDA) to replenish the country’s vaccine stockpile. In 2017, BARDA awarded Bavarian Nordic a contract to develop a freeze-dried version of the vaccine with a longer shelf-life to replace the stockpile. In 2024, a follow-up $156.8m contract was awarded to support these efforts. Bavarian Nordic stated that manufacturing was initiated in 2024, and the first vaccines will be delivered later in 2025. Bavarian Nordic’s CEO Paul Chaplin said: “Today’s FDA approval represents a significant milestone in our development of this next generation of Jynneos and in our collaborative efforts with the US Government to strengthen public health security.” For a time, Jynneos was the only FDA-approved vaccine for the prevention of mpox. Emergent BioSolutions’ ACAM2000 then became the second vaccine for the infectious disease, winning FDA approval to prevent mpox in those at high risk of infection in August 2024. Bavarian Nordic’s product, also known as MVA-BN and Imvanex in other regions, has been a key pillar of fighting the ongoing mpox outbreak in Africa. The biotech has sent more than a million  doses of the vaccine to countries experiencing outbreaks and promised further ramp-ups in vaccine production. The World Health Organization (WHO) has said the mpox outbreak is still a public health emergency, as per a February update. There have been more than 100,000 cases globally in the ongoing outbreak of Clade II mpox. There have been four cases of Clade I mpox in the US, with the most recent two in New Hampshire and New York in February 2025.

Bavarian Nordic inked a manufacturing licensing pact for its popular mpox vaccine with the Serum Institute of India to produce MVA-BN for the Indian market. As Bavarian Nordic works to increase global access to its mpox vaccine, the company has inked a manufacturing licensing pact with the Serum Institute of India (SII) to produce MVA-BN for the Indian market.Under terms of the agreement, SII gets access to the technology for producing the vaccine, which is marketed under the name Jynneos in the U.S., Mexico, Singapore, Switzerland and Canada.Once SII receives regulatory approvals, it may begin producing the mpox shot as a contract manufacturer for Bavarian Nordic (BN). The deal is designed to expand capacity and provide additional global access to the vaccine during outbreaks of the virus, Bavarian Nordic said in a Dec. 16 press release.There were no upfront or milestone payments under the agreement, which is based on a profit-sharing model, BN said. SII is responsible for seeking and keeping regulatory approvals in India, with both parties covering their respective costs related to the technology transfer.Bavarian Nordic said it will continue to search for more global partnership opportunities to expand the availability of the vaccine.“While there are currently no capacity constraints, scaling of global manufacturing is an important step to ensure the continued equitable access to the vaccine for all countries, and we are pleased to establish this collaboration with the Serum Institute, the world’s largest vaccine manufacturer by volume,” Paul Chaplin, Bavarian Nordic’s president and CEO, said in the release. Back in late September, Bavarian Nordic signed a deal with UNICEF to supply 1 million doses of its mpox shot to affected African countries. That deal included 500,000 doses that had been purchased in an agreement reached earlier in the month with Gavi, the Vaccine Alliance, which counts UNICEF as a "core partner."All of the doses under the UNICEF deal are to be produced by the end of 2024 and be available for delivery upon request. The company has previously said it has the capacity to make 13 million doses of its mpox vaccine by the end of 2025, including up to 2 million this year.Competing in the mpox vaccine market is Emergent BioSolutions’ ACAM2000, which received its FDA approval in the indication in August.