Biological E collaborate with Bavarian Nordic to expand Chikungunya Vaccine access in low, middle income countries

This partnership comprises a technology transfer of the current drug product manufacturing process for the Chikungunya Vaccine, with the option to transfer the drug substance process at a later stage. To that effect, the companies have reached an agreement to expand their capacity to provide future supplies to endemic low- and middle-income countries.

The initial technology transfer would be followed by regulatory approval applications and commencement of commercial manufacturing thereafter. BE's existing facilities in Genome Valley, Hyderabad will be augmented to make the Chikungunya Vaccine. The manufacturing of Chikungunya Vaccine at BE is expected to generate up to 300 new jobs.

This agreement has come about as Bavarian Nordic continues to explore opportunities in line with its strategy to provide global access to its Chikungunya Vaccine via partners for markets outside the US and Europe. The recent approval of the Chikungunya vaccine in the US for persons as young as 12 years and the positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use have demonstrated the viability to expand regulatory approvals beyond these markets.

Ms. Mahima Datla, Managing Director, Biological E. Limited, said, “We are pleased to collaborate with Bavarian Nordic to help expand the availability of their Chikungunya Vaccine in low and middle-income countries. The scale of our manufacturing and successful track record in providing global access to vaccines is synergistically aligned with Bavarian Nordic via this strategic partnership. We are committed to utilising our advanced & efficient manufacturing technologies to meet health needs in endemic regions and we are excited that our collaborative efforts will soon help improve public health in preventing Chikungunya in various parts of the world.”

“We are pleased to announce our first collaboration to expand global access to our Chikungunya Vaccine and also our first partnership with Biological E, who have solid expertise and comprehensive experience in supplying vaccines for improving public health worldwide,” said Paul Chaplin, President & CEO of Bavarian Nordic. “Expanding supply is a prerequisite for our ability to address the increasing need for solutions to prevent Chikungunya in vulnerable populations in endemic regions, and we are dedicated to pursuing strong partnerships that can help us achieve this goal.”

CHIKV VLP is an adjuvanted VLP recombinant protein vaccine for active immunization for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 12 years and older. Because VLPs contain no virus genetic material, the vaccine cannot infect cells, reproduce or cause disease.

While the mechanism of action of CHIKV VLP vaccine still needs to be further characterised, it is thought that the vaccine can induce protection from CHIKV infection by inducing neutralising antibodies against certain CHIKV proteins resulting in neutralisation of live virus. An adjuvant is added to increase the magnitude of vaccine-mediated immune responses.

In February 2025, the U.S. Food and Drug Administration (FDA) approved VIMKUNYA (CHIKV VLP) for chikungunya for persons as young as 12 years. The approval was based on results from two phase 3 clinical trials which enrolled more than 3,500 healthy individuals 12 years of age and older. The studies met their primary endpoints, with results showing that 21 days after vaccination, the vaccine induced neutralizing antibodies in up to 97.8% of the vaccinated individuals and demonstrated a rapid immune response starting to develop within one week. The vaccine was well-tolerated and vaccine-related adverse events were mainly mild or moderate in nature.

An EU approval is pending decision from the European Commission following a recommendation in January 2025 by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).

Chikungunya is a mosquito-borne disease caused by the chikungunya virus (CHIKV). In the past 20 years, the virus has emerged across several regions in Asia, Africa, and the Americas, including many popular travel destinations, often causing large unpredictable outbreaks. Since its discovery, CHIKV has been identified in more than 110 countries, with evidence of transmission confirmed in more than 50 countries over the past five years. Chikungunya typically presents with acute symptoms, including fever, rash, fatigue, headache, and often severe and incapacitating joint pain. Most patients recover, but 30-40% of those affected may develop chronic symptoms that can last for months or even years. In 2024, 620,000 cases of chikungunya and over 200 deaths were reported worldwide. Recent data suggest that chikungunya is severely underreported and often misdiagnosed as dengue fever due to a similar symptom profile.