Biological E teams with Danish vax firm to give Chikungunya jabs to LMICs

The manufacturing agreement is to provide Chikungunya Vaccine to low-and middle-income countries

Hyderabad-based Biological E Limited (BE) is partnering with Danish firm Bavarian Nordic to manufacture the latter’s Chikungunya vaccine for low and medium income countries (LMIC).

 

The partnership will entail 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. The initial technology transfer would be followed by regulatory approval applications and commencement of commercial manufacturing thereafter.

 

Biological E’s facilities in Genome Valley, Hyderabad will be augmented to make the Chikungunya vaccine. It is expected to generate up to 300 new jobs.

 

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.”

 

Bavarian Nordic has been exploring opportunities to provide global access to its Chikungunya vaccine via partners for markets outside the US and Europe.

 

In February, the US Food and Drug Administration (FDA) approved VIMKUNYA (CHIKV VLP) as the first chikungunya vaccine for persons as young as 12 years.

 

The recent and first approval of the vaccine in the US as the first Chikungunya vaccine 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, the company said.

 

The US 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 neutralising antibodies in up to 97.8 per cent 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).

 

Paul Chaplin, president and CEO of Bavarian Nordic, said that expanding supply is a prerequisite for their ability to address the increasing need for solutions to prevent Chikungunya in vulnerable populations in endemic regions.

 

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 percent 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.

 

CHIKV VLP is an adjuvanted VLP recombinant protein vaccine for active immunisation 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.

 

Bavarian Nordic is the preferred supplier of mpox and smallpox vaccines to governments to enhance public health preparedness and have a leading portfolio of travel vaccines. Established in 1953, BE is the first private sector biological products company in India and the first pharmaceutical company in Southern India. It supplies its vaccines to more than 130 countries and its therapeutic products are sold in India, the USA and Europe. The portfolio of BE currently consists of 10 WHO-approved vaccines and 10 USFDA-approved Generic Injectables. Recently, DCGI has approved BE’s 14-Valent Pneumococcal Conjugate vaccine.