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Hyderabad: The International Vaccine Institute (IVI) and Bharat Biotech on Wednesday announced the start of Phase II/III clinical trials of Chikungunya vaccine candidate (BBV87) in Costa Rica.
IVI is leading the Global Chikungunya Vaccine Clinical Development Program (GCCDP) consortium in partnership with Bharat Biotech and is funded by the Coalition for Epidemic Preparedness Innovations (CEPI) with the support of the Ind-CEPI mission of India’s Department of Biotechnology. IVI said it is conducting a phase II/III randomized, controlled trial to evaluate the safety and immunogenicity of a two-dose dose of BBV87 chikungunya vaccine in healthy adults at nine clinical trial sites in five countries with endemic chikungunya. Advances the clinical development of BBV87 from
According to an official release, BBIL’s BBV87 vaccine is an inactivated whole-viral vaccine based on a strain derived from an East, Central, South African (ECSA) genotype. The vaccine has completed standard pre-clinical studies, and an optimal immune response was achieved by adjuvant vaccine in phase 1 clinical trials in India.
The inactivated virus technology has a safety profile that potentially makes this vaccine accessible to special populations, such as immunocompromised and pregnant women, where some other technologies cannot.
In addition to trials at the Clinica San Agustin in Costa Rica, trials are expected to begin in Panama and Colombia by September 2021, and in Thailand and Guatemala shortly thereafter.
Dr Sushant Sahasrabuddhe, Acting Associate Director-General at IVI and Principal Investigator, GCCDP, said, “We are thrilled to announce that the first participant was dosed with BBIL’s Chikungunya vaccine candidate in a multi-country phase II/III study .
The start of this trial in Costa Rica is an important milestone in the effort to provide a safe, effective and affordable chikungunya vaccine to the one billion people worldwide at risk of chikungunya virus infection. We are grateful to our partner Bharat Biotech, our clinical trial site partners and partners, and CEPI for this collective effort, which will generate critical safety and immunogenicity data in areas most affected by chikungunya.
The GCCDP seeks to develop and manufacture an affordable chikungunya vaccine with the aim of obtaining WHO pre-qualification to enable its distribution in low- and middle-income countries, in line with CEPI’s core commitment to equitable access, affordability and sustainability. Is. CEPI or Bharat Biotech, as required, for building up a stockpile of the test product to be used for further clinical trials in the event of an outbreak to advance vaccine development or in emergency situations on a national basis with the Emergency Use Authority. may offer to third parties accordingly. or international guidance (such as by WHO).
Dr Krishna Ella, Chairman and Managing Director, Bharat Biotech said, “Pandemic preparedness is an important step in public health care. Bharat Biotech’s vaccine candidate is a simple, well-researched vaccine, and we thank the first volunteer from Costa Rica for participating in this study. The IVI-led multi-country-scale human trial has begun an important trial phase in advancing the evaluation of safety and immunogenicity. As a partner, we are committed to GCCDP’s effort to realize a safe, effective vaccine that can help reduce the worldwide burden of chikungunya disease.
Dr Renu Swarup, Secretary, Department of Biotechnology (DBT) and Chairman, Biotechnology Industry Research Assistance Council (BIRAC) said, “Chikungunya is a serious and devastating disease. Keeping in view the need to develop an effective vaccine for Chikungunya, Department of Biotechnology, Government of India has provided financial assistance to Bharat Biotech for Global Chikungunya Vaccine Clinical Development Program (GCCDP) under Ind-CEPI Mission. It is very encouraging to see the start of the Phase II/III study of BBV87 in Costa Rica. This milestone is the first step towards developing a promising vaccine candidate against chikungunya, a thrush disease. “
According to the official release, CEPI first partnered with IVI and Bharat Biotech International Ltd in June 2020 to provide up to USD 14.1 million for vaccine manufacturing and clinical development of the BBV87 vaccine candidate. The funding is supported by the European Union’s (EU) Horizon 2020 program through an existing framework partnership agreement with CEPI.
The consortium was also supported with a grant of up to USD 2 million from the Ind-CEPI initiative of the Government of India for the establishment of GMP manufacturing facilities for the vaccine in India and subsequent manufacturing of clinical trial materials.
Read also: Bharat Biotech and NIV say COVID vaccines may be available for children by September
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