Govt Asks Pharma Companies To Expand Clinical Trials

New Delhi : Scientists and vaccine developers should apply for complementary clinical trials on infants, children, pregnant women and immunocompromised people, the department of biotechnology (DBT) said, with the aim of expanding the country’s covid-19 vaccination strategy to more population groups.

The trials will be funded by the Coalition for Epidemic Preparedness Innovations (CEPI), a global alliance financing and coordinating the development of vaccines against infectious diseases. The DBT is supporting the implementation of the Ind-CEPI Mission, India Centric Epidemic Preparedness through Rapid Vaccine Development.

CEPI will offer up to $140 million in funding to vaccine developers and other research institutions globally for rapid complementary clinical data on covid-19 vaccines. The clinical trials are sought to advance current covid-19 immunization efforts by providing data on demographics and age groups such as pregnant and lactating women, infants and children, and those who have low immunity levels, who may at present not be eligible to receive vaccines.

If the trials show that these vaccines are safe, tolerable and produce an immune response in such populations, the trial data could inform and influence current vaccination strategies globally to expand access to these key groups, CEPI said. Clinical studies in some age groups such as infants and children could also provide important information on the size of vaccine doses needed to have an impact, it said.

Indian vaccine makers and scientists should also take part in the trials to generate data on whether booster doses are required, the duration a vaccine remains effective and the potential impact of novel coronavirus variants on vaccine performance, the government has said.

India has already revised the intervals between two doses of Covishield from the existing 4-6 weeks to 4-8 weeks following scientific evidence showing enhanced protection against covid by increasing the interval of the second dose. Other nations are considering doing the same or using a mix of vaccines to increase the use of available stock and speed up mass vaccination. The government has said that clinical trials may provide additional data on dose timing and ‘mix and match’ strategies.

DBT is supporting pharmaceutical companies in clinical trials on covid-19 vaccines under various schemes. Some of the companies receiving DBT support are Cadila Healthcare Ltd (Zydus Cadila), Biological E, Gennova, Bharat Biotech International Ltd for two trials, Seagull BioSolutions Pvt Ltd and Aurobindo Pharma Ltd.

India rolled out its nationwide vaccination drive on 16 January with the vaccination of healthcare workers, followed by frontline workers from 2 February. The next phase of vaccination began on 1 March for those more than 60 years and for those aged 45 and above with specified comorbidities. Starting 1 April, the Centre has extended vaccination for all persons above 45 years irrespective of whether or not they have comorbidities.

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