Updated: December 16, 2020 8:58:24 pm
Prime Minister Narendra Modi receives briefing during a visit to the Bharat Biotech facility (archive)
The Covid-19 vaccine indigenously developed by Bharat Biotech has been found to be well tolerated in all dose groups with no serious adverse effects and produces a robust immune response, as interim results from phase I trials revealed.
The Hyderabad-based company, what is Covaxin developing, in collaboration with the National Institute of Virology, an ICMR institute in Pune, has started phase III trials only recently, and has not yet enrolled all participants according to its design.
“Reactogenicity was absent in most of the participants, with mild events. Most of the adverse events were mild and resolved. A serious adverse event was reported, which was found to be unrelated to vaccination. All three vaccine formulations resulted in robust immune responses comparable to a panel of convalescent serum, ”according to findings that have appeared on medRxiv, a preprint server. A preprint is a version of a scientific manuscript published on a public server before formal peer review.
Covaxin is stored between 2 degrees Celsius and 8 degrees Celsius, which is compliant with all cold chain requirements of the national immunization program.
According to the paper, after the first vaccination, local and systemic adverse events were predominantly mild or moderate in severity and resolved quickly, without any prescribed medication. A similar trend was observed after the second injection was administered. Pain at the injection site was the most common local adverse event.
“A serious adverse event was reported. The participant was vaccinated on July 30. Five days later, the participant reported symptoms of Covid-19 and tested positive for SARS-CoV-2, ”according to the findings.
“The symptoms were mild in nature, but the patient was admitted to the hospital on August 15. The participant was discharged on August 22 after a negative nucleic acid result. The event was not causally associated with the vaccine, ”the findings showed.
Last week, it had submitted an application to the Central Drug Standards Control Organization (CDSCO), India’s drug regulator, seeking emergency use approval for Covaxin. Its application was based primarily on safety data from phase I and phase II trials. Bharat Biotech is expected to complete the testing process in February, according to a person familiar with the progress in testing the vaccine.
The multicenter, randomized, double-blind, placebo-controlled, phase III trial will include approximately 28,500 subjects 18 years of age and older. It takes place at about 25 sites in 10 states.
In addition, Covaxin, four other vaccines are in different phases of clinical trial in India with the Serum Institute of India conducting a phase III trial of the Oxford-AstraZeneca Covid-19 vaccine, while the vaccine developed indigenously by Zydus Cadila has completed the phase II clinical trial in the country.
Dr Reddy’s Laboratories has started phase two and three combined clinical trials of the Russian Covid-19 Sputnik V vaccine in India. Additionally, Biological E. Ltd has begun the first phase I and II human trials of its Covid-19 vaccine candidate, officials said last week.
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