Virendra Pandit
Mumbai: Covaxin, India’s first indigenous vaccine against the global pandemic of COVID-19, has shown enhanced immune response without any serious side-effects in the volunteers enrolled for the Phase 1 trials, a study in the prestigious medical publication, The Lancet Infectious Disease Journal, has said.
Covaxin, developed by Bharat Biotech International Ltd (BBIL) in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV), Pune, was granted emergency use authorization (EUA) in clinical trial mode recently by the Union Health Ministry.
More than a million frontline workers, including health professionals, have so far been inoculated in the world’s largest immunization drive launched across India by Prime Minister Narendra Modi on January 16.
Over 90 countries have evinced interest in buying Indian vaccines. India has also started shipping the drug to some of these nations.
BBIL is the first Indian vaccine-maker to publish peer-reviewed data for Phase-1 trials. The other firm, Serum Institute of India (SII), which is manufacturing the Oxford/AstraZeneca-licensed vaccine called Covishield, has not yet published any data from its Indian trials.
A third indigenous vaccine-maker, Zydus Cadila, which is making a three-dose ZyCov-D shot (currently in Phase-3 trials), is also yet to publish the peer-reviewed data, media reported on Friday.
Covaxin, which is now undergoing Phase-3 trials, had raised concerns among experts over its emergency approval granted earlier this month by the drug regulator, Drug Controller-General of India (DCGA).
The BBIL vaccine, codenamed BBV152, was well tolerated in all dose groups with no vaccine-related serious adverse events, noted the authors of the study, funded by BBIL.
These same results were published in the pre-print server medRxiv in December 2020 as well.
All adverse events reported were found mild and moderate, and more frequent after the first dose. The most common adverse event was pain at the injection site, followed by headache, fatigue, and fever.
The randomized Phase 1 trial to assess the safety and immunogenicity of BBV152 was carried out at 11 hospitals across India. Adults aged 18-55 years, deemed as healthy by the investigators, were eligible as volunteers. Between July 13 and 30, 2020, 827 participants were screened, of whom 375 were enrolled. Two intramuscular doses of vaccines were administered to them, 14 days apart.
“BBV152 led to tolerable safety outcomes and enhanced immune responses. The vaccine was well tolerated in all dose groups with no vaccine-related serious adverse events,” the study said.
Given as two doses, three weeks apart, the viral proteins in the vaccine activate the immune system and prepare people for future infections with the actual infectious virus.
According to BBIL, the vaccine can be stored at room temperature for at least a week.