IT Correspondent
New Delhi, Dec 24:
India’s first Make in India vaccine candidate, “Covaxin”, against the COVID-19), being produced by Hyderabad based Bharat Biotech can keep the patients safe for nearly an year, since it develops long-term antibodies as per a research paper published after Covaxin phase II trials.
“After two doses, local and systemic adverse reactions observed in both vaccine groups were minimal. Majority of them were resolved within 24 hours of onset. No serious adverse events were reported in this study,” the experts said in their research paper uploaded on “medRxiv”.
‘’The most common adverse event was pain at the injection site, followed by headache, fatigue, and fever. No severe or life threatening (Grade 4 and 5) solicited adverse events were reported. After any dose, the combined incidence rate of local and systemic adverse events in this study is noticeably lower than the rates for other SARS-CoV-2 vaccine platform candidates and comparable to the rates for other inactivated SARS-CoV-2 vaccine candidates,” the paper said.
For Phase 1 trials, the results show “Covaxin” develops long-term antibody and T-cell memory responses (three months after vaccination). Whereas the Phase II study shows there are “tolerable safety outcomes with enhanced humoral and cell-mediated immune responses”.
T-cell (thymus gland) plays a vital role in developing immune response. In a double-blind, randomised, multi-centre, Phase II clinical trial, a total of 380 healthy children and adults were randomised and administered two intramuscular doses of vaccine candidate. The dose were given four weeks apart.
In a follow-up of the Phase I trial, “Covaxin” reportedly has produced high levels of “neutralising antibodies” that remained elevated in all participants three months (at day 104) after the second vaccination. Based on these results, researcher believe “Covaxin” can generate antibodies that may persist for 6-12 months.
However, this research paper is yet to be peer-reviewed. As such, its findings are provisional and the conclusions/final results may differ. Covaxin is currently under Phase III human clinical trials. These trails began in mid-November and nearly 26,000 volunteers across India are likely to be involved in these trials.
The Bharat Biotech has announced the successful recruitment of 13,000 volunteers, and continued its progress towards achieving its goal of 26,000 participants for phase-III clinical trial across multiple sites in the country.
“ This is India’s first and only Phase-III efficacy study for a Covid-19 vaccine, and the largest phase -III efficacy trial ever conducted for any vaccine in India. Covaxin has been evaluated in approximately 1000 subjects in Phase I and Phase II clinical trials, with promising safety and immunogenicity results, with acceptance in international peer reviewed scientific
journals,” said the company in a statement.
Bharat has already produced about 10 million doses of its still-in-trials Covaxin shot, ahead of an anticipated roll out by the middle of next year. It has a current annual capacity of 300 million vaccines and expects the first 100 million to be deployed by India, which has partly financed the development.
In its bid to halt the spread of the world’s second-largest coronavirus outbreak, India will likely initially lean on the two-dose vaccines manufactured by “Bharat Biotech” and the “Serum Institute of India Ltd”. The latter has partnered with AstraZeneca Plc. to make at least one billion doses of their shot, half of which have been earmarked for India.
