Indian vaccine manufacturer Bharat Biotech on Wednesday announced results of Phase 3 clinical trials of its Covid-19 vaccine candidate, Covaxin, saying the vaccine demonstrates interim clinical efficacy of 81 per cent.
Bharat Biotech said the Phase 3 clinical trials for Covaxin involved 25,800 volunteers, making it the "largest trials ever conducted in India" in collaboration with the Indian Council of Medical Research (ICMR).
"Covaxin has demonstrated 81 per cent interim efficacy in preventing Covid-19 in those without prior infection after the second dose," Bharat Biotech said.
These results were based on the first interim analysis of Covaxin.
"With today's results from our Phase 3 clinical trials, we have now reported data on our Covid-19 vaccine from Phase 1, 2, and 3 trials involving around 27,000 participants," Dr Krishna Ella, Chairman and Managing Director, Bharat Biotech said.
Dr Ella added that apart from demonstrating high clinical efficacy against Covid-19, Covaxin also provides "significant immunogenicity against the rapidly emerging variants" of the virus causing Covid-19.
Covaxin is India's indigenously developed and manufactured Covid-19 vaccine candidate and has been granted emergency use approval by the government.
Covishield, the vaccine developed by Oxford University and AstraZeneca and manufactured by the Serum Institute of India is the second vaccine that has been granted emergency use approval in the country.
Both the vaccines are being used in the nationwide Coivd-19 vaccination drive that started on January 16.
On Tuesday, Prime Minister Narendra Modi also took his first shot of Covaxin at AIIMS, New Delhi.
The Phase 3 study of Covaxin involved 25,800 participants between 18-98 years of age. Of these, 2,433 were over the age of 60 and 4,500 had comorbidities.
The first interim analysis of Covaxin is based on 43 cases, of which 36 cases of Covid-19 were observed in the placebo group versus seven cases observed in the BBV152 (Covaxin) group, resulting in a point estimate of vaccine efficacy of 80.6 per cent.
As per Bharat Biotech, the interim analysis included a preliminary review of the safety database. This showed that severe, serious, and medically attended adverse events occurred at low levels and were balanced between vaccine and placebo groups.
Bharat Biotech said it will share further details of the trial results as additional data become available.
''An additional interim analysis is planned for 87 cases, and the final analysis is planned for 130 cases. All data from the second interim and final analyses will be shared via pre-publication servers as well as submitted to a peer-reviewed journal for publication," Bharat Biotech said.
The firm also revealed that more than 40 countries have expressed their interest to procure and use Covaxin for the vaccination drives.
Source: India Today
BDST: 1653 HRS, MAR 06, 2021
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