On Saturday, Bharat Biotech announced the safety and efficacy analysis data from Phase-3 clinical trials of Covaxin – an indigenous vaccine developed to fight the deadly pandemic Covid-19.
Citing pre-print data from the country’s largest efficacy trial, Bharat Biotech revealed that the Indian-made Covaxin achieved an overall efficacy of 77.8% against symptomatic Covid-19 patients.
The Hyderabad-based biotech company elaborated on its findings from the efficacy analysis to state that Covaxin also demonstrated 93.4% effectiveness against severe symptomatic Covid-19 cases. In addition, Covaxin provides 65.2% protection against the B.1.617.2 or Delta strain, which caused the second wave of the Covid-19 pandemic in the country.
After the conclusion of its Phase-3 efficacy trial, Bharat Biotech said Covaxin provided safety and efficacy of 63.6% against asymptomatic Covid-19 patients. Phase-2 trials of a vaccine are conducted to assess the safety of a vaccine, while Phase-3 trials are conducted to assess the efficacy and effectiveness of a vaccine.
Here are the overall efficacy rates of Covaxin after Phase-3 trials as published by Bharat Biotech in its pre-print analysis:
- Asymptomatic cases: 63% efficacy
- Mild, moderate, and severe cases: 78% efficacy
- Severe Covid-19 cases: 93% efficacy
- Delta variant: 65% efficacy
The Covaxin Phase-3 analysis, published on the medRxiv pre-print server, was carried out across 25 hospitals in India as trial sites.
According to Hindustan Times, the final trials deployed a double-blind, randomised, multi-centre clinical trial, using a sponsor-supplied randomisation scheme where volunteers received two intramuscular doses of either the Covid-19 vaccine or a placebo in a span of four weeks. It consisted of 25,800 volunteers from the age group of 18 to 98 years, the report said.
Bharat Biotech’s Covaxin is one of three vaccines currently being inoculated to the Indian population, along with Serum Institute’s Covishield and Russian-made Sputnik V. Covaxin was granted approval for emergency use in the Indian population in January.
The publication of Phase-3 trial results by Bharat Biotech comes just days after it had received a massive endorsement from America’s top medical research agency.
America’s National Institute of Health says Covaxin effective against Delta variant
Earlier, the top medical research agency of the United States government had stated that India’s first indigenous Covid-19 vaccine effectively neutralises both the Alpha (B.1.1.7) and Delta (B.1.617) variants that caused the second wave of the Chinese pandemic across the country.
The National Institute of Health, the primary agency of the US government responsible for biomedical and public health research, had endorsed Covaxin, developed by Bharat Biotech in collaboration with the Indian Council of Medical Research, stating that the vaccine effectively neutralises both Alpha and Delta variants of coronavirus.
Following its latest results, the NIH said their analysis of blood serum from two people who had received Covaxin showed them that the vaccine generated antibodies that effectively neutralise the B.1.1.7 (Alpha) and B.1.617 (Delta) variants of Sars-CoV-2.