Covaxin shows 81% efficacy in phase 3 clinical trial: Bharat Biotech
India’s first make-in-India vaccine, Covaxin, against coronavirus disease (Covid-19) has an efficacy of 81% in phase 3 clinical trial, show preliminary results, Bharat Biotech, the manufacturer, announced on Wednesday
Putting months of speculations to rest, the vaccine manufacturer made the first interim analysis of its whole virion inactivated BBV152 (Covaxin) public.
The trials, the largest ever conducted in India, involved 25,800 subjects in partnership with the Indian Council of Medical Research (ICMR).
“Today is an important milestone in vaccine discovery, for science and our fight against coronavirus disease. 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. Covaxin demonstrates a high clinical efficacy trend against Covid-19 but also significant immunogenicity against the rapidly emerging variants,” said Krishna Ella, chairman and managing director, Bharat Biotech.
The vaccine is stable at 2°C to 8°C (refrigeration) and is shipped in a ready-to-use liquid formulation that permits distribution using existing vaccine supply chain channels.
According to the company, the product has a 28-day open vial policy as a unique product characteristic, thus reducing vaccine wastage by approximately 10-30%.
“BBV152 is based on an established manufacturing platform with a better safety profile when compared to other vaccine platforms. The inclusion of the Algel-IMDG adjuvant enhances T-cell immune responses to Covid-19, leading to long-term protection,” Bharat Biotech said in a statement.
The phase 3 study enrolled 25,800 participants between 18-98 years of age, including 2,433 over the age of 60 and 4,500 with comorbidities. The primary endpoint of the phase 3 clinical trial is based on the first occurrence of PCR-confirmed symptomatic (mild, moderate, or severe) Covid-19 with onset at least 14 days after the second study vaccination in serologically negative (for Sars-CoV-2) adult participants at baseline.
The first interim analysis 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%.
The interim analysis included a preliminary review of the safety database, which showed that severe, serious, and medically attended adverse events occurred at low levels and were balanced between vaccine and placebo groups. The trial’s conduct and monitoring are as per Good Clinical Practice guidelines and have been outsourced to IQVIA.
An analysis from the National Institute of Virology indicates that vaccine-induced antibodies can neutralise the UK variant strains and other heterologous strains, which has been published in the open access medical portal bioRxiv.
“Bharat Biotech expects to 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,” the company statement read.
At least 40 countries globally have expressed their interest in Covaxin.
“These countries are highly satisfied with the safe, inactivated vaccine technology and robust data package for safety and immunogenicity,” the company said.