Virus World

Aditi TandonTribune News ServiceNew Delhi, April 21 In a major boost to made in India Covid vaccine enterprise, indigenous shot COVAXIN has been shown to successfully neutralise the double mutant  detected in certain parts of India and the world. The Indian Council of Medical Research lab National Institute of Virology announced the development today saying the Bharat Biotech-ICMR made COVID vaccine was effective against multiple strains of the SARS-Cov2 virus.  The ICMR had earlier isolated UK and Brazil strains and shown COVAXIN was effective against these. The results of COVAXIN working against the double mutant were announced on Friday simultaneous to another major research declaration that reveals COVAXIN has 78 to 100 pc efficacy against severe COVID disease. Bharat Biotech and ICMR today jointly shared the interim results from Phase 3 trials of COVAXIN saying these “demonstrate overall interim clinical efficacy of 78 pc and 100 pc efficacy against severe COVID-19 disease”. The second interim analysis is based on more than 87 symptomatic cases of COVID-19.

The firm said due to the recent surge in cases, 127 symptomatic cases were recorded, resulting in a point estimate of vaccine efficacy of 78 pc against mild, moderate, and severe COVID-19 disease. “The efficacy against severe COVID-19 disease was 100 pc with an impact on reduction in hospitalizations. The efficacy against asymptomatic COVID-19 infection was 70 pc, suggesting decreased transmission in COVAXIN recipients,” the results said.  Safety and efficacy results from the final analysis will be available in June, and the final report will be submitted to a peer-reviewed publication, ICMR and Bharat Biotech said. The Phase 3 study enrolled 25,800 participants between 18-98 years of age, including 10 pc over the age of 60, with analysis conducted 14 days post 2nd dose. 

COVAXIN was developed with seed strains received from the National Institute of Virology and the phase 3 clinical trial was co-funded by the Indian Council of Medical Research, making it a true public, private partnership towards public health. Krishna Ella, Chairman and Managing Director, Bharat Biotech, said, “Efficacy against SARS-Cov-2 has been established. COVAXIN has demonstrated an excellent safety record in human clinical trials and in usage under emergency use. COVAXIN is now a global innovator vaccine derived from Research and development from India. The efficacy data against severe COVID-19 and asymptomatic infections is highly significant, as this helps reduce hospitalizations and disease transmission, respectively”.

Findings available in bioRxiv (April 23, 2021):

https://doi.org/10.1101/2021.04.23.441101 

Bharat Biotech's vaccine showed 81% efficacy in preventing symptomatic COVID-19 in an interim analysis of a late-stage trial in India, it said on Wednesday, a major boost for the shot shunned by some due to a lack of such data.  The positive result also brightens prospects for sales overseas, with the vaccine, India’s first successful homemade COVID-19 shot, already attracting interest from more than 40 countries, according to the firm. “COVAXIN demonstrates high clinical efficacy trend against COVID-19 but also significant immunogenicity against the rapidly emerging variants,” Bharat Biotech Chairman Krishna Ella said in a statement, referring to its vaccine. It said the analysis is based on 43 cases of COVID-19 patients who showed symptoms ranging from mild to moderate and severe, and of the total cases, 36 were from a placebo group, while seven were from those who received the vaccine. The results come as India struggles to convince its health and front-line workers to take the Bharat Biotech shot, which was approved in January without late-stage efficacy data.

Only about 11% of the more than 10 million Indians vaccinated had taken the Bharat Biotech shot as of last week, Reuters had reported. Many politicians in India, including Prime Minister Narendra Modi, have been inoculated with COVAXIN this week instead of a rival one developed by AstraZeneca Plc and Oxford University, as they seek to boost confidence in the locally developed vaccine. With more than 11 million infections so far, India is battling the world’s largest COVID-19 outbreak outside the United States. COVAXIN, which can be stored at normal refrigerator temperatures, is likely to be effective against the UK strain of the coronavirus, a study said in late January. The shot is an inactivated vaccine that introduces dead virus into the body to trigger an immune response.

Bharat Biotech is based in the southern Indian city of Hyderabad, a hub for drug and vaccine makers. It began operations in 1996, and has delivered over 3 billion doses globally of various types of vaccines, including ones for Hepatitis-B and typhoid. It is aiming to produce about 700 million doses of COVAXIN this year. The company, which signed a deal with Brazil to supply 20 million doses of the shot, said the next interim analysis will target 87 cases and the final analysis will be based on 130 cases. Its first interim analysis was based on a Phase III clinical trial involving 25,800 participants which was conducted with the Indian Council for Medical Research (ICMR), a federal government body. The trial included 2,433 participants who were older than 60, and 4,500 participants with co-morbidities. The trial results were evaluated by an independent data safety and monitoring board, the ICMR said in a separate statement.