By Sachin Ravikumar and Anuron Kumar Mitra
BENGALURU (Reuters) – Bharat Biotech’s vaccine has shown 81% efficacy to prevent the symptomatic COVID-19 in an interim analysis of a late-stage trial in India. such data.
The positive result also brightens the prospects for sales abroad, with the vaccine, India’s first successful homemade COVID-19 shot, which according to the firm has already attracted interest from more than 40 countries.
“COVAXIN shows high clinical efficacy against COVID-19, but also significant immunogenicity against the rapidly emerging variant,” Bharat Biotech chairman Krishna Ella said in a statement, referring to the vaccine.
The analysis is said to be based on 43 cases of COVID-19 patients showing symptoms ranging from moderate to moderate and severe, and of the total cases, 36 were from a placebo group, while seven of those who had the vaccine received.
The results come as India struggles to persuade its health and front-line workers to take the Bharat Biotech shot, which was approved in January without being approved at the late stage.
Only about 11% of the more than ten million Indians vaccinated took the Bharat Biotech shot from last week, Reuters reports.
Many politicians in India, including Prime Minister Narendra Modi, were vaccinated with COVAXIN this week instead of a rival developed by AstraZeneca Plc and the University of Oxford because they want to increase confidence in the locally developed vaccine.
With more than 11 million infections to date, 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 British coronavirus strain, a study said in late January. The shot is an inactivated vaccine that introduces dead viruses into the body to elicit an immune response.
Bharat Biotech is based in the southern Indian city of Hyderabad, a hub for drug and vaccine manufacturers. It started working in 1996 and delivered more than 3 billion doses of various types of vaccines worldwide, including hepatitis B and typhoid.
It aims to produce approximately 700 million doses of COVAXIN this year.
The company, which has entered into an agreement with Brazil to deliver 20 million doses of the shot, said the next interim analysis would be 87 cases and the final analysis would be based on 130 cases.
Its first interim analysis was based on a Phase III clinical trial with 25,800 participants, conducted with the Indian Council for Medical Research (ICMR), a federal government body. The trial included 2433 participants older than 60, and 4500 participants with co-morbidity.
The trial results were evaluated by an independent board for data security and monitoring, the ICMR said in a separate statement.
(Reporting by Sachin Ravikumar and Anuron Kumar Mitra in Bengaluru; Edited by Shailesh Kuber, Miyoung Kim and Bernadette Baum)