81% Interim Efficacy Data Shot in the Arm for Bharat Biotech’s Covaxin Export Hopes
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The first interim review of Phase-3 trials for Bharat Biotech’s COVID-19 vaccine Covaxin revealed 81 percent efficacy, providing a boost to the Indian business, which is eyeing exports and hopes to join the World Health Organization’s COVAX program for vaccination in low- and middle-income countries.
The first interim study is focused on 43 cases, with 36 cases of COVID-19 in the placebo group versus 7 cases in the Covaxin group, yielding an 80.6 percent point estimate of vaccine efficacy.
In the coming weeks, the Hyderabad-based firm said it would share the second interim analysis based on 87 cases, as well as the final analysis based on 130 cases. This will provide a more complete image of the vaccine’s efficacy.
Bharat Biotech Chairman and Managing Director Krishna Ella had recently said he wanted the firm to be part of the COVAX Facility. In the next three months, the COVAX program has committed to supplying 237 million doses of AstraZeneca’s vaccine to 142 countries.
Bharat Biotech has begun to sign bilateral supply agreements for Covaxin. It announced on February 26 that it had signed a deal with Brazil to supply 20 million doses of its COVID-19 vaccine Covaxin. The deliveries are scheduled to start in the second and third quarters of 2021, but a lack of efficacy data has been a stumbling block, said a report in Moneycontrol. Reuters had reported that Brazilian prosecutors have sought immediate suspension of purchases of India’s Covaxin as the vaccine didn’t have phase-3 efficacy data.
Meanwhile, France is also looking to import Covaxin, Moneycontrol had reported. Covaxin has piqued the attention of more than 40 countries around the world, according to Bharat Biotech. “These countries are highly satisfied with the safe, inactivated vaccine technology and robust data package for safety and immunogenicity,” the firm said.
Covaxin also has a time-tested inactivated platform that has been shown to be successful against mutating strains. Unlike other vaccines that use one of the virus’s most prominent proteins as an antigen, which is susceptible to losing effectiveness if the virus mutates, this one does not. Inactivated vaccines use whole virion, which is more durable and provides a wider range of protection.
Covaxin is also stable at 2 to 8°C (refrigerated) and comes in a ready-to-use liquid formulation, allowing it to be distributed across existing vaccine supply chains.
The company also claims to have a 28-day open vial policy as a unique product feature, which it claims reduces vaccine wastage by 10-30%.
Furthermore, Covaxin has had the government’s full support from the start. Despite criticism that it lacked efficacy evidence, the vaccine was approved for limited emergency use in clinical trial mode in January. Modi’s Atmanirbhar has highlighted Covaxin as a success story.
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