An expert group of the World Health Organization is set to review Biological E’s data on its Covid-19 vaccine, Corbevax, this week. The data review follows BE’s application for an Emergency Use Listing for Corbevax.
An EUL paves the way for more countries to include the vaccine in their innoculation programmes. And if, indeed, Corbevax eventually gets a go-ahead from the WHO, it would be the third vaccine company from India, after Serum Institute and Bharat Biotech, to get an EUL on their Covid-19 vaccine.
The Strategic Advisory Group of Experts on Immunisation (SAGE)’s four-day meeting starts on Monday with the review of several issues, including the global polio eradication programme. The evidence review for Corbevax is slated for October 5 th . According to the WHO draft agenda, SAGE would formulate policy recommendations for this vaccine in case it gets the green-light at a later date.
Explaining the significance of an EUL when the WHO itself has indicated that the end of the pandemic was in sight, BE’s Dr Vikram Paradkar, Executive Vice President (Manufacturing & Technical Operations), said an EUL was a major milestone for any Covid-19 vaccine, especially in terms of meeting quality bench-marks. “Vaccines are still being used in many parts of the world and have expanded to different sections of the population. Having an EUL is essential for any vaccine to be deployed to different parts of the globe,” Paradkar told businessline.
BE is hopeful of approval, not just for adults over 18, but also for children over 5 years and as a booster for those over 18 years, as is the case in India. The reason they believe they have a case is because Corbevax is the same across age-groups, unlike some other vaccines that are not recommended for kids or have separate dosages for different age-groups, he said. The same vaccine is also used as a booster, he added.
Corbevax can be used in all settings, and that has significant advantages in large campaigns, deployments, etc., Paradkar said, adding that their vaccine “would be a much needed addition to the current arsenal,” especially in countries where they are still deploying vaccines and have large populations to vaccinate.
BE is working on a bi-valent vaccine that targets the original Wuhan strain of the virus and the highly prevalent BA.5 offshoot of the Omicron variant, he said.
India had approved Corbevax for the 12–14 age group on March 16th, and presently over 3.18 crore have been vaccinated, he said, making it one of the largest paediatric rollouts in the world in that age group. The company has produced 300 million doses, of which 100 have been given to the government. It has the capacity to make 100 million doses a month.