Bharat Biotech International Limited’s which manufactures India’s homegrown Covaxin has submitted almost complete documentation needed for the apex global health agency’ EUL
When, granted the EUL, it will open the doors for the Indian developed Covaxin to be accepted and used by other countries
New Delhi: The World Health Organization (WHO) may take a decision on granting Emergency Use Listing (EUL) to Bharat Biotech’s covid-19 vaccine Covaxin within four to six weeks, Soumya Swaminathan, Chief Scientist at WHO said on Friday.
She was speaking at a virtual event of the Centre for Science and Environment (CSE). Bharat Biotech International Limited’s (BBIL) which manufactures India’s homegrown covid-19 Covaxin vaccine has submitted almost complete documentation needed for the apex global health agency’ Emergency Use Listing. When, granted the EUL, it will open the doors for the Indian developed Covaxin to be accepted and used by other countries.
“It is mandatory to supply a complete dossier listing safety, efficacy and manufacturing conditions of the vaccine to the WHO. I understand that Bharat Biotech is in this process and I think a decision on their case is likely in the next four to six weeks," said Swaminathan.
WHO’s Emergency Use Listing (EUL) is a prerequisite for COVAX Facility vaccine supply for other countries. The EUL assesses the quality, safety and efficacy of covid-19 vaccines, as well as risk management plans and programmatic suitability, such as cold chain requirements. The assessment is performed by the product evaluation group, composed by regulatory experts from around the world and a Technical Advisory Group (TAG), in charge of performing the risk-benefit assessment for an independent recommendation on whether a vaccine can be listed for emergency use and, if so, under which conditions. So far, the WHO has given EUL to six vaccines.
A study done by Indian Council of Medical Research-National Institute of Virology (NIV) recently showed that covaxin elicits strong antibody response against Beta and Delta variants of SARS CoV2 virus. A vaccine based on whole inactivated coronavirus has an efficacy rate of 77.8% against symptomatic covid-19 infections, phase 3 trial data suggest.
Swaminathan also pointed out that the ongoing spike in many countries is worrying mainly because the cases of Delta variant are rising sharply. “There had been a hope that the number of daily deaths will decrease, but they have been increasing as well," she said.
Swaminathan said COVAX has mobilized significant amounts of resources and access to the vaccines, but due to supply considerations, most of the roll-out is now going to happen in the last quarter of 2021. She also listed some of the reasons for the relatively slow uptake of the vaccines -- lack of knowledge and information, operational issues, and apprehensions about vaccination, among others.
“WHO’s initial 20% goal of vaccine coverage was aimed at covering the vulnerable in each country, the idea being that healthcare and frontline worker and the elderly should be covered so that the mortality rate is brought down. The goal has now been revised to 40% coverage in each country by the end of this year, and 70% by the middle of the next year," she said.
Swaminathan argued that the big challenge in vaccine research is “the need for well-designed effectiveness trials in multiple countries". The only way to increase supplies right now is dose-sharing by countries that have already vaccinated more than 40% of their population," she said.
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