3The wait is over for India’s first-indigenous Covid-19 vaccine, Covaxin of Bharat Biotech International Ltd, as it has been granted emergency use listing (EUL) by the World Health Organization.
The approval for EUL has been given after the data was examined by the Technical Advisory Group (TAG) of the global agency in Geneva on Wednesday. WHO, however, said the data was still inadequate to recommend Covaxin for pregnant women and studies are being conducted to assess it.
The grant of EUL will now enable those who had taken Covaxin to travel globally as many countries are only recognising WHO-approved vaccines while allowing international travellers. While the phase 3 trial data for Covaxin was available in June, EUL process commenced on July 6, with rolling data submission. The Strategic Advisory Group of Experts on Immunization (SAGE) of WHO had reviewed vaccine data on October 5 followed by another review by TAG on October 25 when it sought some additional data by the Hyderabad-based company.
Health Minister Mansukh Mandaviya has thanked WHO for granting EUL to Covaxin. Talking about the nod, Krishna Ella, Chairman and Managing Director, Bharat Biotech, said: “Validation by WHO is a very significant step towards ensuring global access to India’s widely administered, safe, and efficacious Covaxin.’’
Read also - Explainer: What emergency use listing is all about
Suchitra Ella, Joint Managing Director, Bharat Biotech, said, “Covaxin is a great example of a successful public-private partnership in developing a world-class Covid-19 vaccine.’’
Implications
With validation from the WHO, countries can now expedite their regulatory approval processes to import and administer Covaxin. Furthermore, UNICEF, Pan-American Health Organization (PAHO), GAVI COVAX facility, will be able to procure it for distribution to countries worldwide. About 66 countries have shown interest in Covaxin so far.
According to the company, Covaxin has been evaluated through neutralising antibody responses against several variants of concern, namely B.1.617.2 (Delta), B.1.617.1 (Kappa), B.1.1.7 (Alpha), B.1.351 (Beta), P2- B.1.1.28 (Gamma). The data from these studies and others have been extensively published in more than 12 peer-reviewed journals and available for review in the public domain.
Watch video - Bharat Biotech's Covaxin gets WHO's ‘Emergency Use Listing’ status
The EUL to Covaxin has been welcomed widely. Poonam Khetrapat Singh, Regional Director, WHO-South East Asia congratulated India for EUL of its indigenously produced covid vaccine in a tweet.
According to Sangita Reddy, Joint Managing Director, Apollo Hosptitals, WHO validation is an ‘appropriate light at the end of the tunnel’ for the journey that Covaxin has had. “Indians always knew about the efficacy of this #vaccine but global validation helps,’’ she tweeted.