In what can be termed a major achievement in India’s journey in vaccination against Covid-19, Hyderabad-based Bharat Biotech’s Covaxin secured WHO approval for emergency use listing for people aged 18 years and above.
Covaxin is completely ‘made in India’ vaccine by Bharat Biotech in collaboration with Indian Council of Medical Research. In fact, the vaccine’s approval got delayed by a month with the technical advisory group seeking more information and clarification from Bharat Biotech for its final risk assessment. The last meeting was on October 26 when it had asked for additional inputs from Bharat Biotech. On Wednesday, the group met to take a final call.
The technical advisory body provides recommendations to WHO for approval of vaccines. WHO made an announcement of Covaxin’s approval through its social media handle.
However, WHO has not yet recommended the vaccine for pregnant women saying that there is insufficient data on its safety and efficacy during pregnancy.
The approval of emergency use listing of Covaxin will open the doors for Indians vaccinated with the vaccine to travel to countries like Guyana, Mexico, Iran, Paraguay, Zimbabwe, Mauritius, Nepal, Australia, Oman, Sri Lanka, Estonia, Greece which have approved it. Many other countries are waiting for WHO decision to approve Covaxin. The approval will also increase the export of the indigenous vaccine.
Covaxin demonstrated 77.8% effectiveness against the symptomatic Covid-19 and 65.2 per cent protection against the new Delta variant. The Hyderabad–based pharma company said that it had concluded the final analysis of Covid efficacy from the phase III trials.
So far, WHO had approved vaccines of Pfizer-BioNTech, AstraZeneaca,-SK Bio/ Serum Institute of India, Johnson 7 Johnson – Janssen, Moderna, and Sinopharm for emergency use.
EUL review of Covaxin began in July 2021 and the decision regarding it was slated for October when the technical group asked from gender-wise data from the manufacturer.
Dr Krishna Ella, Chairman and Managing Director, Bharat Biotech, termed it a ‘significant step’.