Covaxin Gets WHO Nod: How It Will Benefit Indians & Why It Was Stuck for so Long

In what can be touted as a win for India, the Technical Advisory Group of WHO, which met today gave its nod for the Emergency Use Listing status for Bharat Biotech’s Covaxin.

The technical advisory group, which gives licence to a vaccine for its emergency use listing (EUL), had asked Bharat Biotech on October 26 for additional data to conduct a final risk-benefit assessment before approving the Covid-19 jab for EUL. The company had submitted the data last week, said government sources in the know of the development.

What Took So Long?

The WHO approval procedure for a vaccine consists of four steps namely acceptance of the manufacturer’s expression of interest (EOI), a pre-submission meeting between WHO and the manufacturer, acceptance of the dossier for evaluation by WHO, the decision on the status of assessment, and final approval decision.

Bharat Biotech submitted an emergency use listing (EUL) application to the World Health Organization (WHO)-Geneva in May. On June 23, WHO held a pre-submission meeting with Bharat Biotech. A senior official at the Hyderabad-based pharma company was quoted as saying by Times of India that once Bharat Biotech submits the entire Covaxin Phase-3 clinical trials data, the dossier will be complete and taken up for review by the health body. The official had said the company expects the review process for the EUL application of Covaxin to be taken up in July post submission of the efficacy study data.

Also Read: WHO Nod for Covaxin Likely This Week: How This Will Benefit Indians & Why It’s Stuck Still

As per reports, all documents required for the emergency use listing were submitted to the WHO on July 19. However, what delayed the process further was when failure of Covaxin to get approval from the US Food and Drug Administration on grounds of “insufficient information”. Ocugen, Bharat Biotech’s US partner, stated that the company will pursue complete approval for Covaxin. The FDA also urged the company to conduct an additional trial so that it can file for a Biologics Licence Application (BLA), which is full approval.

After the extended wait, it was however at the beginning of November, a day before India celebrates Diwali that its locally manufactured Covid vaccine got the EUL Nod.

How Will India Benefit?

From international travel ease to the export of the indigenous vaccine, India as a country is likely to benefit a lot from WHO’s approval of its manufactured vaccine.

The downward trend in Covid cases across the world has led to many countries lifting their travel restrictions. Recently, the UAE lifted its restrictions on entry for fully vaccinated residents from a number of countries including India. While some countries like Guyana, Iran, Mauritius, Mexico, Nepal, Paraguay, Philippines, Zimbabwe, Estonia (which has approved the jab for its vaccine passport) have already approved Covaxin, with WHO’s approval today many other countries will open their doors to citizens from India. In addition, it is also likely to ease travel for those Indians who wish to travel due to education, work, or other personal purposes.

Oman added Covaxin to the approved list of Covid-19 vaccines for travel on Wednesday, lifting quarantine requirements for passengers from India who have received two doses of the vaccine at least 14 days before the estimated arrival date. Travel platforms said they are seeing an uptick in bookings for destinations that are accepting Covaxin such as Greece, Sri Lanka.

An emergency use approval will also encourage countries to import Covaxin, facilitate its manufacturing abroad and ease travel for those vaccinated with it. The emergency listing will also mean that Covaxin can be used to Covax, the global vaccine alliance, later to vaccinate people in many developing countries.

Hungary and Paraguay had earlier approached New Delhi about exporting 1 million doses of Covaxin, with the first offering access to the EU.

Decisions on exports are commercial in nature and must be made by Bharat Biotech. Bharat Biotech stated in February that it has reached a deal with Ocugen Inc, allowing the US-based biopharmaceutical company to co-develop, supply, and commercialize the Indian vaccine maker’s Covid-19 vaccine Covaxin in the US market.

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