Booster for India, indigenous Covaxin finally gets WHO nod

Aditi Tandon

Tribune News Service

New Delhi, November 3

In a massive boost to India’s self-reliance goals in vaccine production, the World Health Organisation on Wednesday approved India’s indigenous Covid-19 shot Covaxin for emergency use, making it the seventh global jab to be included in the world body’s emergency use listing.

A product of public-private partnership between Hyderabad-based Bharat Biotech and Indian Council of Medical Research, Covaxin is now placed alongside US-made Pfizer, Johnson and Johnson and Moderna, Oxford University’s AstraZeneca, and Chinese Sinopharm and Sinovac in the EUL category.

Commenting on the approval to Covaxin, WHO Assistant Director General for Access to Medicines, Vaccines and Pharmaceuticals Mariangela Simao said the vaccine approval process was based on internationally recognised standards for clinical trials, good manufacturing practices, drug safety and quality.

“The process of inclusion in the EUL starts with the company submitting to the WHO the entire clinical information on the product. At the end of the assessment process, the WHO submits its findings to an external technical advisory group consisting of experts from six different countries. That group met today and recommended that the WHO should proceed with the emergency use listing of Covaxin. So Covaxin is now listed,” Simao said.

Asked what it means for a vaccine to be so listed, the WHO expert said the EUL facilitates international procurement of a listed jab.

The EUL means people inoculated with Covaxin will now find it easier to travel across the world with several nations, including the EU, accepting vaccines approved by the WHO. The EUL procedure basically assesses the suitability of novel health products during public health emergencies.

With validation from the WHO, countries can now expedite their regulatory approval processes to import and administer Covaxin.

This could be key to ramping up global vaccination coverage, especially with improved access to Covaxin in lower middle income and low income countries.

Krishna Ella, chairman, Bharat Biotech, said, “Validation by the WHO is a very significant step towards ensuring global access to India’s widely administered, safe, and efficacious Covaxin.” Bharat Biotech had submitted additional information to the World Health Organisation in September and October.

Biotech Jab shelf life extended to a year

• Bharat Biotech said the shelf life of Covaxin has been extended up to 12 months from the date of manufacture
• The firm was initially given permission for the sale and distribution of Covaxin with a shelf life of six months. It was later extended to nine months
• The shelf life extension of the vaccine has been communicated to “our stakeholders,” the company added

How it got there

• Phase 3 trial data available in June 2021
• WHO emergency use listing process began on July 6
• Advisory group of WHO reviewed data on Oct 5
• Designed to meet needs of global chains, especially in low and middle income countries.
• Formulated for long-term storage at 2-8ºC and to cut open vial wastage