Bharat Biotech to expedite Covaxin WHO emergency listing with govt backing

Pre-submission meetings provide guidance before submission of the dossier, as well as an opportunity for the applicant to meet WHO medicines assessors, who will be involved in evaluating their product.

The pre-submission meeting will be followed by acceptance of the dossier for review, following which WHO gives a targeted action date or anticipated decision date.

According to WHO, only COVID-19 vaccines that have undergone phase IIb or phase III studies and have been submitted to the NRA (National Regulatory Agency) of record, are in the consideration.

WHO decision on listing will not be made until the NRA of record has authorized the vaccine.

In the case of Covaxin, the NRA is the Drug Controller General of India (DCGI).

The DCGI has issued emergency use authorisation (EUA) to Covaxin in January, even as the vaccine has completed its Phase-3 trial in India involving 25,800 subjects, though it is yet to publish that final efficacy data in a reputed peer-reviewed scientific journal.

While WHO's primary efficacy endpoint estimate should be at least 50 percent for approval, Covaxin was found to have 78 percent efficacy in the second interim analysis of Phase-3 clinical trials.

The final efficacy analysis is still awaited. Also, there is real world evidence backing vaccine safety and efficacy on over two crore people.

Covaxin, which can be stored at 2-8 degrees Centigrade, is also well suited to meet cold chain requirements of most countries.

Along with India, Covaxin was approved for emergency use in eight other countries including Philippines, Mauritius, Iran, Nepal, Mexico, Guyana, Paraguay, and Zimbabwe.

Recently the company announced approval of a phase III clinical vaccine study in Brazil. The study will be conducted on 4,500 volunteers.

Bharat Biotech's US partner Ocugen, also said it is planning to conduct Phase-3 clinical trials there as well.

Process of getting WHO emergency use listing

As part of the EUL, the manufacturer is expected to complete the development of the product and submit for licensure and WHO prequalification. A panel of WHO experts will review the quality, safety, efficacy, and immunogenicity data.

WHO also reviews inspection reports from the responsible DCGI showing compliance with GMP requirements.

Generally, WHO's Prequalification Unit – Inspection Team will inspect the manufacturing facilities of Bharat Biotech manufacturing Covaxin.

For manufacturing sites that make WHO prequalified products, the agency may waive an on-site inspection due to COVID challenges and as a temporary measure, is carrying out a desk assessment to determine the compliance of the site with Good Manufacturing Practices (GMP) and Quality Management System (QMS) requirements.

Based on the review by a panel of experts, WHO may recommend for an EUL.

The importance of WHO's EUL

WHO has so far listed Pfizer-BioNTech, Astrazeneca-SK Bio-Serum Institute of India (Covishield vaccine), Janssen, Moderna and Sinopharm vaccines for emergency use.

The WHO EUL has become imperative as many countries who are opening up in Europe are recognising the COVID-19 vaccines approved by their regulator or having a WHO EUL for accepting foreign inbound travellers, making those people who are vaccinated with Covaxin ineligible.

The Indian government too is now concerned about this and is talking to Bharat Biotech on how to speed up things.

Questions sent to Bharat Biotech by Moneycontrol have not yet elicited a response.