“The WHO independent TAG met today and asked for additional clarifications from the manufacturer Bharatbiotech to conduct a final EUL risk-benefit assessment for global use of Covaxin,” WHO’s chief scientist Soumya Swaminathan tweeted.
TAG will reconvene for the final assessment on Wednesday, if Bharat Biotech is able to send the required data.
“The TAG expects to receive these clarifications from the manufacturer by the end of this week, and aims to reconvene for the final risk-benefit assessment on Wednesday, 3 November,” WHO told ET in an email response.
The Technical Advisory Group for Emergency Use Listing (TAG-EUL) is an independent advisory group that provides recommendations to the WHO on whether a Covid 19 vaccine can be listed for emergency use under the EUL procedure.
While the WHO has so far approved Covid-19 vaccines of Pfizer-BioNTech, AstraZeneca-SK Bio/Serum Institute of India, Johnson & Johnson-Janssen, Moderna, and Sinopharm for emergency use, Covaxin’s approval is long awaited.
According to the WHO, the duration of the EUL assessment process depends on how fast the company can provide the required data and information for WHO to be able to carry out the assessment.
The TAG has been carrying out the risk/benefit assessment and come to a final decision whether to grant Emergency Use Listing to the vaccine.
The UN agency had last week said that the experts have been reviewing the data and it was expecting one additional piece of information from the company. The WHO did not however, specify the details of the information that was required from the company.
“The exchange of data between WHO and companies is confidential – if the company wishes to disclose the kind of data requested, it is up to their discretion to do so,” it said.
Hyderabad-based Bharat Biotech had submitted its Expression of Interest (EOI) on the 19th of April and a pre-submission meeting was held in May-June 2021.
WHO’s EUL is a prerequisite for Covax facility vaccine supply. The WHO’s approval gains significance as the move will allow people inoculated with Bharat Biotech’s Covid-19 vaccine to travel abroad without restrictions.
An emergency approval from the WHO will also allow Bharat Biotech to export Covaxin.
The EUL assesses the quality, safety, and efficacy of Covid-19 vaccines, as well as risk management plans and programmatic suitability, such as cold chain requirements.