The Technical Advisory Group (TAG) to the World Health Organization (WHO) will meet on Tuesday to finalise the assessment required for granting the much-awaited emergency use Listing (EUL) to Bharat Biotech‘s Covaxin.
“If there are no outstanding issues, the group will make a recommendation to WHO on that or the following day,” WHO told ET in response to a query.
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 awaited.
The WHO said that Covaxin has “not taken” longer than all the other vaccines that have been through EUL.
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 will carry 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 April 19 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.
Bharat Biotech had in June presented its phase-3 clinical trials data, demonstrating 77.8% efficacy, to the subject expert committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO).
