Bharat Biotech’s pre-submission meeting for COVAXIN’s approval to be held on June 23: WHO


The World Health Organization (WHO) announced that the Hyderabad-based Bharat Biotech’s pre-submission meeting has been scheduled on June 23 for evaluation of its indigenous COVID-19 vaccine COVAXIN for WHO’s Emergency Use Listing (EUL).

In May 2021, Bharat Biotech had informed that the company is confident of getting WHO’s Emergency Use Listing for its COVID-19 vaccine COVAXIN. Last month, Bharat Biotech had submitted 90 per cent of the documentation required for WHO’s Emergency Use Listing of COVAXIN. The remaining papers are to be submitted in June.

The External Affairs Ministry and Bharat Biotech are coordinating throughout the process to secure WHO’s Emergency Use Listing for the COVID-19 vaccine COVAXIN.

COVAXIN is currently one of the three vaccines being administered in India during the vaccination drive against the COVID-19 pandemic.

What is WHO’s Emergency Use Listing?

•The World Health Organization (WHO)’s Emergency Use Listing is a risk-based procedure for the assessment and listing of three product streams: unlicensed vaccines, in vitro diagnostics, and therapeutics.

•The listing allows countries in expediting their own regulatory approval to import and administer COVID-19 vaccines.

•The Emergency Use Listing assesses the efficacy, safety, and quality of COVID-19 vaccines, cold chain requirement, and risk management plans.

• This assessment is carried out by the product evaluation group, comprising regulatory experts across the world and a Technical Advisory Group (TAG). The experts and the TAG members perform a risk assessment on whether a vaccine can be used for emergency use.

Goal of WHO’s Emergency Use Listing

•The goal of Emergency Use Listing is to make vaccines, diagnostics, and medicines available while adhering to the stringent parameters of efficacy, safety, and quality of novel health products.

Eligibility for WHO’s Emergency Use Listing

•The requirements for the three product streams: unlicensed vaccines, in vitro diagnostics, and therapeutics to be eligible for WHO’s Emergency Use Listing are:

(i) The disease for which the health products are to be approved must be life-threatening or serious or possess the potential of causing an outbreak, pandemic, or epidemic.

(ii) Other health products in use have not been able to eradicate the disease or are falling short at preventing the outbreaks.

Vaccines approved under WHO’s Emergency Use Listing

•Sinopharm COVID-19 vaccine,

•Pfizer-BioNTech COVID-19 vaccine,

•Two AstraZeneca-Oxford COVID-19 vaccines produced by AstraZeneca-SKBio (Republic of Korea) and the Serum Institute of India,

•Johnson & Johnson’s Janssen COVID-19 vaccine

•Moderna mRNA COVID-19 vaccine

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