Bharat Biotech is likely to hold a pre-submission meeting with the World Health Organization (WHO) this month or in June before applying for emergency use listing (EUL) for its COVID-19 vaccine Covaxin.
A guidance document on WHO website, updated last week, showed that Bharat Biotech submitted expression of interest for EUL on April 19. However, the health agency sought more details from the company.
WHO's EUL is a prerequisite for COVAX facility vaccine supply. It also allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines.
The EUL pathway involves a rigorous assessment of late phase II and phase III clinical trial data as well as substantial additional data on safety, efficacy, quality and a risk management plan.
"In the pre-submission meeting, Bharat Biotech will state what data they have and will receive guidance from the WHO on what documents have to be submitted," Mint quoted a vaccine regulations expert as saying.
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. The assessment is performed by the product evaluation group, composed by regulatory experts from around the world and a Technical Advisory Group (TAG), in charge of performing the risk-benefit assessment for an independent recommendation on whether a vaccine can be listed for emergency use and, if so, under which conditions.
The assessment process may also include on-site inspection of production facility.
Bharat Biotech has so far not produced the complete phase III trial data for Covaxin. Announcing the interim results from Phase III trials of Covaxin, Bharat Biotech had in April said that the vaccine showed an overall interim clinical efficacy of 78 per cent and 100 per cent efficacy against severe COVID-19 disease.
WHO has so far given EUL to COVID-19 vaccines of Pfizer/BioNTech, AstraZeneca/Oxford, Janssen (Johnson & Johnson) and China's Sinopharm.
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