Hyderabad-based Bharat Biotech has confirmed that it has submitted application for emegency use listing (EUL) of its coronavirus vaccine Covaxin before the World Health Organisation. The Indian vaccine manufacturer expects the global health agency to grant the same within July to September period this year.
A guidance document updated last week on WHO's official website showed that Bharat Biotech submitted expression of interest for EUL on April 19. However, the request was not granted as the health agency wanted some more details from the company.
EUL certifies the quality, safety and efficacy of COVID-19 vaccines, as well as risk management plans and programmatic suitability, such as cold chain requirements, all of which are thoroughly assessed before authorisation.
WHO's EUL authorisation is a pre-requisite for COVAX facility, which is meant to ensure COVID-19 vaccine supply to poorer nations. 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 extensive additional data on safety, efficacy, quality and a risk management plan. This scrutiny is carried out 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 added that regulatory approvals for Covaxin are in process in more than 60 countries including the US, Brazil, Hungary, etc. Meanwhile, emergency use authorisaton has been obtained in 13 countries, with more in the pipeline, the Indian pharma major added.
Covaxin is the first coronavirus vaccine to be completely developed in India. Bharat Biotech formulated the jab based on the SARS-CoV-2 strain isolated by the National Institute of Virology (NIV), Pune. The company has deployed three facilities - in Hyderabad, Bengaluru and Ankleshwar - to manufacture the vaccine. It is in the process of scaling up production capacity to 1 billion doses per annum.