Hyderabad-based Bharat Biotech has submitted 90% of the documents to WHO for obtaining the EUL for Covaxin
The remaining documents are expected to be submitted to WHO in June
Hyderabad-based Bharat Biotech has applied to the World Health Organization (WHO) for the Emergency Use Listing (EUL) of its Covid-19 vaccine candidate, Covaxin, becoming the second India-made vaccine to apply at the global health agency for authorisation.
Covaxin is among the three coronavirus vaccines currently being administered in the country. India's homegrown vaccine was granted restricted emergency use approval in 'clinical trial mode' on 2 January.
However, the WHO has sought "more information" from Bharat Biotech on its EUL application for Covaxin, as per the documents on the global health body's website.
Bharat Biotech has submitted 90% of the documents to WHO for obtaining the EUL for Covaxin. The remaining documents are expected to be submitted to WHO in June, news agency PTI quoted sources as saying.
Bharat Biotech applies for WHO EUL
The Hyderabad-based company had submitted its Expression of Interest (EOI) on 19 April, with more information required, as per the documents.
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 coronavirus 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.
As per reports, it will have to now go through three more stages, pre-submission meeting, dossier accepted for review and the final status of assessment. The pre-submission meeting will take place later in May or June.
"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," an expert in vaccine regulations said.
EUL assesses the quality, safety and efficacy of 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.
In April, the firm had issued a statement, saying that the second interim data from its phase 3 trial of nearly 26,000 participants showed that the vaccine has an efficacy of 78% in preventing the virus, which was partially lower than the 80.6% found in the first interim data in March.
WHO’s cutoff for the efficacy of Covid-19 vaccines is 50%, the same as the lower limit set by regulators in India, the US and other countries.
So far, the global health body has given EUL to Covid-19 vaccines of Pfizer/BioNTech, AstraZeneca/Oxford, Janssen (Johnson & Johnson) and China's Sinopharm.
Less than 10 countries have officially approved the Covaxin, according to the data available on covid19.trackvaccines.org. Most nations only recognise Oxford-AstraZeneca’s Covishield, manufactured by Serum Institute, as the required vaccine for passengers coming from India.
Meanwhile, Bharat Biotech may begin paediatric trials of its Covid-19 vaccine Covaxin from June.
The firm will also be ramping up the manufacturing capacity of Covaxin to 700 million doses by the end of this year.
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