A decision on Bharat Biotech's submission seeking emergency use listing for COVID-19 vaccine 'Covaxin' will be made in October, the World Health Organization (WHO) said.
The WHO document also states that the rolling review had started on July 6. According to WHO official Poonam Khetrapal Singh, Bharat Biotech's dossier seeking WHO's Emergency Use Listing is being reviewed by technical experts and a decision is expected after the completion of the process.
Earlier on Tuesday, Hyderabad-based Bharat Biotech had said it is working with the World Health Organisation for the emergency use authorisation (EUA) for Covaxin at the earliest.
"As a responsible manufacturer with past approvals for our other vaccines, we do not find it appropriate to speculate or comment on the regulatory approval process and its timelines. We are diligently working with the WHO to obtain EUL at the earliest," Bharat Biotech said as quoted by India Today TV.
On the other hand, the assessment of Russia's Sputnik V has been put on hold. The Sputnik V vaccine was the first jab against coronavirus in the world that was rolled out in 2020.
Another important vaccine for India is Covovax (known as Novavax outside India) that is being developed by the Serum Institute of India (SII) and is being tested on children as well. The WHO document says Covovax vaccine's approval is 'To Be Expected'.
Review of the data for the Covovax vaccine started on August 10. An anticipated date will be set once all data is submitted and follow-up of inspection observations are completed, said WHO officials.