The World Health Organization (WHO) has accepted Bharat Biotech’s expression of interest (EoI) for Covaxin and scheduled a pre-submission meeting on June 23.
The meeting will not be a detailed review on the vaccine, the company will have an opportunity to put forth a summary on the overall quality of its COVID-19 vaccine.
Last month the Hyderabad-based company submitted 90 per cent of the documentation needed for WHO’s emergency use listing. It said that the rest of the documents would be submitted this month.
The government is working “closely” with Bharat Biotech and the WHO on the issue, Dr VK Paul, Member (Health) Niti Aayog, said earlier this month.
“We have been working with Bharat Biotech and WHO, data sharing is on, we are keen that this milestone is achieved soon. We are pursuing it,” he said at a press conference.
Last week the US Food and Drug Administration rejected the company’s proposal for emergency use authorisation of Covaxin. It asked the company to launch an additional trial so that it can file for a Biologics Licence Application (BLA), ie a full approval.
Following the rejection, the US partner of Bharat Biotech, Ocugen, said the company will now be seeking a full approval of Covaxin.
“Ocugen Inc today announced that upon recommendation from the US Food and Drug Administration, it will pursue submission of a biologics licence application for its COVID-19 vaccine candidate, Covaxin. The company will no longer pursue an emergency use authorisation for Covaxin,” it said in a statement.
“The FDA provided feedback to Ocugen regarding the master file the company had previously submitted and recommended that Ocugen pursue a BLA submission instead of an EUA application for its vaccine candidate and requested additional information and data,” it said.