The vaccine maker also said that it is in the process of seeking regulatory approvals for Covaxin in more than 60 countries including US, Brazil, Hungary, among others.
Bharat Biotech’s Covaxin was granted restricted emegency use approval in ‘clinical trial mode’ on January 2.
Bharat Biotech on May 25 said it had submitted application for WHO Emergency Use Listing (EUL), and regulatory approvals are expected in July-September, 2021.
The vaccine maker also said that it is in the process of seeking regulatory approvals for Covaxin in more than 60 countries including US, Brazil, Hungary, among others.
The company said it has obtained emergency use authorisations in 13 countries with more nations are expected to follow.
“Most countries recommend vaccinations against COVID-19. Unvaccinated travelers can travel with negative RT-PCR tests prior to travel, in the absence of any other country specific travel restrictions,” the company said in a statement.
Moneycontrol on May 24 reported about Bharat Biotech expediting Covaxin WHO emergency listing with govt backing.
The global body has sought more information from Bharat Biotech. The pre-submission meeting is planned for May-June.
Pre-submission meetings provide guidance before submission of the dossier, as well as an opportunity for the applicant to meet WHO medicines assessors, who will be involved in evaluating their product.
The pre-submission meeting will be followed by acceptance of the dossier for review, following which WHO gives a targeted action date or anticipated decision date.
Viswanath Pilla is a business journalist with 14 years of reporting experience. Based in Mumbai, Pilla covers pharma, healthcare and infrastructure sectors for Moneycontrol.
