PharmaLytica 2021 Hyderabad review.

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Bharat Biotech expects WHO nod for emergency use of Covaxin within 2-4 months

Most countries recommend vaccinations against Covid-19. Unvaccinated travellers can travel with negative RT-PCR tests prior to travel, in the absence of any other country-specific travel restrictions, Bharat Biotech said.

25th May, 2021 Mumbai

Days after Bharat Biotech applied to the World Health Organization for the Emergency Use Listing of its Covid-19 vaccine candidate, Covaxin, the Hyderabad-based firm on Tuesday said that the application for EUL has been submitted to WHO and the regulatory approvals are expected between July to September this year.

With this, Covaxin became the second India-made vaccine to apply at the global health agency for authorisation.

The company said regulatory approvals for Covaxin are in process in more than 60 countries including the USA, Brazil and Hungary among others. "Regulatory approvals for Covaxin are in process in over 60 countries. Emergency Use Authorisations have been obtained in 13 countries with more to follow," the Indian vaccine manufacturer said.

Most countries recommend vaccinations against Covid-19. Unvaccinated travellers can travel with negative RT-PCR tests prior to travel, in the absence of any other country-specific travel restrictions, Bharat Biotech said. On Monday, while citing a WHO document, Mint had reported that Bharat Biotech may hold a preliminary meeting with the WHO this month or the next before applying for an EUL for Covaxin.

While Bharat Biotech had submitted its expression of interest for Covaxin's EUL to the WHO on 19 April, it's not yet clear if the company has made its final submission yet.

Meanwhile, Bharat Biotech has conveyed to the government that it has already submitted 90% of the documents to WHO for obtaining EUL for the Covaxin vaccine.

The remaining documents are expected to be submitted by June, the Hyderabad-based Bharat Biotech informed the Centre during a discussion on obtaining the WHO's authorisation for emergency use listing for Covaxin. Sources say, BBIL is confident about obtaining WHO's emergency use listing. Noting that Covaxin has already received regulatory approval from 11 countries, sources said there was also interest from other 11 companies in seven nations for technology transfer and production of Covaxin.

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