The Technical Advisory Group of the World Health Organisation (WHO) has recommended Emergency Use Listing (EUL) status for Bharat Biotech's Covaxin, the health body tweeted on Wednesday, 3 November.
Reacting to this development, Covaxin maker Bharat Biotech said the Emergency Use Listing approval by WHO "validates the international safety and quality standards of COVAXIN".
WHAT DID WHO SAY ON WEDNESDAY?
The Technical Advisory Group, convened by WHO and made up of regulatory experts from around the world, has determined that the Covaxin vaccine meets WHO standards for protection against COVID-19, that the benefit of the vaccine far outweighs risks and the vaccine can be used, the WHO said on Wednesday.
Covaxin vaccine was also reviewed by WHO’s Strategic Advisory Group of Experts on Immunization (SAGE), and recommended use of this vaccine in two doses, with a dose interval of four weeks, in all age groups 18 and above, it added.
Available data on vaccination of pregnant women with the Covaxin vaccine are insufficient to assess vaccine safety or efficacy in pregnancy, it further said, adding that studies in pregnant women are planned, including a pregnancy sub-study and a pregnancy registry.
WHAT DID BHARAT BIOTECH SAY?
Along with stating that they are motivated to mitigate the pandemic, Bharat Biotech also, according to ANI, said:
"With validation from WHO, countries can now expedite their regulatory approval processes to import and administer Covaxin. UNICEF, Pan-American Health Organization (PAHO), GAVI COVAX facility, will be able to procure Covaxin for distribution to countries worldwide."
HEALTH MINISTER, ICMR DG REACT
Soon after WHO cleared Covaxin, Health Minister Mansukh Mandaviya took to Twitter to thank the health body, calling the development a sign of capable leadership and the story of PM Modi's resolve.
Meanwhile, ICMR Director General Balram Bhargava said that with this development, "the whole world opens up for us."
"With this, the whole world opens up for us, for sending this vaccine. Now that we have administered a large number of vaccine doses, we will be able to send this absolutely indigenous vaccine to the rest of the world."
BACKGROUND
The WHO on Thursday, 28 October had said that Bharat Biotech had been submitting information required for EUL of Covaxin "regularly and very quickly" to a technical committee that helps the global health agency in assessing the vaccine, reported news agency PTI.
The UN body said this at a press briefing in Geneva, and asserted that it trusted India's vaccine manufacturing industry, that produces "high quality" vaccines.
Bharat Biotech had on 19 April submitted EOI (Expression of Interest) to WHO for EUL of Covaxin.
(With inputs from ANI)
(This is a developing story. It will be updated with more details)
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