New Delhi: Covaxin, manufactured by Bharat Biotech and developed jointly by the company and the Indian Council of Medical Research (ICMR), was granted emergency-use listing (EUL) by the World Health Organization (WHO) Wednesday evening.
In a series of tweets, the WHO wrote: “WHO has granted emergency use listing (EUL) to #COVAXIN® (developed by Bharat Biotech), adding to a growing portfolio of vaccines validated by WHO for the prevention of #COVID19. 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 #COVID19, that the benefit of the vaccine far outweighs risks & the vaccine can be used.”
It added: “#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. #COVID19. #Covaxin was found to have 78% efficacy against #COVID19 of any severity, 14 or more days after the second dose, and is extremely suitable for low-and middle-income countries due to easy storage requirements.”
Bharat Biotech had first applied for the approval in May. After that, additional information was sought by the WHO through eight communications, with more inputs sought after the last two meetings of its Technical Advisory Group on Vaccines.
The matter of Covaxin’s EUL also came up during a meeting between Union Health Minister Mansukh Mandaviya and WHO Director General Dr Tedros Adhanom Ghebreyesus about two weeks ago.
WHO added in the tweet thread: “#Covaxin EUL expands the availability of, the most effective medical tools we have to end #COVID19. It was assessed under the WHO EUL procedure based on the review of data on quality, safety, efficacy, a risk management plan & suitability in low- & middle-income countries.”
The WHO’s EUL procedure, the agency said, “assesses the quality, safety and efficacy of #COVID19 vaccines and is a prerequisite for #COVAX (global initiative for equitable access to vaccines) vaccine supply”.
“It also allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines,” it added.
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12.14 crore doses of Covaxin given so far
Covaxin began to be administered in India from 16 January, when its phase III trial data was yet to come in. It was granted emergency-use authorisation on the ground that as a whole virion vaccine it is more likely to be effective against variants of SARS-CoV-2. Since then, 12.14 crore doses of the vaccine have been administered in India.
The vaccine is also now awaiting regulatory approval in India for the 2-18 years age group. The WHO approval pertains only to the administration of the vaccine among adults. The approval means that Covaxin will now be a part of the basket of vaccines that are given out to countries as part of various global initiatives.
An earlier version of the report erroneously said the listing came Thursday. The error is regretted.
(Edited by Poulomi Banerjee)
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