New Delhi: In a major development, the World Health Organisation (WHO) on Wednesday said it has granted emergency use listing (EUL) to Bharat Biotech’s COVID-19 vaccine Covaxin.
This comes after the Technical Advisory Group (TAG), an independent advisory committee of the WHO, recommended EUL status for Covaxin.>
“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 COVID-19,” the global health body said in a tweet.
Thanking WHO for granting the licence to Covaxin, Union health minister Mansukh Mandaviya said the achievement is a “sign of capable leadership and [Prime Minister Narendra] Modi ji’s resolve, a tale of people’s trust and this is Diwali of self-reliant India”.>
Poonam Khetarpal Singh, regional director of WHO South East Asia, in a tweet, said, “Congratulations India for Emergency Use Listing of its indigenously produced COVID-19 vaccine Covaxin.”
The WHO said the TAG convened by it and made up of regulatory experts from around the world determined that Covaxin meets its standards for protection against COVID-19, and that the benefit of the vaccine far outweighs risks and thus can be used.>
In another tweet, it said Covaxin was also reviewed by WHO’s Strategic Advisory Group of Experts on Immunization (SAGE), and recommended the use of this vaccine in two doses, with a dose interval of four weeks, for all age groups 18 and above.>
The global health body, however, said that available data on vaccination of pregnant women with the Covaxin vaccine is insufficient to assess safety or efficacy.>
“Available data on vaccination of pregnant women with the #Covaxin vaccine are insufficient to assess vaccine safety or efficacy in pregnancy; studies in pregnant women are planned, including a pregnancy sub-study and a pregnancy registry,” it said in a series of tweets.
Covaxin was found to have 78% efficacy against COVID-19 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, it said.>
“Covaxin EUL expands the availability of Syringe, 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,” it stated.>
WHO’s EUL procedure assesses the quality, safety and efficacy of COVID-19 vaccines and is a prerequisite for COVAX vaccine supply. It also allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines.>
“The EUL procedure assesses the suitability of novel health products during public health emergencies. The aim is to make medicines, vaccines & diagnostics available as rapidly as possible while adhering to stringent criteria of safety, efficacy & quality
“The Technical Advisory Group for Emergency Use Listing is an independent advisory group that provides a recommendation to WHO whether an unlicensed vaccine can be recommended for emergency use under the EUL procedure, and if so, under what conditions,” the WHO said.>
Before the WHO announcement, a source told PTI: “The Technical Advisory Group of WHO has recommended Emergency Use Listing status for Covaxin.”>
The TAG on October 26 had sought “additional clarifications” from the company for Covaxin to conduct a final “risk-benefit assessment” for EUL.
Prime Minister Modi met WHO director general Tedros Adhanom Ghebreyesus at the G20 summit recently.>
Besides demonstrating 77.8% effectiveness against symptomatic COVID-19, Covaxin has shown 65.2% protection against the delta variant.>
In June, the company said it concluded the final analysis of Covaxin efficacy from Phase 3 trials.
Bharat Biotech’s Covaxin and AstraZeneca and Oxford University’s Covishield are the two widely used vaccines in India.>
(PTI)>
Note: This article was originally published at 5:51 pm on November 3, 2021 and updated at 7:29 pm on November 3, 2021.>