Made-in-India Covaxin gets WHO's emergency use licence

In a major development, the 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 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 Modi ji's resolve, a tale of people's trust and this is Diwali of self-reliant India".

Dr 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 use of this vaccine in two doses, with a dose interval of four weeks, in all age groups 18 and above.

The global health body, however, said that available data on vaccination of pregnant women with the Covaxin vaccine are insufficient to assess vaccine safety or efficacy in pregnancy.

"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 per cent 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 Emergency Use Listing of the vaccine.

Prime Minister Narendra Modi met WHO Director General Dr Tedros Adhanom Ghebreyesus at the G20 summit recently.

Besides demonstrating 77.8 per cent effectiveness against symptomatic COVID-19, Covaxin has shown 65.2 per cent protection against the new 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.