UNITED NATIONS/GENEVA: The World Health Organisation is in negotiations with Bharat Biotech, whose COVID-19 vaccine Covaxin was given Emergency Use Listing, to join the global health agency's technology access pool to share technology and know how, a top WHO official said Wednesday.
The UN health agency on Wednesday issued an emergency use listing (EUL) for Covaxin developed by Bharat Biotech, adding to a growing portfolio of vaccines validated by WHO for the prevention of COVID-19 caused by SARS-CoV-2.
"I think it's very important that there is increased production of vaccines in different continents. And I'm happy to say that we are in negotiations with Bharat to join what we call the COVID technology access pool," the platform through which WHO coordinates with other partners on sharing technology, know-how and licensing regarding COVID-19 vaccines and treatments, said Dr Mariangela Simao, WHO Assistant-Director General for Access to Medicines and Health Products.
"So this conversation is ongoing already that would allow for a good basis for technology transfer to other countries, she said during a virtual Q&A session after Covaxin was issued the EUL by WHO Wednesday.
Covaxin was assessed under the WHO EUL procedure based on the review of data on quality, safety, efficacy, a risk management plan and programmatic suitability.
The Technical Advisory Group (TAG), convened by WHO and made up of regulatory experts from around the world, has determined that the vaccine meets WHO standards for protection against COVID-19, that the benefit of the vaccine far outweighs risks and the vaccine can be used globally, WHO said.
The Bharat Biotech's vaccine is formulated from an inactivated SARS-CoV-2 antigen and is presented in single dose vials and multidose vials of 5, 10 and 20 doses.
Simao said that in the case of Bharat Biotech's Covaxin, the expert group was composed of six experts from six different nationalities.
"In the case, we're very happy to be announcing today" that the technical advisory group met and recommended to WHO proceed with the listing of this vaccine, she said.
Responding to a question on the efficacy of the vaccine, Dr Joachim Hombach from the Secretariat - WHO Strategic Advisory Group of Experts, said that WHO has the data from the clinical trial and the efficacy was estimated to be in the range of 79%.
"There were relatively few cases of more severe disease so the estimation of the effectiveness or efficacy against severe disease is more difficult, but it is reasonable to assume that this effectiveness is higher, as we see for all of these products, but the clinical trial didn't have sufficient power in order to estimate the efficacy against severe disease."
Simao said the process to issue EUL for COVID-19 vaccines is very structured and very transparent process and the procedures are based on internationally recognized standards for clinical trials, good manufacturing practices and other issues that are important for safety and quality of any health product.
Meanwhile, WHO Director-General Tedros Adhanom Ghebreyesus on Wednesday said he is "glad" to see Covaxin get the Emergency Use Listing approval, as he underlined that the more products the world has to fight the coronavirus pandemic, the better it is.
The approval came after the Technical Advisory Group (TAG), an independent advisory committee of WHO recommended EUL status for Covaxin.
"Glad to see one more vaccine, #Covaxin, being granted @WHO emergency use listing. The more products we have to fight #COVID19, the better, but we must keep up the pressure to deliver VaccinEquity & prioritize access to vulnerable groups who are still waiting for their 1st dose," Ghebreyesus said in a tweet.
India's Permanent Representative to the United Nations in Geneva Indramani Pandey also hailed the WHO's decision and thanked Dr Tedros.
"We thank @DrTedros, DG, WHO, and his Team for their contribution in grant of EUL to Covaxin, a step towards fulfillment of the shared goal of India and @WHO of early vaccination and vaccine equity," Pandey said in a tweet.
Following the EUL approval for Covaxin, manufactured by Bharat Biotech, WHO Chief Scientist Soumya Swaminathan also congratulated India on getting the approval for Covaxin.
"One more vaccine gets @WHO emergency use listing. Congratulations India @BharatBiotech @ICMRDELHI @MoHFW_INDIA for successful development of indigenous vaccine #Covaxin as well as for a massive vaccination program!," she said.
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.
Prime Minister Narendra Modi met WHO Director General Ghebreyesus on the sidelines of the G20 summit in Rome 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.