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.
A top WHO official on Wednesday confirmed that talks are on between the World Health Organisation (WHO) and Indian vaccine manufacturer Bharat Biotech, whose Covid-19 shot Covaxin was given Emergency Use Listing (EUL) status a day ago, to join the global health agency's technology access pool to share technology and manufacturing details.
Covaxin was accredited an emergency use listing (EUL) status by the UN health agency on Wednesday, which got added 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.
(With PTI Inputs)