A World Health Organization official on Thursday said that the health body trusts the Indian vaccine industry to manufacture high quality antidotes, reported PTI.
Mariangela Simao, the assistant director general of Access to Medicines and Health Products at the World Health Organization was responding to a journalist on the delay in granting emergency use listing approval to Bharat Biotech’s coronavirus jab Covaxin.
“We are right now at the last stage of the assessment by external advisory group and we hope to have a final recommendation to the World Health Organization next week,” Simao said at a press briefing.
India had applied to the World Health Organization for emergency use listing for Covaxin in April. Emergency use listing is a procedure by the global health body to approve vaccines and other products for use during public health emergencies. The duration of the emergency use listing process depends on the quality of the data submitted by the vaccine manufacturer.
Last month, the World Health Organization had said that Bharat Biotech began submitting “rolling data” on July 6. In a rolling review, the global health body can analyse information when it comes in from an applicant, thus accelerating the process.
On Tuesday, the World Health Organization’s technical advisory group had sought “additional clarifications” from Bharat Biotech to conduct a final risk-benefit assessment for the emergency use listing of Covaxin.
At the briefing, Simao said that Bharat Biotech has been submitting data “regularly and very quickly”, and the last batch of information was submitted on October 18. The technical advisory group had met on October 26 to decide on Covaxin’s approval.
“Let me just clarify and without wanting to mention any specific manufacturer but saying that we have assessed an Indian manufacturer earlier in the year and it took 30 days,” she said.
Simao was referring Serum Institute of India’s Covishield vaccine. It was granted emergency use listing in February.
She also clarified that the global health body’s process of issuing emergency use listing was a transparent process and there were “no secrets” involved, except in case of an confidential information.
“Everything else, the procedures that World Health Organization uses, are independent of which country is manufacturing the vaccine,” she said, adding that the technical advisory group comprises experts from six different countries.
Simao said the World Health Organization was currently evaluating eight vaccine candidates, including Covaxin.
Bruce Aylward, senior advisor to World Health Organization chief Tedros Adhanom Ghebreyesus, said that the health body was committed to completing the process as quickly as possible.
“But let’s be very clear, the timeline for EULing [emergency use listing] a vaccine depends 99% on manufacturers...The speed, the completeness with which they can get data to the independent groups that assesses for World Health Organization,” he said.
So far, the World Health Organization has approved six vaccines from Pfizer, Johnson & Johnson, AstraZeneca-Oxford, Moderna, Sinopharm, and Sinovac.
The Drugs Controller General of India had granted approval for restricted emergency use to Covaxin in January.
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