No WHO approval for Covaxin yet as panel wants more details
WHO said it expects the clarifications to come in by the end of this week and it will meet again on November 3 to discuss the approval, technically known as an emergency use listing.
An expected approval for Covaxin by the World Health Organization (WHO) has been delayed further after experts asked the vaccine’s maker Bharat Biotech for some clarifications, the United Nations health body said following a meeting on Tuesday.
Millions of Indians and the Centre have been watching the process, which was expected to reach some sort of conclusion by the end of October. An approval will allow for a larger recognition of Covaxin by other countries to allow Indian travellers who have taken the dose to qualify for vaccine mandates. Conversely, a rejection could hurt confidence in the dose.
WHO said it expects the clarifications to come in by the end of this week and it will meet again on November 3 to discuss the approval, technically known as an emergency use listing (EUL).
“The Technical Advisory Group for Emergency Use Listing (TAG-EUL) is an independent advisory group that provides recommendations to WHO on whether a Covid-19 vaccine can be listed for emergency use under the EUL procedure. The TAG met today (26 October 2021) and decided that additional clarifications from the manufacturer are needed to conduct a final EUL risk-benefit assessment for global use of the vaccine,” said WHO in a written response to HT.
“The TAG expects to receive these clarifications from the manufacturer by the end of this week, and aims to reconvene for the final risk-benefit assessment on Wednesday, 3 November.”
The grant of EUL will also make the vaccine eligible for distribution to low and middle income countries under the COVAX facility.
Earlier, during Tuesday’s media briefing, Union health minister Mansukh Mandaviya said: “WHO has a system in place under which one technical committee observes the data, followed by another technical committee further analysing the data. The first committee has approved the data and the approval for Covaxin will be granted on the basis of what the second committee recommends.”
On October 5, WHO announced through a series of tweets that emergency use approval for Covaxin was a week away. “We are aware that many people are waiting for WHO’s recommendation for Covaxin to be included in the COVID19 Emergency Use Listing, but we cannot cut corners - before recommending a product for emergency use, we must evaluate it thoroughly...,” tweeted WHO.
The last set of documents WHO sought from the company was submitted on September 27. “All documents required for emergency use listing (EUL) of Covaxin have been submitted to WHO as of 9th July. The review process has now commenced with the expectation that we will receive EUL from WHO at the earliest,” Krishna Ella, chairman and managing director, Bharat Biotech, said last month.
