The World Health Organisation (WHO) sought “additional clarifications” from Bharat Biotech for its assessment of the Covaxin vaccine. The organisation said that this was necessary to complete a “risk-benefit assessment” to finally approve the jab for emergency use.
The assessment is being conducted by the WHO’s technical advisory group (TAG), which is responsible for assessing vaccines for Emergency Use Listing. It acts as an independent group that advises the WHO on whether a COVID-19 vaccine should be approved for emergency use.
The decision to seek additional clarifications came during the group’s meet on Tuesday. NDTV quoted an email by the WHO saying: “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.” Further, it said that the group expects a response from Bharat Biotech by the end of the week. The group is now scheduled to meet on November 3 to deliver the final verdict on India’s homegrown jab.
Addressing a media briefing earlier on Tuesday, Dr. Margaret Harris, the spokesperson for the WHO, said that the group was conducting a review of all relevant data on the vaccine. She said, “Now if all is in place, and all goes well, and if the committee is satisfied, we could expect a recommendation within the next 24 hours or so.”
Previously, the WHO has said that it could not “cut corners” while recommending jabs for emergency use. Keeping this in mind, it clarified that it would only deliver its verdict after all the data had been analysed. It said that the timeline for approving the vaccine for emergency use depends on the manufacturing company and how soon it can provide the WHO with the required data, noting: “When the information provided addresses all questions raised, WHO and the Technical Advisory Group will complete the assessment and come to a final recommendation whether to grant Emergency Use Listing to the vaccine.”
In the run-up to the TAG’s meeting, Indian Prime Minister Narendra Modi met with representatives of Bharat Biotech, discussing any prospective obstacles in the approval of Covaxin for emergency use.
Covaxin is produced by the Hyderabad-based Bharat Biotech. The pharmaceutical company presented its Expression of Interest for Emergency Use Listing on April 16. It has reported an efficacy of 77.8% against symptomatic COVID-19 and 65.2% efficacy against the Delta variant. It has already been approved by local health authorities from 14 countries.
However, the company has been for WHO approval so that its vaccine is recognised for international travel and more generally global acceptance. The organisation has already approved the Oxford-AstraZeneca, Pfizer, Moderna, Johnson & Johnson, and Sinopharm vaccines for emergency use.