Seeking “additional clarifications” for a final “risk-benefit assessment” in order to grant emergency use listing (EUL) to Bharat Biotech’s Covid-19 vaccine, Covaxin, the technical advisory group (TAG) of the World Health Organisation (WHO) has held back approval for the indigenously developed vaccine, till at least one more week, if not longer. This, after the TAG convened on Tuesday specifically to discuss granting EUL to Covaxin.
The TAG — which is an independent advisory group that recommends to WHO on whether a Covid-19 vaccine fulfils criteria for EUL or not — will meet next on November 3.
This increases the uncertainty about the vaccination status of millions of people who received the two jabs of Covaxin as several regions, including North America and the European Union, only consider those people fully vaccinated who have received their full course of WHO-approved vaccines.
The WHO last week said that it “cannot cut corners” in granting EUL to the vaccine. It had also put the onus of the delay on Bharat Biotech, saying that the timeframe for granting EUL depends on how quickly a company can submit all the data required in order to evaluate the vaccine’s quality, safety, efficacy and its suitability for low- and middle-income countries.
The company, which has been submitting clinical trial data of its vaccine on a rolling basis to the WHO, had earlier in May said that it had applied for WHO’s EUL that was expected between July to September. Later in June, it claimed that it had held a “pre-submission” briefing with the world health body regarding EUL approval for Covaxin. Last month, in a statement, it said that “all data was submitted for EUL Application to WHO in early July.”
A pre-submission briefing provides an opportunity to the company to receive advice and guidance before submission of the final dossier, as well as an opportunity to meet WHO assessors who will be involved in examining their product. This implies that it should be held before submitting the application — and not after it.
Even earlier this month, the Strategic Advisory Group of Experts on Immunisation (SAGE) of the WHO had held back on giving EUL to Covaxin, which has demonstrated 77.8% efficacy against symptomatic Covid-19 and 65.2% efficacy against the Delta variant.