Covaxin's WHO emergency use listing to be delayed? Bharat Biotech says 'won't speculate'

Vaccine maker Bharat Biotech said that “it would not speculate on the WHO regulatory approval process and its timeline,” after it emerged that the international health body had sought more details to list Covaxin for global emergency use acceptance.

WHO’s Emergency Use Listing (EUL) is a green light for a vaccine's roll-out globally. It also allows countries to expedite their own regulatory approval to import and administer Covid-19 or other vaccines.

The Hyderabad-based firm had in May this year applied to the World Health Organization for Covaxin's EUL and expected to get approval by July-September.

In mid-July, Bharat Biotech International Limited CMD Dr Krishna Ella announced that “all documents required for EUL of Covaxin have been submitted to WHO.”

Also Read | Shortage of staff, production crunch: Why Covaxin couldn’t lead India’s vaccination efforts

Around the same time, WHO's chief scientist Soumya Swaminathan said that a decision on Covaxin's EUL is likely to be taken in four to six weeks.

However, WHO has now reportedly asked Bharat Biotech for more data on its Covid-19 vaccine, which could further delay the global acceptance tag for the homegrown vaccine.

“As a responsible manufacturer with past approvals for our other vaccines, we do not find it appropriate to speculate or comment on the regulatory approval process and its timelines,” Bharat Biotech stated on Tuesday, adding that it is “diligently working with the WHO to obtain EUL at the earliest.”

While not disclosing what sort of information was sought by WHO, Bharat Biotech said that it “will make announcements to indicate the availability of regulatory approvals, at appropriate times.”

Also read | Paediatric Covaxin: Bharat Biotech completes phase 2/3 trials

The EUL assesses the quality, safety and efficacy of Covid-19 vaccines, as well as risk management plans and programmatic suitability, such as cold chain requirements.

WHO says that its EUL is a risk-based procedure for “assessing and listing unlicensed vaccines, therapeutics and in vitro diagnostics with the ultimate aim of expediting the availability of these products to people affected by a public health emergency.”

Serum Institute of India's Covishield, a version of the AstraZeneca/Oxford University Covid-19 vaccine, had received WHO emergency listing in February.

Both Covishiled and Covaxin are part of the ongoing Covid-19 immunisation programme in the country.

Covaxin, jointly developed by the ICMR, National Institute of Virology and Bharat Biotech last year was approved for emergency use in the country in January.

The final Phase-3 trial results of the vaccine's safety and efficacy came out six months later.

In July, the firm claimed that Covaxin was showing an overall efficiency of 77.8 per cent against the coronavirus and is 93.4 per cent effective in severe cases of Covid-19 infection.

The indigenous Covid-19 vaccine is offering 63.6 per cent immunity in asymptomatic cases, and is also demonstrating 65.2 per cent protection against the Delta variant infection, Bharat Biotech had announced in a joint statement with Indian Council of Medical Research.

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