Hyderabad-based Bharat Biotech said on Tuesday that it is “diligently working with” the World Health Organization to obtain the emergency use listing (EUL) at the earliest for its Covid-19 vaccine, Covaxin.
The company didn’t indicate how long the process could take, saying that it was not appropriate to speculate.
“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,” it said.
Soumya Swaminathan, WHO’s chief scientist, told ET on Tuesday that the “process is ongoing”.
Bharat Biotech said it will make announcements to indicate the availability of regulatory approvals at an appropriate time.
“We request media organisations to exercise restraint while reporting on public health-related issues and timelines, as it has an impact on millions of lives and livelihoods,” it said.
A WHO panel is likely to meet in the first week of October to review Covaxin for granting EUL, people in the know told ET.
An emergency approval from the WHO will allow Bharat Biotech to export Covaxin to more countries and enable easy international travel for people who have received this vaccine.
The WHO Global Advisory Committee on Vaccine Safety will assess the immunogenicity, safety and effectiveness of Covaxin, a crucial step for granting EUL, the people said.
“A series of meetings have taken place to assess pre-clinical and clinical data. A presentation on the safety of Covaxin was also made before the WHO recently,” said one of the people.
The EUL pathway involves a rigorous assessment of clinical trial data as well as additional data on safety, efficacy, quality and a risk management plan. Bharat Biotech had in June presented its phase-3 clinical trials data, demonstrating 77.8% efficacy, to the subject expert committee of India’s Central Drugs Standard Control Organisation.
Submission of phase-3 data is key to obtaining prequalification from the WHO.
