The WHO will take a decision on Bharat Biotech’s Covaxin for granting Emergency Use Listing (EUL) in October. While the rolling review started in July, the WHO document on the evaluation of EUL for Covid vaccines, the decision for Covaxin will be taken in October.
Soumya Swaminathan, WHO’s chief scientist, told ET that the “process is ongoing”. The latest ‘Status of COVID-19 vaccines within WHO EUL/PQ evaluation process’ guidance document dated September 29 on the WHO website said that the decision date for Bharat Biotech’s Covaxin is “October 2021”.
The WHO said it began rolling data of the vaccine on July 6.
On Tuesday the company said that it was diligently working with the World Health Organisation (WHO) to obtain EUL at the earliest.
It said that it was not “appropriate to speculate” on the regulatory approval process and the timelines.
“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 & its timelines,” it said.
The company said it will make announcements to indicate the availability of regulatory approvals at an appropriate time.
“We request media organizations to exercise restraint while reporting on public health-related issues and timelines, as it has an impact on millions of lives and livelihoods,” it further said.
The World Health Organisation panel is likely to meet in the first week of October to review Covaxin for granting EUL, a move that will allow people inoculated with Bharat Biotech’s Covid-19 vaccine to travel abroad without restrictions.
The WHO global advisory committee on vaccine safety will assess immunogenicity, vaccine safety and vaccine effectiveness of Covaxin, a crucial step for granting EUL, people in the know told ET.
An emergency approval from the WHO will allow Bharat Biotech to export Covaxin and enable easy international travel of people who have received this vaccine.
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 (SEC) of the Central Drugs Standard Control Organisation (CDSCO).
The WHO has so far approved Covid-19 vaccines of Pfizer-BioNTech, AstraZeneca-SK Bio/Serum Institute of India, Johnson & Johnson-Janssen, Moderna, and Sinopharm for emergency use.
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