Hyderabad: Denouncing media reports of delay in getting WHO approval for emergency use listing (EUL) for Covaxin, Bharat Biotech said that the company is diligently working with the UN body for the same.
The Hyderabad-based firm also said that the announcements indicating the availability of regulatory approvals will be made at appropriate times. Bharat Biotech also requested media outlets to exercise restraint while reporting on public health-related issues and timelines.
Further, Bharat Biotech also said in a tweet that it does not find it appropriate to speculate or comment on the regulatory approval process and its timelines.
Bharat Biotech had sought EUL in early July 2021. EUL hastens the availability of unlicensed vaccines, therapeutics and in vitro diagnostics to people in the wake of a public health emergency. The listing will bolster global acceptance of the vaccine, benefitting Indians who want to travel to foreign countries.
Earlier, Minister of State for Union Ministry of Health and Family Welfare Dr Pravin Bharati Pawar had said, "There is the procedure of submitting the documents for approval. WHO's emergency use authorisation is expected soon."
In June 2021, a pre-submission meeting for EUL was also held. Phase 3 clinical trials data of Covaxin that demonstrated 77.8 per cent efficacy was submitted by Bharat Biotech to the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO).
Covaxin was developed by Bharat Biotech along with the Indian Council of Medical Research and the National Institute of Virology. The vaccine is stable at two degrees Celsius to eight degrees Celsius (refrigerated). Covid-19 vaccines by Pfizer-BioNTech, AstraZeneca, Johnson and Johnson, Moderna and Sinopharm have been approved by the WHO.
Also read: Paediatric Covaxin: Bharat Biotech completes phase 2/3 trials
