Covaxin Delayed Emergency Approval from WHO until 5 October

Approvals to COVID-19 Covaxin, developed by the Bharat Biotech based in Hyderabad, is expected to be delayed until October 5, by the World Health Organisation(WHO).

The WHO will meet on 5 October with the EUA awarding Covaxin to the Strategic Advisary Group of Immunization Experts (SAGE).

SAGE member Hanna Nohynek will introduce the objectives for the meeting, a regulatory update and an overview of results achieved by the Working Group.

The session will recommend EUA based on the clinical data on Covaxin from phase 1, 2, 3 trial and post-marketing studies on safety, immunogenicity, efficacy and effectiveness.

It will update on global, regional and country-level plans for vaccine safety monitoring.

The evaluation of the available evidence by the SAGE working group will determine EUA.

Bharat Biotech said on Friday that it submitted all data on its Covaxin vaccine COVID-19 to the International Health Organization (WHO). The UN Public Health Agency is waiting for feedback.

In a series of tweets, Bharat Biotech said that Covaxin clinical trial was fully compiled and available in June 2021.

“#COVAXIN clinical trial data was fully compiled and available in June 2021. All Data was submitted for Emergency Use Listing (EUL) Application to World Health Organization in early July. We have responded to any clarifications sought by #WHO and are awaiting further feedback,” Bharat Biotech tweeted.

As a responsible manufacturer with past approvals for its other vaccines, the company said it would not find it appropriate to speculate or comment on the approval process and its timelines, it further said.

“We are continuing to work diligently on obtaining WHO EUL at the earliest,” it added.

Bharat Biotech has submitted its Phase 3 clinical trials data that demonstrated 77.8 per cent efficacy to the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO).

Covaxin was developed by Hyderabad-based Bharat Biotech in association with the Indian Council of Medical Research and the National Institute of Virology. Covaxin, which has been developed in collaboration with the Indian Council of Medical Research (ICMR), contains a whole virion inactivated SARS-CoV-2 vaccine, which is produced in Vero cells.

The vaccine is stable at 2 degrees Celsius to 8 degrees Celsius (refrigerated) and is shipped in a ready-to-use liquid formulation that permits distribution using existing vaccine supply chain channels.

The WHO has so far approved Covid vaccines developed by Pfizer-BioNTech, US pharma majors Johnson & Johnson, Moderna, China’s Sinopharm and Oxford-AstraZeneca for emergency use.