Covaxin emergency use approval may be delayed, WHO seeks more data

Despite the Indian government saying that it is expecting WHO to authorise emergency use of indigenously made Covaxin, developed by the Hyderabad-based Bharat Biotech, there could be an inordinate delay in the approval process, according to some reports.

“World Health Organization (WHO) has asked for more data from Bharat Biotech for its COVID19 vaccine Covaxin. The Emergency Use Authorisation (EUA) for the vaccine will be delayed by a few more days,” an ANI report quoting sources said.

“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. We are diligently working with the WHO to obtain EUL at the earliest,” Bharat Biotech said in a statement.

It had earlier said in a tweet that all data was submitted to the WHO and responded to clarifications.

“#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.

Also read: Covaxin turns bane for expats as Gulf nations stress on Covishield

Although officials in the health ministry had earlier said that the Emergency Use Authorisation (EUA) was expected on October 5, it is now learnt that a top body of experts, Strategic Advisory Group of Experts on Immunization (SAGE), will be meeting on October 5 to grant EUA to Covaxin.

On the other hand, the lack of approval by WHO is also affecting those who wish to travel abroad as Covaxin is not among the authorised vaccines for Covid-19 in many parts of the world, especially the US, UK, Australia, Europe, Canada, and those who have taken it are considered unvaccinated.

In June, the US’ Food and Drug Administration, the body which approves medicines and drugs and vaccines for public use, had rejected the use of Covaxin in the country due to lack of enough data, primarily data from the Phase 3 trials. However, Bharat Biotech had then said that “it no longer intends to seek EUA from the US authority but a full approval”.

Brazil which had initially approved the use of Covaxin under controlled conditions later revoked the approval on allegations of corruption in the Jair Bolsonaro government and the fact that Pfizer was giving vaccines at a cheaper rate.

Also read: Each batch of Covaxin subject to more than 200 tests: Bharat Biotech

Brazil’s vaccine regulatory body Anvisa also highlighted that Bharat Biotech was not able to ensure that Covaxin completely killed the SARS-CoV-2 virus and also that it did not have enough evidence to prove that the virus was “incapable of multiplying in the human body.”

As of September 28, India has administered over 10 crore doses of Covaxin to its people after having approved it for Emergency Use Authorisation in January.

Eight other countries – Guyana, Iran, Mauritius, Mexico, Nepal, Paraguay, Philippines, and Zimbabwe – have authroised the use of Covaxin.