WHO explains delay in emergency use listing status of Covaxin; 'We trust Indian industry'

The World Health Organization (WHO) on Thursday opened up on the delay of approval of the Covaxin in its Emergency Use Listing (EUL). The WHO on October 27, sought more clarifications from Bharat Biotech (manufacturer of COVAXIN) in order to approve the made-in-India COVID-19 vaccine in its Emergency Use Listing. The WHO on Thursday clarified that India's Bharat Biotech has been submitting data on the EUL of Covaxin regularly and very quickly to a technical committee that hopes to have a final recommendation to the WHO next week.

"Bharat Biotech has been submitting data regularly and very quickly, but they submitted the last batch of data on the 18th of October, Dr Mariangela Simao, Assistant Director-General, Access to Medicines and Health Products at WHO, said at a press briefing in Geneva. 

She was responding to a question on the delay in granting the Emergency Use Listing to Covaxin while Chinese vaccines Sinopharm and Sinovac were given approval even with lack of data. Simao said that when the technical advisory group met on October 26 to discuss the EUL for Covaxin, they asked Bharat Biotech for further clarifications.

'We really trust the Indian industry,' says WHO

Furthermore, Mariangela Simao added that WHO is in touch with Bharat Biotech and has "daily conversations and calls and meetings clarifying what additional data needs" to be submitted to the technical expert group.

"Let me just clarify and without wanting to mention any specific manufacturer but saying that we have assessed an Indian manufacturer earlier in the year and it took 30 days, she said, a reference to the Serum Institute of India which manufactures the AstraZeneca Covishield vaccine," said Mariangela Simao. 

"So this is not about moving quicker with one or another vaccine. We really trust the Indian industry. India produces different majority of vaccines in the world, high quality vaccines. We are right now at the last stage of the assessment by this external advisory group and we hope to have a final recommendation to the WHO next week. I hope that's well understood," added Mariangela Simao. 

COVAXIN and WHO

Hyderabad-based Bharat Biotech, which has developed Covaxin, had submitted Expression of Interest (EOI) to the WHO on April 19 for the vaccine's Emergency Use Listing (EUL). A technical advisory group of the UN health agency which met on Tuesday has sought "additional clarifications" from Bharat Biotech for Covaxin to conduct a final risk-benefit assessment for Emergency Use Listing of the vaccine. The technical advisory group will now meet on November 3 for a final assessment.

Covaxin is a Whole Virion Inactivated Coronavirus Vaccine developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV). While the phase 3 trials entailed 25,800 participants between 18-98 years of age including 10% over the age of 60, the analysis was conducted 14 days after administering the second dose of the vaccine. It has shown overall 77.8% efficacy and 93.4% efficacy against severe COVID-19 disease as per the final results.

Bharat Biotech's Covaxin and AstraZeneca and Oxford University's Covishield are the two widely used vaccines in India. 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.

(Image: PTI/Shutterstock)

(Inputs: PTI)