Bharat Biotech’s Covaxin On its Way Towards WHO Approval

Image courtesy: Bharat Biotech

Covaxin, India’s first indigenous COVID-19 vaccine developed by Bharat Biotech, was approved by the Drugs Controller General of India for emergency use in January 2021. Since then, more than 20 million doses have been administered in India.

Covaxin has been approved for emergency use in Iran, the Philippines, Mauritius, Mexico, Nepal, Guyana, Paraguay, and Zimbabwe. The inactivated whole-virion vaccine demonstrated an efficacy of 81% in preliminary Phase 3 clinical trials. In addition, it was found to be effective against most variants such as alpha (B.1.7) and delta (B.1.617), according to data submitted to US NIH. However, the complete Phase 3 clinical data is not available. 

Pricing Controversy in Brazil

In May 2021, Brazil ordered about 20 million doses of Covaxin. However, the $324 million contract ran into controversy when a health ministry official, Luis Ricardo Miranda, raised suspicions about pricing and possible advance payments for the vaccine deal with Bharat Biotech. This raised concerns since Pfizer had made offers to Brazil in 2020 for a deal at a competitive price, given that US FDA and WHO have approved its vaccine.

On June 24th, federal prosecutors opened an investigation on the high price per dosage and the lack of regulatory approvals for Covaxin. On June 29th, Brazil’s health minister said that the contract was suspended. In a press statement, the ministry said, “According to the preliminary analysis of the CGU, there are no irregularities in the contract, but, for compliance, the health ministry chose to suspend the contract.”

Bharat Biotech clarified that it has not received advance payments and is in compliance with regulatory policies and pursuing appropriate approvals from WHO and other regulators. 

Towards Emergency Approval from WHO

The World Health Organization (WHO) has a recommended list of vaccines in the Emergency Use Listing (EUL) which have been reviewed for efficacy and safety; to streamline all COVID-19 vaccine products. Covaxin is not on the list since its Phase 3 clinical trial data has not yet been evaluated.

Bharat Biotech is in partnership with Ocugen to bring Covaxin to the US and Canada. However, on June 10th, the FDA rejected Bharat Biotech’s application for EUA and suggested they apply for a Biologics Licence. Featuring on the WHO list is necessary for Covaxin to be approved in other countries. Currently, individuals vaccinated with Covaxin have trouble traveling to the US and Europe since it is not approved by WHO. 

Bharat Biotech submitted the EOI (expression of interest) on April 19th, 2021. It needs to undergo three more steps for the vaccine to be approved by WHO. A pre-submission meeting was held on June 23rd. The company needs to provide complete Phase 3 clinical data for review, assessment, and final decision.

Bharat Biotech expects the whole process to be completed during July-September 2021. The company’s joint Managing Director, Dr. Suchitra Ella, tweeted on June 29th, “We are working closely with the World Health Organisation for inclusion of Covaxin in its Emergency Use Listing (EUL). Approval from WHO is not expected to be a long-drawn process as the cell line and majority of our facilities have already been audited and approved by WHO for our other vaccines in the past”.

Meanwhile, WHO’s Chief Scientist, Dr. Soumya Swaminathan, told NDTV that the decision on the emergency approval will be made by the second week of August.

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Sahana Shankar