On 12 April 2022, the USFDA had suspended the Phase 2/3 clinical trial of Bharat Biotech’s COVID-19 vaccine Covaxin.
Bharat Biotech (Bharat Biotech) has announced that the vaccination of Covaxin doses will resume. The company tweeted that this dosage will resume in the US after the Food and Drug Administration lifts the ban on clinical trials of 2/3 phase of Covaxin. Covaxin is approved for use in adults in India and is also authorized for emergency use in 25 countries while EUA applications are pending in more than 60 other countries. However, Covaxin has been involved in many delays and rejections.
When and why was Covaxin put on hold?
On 12 April 2022, the USFDA had suspended the Phase 2/3 clinical trial of Bharat Biotech’s COVID-19 vaccine Covaxin. According to a press release for Covaxin by Ocugen Inc., partner of Bharat Biotech for the US and Canada, the FDA’s decision to temporarily stop it following World Health Organization comments on the Covaxin manufacturing plant was based on the US firm’s decision.
What did the WHO say?
The World Health Organization (WHO) in a statement issued on 2 April 2022 had confirmed the suspension of the supply of Covaxin produced by Bharat Biotech through United Nations procurement agencies. The WHO said in its statement, “This suspension was made in view of the results of subsequent WHO EUL inspections (March 14-22, 2022) and the identification of GMP-Good Manufacturing Practice deficiencies at Bharat Biotech’s manufacturing plants which are It needs to be upgraded to fix this. The supply of Covaxin will be disrupted due to the halt in production for exports.
Covaxin also faced delays in Emergency Use Authorization (EUA) from WHO. On 9 July 2021, Bharat Biotech submitted all the necessary documents for emergency use listing.
WHO raised further questions on Covaxin and those questions have been sent to Bharat Biotech for their clarification. When it comes to approving a vaccine in the Emergency Use Listing (EUL), the WHO sets a procedure. It begins with the Manufacturer’s Expression of Interest (EoI), a pre-sessional meeting between WHO and the manufacturer, acceptance of the dossier for review by the WHO, decision on the status of evaluation and the final decision on acceptance. When it comes to Covaxin, WHO rejected Bharat Biotech’s EoI saying that more information is needed.
Rejection and delay timeline
- On 19 April 2021, the Hyderabad-based company applied for WHO approval by providing its expression of interest.
- On 9 July 2021, Bharat Biotech submitted all the necessary documents for emergency use listing.
- This was also confirmed by Dr. Krishna Eela, Chairman and Managing Director of Bharat Biotech. Just before this, the company’s co-founder and joint managing director Suchitra Eela said that she hopes that the WHO approval will not be a long-lasting process.
- On 10 June 2021, the US Food and Drug Administration (FDA) rejected Ocugen Inc’s proposal for an EUA of Covaxin in the US.
- The FDA rejected Bharat Biotech’s proposal because the company had submitted partial trial data since March this year. Ocugen Inc. is a partner of Bharat Biotech, which is co-developing Covaxin for the US market. It announced that it would now move towards full approval of the vaccine for use in the US instead of the Emergency Use Authorization (EUA) for Bharat Biotech’s Covaxin.
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