Why Bharat Biotech’s Covaxin is not getting approval in highly regulated countries

India made COVID-19 vaccine, Covaxin manufactured by Bharat Biotech in collaboration with Indian Council of Medical Research  is been used extensively in most of the countries. However, the regulatory body of USA, USFDA has still not given the approval of usage of Covaxin on their citizens. It is believed that their regulatory body wants further clarification on the clinical trials conducted for Covaxin by Bharat Biotech.

What is the reason behind USFDA’s unapproval?

USFDA has asked Bharat Biotech to submit the clinical trial data of Covaxin so as to get the vaccine approval in United States. But after the submission of partial data of clinical trials of Covaxin, the regulatory body of USA rejected the approval and has asked Ocugen( Hyderabad based pharma company which is also Bharat Biotech’s US partner) to submit the additional trial data. Covaxin is therefore rejected for emergency use due to lack of scientific data according to US regulators. However,  if they get the complete trial data from Bharat Biotech they can file a Biologics License Application(BLA) seeking a full approval instead.

Recently, USFDA has revised their guidelines for emergency use authorization and stated that they won’t be entertaining further requests. After all this, Occugen remains hopeful for a good news.

Bharat Biotech’s delay to share Phase- 3 clinical trial data

Bharat Biotech has not yet shared the clinical trial data of phase 3 trials and are expected to share it on next month. Following which, the company will start applying for a full licensure of Covaxin. “Once data from the final analysis of phase III studies are available, Bharat Biotech will apply for full licensure for Covaxin,” Bharat Biotech told the news channels.

Further they added, they have already taken the data of Phase-4 clinical trials which is the post- marketing surveillance to check the safety and effectiveness of the vaccine.

Hurdles of Bharat Biotech’s Covaxin

COVID-19 vaccine, Covaxin manufactured by Bharat Biotech has been facing enormous hurdles in front of them pertaining to it’s approval. The wait of Phase 3 clinical trial data is taking long and that is the reason it is still not being validated by World Health Organization(WHO). Without which they are unable to export their vaccine and make an entry into the Covid 19  passport.   

Different countries has different regulations and also some of the them have stingent  regulations. Due to which COVID- 19 vaccine manufactured by Bharat Biotech, Covaxin remains unapproved in all those countries without their Phase 3 clinical trial data.  This is the reason why, foreign universities are also not considering students who has been vaccinated with Covaxin. They are considering them as “un-vaccinated” in this regard.

Now it remains to be seen how soon they can procure the clinical trial data of phase 3 and then they can get the approval from foreign countries for emergency use. Also, the approval from WHO is required to get into the coveted COVID-19 vaccine passport. “We are aware that Bharat Biotech has sought the WHO emergency-use listing for Covaxin. We hope that the process of getting this approval is completed at an early date,” said Ministry of External Affairs spokesperson, Arindam Bagchi on this issue.

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