Bharat Biotech reaches out to FDA for phase 3 clinical trials of COVAXIN in US

National

According to Dr. Raches Ella, Bharat Biotech’s Business Development and International Advocacy Head said that the COVAXIN is expected to be approved by the WHO by the end of the third or fourth quarter of 2021. Ninety per cent of the documents required for Emergency Use Listing of  Covaxin have been submitted to the WHO and the remaining are expected to be filed in June. The company is confident about getting the approval from the international body. 

As an inter-ministerial group headed by Foreign Secretary Harsh Shringla met with company representatives in Delhi on Monday, the government took note of Bharat Biotech’s application process with the World Health Organization (WHO) for regulatory clearances for the vaccine. Covaxin has already received regulatory approval from 11 countries, furthermore according to the many sources there was also interest from other 11 companies in seven nations for technology transfer and production of Covaxin.

The company is in the final stages of negotiations with the US Food and Drug Administration to perform small-scale phase-III clinical trials of Covaxin in the US. BBIL is also in the final stages of submission of required documents for regulatory approvals to Covaxin in Brazil and Hungary. According to sources, no country has implemented a “vaccine passport,” and that countries all over the world have their own approval criteria, which in most cases include travelling with a COVID-19 negative RT-PCR test result. 

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Bharat Biotech is yet to publish the findings of its Phase-3 trials in a peer-reviewed journal, and has only released preliminary clinical results that claim 81 percent efficacy. Dr. Balram Bhargava, the chairman of the Indian Council of Medical Research (ICMR), has also stated that the publication would most likely take place in June.