Hyderabad-based Bharat Biotech will publish its phase 3 clinical trial data soon, the company has recently said amid criticisms of delay in publishing the findings which were supposed to be out in June. The Food and Drug Administration of the United States has also refused to grant emergency use authorisation to the Indian vaccine, which has also invited backlash from several quarters. However, the company has said that it is fully committed to maintaining transparency. And the FDA denial is not being considered as a setback as the US is not giving emergency use approval to any vaccine now as the Covid-19 situation in the US is relatively under control. Also, the company will now pursue full licence, which no vaccine produced in India has in the US.
Clinical trials in the US
Bharat Biotech will conduct clinical trials of Covaxin, the Covid-19 vaccine developed by the company in association with the Indian Council of Medical Research, in the United States as its US partner Ocugen has said that it will now apply for a full licence in the US. To obtain this, Bharat Biotech — through its US partner will have to follow the process of biologics licence application for which clinical trial will be required. So, the vaccines will be now tested on US participants. It is not yet known whether it will be a large-scale study or a small bridging study. The company will not go down the emergency use authorisation route again after being denied by the Food and Drugs Administration.
Research papers on Covaxin
The company said that there is enough data on the efficacy of the vaccine. There are nine research studies on the safety and efficacy of Covaxin in five globally reputed peer-reviewed journals, it said. It is the first and only product to have published any data from human clinical trials in India. It is the only product to have any data on emerging variants.
EUA in Canada
Bharat Biotech’s US partner has said it will pursue an emergency-use approval application in Canada. The company has already secured exclusive right to commercialise Covaxin in Canada
How many countries are administering Covaxin?
Covaxin is being administered in six countries at present while the EUA has been obtained in 13 countries.
If Covaxin gets full licensure in the United States, it will be a great leap, the company said as no vaccine manufactured or developed from India has ever received EUA or full licensure from USFDA.
Covaxin in India
The government has said that it is satisfied with the data it provided to the Drug Controller General of India and the FDA decision will have no impact on India’s ongoing vaccination drive. While the company is ramping up its production, its trial on children between the age of 12 to 18 years is going on.