The US Drugs Controller (FDA) has currently refused emergency approval to Bharat Biotech’s Corona Vaccine Covaccine. This has dealt a blow to the company’s attempt to launch this vaccine in America. The FDA has asked Bharat Biotech’s partner Ocugen in the US to adopt the Biologics License Application (BLA) route for this vaccine. Under this, more data has been sought. Due to this, the emergency use of this vaccine in America has collapsed.
FDA asked to adopt BLA route for licenses
Ocugen said in its statement on Thursday that Biologics will try to adopt the license application route for Cavaxin in accordance with ADF’s instructions. The FDA considers BLA to be a fool proof mechanism for vaccinating drugs. Due to the lack of FDA approval, the launch of Covaccine in the US market has been postponed. Ocugen said that for the time being it will not move in the direction of taking the right to emergency use of the vaccine. Negotiations are going on between the company and the FDA regarding the documents to be submitted in support of BLA.
Preparations to launch vaccine in Canada
The FDA had given feedback to Ocugen regarding the master file. It is worth noting that Hyderabad-based Bharat Biotech had told on Thursday that the final data of the third phase trial of the vaccine will be made public in July. The company has said that only after that it will apply for its full license. Ocugen recently announced that it has acquired exclusive rights to sell Covaccine in Canada as well. It has started talks with Health Canada for regulatory approval in Canada. Ocugen is trying to launch a vaccine there under new policies made in Canada regarding the import, sale and advertising of COVID-19 medicines.