Canada to review Bharat Biotech's Covaxin COVID vaccine for emergency-use authorization

Bharat Biotech's Covaxin has been reportedly placed under review for emergency-use authorization by Canada. According to the data listed on Health Canada's official website, a vaccine candidate by 'Vaccigen Ltd' has been placed in its list of COVID-19 related treatments. Notably, Vaccigen Ltd is the Canadian affiliate of Ocugen-- which is Bharat Biotech's partner for the US.

The rolling submission process by Occugen has been accepted under the Minister of Health's Interim Order, as per a regulatory filing by the US pharma group. Health Canada will take a decision on the emergency authorisation of Covaxin after reviewing the data submitted to support its efficacy, it said.

“The rolling submission process was recommended and accepted under the Minister of Health’s Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to Covid-19 and transitioned to a New Drug Submission for Covid-19, which permits companies to submit safety and efficacy data and information as they become available,” Ocugen said in a regulatory filing. 

Bharat Biotech submits data to WHO 

Meanwhile, Bharat Biotech has submitted all the documents required for Emergency Use Listing (EUL) of Covaxin on July 9 to the World Health Organization (WHO). "All documents required for EUL of Covaxin have been submitted to WHO as of July 9th. The review process has now commenced with the expectation that we will receive EUL from WHO at the earliest," Dr. Krishna Ella, chairman and managing director of Bharat Biotech, said in a statement. 

The results from the clinical trials of Covaxin showed promising signs. The vaccine has shown 93.4 percent efficacy against severe COVID-19 symptomatic cases, 78 percent against mild or moderate cases, and 63 percent against asymptomatic cases. Close to 65.2 percent efficacy was shown by the Indian jab in neutralizing the highly contagious Delta variant of SARS-CoV-2 lineage. 

"It is good that these results have finally been published and this will help to get Covaxin the WHO emergency use listing. People who have been administered Covaxin in India will be able to travel without restrictions", Dr. NK Arora, the chief of the National Technical Advisory Group on Immunisation (NTAGI) said in an interview with ANI.