Hyderabad: Hours after the Pune-based pharma firm Serum Institute of India (SII) applied to the Drugs Controller General of India (DCGI) seeking emergency use authorisation for Oxford-AstraZeneca COVID-19 vaccine ‘COVISHIELD’ in India on Monday (December 7, 2020), there are reports that the Bharat Biotech is also likely to file for emergency use approval for its coronavirus vaccine ‘COVAXIN’.
As per sources, the Bharat Biotech is most likely to seek emergency use approval for the COVID-19 vaccine COVAXIN within this week. It is developed in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV).
Earlier on November 16, it had announced the commencement of Phase III trials of its coronavirus vaccine and said that it will involve 26,000 volunteers across India.
“It is the largest clinical trial conducted for a COVID-19 vaccine in India. This is India’s first phase 3 efficacy study for a COVID-19 vaccine, and the largest phase III efficacy trial ever conducted in India,” the Genome Valley-based company had said in an official statement.
The company was the talk of the town recently when the Haryana minister Anil Vij said that he has contracted COVID-19, 15 days after taking a coronavirus vaccine shot.
Subsequently, the Bharat Biotech issued a clarification on December 5 saying that the efficacy of the vaccine can only be determined 14 days after the second dose.
They stated, “COVAXIN clinical trials are based on a two-dose schedule, given 28 days apart. The vaccine efficacy will be determined 14 days after the second dose. COVAXIN has been designed to be efficacious when subjects receive both the doses.”
Bharat Biotech further informed that the Phase-III trials are double-blinded and randomised, where 50 per cent of the subjects will receive the vaccine and 50 per cent will receive a placebo.
“As per CDSCO-DCGI guidelines for reporting adverse events, patients are required to contact the site Principle Investigator (PI) during active follow up, or when the PI determines the severity of the adverse effect; then the reports are to be submitted to site Ethics Committees, CDSCO-DCGI, Data Safety Monitoring Board and the sponsor,” the company said.
The Health Ministry too came out in support of the drug company and asserted that Vij had only taken one dose of the two-dose vaccine and so he contracted COVID -19.
Vij, 67, was given the coronavirus vaccine dose at the Civil Hospital in Ambala on November 20.