Bharat Biotech likely to apply for emergency use approval for coronavirus COVAXIN vaccine this week
Hyderabad: Hours after the Pune-based pharma agency Serum Institute of India (SII) utilized to the Drugs Controller General of India (DCGI) searching for emergency use authorisation for Oxford-AstraZeneca COVID-19 vaccine ‘COVISHIELD’ in India on Monday (December 7, 2020), there are studies that the Bharat Biotech can also be prone to file for emergency use approval for its coronavirus vaccine ‘COVAXIN’.
As per sources, the Bharat Biotech is more than likely to hunt emergency use approval for the COVID-19 vaccine COVAXIN inside 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 introduced the graduation of Phase III trials of its coronavirus vaccine and stated that it’s going to contain 26,000 volunteers throughout 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 firm had stated in an official assertion.
The firm was the speak of the city just lately when the Haryana minister Anil Vij stated 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 solely be decided 14 days after the second dose.
They acknowledged, “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 additional knowledgeable that the Phase-III trials are double-blinded and randomised, the place 50 per cent of the topics will obtain the vaccine and 50 per cent will obtain 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 corporate stated.
The Health Ministry too got here out in help of the drug firm and asserted that Vij had solely taken one dose of the two-dose vaccine and so he contracted COVID -19.
Vij, 67, was given the coronavirus vaccine dose on the Civil Hospital in Ambala on November 20.
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