As Anil Vij tests COVID positive, Bharat Biotech clarifies Covaxin efficacy determined after 2 doses

Bharat Biotech issued a clarification on its COVID-19 vaccine COVAXIN saying that the efficacy of the vaccine can only be determined 14 days after the second dose.

New Delhi: Hours after the news of Haryana minister Anil Vij contracting COVID-19 despite taking a coronavirus vaccine was reported, the vaccine company Bharat Biotech issued a clarification on Saturday (December 5, 2020) saying that the efficacy of the vaccine can only be determined 14 days after the second dose.

Anil Vij had been administered the vaccine dose around two weeks ago on November 20.

Bharat Biotech in a statement said, "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, it asserted that Vij had only taken one dose of the two-dose vaccine and so he contracted COVID -19.

"The antibodies against the infection build up in a human being only after a specific number of days pass after the second dose of the vaccine is taken. Since, this is a two-dose vaccine. Minister in question has taken only one dose of the vaccine," the ministry said in a statement.

Earlier on Saturday, Vij tweeted, "I have been tested Corona positive. I am admitted in Civil Hospital Ambala Cantt. All those who have come in close contact to me are advised to get themselves tested for corona."

The 67-year-old BJP minister was given the coroanvirus vaccine dose at the Civil Hospital in Ambala on November 20.