New Delhi: Weeksafter participating in the Bharat Biotech' Covaxin trial, the Haryana Health Minister, Anil Vij recently tested positive for the virus, the news which created a stir across the country raising question on the efficacy of the company's vaccine.
The incident prompted Bharat Biotech to issue a clarification regarding the trial, wherein, it has now clarified on two fronts. Firstly, it pointed out that as a part of the trial 50 percent of the subject received the vaccine while others received a placebo. Secondly, the vaccine's efficacy is based on two doses of the vaccine which is administered 28 days apart, adding that the vaccine efficacy will be determined 14 days post the 2nd dose.
The Minister was among the first volunteers for the third phase trial of the vaccine, was administered the dose at the Civil Hospital in Ambala on November 20. He became the first Cabinet minister of any state government who has volunteered to take the trial dose. As per IANS, before administering the dose, Vij underwent some tests at the hospital.
Also Read: Covaxin Phase 3 Trial To Begin On November 20, Minister Anil Vij Offers To Be 1st Volunteer
However, days after getting Covaxin shot, the minister tested COVID-19 positive. Confirming the same, 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.
— ANIL VIJ MINISTER HARYANA (@anilvijminister) December 5, 2020
The Hyderabad-based vaccine maker has now issued a clarification, wherein, it told that COVAXIN has been designed to be efficacious and clarified that COVAXIN clinical trials are based on a 2 dose schedule, given 28 days apart. The vaccine efficacy will be determined 14 days post the 2nd dose.
"COVAXIN has been designed to be efficacious when subjects receive both doses and post the 14 day period after the 2nd dose. The phase 3 trials are double-blinded and randomized, where 50% of subjects will receive the vaccine and 50% of subjects will receive placebo," the company said in a statement.
Elaborating on adverse event reporting process as per CDSCO-DCGI guidelines, the firm mentioned in its statement, "Patient contacts the site PI, or during active follow up. PI determines the severity of the AE. Reports are submitted to site Ethics Committees, CDSCO-DCGI, Data Safety Monitoring Board and Sponsor."
"COVAXIN is a fully indigenously developed COVID-19 vaccine, with the largest Phase 3 clinical trial conducted in India, in ~ 26,000 subjects across ~ 25 sites. The goal is to evaluate the efficacy of COVAXIN across India," the company added.
Stating that the phase 3 trials of COVAXIN is the only efficacy trial being conducted in India for COVID-19 vaccines, to determine its suitability to the diverse Indian population, it further added, "Bharat Biotech is an innovator, vaccine developer, and manufacturer, safety of vaccines is our primary objective, followed by efficacy. The company in its 20-year history has conducted more than 80 clinical trials, across 18 countries, in ~ 600,000 subjects."
"The same reporting procedure is followed for all clinical trials. All clinical trials are conducted in compliance with Good clinical practices. Bharat Biotech is one of the few companies to conduct human challenge studies at Oxford University, United Kingdom, Bharat Biotech is also conducting other clinical trials USA and UK," it mentioned in its clarification.
Furthermore, it added that the company has supplied more than 4 billion doses, to more than 80 countries, with an excellent track report of safety.
"Safety is our primary criteria in vaccine development. Inactivated vaccine technology has delivered the safest form of vaccines for the past several decades, as apposed other new and unproven technologies. The vero cell manufacturing platform used for COVAXIN has delivered more than 300 million doses till date, with an excellent safety track record."