ICMR, DG, Dr Rajiv Bahl, in the letter, said that the apex research body cannot be associated with this poorly-designed study which purports to present a "safety analysis" of Covaxin.
Calling the reports completely misleading, fallacious, and ill-informed the Health Ministry said, "The government of India and the national regulator Central Drugs Standard Control Organisation (CDSCO) have followed a scientific approach and prescribed norms in approving the Covid-19 vaccines for emergency use authorization."
Ella, Chairman, and MD of Bharat Biotech, which produces Covaxin, met state Minister for Large and Medium Industries Dr. Murugesh R. Nirani, in Hyderabad on Friday, stated the official press release from the ministry of large and medium industries.
The study by 'bioRxiv', an open-access preprint repository for the biological sciences, shared on Tuesday that its study shows that administration of Covaxin booster dose will enhance the vaccine effectiveness against the Delta variant infection and give protection against the Omicron variants BA.1.1 and BA.2.
According to the Union Health Ministry, dedicated centres can be established for the same.
The WHO's EUL approval for Covaxin was expected by 5 October as WHO's Strategic Advisory Group of Experts on Immunization (SAGE) was scheduled to meet on this day to make its recommendations on Bharat Biotech's Covaxin for Emergency Use Listing. The process has been delayed as more technical data has been sought from the pharma major.
"We must give time to WHO to make their decisions based on science. However, we hope that these decisions can be taken quickly because people who are receiving Covaxin have certain imperatives of travel. Most of us, who chose the concurrency, is important in terms of licensure. We are hoping for an early decision,"
The WHO approval for emergency use of Covaxin will not only declare it safe for use in other countries but will also enable people receiving the shot to travel abroad without mandatory quarantine, he said.
“The closure has created backlogs and paved the way for chaos at vaccine centres. The situation can get worrisome if maximum people are not vaccinated before the onset of the third wave.”
The National Covid-19 Vaccination Programme has been successfully going on across all states and Union Territories since 16th January, 2021, he added.
