Forty-nine scientists and doctors, while vouching for the safety of Bharat Biotech’s Covaxin and Serum Institute of India’s Covishield, expressed shock at the “irresponsible statements by vested interest in media…defaming scientific community”.
Just one day away from the vaccine roll-out, a statement signed by T D Dogra, former director of All India Institute of Medical Sciences on behalf of the group, said, “Such reprehensible utterances are causing huge credibility crisis for Indian scientific community who have devoted their lifetimes to make India a name to reckon with in export of vaccines all over the world.”
The health ministry has, meanwhile, also issued directions to all vaccine programme managers to use a comparative fact-sheet of both vaccines and ensure precautions such as waiting-period of four to eight weeks for those with active infection and ensuring that vaccines are not interchanged at the time of second dose.
The comparative fact-sheet lists the adverse events that may occur for both vaccines individually. For Covishield, besides the common adverse events associated with vaccination, the list says that “very rare demyelinating disorders — (nerve tissue damage) without causal relationship establishment” and it also recommends paracetamol for relief from certain symptoms.
The list of adverse effects for Covaxin includes mild events such as injection site pains, fatigue, headache, fever, nausea, vomiting, dizziness.
The decision of Drugs Controller General of India to allow accelerated approval or the emergency use approval for Covaxin had become a contentious issue with many including Gagandeep Kang, vice-chair of the board of Coalition for Epidemic Preparedness Innovations, questioning the approval being given without any efficacy data.
Opposition leaders too have shown doubts over the decision of the regulator to grant approval to the Bharat Biotech vaccine.
The letter by the scientific community was shared by the Union health ministry on Thursday. It said that Covaxin is a whole virion inactivated coronavirus vaccine based on a vero cell platform which has a well-established track record of safety and efficacy in the country and globally.
The doctors and scientists also said that this vaccine is likely to have better protection against the mutant strains of the virus as the immune response will be against multiple antigens and not only against spike protein of the virus.
“For Covaxin, though efficacy data is not available but safety parameters are very good and there is a robust immune response seen with this vaccine,” they said. Over 22,000 volunteers have been enrolled for the efficacy study of this vaccine. The Indian studies of Covaxin on animals including young rats, mice rabbits, hamsters and monkeys as well as non-human primates have shown safety and immunogenicity.
Covisheld too, scientists have said, still needed data from India on immunogenicity and efficacy but has been given the EUA keeping in mind the difficult times due to Covid pandemic. The vaccine has been developed at the SII laboratory using a master seed from AstraZeneca. The Oxford-AstraZeneca vaccine has undergone three phases of clinical trials for safety, immunogenicity and efficacy on 23,745 participants over 18 years of age.
At present, SII is conducting phase two and three trials at 15 different centres in India as bridging studies.
Niti Aayog member V K Paul said in an interview that both Covaxin and Covishield were equally important and hugely immunogenic and that no vaccine was a backup to other, thus putting to the rest the speculations that Bharat Biotech’s candidate may be used as a second option.
The scientific community in its statement said that due to their untiring efforts, India had emerged as a global leader in supplying vaccines to the world. “Indian vaccine market reached a value of Rs 94 billion in 2019 and has still got unused potential for the future.”
The list of signatories included Ranjan Pai, chairman of board, Manipal Education and Medical Group, M C Mishra, former director of AIIMS Delhi, S L Broor, senior consultant at Delhi’s Apollo hospital and several former scientists of Council of Scientific and Industrial Research in Hyderabad among others. – Business Standard