The scientists, in their letter, said, ‘The Government and the Central Drugs Standard Control Organisation (CDSCO) have undermined confidence in Covaxin and other vaccines against Covid-19, in particular concerning Covaxin, due to the lack of evidence and unsatisfactory scientific basis, non-transparency and concerns around possible political pressure’. Apart from re-considering the approval for Covaxin, the network has demanded that phase-III efficacy trials for both vaccines continue without extraneous pressure and the data be published at the earliest. In anticipation, the network has also demanded that no vaccine or covid-19 related drug be released for commercial use in the private sector until regular approvals as per protocols are obtained.
S Chatterjee, the president of AIPSN, while talking to TOI, said that they are making quite legitimate and obvious demands. “If the purpose of the vaccine is to protect the users, then there should be enough data to prove that the purpose is achieved. Without proven efficacy data, how will anyone be confident about taking the vaccine shot?” he asked. He also questioned the blatant turnaround by the Subject Expert Committee (SEC) of CDSCO, which had earlier sought additional data from phase-III trials, and has now given an approval based on phase-I and phase-II data. “There needs to be transparency and standards are to be met. When the number of cases are dropping steadily and experts are not anticipating a sudden increase, what was the need to rush into giving approvals?” asked Chatterjee.
The general secretary of the network, P Rajamanickam, said that even for Covishield, manufactured by the Serum Institute of India (under technology transfer from Oxford University – AstraZeneca), the data is not provided in public domain, though it has been approved on the basis of phase-III clinical trials data from other countries. He also said that it appears like the Covaxin has been rolled out in order to conduct phase-III clinical trials, which is unethical.
The letter also mentioned that the serious doubts of the SEC on Covaxin are reflected in the CDSCO’s statement saying Covishield is approved “for restricted use in emergency situation subject to certain regulatory conditions” whereas, in contrast, approval for Covaxin is given with numerous conditions such as “restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains”.