With India’s vaccine roll-out to commence on Saturday, January 16, the All India Peoples Science Network (AIPSN) has said that it is “shocked” that the Central Government is distributing Bharat Biotech-ICMR’s Covaxin alongside Serum Institute of India-Oxford Astra Zeneca’s Covishield with the former given conditional approval “in clinical trial mode.”
In a press release issued by the Drugs Controller General of India on January 3, the government had said that both vaccines were “being approved for restricted use in emergency situation.” About the use of Covaxin, the release had said: “The Subject Expert Committee (SEC) has reviewed the data on safety and immunogenicity of the vaccine and recommended for grant of permission for 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. The clinical trial ongoing within the country by the firm will continue.”
In a statement issued on Friday, the AIPSN said that the government’s move was in “open defiance of the conditions imposed by the Central Drugs Standards Control Organization (CDSCO)” for the use of Covaxin. It added that the CDSCO and its SEC had “clearly differentiated” between the two and that Covaxin had obtained conditional approval “after apparent overnight arm-twisting of the SEC.”
“56 lakh doses, i.e. inoculation of 28 lakh persons, cannot be considered a ‘trial’ by any stretch of the imagination, especially when Phase-3 clinical trials for Covaxin are already underway involving around 26,000 volunteers. Clearly, the Government has placed Covaxin and Covishield on similar footing, other than total numbers as of now,” the statement added.
AIPSN said that any vaccine which was under trial should be monitored with follow-ups and institutional arrangements, mentioning that there was no available information about whether the government had instituted a specific protocol for Covaxin inoculation. “Most importantly, clinical trials should require informed consent or refusal by Covaxin recipients, after being made fully aware of conditions imposed by the CDSCO and the absence of Phase-III efficacy data,” it added.
On Tuesday, January 12, the Centre had said that recipients of the vaccines would not have the right to choose between the two vaccines. AIPSN said that the move made “it clear that the Central Government is intent on shoving Covaxin down the throats of State Governments and into the arms of innocent recipients, in this first round the health workers and ‘Covid heroes’ regardless of the CDSCO conditions.”
The organisation said that the Government would have only “itself to blame if public suspicion about Covaxin and vaccine skepticism increases further due to its own complete opacity in rolling out Covaxin, with no information on any of the questions raised here. Unfortunately, the CDSCO and the Union Health Ministry have subverted the scientific criteria regarding the regulation of vaccines including their own guidelines for emergency use.”
It added that such move would compromise both people’s interests and the credibility of the Indian pharmaceutical industry as a whole. Concluding its statement, the organisation urged the Centre to:
● The Union Government issue special protocols for Covaxin administration in “clinical trial mode,” including obtaining informed consent or refusal of recipients and ensuring compliance with all CDSCO/SEC approval conditions;
● CDSCO and ICMR to ensure that all clinical trials conform to necessary ethical, scientific and technical standards;
● All State Governments take a hard decision on whether to deploy Covaxin widely, or whether to strictly conform to CDSCO/SEC conditions of limited “trial mode” deployment;
● All doses of Covaxin distributed to States so far be held in stock by them and not administered till greater clarity is given by the Government or till CDSCO/SEC approval conditions are amended based on efficacy data from Bharat Biotech-ICMR as promised.