India’s COVID-19 vaccination programme is being plagued by high vaccine hesitancy. However, the central government has barely done anything to fight the lack of enthusiasm for the vaccine. On the other hand, Union Home Secretary Ajay Bhalla issued a letter to the chief secretaries of all states, pointing out that the states can take penal actions against individuals and organisations raising doubts and concerns about the efficacy of the vaccines.
The letter dated January 19 said, “I would like to strongly emphasise that the National Regulatory Authority of the country has found both the vaccines safe and immunogenic. However, it has been reported that unfounded and misleading rumours are circulating, in the social and other media, creating doubt about the safety and efficacy of these vaccines.”
It added, “Penal action may be taken against the person/s or organisation/s, who is/are found to have indulged in such activities, under the relevant provisions of the Disaster Management Act, 2005 and the Indian Penal Code, 1860.”
Experts and activists have condemned this move by the Home Secretary, and said that the vaccine hesitancy needs to be dealt with more sensitively, and instead of penalising those who raise doubts and concerns, the government should work towards answering these questions. Questions have also been raised as to why this notice was issued by the Home Secretary, and why it is not the Ministry of Health and Family Welfare (MoHFW) that is looking into the matter.
Speaking to NewsClick, a doctor from the Department of Pulmonology, AIIMS, Delhi, said on the condition of anonymity, “The government cannot show us any data about the phase III clinical trials of the vaccines. And yet, we will have to take the vaccines, because there are no other options. We cannot raise questions, we cannot have doubts. So, we have to voluntarily participate in the clinical trial of the vaccine”
Public health experts have been raising concerns about the National Regulatory Authority’s hurried emergency clearance to Bharat Biotech’s Covaxin in clinical trial mode. No details were made public by the drug regulator about what clinical trial means, and no further guideline was released on the way it was to be implemented.The MoHFW did not elaborate how it proposed to carry out mass vaccination in a “clinical trial mode.”
All India People’s Science Network (AIPSN) had urged the Union government to issue special protocols for Covaxin administration in “clinical trial mode,” including obtaining informed consent or refusal of recipients and ensuring compliance with all Central Drugs Standard Control Organisation (CDSCO) approval conditions. It had also urged CDSCO and Indian Council of Medical Research (ICMR) to ensure that all clinical trials conform to necessary ethical, scientific and technical standards, and all state governments to take a hard decision on whether to deploy Covaxin widely, or whether to strictly conform to CDSCO/SEC conditions of limited “trial mode” deployment.
However, the government did not pay any heed to any of these recommendations. AIPSN said in a statement earlier this month, “There is no information yet available in the public domain if the Government has communicated any special protocols 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, “In contrast, Secretary, Union Health Ministry stated in a press conference that recipients would have no right to choose between the two vaccines, making 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.”
AIPSN pointed out that the Union Government only has itself to blame if public suspicion about Covaxin and in general, vaccine scepticism increases further due to opaqueness in rolling out Covaxin. The letter issued by Home Secretary Ajay Bhalla seems like a desperate attempt to shift the blame on those asking the questions, and shift the focus away from the government’s inability to answer them.