India’s COVID-19 vaccination program is beset by strong reluctance to vaccinate. However, the central government has done little to address 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, stressing that states can initiate criminal proceedings against individuals and organizations raising doubts and concerns about the effectiveness of vaccines.
The letter as of January 19 said: “I would like to insist stronglyse that the country’s national regulatory authority has found the vaccines safe and immunogenic. However, there have been reports of unfounded and misleading rumors circulating, in social media and elsewhere, creating doubt about the safety and effectiveness of these vaccines.
He added: “Criminal sanctions can be taken against the person orsation / s, who have engaged in such activities, under the relevant provisions of the Disaster Management Act 2005 and the Indian Penal Code of 1860. “
Experts and activists condemned the Home Minister’s move and said reluctance to immunize must be treated more sensitively and that instead of penalizing those who raise doubts and concerns, the government should endeavor to answer these questions. Questions have also been raised as to why this notice was published by the Minister of the Interior and why it is not the Ministry of Health and Family. (MoHFW) it is to examine the question.
Speaking at NewsClick, a physician from the Department of Respirology, AIIMS, Delhi, said on condition of anonymity: “The government cannot show us data on Phase III clinical trials of vaccines. And yet, we will have to take the vaccines, because there are no other options. We cannot raise questions, we cannot have doubts. We must therefore voluntarily participate in the clinical trial of the vaccine ”
Public health experts have raised concerns about the rushed emergency clearance by the National Regulatory Authority to Covaxin from Bharat Biotech in clinical trial mode. No details were made public by the drug regulator on the significance of the clinical trial, and no further guidance was issued on how it was to be implemented. The MoHFW did not specify how it proposed to carry out mass vaccination in a “clinical trial mode.“
The All India People’s Science Network (AIPSN) had urged the Union government to publish special protocols for the administration of Covaxin in “clinical trial mode”, including obtaining informed consent or refusing recipients and compliance with all Central Drugs Standard Control Organization (CDSCO) approval conditions. . He also urged CDSCO and the Indian Council of Medical Research (ICMR) to ensure that all clinical trials meet the necessary ethical, scientific and technical standards, and all state governments to make a tough decision on whether to deploy Covaxin widely or to do so strictly. Comply with CDSCO / SEC Limited Deployment Conditions in “Trial Mode”.
However, the government paid no 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 released special protocols for inoculation of Covaxin. More importantly, clinical trials must require informed consent or denial from Covaxin recipients, after being fully informed of the conditions imposed by CDSCO and the lack of phase III efficacy data. “
He added: “In contrast, the secretary of the Union’s health ministry told a press conference that recipients would not have the right to choose between the two vaccines, making it clear that the central government intends to push Covaxin down the throats of state governments and the guns of innocent recipients, in this first round health workers and ‘Heroes of Covid‘ regardless of the CDSCO conditions. “
AIPSN stressed that the Union government has to blame itself only if the public’s suspicions regarding Covaxin and in general, vaccine skepticism still increases due to opacity in the deployment of Covaxin. The letter released by Home Secretary Ajay Bhalla appears to be a desperate attempt to shift blame on those asking the questions and distract from the government’s inability to answer them.