Plea in SC seeks disclosure of clinical trials data for Covid-19 vaccines

A plea in the Supreme Court has sought disclosure of data in Covid-19 vaccine clinical trial and data recording and reporting adverse events after the administration of the jab.

The petition filed by Dr Jacob Puliyel, a former member of the National Technical Advisory Group on Immunisation, also asked the court to declare the vaccination mandate as unconstitutional.

The plea filed through advocate Prashant Bhushan sought direction to the government to make public the segregated data of the clinical trials for the vaccines that are being administered to the people under the Emergency Use Authorisation granted by the Drugs Controller General of India (DCGI).

It asked the court to direct the government to disclose the post-vaccination data regarding adverse effects, on people who got infected with Covid, those who needed hospitalisation and those who died after such infection post-vaccination.

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The petitioner also asked to direct the government to widely publicise the data collection of such adverse events through the advertisement of toll-free telephone numbers where such complaints can be registered.

“In India, the manner in which the vaccines have been licensed vitiates and even precludes the possibility that the vaccines can be evaluated objectively in the future. Under these circumstances the petitioner is forced to appeal to this court for public disclosure of trial data and post-vaccination data, as required by international medical norms,” it added.

It said authorities should carefully monitor vaccine recipients and publicly record all adverse events.

“In other countries, this type of observation has helped identify the occurrence of blood clots and strokes in vaccine recipients, plea further said, adding that many countries stopped administering the vaccine till they evaluated this occurrence and countries like Denmark have completely banned the use of the Astra Zeneca vaccine (branded as Covishield in India),” the plea stated.

India, with its huge population and numbers vaccinated, should have reported these adverse events first. But due to poor follow-up, poor Adverse Events Following Immunization (AEFI) evaluation and suppression of data, these events have not been put in the public domain, endangering many more to suffer the same fate, it said.