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Plea in SC seeks data of Covid-19 vaccine clinical trials

New Delhi, May 14 (UNI): A plea has been filed in the Supreme Court seeking data for the public regarding clinical trials of Covid-19 vaccines administered under the Emergency Use Authorisation granted by the Drugs Controller General of India (DCGI).

In the plea, petitioner Dr Jacob Puliyel, a former member of the National Technical Advisory Group on Immunisation, also sought transparency in Covid-19 vaccine clinical trial and 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.

The plea also prayed that the court may declare vaccination mandates unconstitutional.

While praying the top court to direct the Centre to disclose the post-vaccination data, the plea also asked authorities to carefully monitor vaccine recipients and publicly record all adverse events.

The petitioner has made the Centre, Central Drugs Standard Control Organisation, the Indian Council of Medical Research, Bharat Biotech (the maker of Covaxin), and the Serum Institute of India (producing Covishield) respondents.

According to the plea, the importance of disclosure of segregated data of vaccine clinical trials — with an age-wise enumeration of numbers — cannot be undermined and must be disclosed through peer-reviewed scientific journals.

India, with its huge population and numbers vaccinated, should have reported these adverse events first, the plea said.

“But due to poor follow-up, poor Adverse Events Following Immunisation (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.

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