SC notice to Centre on plea seeking Information on Vaccine Clinical Trials

Vaccine Law Insider
Vaccine Law Insider

Shivangi Prakash

Published on: August 09, 2021, at 14:08 IST

The Supreme Court issued a notice to the Centre on Monday in response to a Public Interest Litigation (PIL) seeking clinical trial data for Covid-19 vaccinations, which have been awarded Emergency Use Authorization (EUA) throughout the country.

Jacob Puliyel, a former member of the National Technical Advisory Group on Immunization, has filed a petition demanding segregated data from clinical trials of vaccines used in the country’s Covid-19 vaccination campaign.

The PIL, filed by advocate Prashant Bhushan, also requested the Supreme Court to order the Government to release post-vaccination statistics on adverse effects, including persons who became infected with Covid after immunisation, required hospitalisation, and died.

The data should also be widely disclosed, according to the Petition.

Vaccine requirements that caused people to get compulsorily vaccinated or lose their jobs were also challenged in the lawsuit.

“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,” the Plea stated.

The Supreme Court made it plain that it did not want to send “a signal on the safety of vaccines” because the country was already dealing with vaccine hesitancy and questioning vaccine safety, which could cause people to have worries about the vaccines’ safety.

The Court agreed to look into the matter because it considered it as a crucial point of personal autonomy in seeking information over the right to public health.

While stating that the petition is not an “Anti-vaccine petition” and that the petitioner is not attempting to discontinue Covid immunisation in the country, Bhushan stated that transparency on the subject is required and that data disclosure would dispel all ambiguities.

While vaccines can be very useful in preventing diseases and pandemics, they can also have major unexpected side effects, according to the petition.

As a result, before vaccinations are licenced, they must be properly tested and examined in clinical trials, with test data made available for impartial experts to review.

After four weeks, the case will be heard.

Also Read: Legal View: COVID-19 Vaccination in India

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