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Plea in Supreme Court seeks COVID-19 vaccine trials’ data

A view of the Supreme Court of India. File   | Photo Credit: S. Subramanium

A petition has been filed in the Supreme Court to make public the segregated data of clinical trials of COVID-19 vaccines administered under the Emergency Use Authorisation granted by the Drugs Controller General of India (DCGI).

Former member of National Technical Advisory Group on Immunisation Dr. Jacob Puliyel, represented by advocate Prashant Bhushan, asked the court to direct the government, its bodies and the vaccine manufacturers – the Serum Institute of India and Bharat Biotech -to transparently reveal clinical trial and vaccination data, including the recording and reporting of adverse events.

Further, the petition urged the court to direct the government to not issue any “coercive mandates” for use of “these inadequately tested vaccines”.

Mr. Bhushan argued that courts should “reiterate that vaccine mandates are repugnant to the right of humans to autonomy and right to self-determine what may be injected into their bodies”.

“The respondents (Centre, its agencies like DCGI and ICMR and vaccine manufacturers) have maintained opacity about the clinical trial data of the two vaccines administered through emergency authorisation in India. Non-disclosure of this important data violates the basic ethics of clinical research that requires results of clinical research studies to be published and brought to the knowledge of the medical community, participants to the research and the general population,” the petition said.

Dr. Puliyel, also represented by advocate Cheryl d’Souza, said the lack of transparency raised concerns over the efficacy and safety of the two vaccines.

WHO statement

“The World Health Organisation (WHO) has released a strong statement advocating for public disclosure of all clinical trial results. According to the statement, when data is not released it means that doctors, patients and medical regulators cannot make informed decisions about which treatments are best,” the petition stated.

The petition said transparency in publishing clinical trial data by the Central Drugs Standard Controls Organisation (CDSCO) that granted final approval for the vaccines by various manufactures to enter the immunisation chain flowed from Section 4 of the Right to Information Act, 2005, which required the government to make “proactive disclosures of its records through the internet and other means of communications to the general public”.

The petition said the 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. Many countries had stopped administering the vaccine till they evaluated this occurrence. Countries like Denmark have completely banned the use of the Astra zeneca vaccine (branded as Covishield in India),” it stated.

Adverse events

Mr. Bhushan argued that 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 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,” the plea said.


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Printable version | Jun 17, 2021 2:50:30 AM | https://www.thehindu.com/news/national/plea-in-supreme-court-seeks-covid-19-vaccine-trials-data/article34558317.ece

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