Can’t disclose data on trials: Vaccine makers to Supreme Court

Updated on Mar 23, 2022 05:04 AM IST

Submitting its reply to Puliyel’s petition in November last, the central drugs standard control organization (CDSCO) said that entertaining such a petition would harm public interest.

A student receives a dose of a Covid vaccine in Noida. (HT photo/Sunil Ghosh)
A student receives a dose of a Covid vaccine in Noida. (HT photo/Sunil Ghosh)

Primary data on clinical trials and adverse events of Covid-19 vaccines cannot be put out in public domain and only the drug regulators should have access to such data, vaccine manufacturers Bharat Biotech Ltd and Serum Institute of India (SII) told the Supreme Court on Tuesday.

Opposing a petition filed by Dr Jacob Puliyel, a former member of the National Technical Advisory Group on Immunisation, the vaccine companies maintained that the regulations require them to submit pertinent data on clinical trials and adverse events to the Drugs Controller General of India (DCGI) for evaluation and they have done so.

Senior advocate Guru Krishnakumar, appearing for Bharat Biotech, submitted before a bench led by justice L Nageswara Rao that there is no legal mandate to disclose raw data to an individual or a group of persons when the regulator has already been in custody of such data for conducting an evaluation and taking suitable measures.

“The petitioner today is asking for redacted data. Tomorrow, he will start asking for further details. There won’t be an end to this. Further, the WHO guidelines referred to by the petitioner do not mandate the disclosure of the primary data but only talks about analysis of the data. The petitioner, who claims to be a domain expert, should be aware of this,” argued Krishnakumar.

He added that the efficacy of Covaxin (Bharat Biotech’s vaccine) has been established with the passage of time and that Covaxin follows the inactivated virus model which is identified as the safest in the world. “Therefore, the premise of the petition simply does not stand. Our trials are going on and informed consent is taken,” said Krishnakumar.

Krishnakumar said that the issue has to be seen in the light of the fact that over 1.8 billion doses administered, only 0.004% adverse events were reported, adding even the Right To Information (RTI) exempts disclosure of information that include commercial confidence, trade secrets or intellectual property and can harm the competitive position of a third party. Most of the doses administered in India are of Covishield, made by Serum Institute.

The counsel for SII also opposed Puliyel’s plea for disclosure of raw data. “As a matter of principle, they cannot ask for data. My data is with the regulator. That is where it should be,” said SII’s counsel.

Puliyel’s petition, besides challenging the specific vaccine mandates issued by some of the state governments, also raised the issue of transparency with regard to information on vaccine trials before they were given emergency use authorization. It also sought segregated data for each of the phases of clinical trials undertaken with regard to the Covid vaccines administered in the country and the adverse effects following immunization. The plea also questioned the efficacy of the vaccines against the infection.

Submitting its reply to Puliyel’s petition in November last, the central drugs standard control organization (CDSCO) said that entertaining such a petition would harm public interest. “Any misgivings and misconceived doubts and motivated propaganda against vaccination can only result into a potential threat of setting vaccine hesitancy again, which will not be in public interest,” the agency’s affidavit said.

In another affidavit filed by the Union health ministry earlier this month, the Centre also opposed the petition’s demand to access the raw vaccine trial data. “Any disclosure of raw data would lead to different people evaluating the data and irresponsibly throwing their own conclusions. Such a relief would not enhance public interest but would harm public interest as this data is given in trust…since the participants have volunteered on assurance that medical record will not be shared except with the statutory authorities.” As per the guidelines, the identities and medical records of subjects of vaccine trials are to be kept confidential, it added.

Representing the Centre, solicitor general Tushar Mehta on March 15 also argued that access to primary data could further spread misinformation leading to vaccine hesitancy. “There is natural hesitancy in volunteers to come forward and participate in trials…It may be kept in mind that the entire drug development process relies on volunteers in clinical trials and in such a situation, it would be very difficult to get volunteers. Any disclosure of such raw data would lead to an honest or dishonest spread of misinformation resulting in vaccine hesitancy,” said the S-G.

Meanwhile, states of Tamil Nadu, Maharashtra and Madhya Pradesh justified the government orders which have mandated inoculation to avail some public utilities and access public places.

Appearing for the Tamil Nadu government, its additional advocate general Amit Anand Tiwari asserted that the state has mandated vaccination for accessing public spaces and this stipulation is in larger public interest. He added that the state government derives the power to impose the vaccine mandate from the Tamil Nadu Public Health Act, 1939 and the Disaster Management Act, 2005. Tiwari said that the 1939 Act empowers the state government to confer special powers on officers to control notified diseases and make vaccination compulsory.

On his part, advocate Rahul Chitnis, appearing for the Maharashtra government, submitted that the Government has mandated vaccination to enter shops, malls, and also to avail public transportation. He claimed that the mandate was a reasonable restriction fulfilling the tests of proportionality. “This imposition is important to even protect the life of the petitioner. Especially when it might affect others. Rights have to be balanced. State would be justified in protecting larger number of people”, argued Chitnis.

The counsel for the Madhya Pradesh government also emphasised on the need to balance different rights in the context of vaccination.

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