Vaccine makers said to the head Court that they can’t disclose data on trials

23-03-2022

Delivering its answer to Puliyel’s petition in November last, the union drugs standard control organization (CDSCO) noted that considering such a petition would harm public interest.

Initial information on clinical trials and adverse events of Covid-19 vaccines can't be put go into property right and only the drug regulators should have access to such data, vaccine developers Bharat Biotech Ltd and Serum Institute of India (SII) told the Supreme Court on Tuesday.

Objecting the 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 that they have done so.

Senior advocate Guru Krishnakumar, appearing for Bharat Biotech, submitted before a bench led by justice L Nageswara Rao that there's no legal mandate to disclose information to a personal or a bunch 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 soliciting for redacted data. Tomorrow, he will start inquiring for further details. There won’t be an end to the present. Further, the WHO guidelines said by the petitioner don't mandate the disclosure of the first data but only talks about analysis of the information. The petitioner, who claims to be a website expert, should remember of this,” argued Krishnakumar.

He added that the efficacy of Covaxin (Bharat Biotech’s vaccine) has been established with the passage of your time which Covaxin follows the inactivated virus model which is identified because the safest within the world. “Therefore, the premise of the petition simply doesn't stand. Our trials are occurring and consent is taken,” said Krishnakumar.

Krishnakumar said that the problem must be seen within the light of the actual fact that over 1.8 billion doses administered, only 0.004% adverse events were reported, adding even the proper To Information (RTI) exempts disclosure of knowledge that include commercial confidence, trade secrets or property and may harm the competitive position of a 3rd 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 information. “As a matter of principle, they can't evoke data. My data is with the regulator. that's where it should be,” said SII’s counsel.

Puliyel’s petition, besides challenging the precise vaccine mandates issued by a number of the state governments, also raised the problem of transparency with reference to information on vaccine trials before they got emergency use authorization. It also sought segregated data for every of the phases of clinical trials undertaken with relevancy the Covid vaccines administered within the country and also 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 possible threat of setting vaccine hesitancy again, which is able to not be publicly 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 data would cause different people evaluating the information and irresponsibly throwing their own conclusions. Such a relief wouldn't enhance public interest but would harm public interest as this data is given in trust…since the participants have volunteered on assurance that anamnesis won't be shared except with the statutory authorities.” As per the rules, the identities and medical records of subjects of vaccine trials are to be kept confidential, it added.

Representing the Centre, peace officer Tushar Mehta on March 15 also argued that access to primary data could further spread misinformation resulting in vaccine hesitancy. “There is commonly hesitancy in volunteers to return forward and take part in the  trials…It is also considered in the note that the complete drug improvement process relies on volunteers in clinical trials and in such a situation, it'd be very difficult to induce volunteers. Any disclosure of such information would cause an honest or dishonest spread of misinformation leading to vaccine hesitancy,” said the S-G.

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

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

On his part, advocate Rahul Chitnis, appearing for the Maharashtra government, submitted that the govt. has mandated vaccination to enter shops, malls, and also to avail public transportation. He claimed that the mandate was an affordable restriction fulfilling the tests of proportionality. “This is key to even guarding the lifetime of the petitioner. Mostly when it affects others. Rights should be in equilibrium. State would be justified in guarding a huge number of public”, argued Chitnis.