A bad omen for public trust in vaccines

A medic administers a dose of a COVID-19 vaccine to a woman at a vaccination centre in Malpura village near Beawar in Ajmer, Rajasthan.
| Photo Credit: Getty Images/iStockphoto

Over the last few years, multiple petitions have been filed before the courts regarding vaccines. While most of them pertain to COVID-19 vaccines, two of them pertain to a rabies vaccine and a rotavirus vaccine. While not all these petitions have been admitted by the courts, they reflect growing concerns related to how vaccines are approved and administered in India.

Concerns in petitions

It would be a mistake to dismiss these petitions as part of the larger ‘anti-vax’ movement, which is fuelled primarily by conspiracy theories. One of these petitions was filed by a group in Kerala before the Supreme Court. The group complained about deaths caused due to the alleged failure of anti-rabies vaccine. Other petitions raise questions about transparency of clinical trial data, inadequate disclosure of the side-effects of vaccines, the monitoring of vaccine-related adverse events, and compensation in cases where vaccines may have caused deaths or serious adverse events. Trust in the regulator appears to be abysmal since the petitioners in the cases pertaining to the rabies vaccine and COVID-19 vaccines have requested courts to form independent committees to re-evaluate clinical trial data submitted by the vaccine manufacturers to the regulator.

Courts are poorly placed to decide such issues. If history is any indicator, these cases will drag on for years before poorly reasoned orders with unsatisfactory conclusions are provided. To complicate matters, vaccine manufacturers such as Serum Institute and Bharat Biotech have gone on a spree filing defamation lawsuits against those questioning or criticising their vaccines. Some courts have granted these companies ex-parte interim injunctions. These responses are not good for public health or the credibility of India’s vaccine manufacturers. It is time for policymakers in the Ministry of Health to tackle some of these issues through policy deliberations instead of litigation.

The trigger for many of these petitions has been the opacity with which vaccines were approved by the drugs regulator, the Central Drugs Standard Control Organisation (CDSCO). There are two issues on the transparency front. The first is that the CDSCO makes key regulatory decisions along with “independent” doctors, but their details are not disclosed. Disclosing the names of the people and their potential conflicts of interest along with a transcript of their deliberations during the approval process is a bare minimum to build public confidence in the process.

The second issue is regarding the clinical trial data which forms the basis of the approval process. Typically, pharmaceutical companies conduct clinical trials and submit data to the regulator. As of now, the CDSCO does not release any information it evaluates prior to granting regulatory approval. This needs to change. The CDSCO should publicly disclose all raw clinical trial data and its own internal analysis, subject to redactions to protect patient privacy.

The other issue raised in one of the COVID-related petitions is the disclosure required to be made to citizens about the possible side-effects of a vaccine, without which there cannot be informed consent. It is not enough for the government to disclose such information on some obscure website. It needs to be made in a format which is understandable to citizens at the time of vaccination so as to enable them to make an informed decision. Indian law does not spell out a framework for ‘informed consent’ outside the context of clinical trials.

A related issue here is putting in place a transparent pharmacovigilance system which collects data on adverse events due to vaccination, known as an ‘adverse event following immunisation’ (AEFI). India has ad-hoc guidelines in place, but these lack the force of a parliamentary law and do not appear to be implemented well. A well-functioning AEFI system will go a long way in collecting data of high quality that pharmaceutical companies cannot control.

Issue of compensation

The last issue is that of compensation for those who lost family members due to the side-effects of COVID-19 vaccines. The Kerala High Court in Sayeeda v. Union of India (2022) asked the government to put in place a policy to deal with such claims. The government approached the Supreme Court against this order. Final arguments remain pending.

Under the first principles of tort law, such claims of compensation should be made against the vaccine manufacturers because they manufactured, sold, and profited from the vaccines. There is no reason for the government to step in and provide compensation unless it has agreed to indemnify vaccine manufacturers. Since the government has refused to make vaccine purchase agreements public, we do not know whether such an indemnification clause exists in these agreements. In fact, foreign vaccine manufacturers did not bid for tenders during the pandemic specifically due to the government’s refusal to indemnify them; as a result, Indian vaccine manufacturers profited handsomely. As a corollary, they should also bear the risk.

Save for the compensation issue which has to be resolved by the courts, it would be a blunder for the Ministry of Health to leave the other issues to lawyers and judges. These are critical policy issues with long-term consequences for public trust in vaccines. It would behove the Health Minister to assure the petitioners in these cases that the government is cognisant of their concerns and promise them a policy response, preferably through a new law.

Dinesh S. Thakur and Prashant Reddy T. are co-authors of The Truth Pill: The Myth of Drug Regulation in India (2022)