COVID-19: Judicial order to publish data on clinical trials, side-effects may feed vaccine hesitancy, says SC

A medical staff member seen showing Covisheild vaccine during covid 19 vaccination in progress at a centre at Jahangirpuri, in New Delhi.   | Photo Credit: SUSHIL KUMAR VERMA

The Supreme Court on August 9, said a judicial order to publish data on clinical trials of COVID-19 vaccines and post-vaccination side-effects may feed vaccine hesitancy amid the pandemic.

“Do you really think this is in the larger public interest? Fifty crore people have been vaccinated... By asking us to launch an enquiry now, are you not throwing doubts into the minds of the people about the vaccines,” Justice L. Nageswara Rao asked advocate Prashant Bhushan.

“But if you don’t have transparency, there is more reason for vaccine hesitancy,” Mr. Bhushan replied.

The court also voiced scepticism about Mr. Bhushan’s criticism of the government’s “coercive vaccine mandates” which banned the unvaccinated from public spaces, offices, shops, etc. Mr. Bhushan said the government could not force people to use “inadequately tested vaccines” through “mandates which are repugnant to the right of humans to autonomy and right to self-determine what may be injected into their bodies”.

“Are you pressing personal autonomy against the concern for public health,” Justice Rao asked. The judge said courts across the globe, including in the U.S., Europe, and Canada, had favoured similar government steps to ensure that all were vaccinated for the sake of public health.

Mr. Bhushan represents Dr. Jacob Puliyel, a former member of National Technical Advisory Group on Immunisation, who wants the court to direct the government, its bodies and the two domestic vaccine manufacturers — Serum Institute of India and Bharat Biotech — to transparently reveal clinical trial and vaccination data, including the recording and reporting of adverse events.

Reply sought in four weeks

Though the court sought a reply from the government in four weeks, the Bench, also comprising Justice Aniruddha Bose, was sceptical about enquiring into the efficacy and adverse effects of the vaccines when the “situation regarding the pandemic was still grave”. At one point, when Mr. Bhushan said thousands of deaths had been reported around the world due to the side-effects of the various COVID-19 vaccines, Justice Rao pointed to how the vaccines may have saved lakhs of lives.

Mr. Bhushan pointed out it was the first time in history that vaccines were granted Emergency Use Authorisation by the Drugs Controller General of India (DCGI). The authorities were required to publish the clinical trials’ data under the Declaration of Helsinki, recognised by India, and rules of the World Health Organisation (WHO), he submitted.

“You say that this [rolling out vaccines without publishing data of clinical trials] has never happened before. But we had not had a pandemic like this for 100 years... We have to balance the immediate need to give the vaccines with the potential risk,” Justice Rao said.

‘People have right to be informed’

“But experts need to see the data... Why keep it under a shroud? I am not saying they stop the vaccination. I am only urging them to be transparent. People have the right to be informed,” Mr. Bhushan said.

Justice Rao continued to raise the court’s apprehensions about how judicial intervention at this point may encourage vaccine hesitancy. “There is already vaccine hesitancy, WHO puts it as one of the 10 major problems confronting the battle against the spread of the virus. Initially, doctors themselves had raised doubts about what the vaccines would do to the human body. Now, hesitancy has been reduced to the rural areas... So, unless there has been something seriously wrong in what has been done, the court cannot get into the policy fixed by the elected representatives of the people,” Justice Rao queried.

In his petition, Mr. Puliyel said the Centre, its agencies like the DCGI and the Indian Council of Medical Research and vaccine manufacturers had 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 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 pointed out.

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 authorities had to also 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 said.

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 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 | Nov 27, 2021 11:36:05 PM |

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