AstraZeneca Statement On Rare Vaccine Side Effect : Recalling Supreme Court Verdict On Covid Vaccine Trials & AEFI Reporting

A statement made by AstraZeneca that its vaccine against COVID-19 (which was made and sold in India as Covishield) can cause adverse effects related to blood clotting in rare cases has created a certain degree of panic among some people in India, particularly among those who received the Covishield vaccine. However, many in the medical field point out that the statement by AstraZeneca - which was made in a court proceeding in the United Kingdom- is nothing new and that the product information with the vaccine clearly mentioned the possibility of Thrombosis with Thrombocytopenia Syndrome (TTS) in rare cases.

AstraZeneca made the statement in a case in the High Court of London filed by certain individuals who complained of side effects due to the vaccine. The document filed by the company reportedly stated :

“It is admitted that the AZ vaccine can, in very rare cases, cause TTS. The causal mechanism is not known. Further, TTS can also occur in the absence of the AZ vaccine (or any vaccine). Causation in any individual case will be a matter for expert evidence.”

In this backdrop, it is worthwhile to revisit a judgment delivered by the Supreme Court in May 2022 dealing with various aspects related to the Union Government's COVID vaccination policy, vaccine mandates, publication of clinical trials and Adverse Effects Following Immunization (AEFI). It was the judgment delivered by a bench comprising Justices L Nageswara Rao and BR Gavai in the case Dr.Jacob Puliyel v. Union of India.

The petitioner Dr Jacob Puliyel was a former member of the National Technical Advisory Group of Immunization, who questioned the constitutional validity of the vaccine mandates imposed by States. He also sought directions to disclose the data pertaining to clinical trials of the COVID-19 vaccines administered to adults as well as children in India. The petitioner also urged the Court to revamp the Adverse Events Following Immunization Reporting System, which he alleged was opaque, flawed, and unknown to the public at large.

Nobody can be forced to get vaccinated

The Court held that no individual can be forced to get vaccinated and the right to bodily integrity of a person under Article 21 of the Constitution includes the right to refuse vaccination.

The Court also recognized the right of the Government to impose reasonable restrictions on the rights of unvaccinated persons in the interests of public health. However, such restrictions must be reasonable and proportionate. The Court found that the vaccine mandates imposed by various States were disproportionate and directed them to be reviewed.

Emergency authorization given to vaccines as per due process

The Court rejected the petitioner's contention that restricted emergency use approvals had been granted to Covishield and Covaxin in haste, without a thorough review of the relevant data. It also said that so long as the relevant information relating to the minutes of the meetings of the regulatory bodies and the key outcomes and findings of the trials are available in the public domain, the petitioner cannot contend that “every minute detail relating to clinical trials be placed in public domain”.

"As required by the WHO Statement on Clinical Trials and the GCP guidelines, findings of the clinical trials and the key outcomes of the trials have been published. In light of the existing statutory regime, we do not see it fit to mandate the disclosure of primary clinical trial data, when the results and key findings of such clinical trials have already been published," the judgment stated.

The Court noted that both vaccines have been approved by the WHO and that there was "material compliance" with the procedure prescribed under the Drugs and Cosmetics Act, 1940 and the New Drugs and Clinical Trials Rules, 2019, before granting of approval for the emergency use of the two vaccines.

At the same time, the Court directed the disclosure of the data of the post-approval clinical trials of the vaccines.

"However, it is made clear that subject to the protection of privacy of individual subjects and to the extent permissible by the 2019 Rules, the relevant data which is required to be published under the statutory regime and the WHO Statement on Clinical Trials shall be made available to the public without undue delay, with respect to the ongoing post-marketing trials of COVAXIN and COVISHIELD as well as ongoing clinical trials or trials that may be conducted subsequently for approval of other COVID- 19 vaccines / vaccine candidates."

Reporting of AEFI

The Court expressed satisfaction with the protocol developed by the Union Government for the reporting of the Adverse Effects Following Immunizations (AEFI), terming them “well-defined”

The Court refused to accept the petitioner's contention that the surveillance system of AEFIs is faulty and the correct figures of those who have suffered any side effects, severe reactions or deaths post-inoculation have not been disclosed.

At the same time, the Court directed the Union to accept the petitioner's suggestion that individuals and private doctors should also be allowed to report adverse events.

"However, we are in agreement with the suggestion made by the Petitioner that there should be a mechanism by which individuals and private doctors should be permitted to report suspected adverse events."

Stressing the importance of proper documentation of adverse effects, the Court said : "Information relating to adverse effects following immunisation is crucial for the purpose of understanding the safety of the vaccines that are being administered, apart from being instrumental in further scientific studies around the pandemic. There is an imminent need for collection of requisite data of adverse events and wider participation of people in reporting the adverse events is necessary for the purpose of gathering correct information."

The Union Government was directed to facilitate self-reporting of suspected adverse events :

"Thus, the Union of India is directed to facilitate the reporting of suspected adverse events by individuals and private doctors on a virtual platform and the reports so made shall be publicly accessible after being given unique identification numbers, without listing any personal or confidential data of the persons reporting. All necessary steps to create awareness of, and to navigate, this platform for self-reporting shall be effectuated by the Government, roping in and training relevant participants right from the ground level of vaccine administration.”