Madras HC issues notice on plea alleging serious side effects during COVISHIELD trial

The Madras High Court on Friday issued notice on the plea filed by a participant of the COVISHIELD clinical trial who allegedly suffered serious side effects after receiving the first dose of the vaccine. The notice was issued to the Union Health Secretary, the Drugs Controller General of India (DCGI), ICMR Director-General, Serum Institute of India CEO Adar Poonawalla, AstraZeneca UK CEO and the chairman of the Ethics Committee and the matter was adjourned to March 26. The petitioner claimed that he suffered from a 'Serious Adverse Effect' as per the New Drugs and Clinical Trial Rules, 2019 owing to which he was hospitalized from October 11-October 26, 2020. 

According to him, the Participant Information Sheet promised that the vaccine was safe and if there was any side effect, it would be very mild. Instead, the petitioner noted that he was diagnosed with 'Acute Neuro Encephalopathy' causing various neurological issues such as trembling of hands, anxiety etc. Mentioning that he lost out on work opportunities because of these problems, he accused of trying to brush aside the adverse effect that the vaccine had on him. Therefore, he sought a declaration to the effect that the vaccine is unsafe and asked for a compensation of Rs.5 crore.

Read: 21.5% Of The Population Exposed To COVID-19: ICMR's 3rd Nationwide Serosurvey Reveals

COVID-19 vaccination in India

On January 3, the Drugs Controller General of India accepted the recommendations of the Subject Expert Committee of the Central Drugs Standard Control Organisation, paving way for the approval of COVISHIELD and COVAXIN. Manufactured by the Serum Institute of India with technology transfer from Oxford University-AstraZeneca, COVISHIELD is a Recombinant Chimpanzee Adenovirus vector vaccine with its overall efficacy of 70.42 per cent. On the other hand, COVAXIN is a Whole Virion Inactivated Corona Virus Vaccine developed by Bharat Biotech in collaboration with ICMR and NIV.

It wasapproved in "public interest" in the clinical trial mode so that there can be more options for vaccination in case of infection by mutant strains. Countering the charge that COVAXIN was approved hastily, Union Health Minister Dr. Harsh Vardhan has made it clear that all the recipients of this vaccine will be tracked and monitored as if they are in clinical trial mode. On January 16, PM Modi launched the pan-India rollout of the novel coronavirus vaccination drive via video conferencing. Congratulating the citizens for their resilient fight against the pandemic, he requested them to shun conspiracy theories about the vaccines. So far, the total number of vaccinations stands at 1,01,88,007. 

Read: India-Australia Will Play Important Role In Shaping Post-COVID World: PM Modi