The Chennai-based volunteer who took part in the clinical trials for the University of Oxford and AstraZeneca’s coronavirus vaccine has also sought an immediate stop to the testing, manufacturing, and distribution of Covishield.
A Chennai-based volunteer is demanding that testing, manufacturing and distribution of experimental coronavirus vaccine ‘Covishield’ be halted immediately. The vaccine is being developed by the University of Oxford and AstraZeneca in collaboration with the Pune-based Serum Institute of India (SII).
In addition to demanding that manufacturing and distribution of the Covid-19 vaccine is stopped, the 40-year-old business consultant has also sought Rs 5 crore as compensation citing neurological and psychological issues as a result of taking the dose. The volunteer was administered a shot of Covishield at Sri Ramachandra Institute of Higher Education and Research (SRIHER) in Chennai on October 1.
The Drugs Controller General of India (DGCI) and the institutional ethics committee at the implementation site are in the process of verifying whether the problems being faced by the volunteer were a consequence of having taken a shot of the experimental vaccine.
At the volunteer’s request, a law firm sent notices to the Director-General of the Indian Council of Medical Research (ICMR), the DGCI and the Central Drugs Standard Control Organisation on November 21. Legal notices were also sent to the CEO of Astra Zeneca UK, Professor Andrew Pollard, Chief Investigator, Oxford Vaccine Trial and Vice-Chancellor of Sri Ramachandra Higher Education and Research.
“He further states that he is still far from being all right and has to be under medical care for a long time to come. Therefore, for all the trauma he is undergoing and with an uncertain future in his health, he should be given a financial compensation of Rs 5 crores within two weeks from the receipt of this notice,” the notice read.
This development comes less than 24 hours after SII CEO Adar Poonawalla told media outlets that the company will approach Indian regulators for emergency use authorisation of Covishield within the next two weeks. Earlier this week, AstraZeneca’s CEO announced that the pharma giant will initiate an additional global clinical trial to further assess the relationship between dosage and efficacy.
Responding to the volunteer’s claims, SII said in a statement, “The allegations in the notice are malicious and misconceived. While the Serum Institute of India is sympathetic to the volunteer’s medical condition, there is absolutely no correlation between the vaccine trial and the medical condition of the volunteer. The volunteer is falsely laying the blame for his medical problems on the COVID vaccine trial.”
“The claim is malicious because the volunteer was specifically informed by the medical team that the complications he suffered were independent of the vaccine trial he underwent. In spite of specifically being made aware of the same, he still chose to go public and malign the reputation of the company,” the statement added.
SII went on to say, “It is evident that the intention behind the spreading of such malicious information is an oblique pecuniary motive. The Serum Institute of India will seek damages in excess of Rs 100 crore for the same and will defend such malicious claims.”
Responding to the allegations, head of the Epidemiology and Communicable Diseases (ECD) division of the ICMR, Dr Samiran Panda told news agency PTI, “Any hurried inquiry or inference is prone to be wrong. Both the institutional ethics committee and the DCGI are investigating the causal links, if any, between the adverse events and investigational product, which is an anti-coronavirus vaccine.”
The DGCI had, earlier this month suspended phase 2 and phase 3 clinical trials in India. This was done in the wake of AstraZeneca’s decision to pause the trials after a volunteer in the US began to exhibit signs of spinal inflammation.
However, permission was granted to the SII to resume the clinical trials on September 15.