The Serum Institute of India has denied claims made by a former trial volunteer in a lawsuit that the Covid-19 vaccine it is conducting trials of that was developed by AstraZeneca and the University of Oxford caused serious neurological side effects, threatening to countersue and seek damages for the “malicious and misconceived” allegations.
A participant in the trial of the vaccine, which is being marketed in India as Covishield, sent legal notice to SII and a number of other involved parties, including Oxford and AstraZeneca, alleging neurological harm as a result of the vaccine, something SII denies, saying that there is “absolutely no correlation with the vaccine trial and the medical condition of the volunteer.”
SII says the volunteer — who is seeking approximately $676,000 in damages — was made aware that his condition had no relation to the vaccine trial.
SII and AstraZeneca did not immediately respond to Forbes’ request for comment.
Of all the late-stage Covid-19 vaccines currently in development, the AstraZeneca-Oxford vaccine has faced particular scrutiny over how it is being tested. Promising results from Phase 3 clinical trials — which have led to the vaccine being considered for emergency use approval by the U.K. government — revealed a puzzling and unexpected outcome whereby participants receiving a half-shot-dose in the first of the two shots needed for the vaccine were significantly better protected than those receiving a full dose. While this is obviously a boon for being able to vaccinate more people with the same amount of vaccine, the results arose from a mistake and were presented confusingly in a press release. Even those running the trial admitted that they did not understand the outcome. In the days following its announcement, the trial was slammed for its lack of transparency and rigor, with the company announcing that it would run a new trial for the vaccine.
SII to sue man over claims of Covishield side effects (Hindustan Times)