Indian regulators investigate suspected reaction to AstraZeneca shooting, trial continues

NEW DELHI / MUMBAI (Reuters) – The Indian Medical Research Council (ICMR) is involved in an investigation into a suspected adverse reaction to AstraZeneca’s COVID-19 vaccine trial, but found no reason to recommend its shutdown, a senior regulator official said on Sunday.

A 40-year-old man said in a complaint seen by Reuters that he suffered severe “neurological and psychological” symptoms after receiving the vaccine in a trial conducted by British manufacturer partner Serum Institute of India ( SII).

“There was no immediate cause for concern at this point,” Samiran Panda, head of epidemiology and communicable diseases at ICMR, the research body involved in the trials, told Reuters.

“It doesn’t mean that a long-term evaluation won’t take place, it always happens. I am aware of the activity, ”said Panda.

AstraZeneca did not respond to a request for comment.

Law firm NGR Prasad & R. Rajaram Advocates sent the complaint of the anonymous volunteer, who asks for 50 million rupees ($ 676,288) in compensation and a suspension of testing, manufacturing and distribution of the vaccine, to ICMR, SII, AstraZeneca and the Drugs Comptroller General of India.

“While the Serum Institute of India is sensitive to the health status of the volunteer, there is absolutely no correlation with the vaccine trial,” SII said.

“(The) volunteer was specifically informed by the medical team that the complications he suffered were independent of the vaccine trial he underwent,” he added.

India’s Comptroller General of Drugs, who is responsible for approving drugs and vaccines, could not be reached immediately for comment on Sunday.