The Indian Council of Medical Research (ICMR) is assisting an inquiry into an alleged adverse reaction during AstraZeneca’s COVID-19 vaccine trial but has found no reason to recommend halting it, a senior official at the regulator said.
A 40-year-old man said in a complaint seen by Reuters news agency that he had suffered serious “neurological and psychological” symptoms after receiving the vaccine in a trial being run by the British drugmaker’s partner, the Serum Institute of India (SII).
“There was no immediate cause of concern at this stage,” Samiran Panda, head of Epidemiology and Communicable Diseases at the ICMR, the research body involved in trials, told Reuters.
“It doesn’t mean that long term assessment will not happen, it is still happening. I am aware of the activity,” Panda said.
AstraZeneca did not respond to a request for comment.
Law firm NGR Prasad & R Rajaram Advocates sent the complaint by the unnamed volunteer, who is seeking 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 Controller General of India.
The Serum Institute of India responded in a statement saying the “allegations in the notice are malicious and misconceived”.
“While the Serum Institute of India is sympathetic with the volunteer’s medical condition, there’s absolutely no correlation with the vaccine trial. The volunteer is falsely laying the blame for his medical problems on the COVID 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,” it added.
India’s novel coronavirus cases rose by 38,772 on Monday, the health ministry said, making it the 23rd straight day that daily cases stayed below 50,000.
The country now has recorded a cumulative 9.43 million infections, the second-highest in the world after the United States, but daily cases have been dipping since hitting a peak in September.
Deaths rose by 443 in the last 24 hours and now total 137,139.