How Safe is Covishield? Serum Institute Volunteer Suffers a Neurological Disorder After a Dose


How Safe is Covishield? Serum Institute Volunteer Suffers a Neurological Disorder After a Dose

Illustration: Robin Chakraborty

The coronavirus vaccine is just around the corner. Companies have made grand announcements and discussions on rollout and distribution have already taken center stage. However, caution is due when timelines are pushed and emergency authorisations are demanded.

A 40-year-old Chennai-based business consultant, who was a volunteer for the Covishield vaccine that is under development at the Pune-based Serum Institute of India (SII), has sought ₹5 crore compensation for the neurological complications he developed after being administered the test dose, PTI reported.

A notice was sent to Serum Institute of India seeking Rs 5 crore compensation for a 40-year-old man from Chennai who was a part of the #Covishield vaccine trails after he allegedly suffered from serious ‘neurological’ side-effects.@omjasvinMD @xpresstn

— The New Indian Express (@NewIndianXpress) November 29, 2020

Serum Institute of India has partnered with British drugmaker AstraZeneca and the University of Oxford to conduct trials on its vaccine in India. The man has sought ₹5 crore as compensation and demanded that the vaccine trial be immediately halted and all plans for its “manufacture and distribution” be suspended, failing which legal action would be taken.

The notice says that the public spirit in him was ignited when he learnt that human trials for the vaccine were commencing and they needed volunteers. The volunteer was informed by the Ramachandra Institute that it was a randomised controlled study to determine the safety and immunogenicity of Covishield (Covid-19 vaccine) in the health of Indian adults. The notice claims that the trial investigator assured the volunteer that the vaccine has already been found to be safe and that this study is to further confirm the safety and immune response of Covishield in Indian adults.

A legal notice sent to the vaccine developer on behalf of the participant alleged that the man suffered serious neurological impairment after the under-trial vaccine was administered to him.

— The Wire (@thewire_in) November 29, 2020

“For 10 days after vaccination, there was no adverse reaction, but on October 11, the volunteer woke up at 5.30 am with a severe headache and went back to sleep and did not get up when his wife tried to wake him up at 9 am. At 2 pm, he woke up and vomited and went back to sleep, saying he had a severe headache. There was a total behavioural change in him – he was not aware of his surroundings, he showed irritation towards light and sound, and was resisting any effort to make him get up from bed,” the notice said, citing his wife.

The volunteer vomited enroute the emergency ward of the Sri Ramachandra Medical College Hospital. He was discharged from the hospital on October 26, with the discharge summary stating that he had suffered “acute encephalopathy”. “He says that in the 16 days that he was in the hospital, almost all possible medical tests and investigations were done on him to connect his neurological set back to any of his earlier health conditions, that is, to connect it to some factor other than the test vaccine that was administered on him on October 1. But all the tests done on him was found to be negative, confirming that the setback in his health was due to the test vaccine he was administered on October 1, and not because of any prior health condition,” the notice said.

A 40-year-old participant in the trials of India’s first Covid vaccine wants Rs 5 crore in compensation

— Economic Times (@EconomicTimes) November 28, 2020

Serum Institute has counter-sued the person for defamation. In a statement, it said that the claim is malicious and the volunteer was specifically informed by the medical team that the complications were independent of the Covishield trial. The statement concludes that it deems the notice to be “malicious information” with an “oblique pecuniary motive”, and that the company will seek “damages in excess of ₹100 crore” and “defend such malicious claims”.

.@SerumInstIndia issues statement on the recent Chennai volunteer case; stating that the claim is malicious & the volunteer was specifically informed by the medical team that the complications were independent of the vaccine trial @adarpoonawalla @PMOIndia #CovidVaccine

— ET NOW (@ETNOWlive) November 29, 2020

SR Ramakrishnan, the lead investigator at Sri Ramachandra Institute, meanwhile, said that an “extensive investigation” had been carried out and the report for the same was submitted to the Data and Safety Monitoring Board of the Serum Institute and the drug regulator.

“He recovered very well and we treated him as per protocol and he even came back for a follow-up… All the expenses were borne by the hospital,” Ramakrishnan told The Economic Times, adding that “the subject was now alright”.

Vaccine trial participant sues Serum Institute for ‘severe adverse effect’, DCGI begins inquiry #SmartNews

— 🆘🌊 68 & Still Learning 🌊🆘 (@MikeRJohnson777) November 29, 2020

While there is understandable impatience around vaccine rollout, to skip key procedures and checks could do more harm than good. The issue must be understood and thoroughly checked by all stakeholders. We’ve waited months, we can stretch it out a few more weeks but the release of a vaccine, like Covishield with potential side effects could have unfortunate consequences.