New Delhi: After drawing flak for its Rs 100 crore defamation suit against a Covid-19 vaccine volunteer who had alleged serious side-effects, Pune-based Serum Institute of India (SII) Tuesday said the vaccine won’t be released for mass use unless it is proven safe.
A Chennai-based resident, who was a participant in the trials of Covishield vaccine, being manufactured by the SII, has allegedly suffered serious neurological and psychological symptoms after taking the experimental shots.
On the participant’s behalf, a law firm sent a legal notice to SII on 21 November seeking compensation of Rs 5 crore. However, SII, on 29 November, filed a Rs 100 crore defamation suit against the volunteer. Experts had labelled the SII’s move as “an attempt to intimidate” the volunteers.
In its fresh statement, the company, however, said: “The incident with the Chennai volunteer, though highly unfortunate, was in no way induced by the vaccine, and Serum Institute of India is sympathetic with the volunteer’s medical condition.”
It emphasised that “Covishield vaccine is safe and immunogenic”, adding, “we would want to assure everyone that the vaccine won’t be released for mass use unless it is proven immunogenic, and safe”.
The SII clarified that it filed the suit against the participant to protect its brand image.
“Taking into consideration the complexities and existing misnomers about vaccination and immunisation, the legal notice was sent, therefore, to safeguard the reputation of the company, which is being unfairly maligned.”
The vaccine, Covishield, is being developed by the University of Oxford and drugmaker AstraZeneca. The SII has a tie-up with the Swedish-British pharma giant for manufacturing of billion doses of the vaccine. Covishield is among the frontrunner vaccines against Covid-19.
No rules were broken, says SII
According to the SII’s statement, the company had informed the authorities concerned about the condition of the participant and that all rules were followed.
“We would like to clarify that all the requisite regulatory and ethical processes and guidelines were followed diligently and strictly.”
“…the principal Investigator, Data and Safety Monitoring Board and the Ethics Committee independently cleared and reckoned it (the condition of the participant) as a non-related issue to the vaccine trial,” SII said.
After clearance from the top authorities, the company said, it kept on continuing the trials.
“We submitted all the reports and data related to the incident to the Drug Controller General of India. It is only after we cleared all the required processes that we continued with the trials,” it said.
The issue related to the side-effect has come up at a time when SII, which is known as one of the world’s largest vaccine makers, is aiming to manufacture 10 crore vaccine doses by this month for an inoculation drive to begin in India.
Adar Poonawalla, chief executive officer of SII, had said last month that the company is expecting emergency authorisation for the use of its vaccine by December.
‘No basis to the SII’s claim’
Experts, meanwhile, said there’s no basis to the SII’s claim that the vaccine is safe and immunogenic.
“Serum’s statement claims in the opening sentence that the Covishield vaccine is safe and immunogenic. But there is absolutely no basis for this claim given the Phase 2/3 trial looking at safety and immunogenicity is still underway,” said Malini Aisola, co-convener, All India Drug Action Network, a group of NGOs involved in ensuring healthcare access.
“It also says ‘It is only after we cleared all the required processes that we continued with the trials’, which seems to imply that the trial was put on hold. There is no indication that the trial was ever paused for even a brief period of time. One of the objectives of the study is to assess safety. It is of utmost importance that information about this SAE (serious adverse effects) is conveyed honestly and transparently to the public,” Aisola added.