The Centre on Tuesday sought to dispel doubts about the Serum Institute of India’s potential coronavirus vaccine Covishield after a volunteer claimed that he had faced “severe adverse effects” following the trial. These were the first comments by the government on the matter.

“After initial causality assessment, findings did not necessitate stoppage of the Serum trials,” Health Secretary Rajesh Bhushan said at a press briefing, NDTV reported. “SII vaccine trials have entered Phase 3. After reviewing all documents, SII has been given permission to conduct Phase 3 trials.”

On November 21, a 40-year-old volunteer from Chennai sued Serum Institute for Rs 5 crore alleging that the vaccine triggered an adverse reaction, including neurological impairment. The volunteer demanded that the trial be immediately halted and all plans for its “manufacture and distribution” be suspended, failing which legal action would be taken. According to the legal notice, there was a total “behavioural change” in the participant and he seemed unaware of his surroundings.

The Serum Institute denied these charges and filed a Rs 100 crore defamation case against the volunteer, calling the allegations “malicious” and “misconceived”.

Checks and balances

Bhushan said that the alleged adverse event will not affect the timeline of the vaccine in any manner. The health secretary added that there were several measures in place to monitor any adverse reactions during such trials, according to The Indian Express. The first of these was the “prior informed consent form” that a volunteer must sign before participation.

“Second, these vaccine trials are multi-centric and multi-site; the subjects are given the vaccine under medical care, they are monitored and observed,” Bhushan said. “Every site has an institutional ethics committee, which is independent of the sponsors and government. Whenever there is an adverse event, the ethics committee takes note of it and gives its findings…to the regulator within 30 days.”

Besides the ethics committee, the Data Safety and Monitoring Board – which is independent of the government and the drug firm – also monitors the trial and reports on adverse events. “They can also recommend if they decide to temporarily halt the trial or conduct an investigation,” he said, adding that according to the rules, a “Form-5 has to be filled by the chief investigator and the report is submitted to the regulator” in case of an adverse event.

The health secretary continued that the ethics panel and the data safety board analyse if there is a “one-to-one correlation between the adverse event and the vaccination”. After the drug regulator examines all these reports, it decides on either continuing or stopping the trials.

“In the present case, Serum Institute’s vaccine trials clubbed phase 2/3 and phase 3 permission has been given based on examination of these documents… The adverse event being referred to in case of the vaccine developed by Oxford-Serum happened in October,” Bhushan said, urging people not to assume that the processes were not complied with.

‘No role in legal claims’

The Centre also distanced itself from the legal claims filed in connection with the incident. “Indian Council of Medical Research has no role in endorsing or not endorsing a legal claim filed anywhere in the country,” Bhushan said. The Serum Institute recruited 1,600 people to take part in its Covid-19 vaccine trial that it is developing with the ICMR.

When asked specifically about the Serum Institute’s Rs 100 crore suit, Bhushan noted that it takes eight to ten years usually to develop a vaccine but it was being compressed into 16-18 months because of the pandemic. “When you have this context, there is a potentiality that commercial interest would dictate certain strategic actions on part of commercial entities,” Bhushan said. “Governments of the day have nothing to do with it.”

Earlier on Tuesday, the Serum Institute had dismissed the claims of the Chennai volunteer and said that the vaccine was “safe and immunogenic” and was not the reason behind the complications faced by the volunteer. The Pune-based firm also said that it had followed “requisite regulatory and ethical processes and guidelines” during the administering of the vaccine.

Last week, Serum Institute Chief Executive Officer Adar Poonawalla had said that his firm was preparing to apply for emergency use of its vaccine in two weeks. He also said that the Centre was likely to buy 300-400 million [30 to 40 crore] doses of the vaccine by July 2021, though it did not sign a written agreement with the firm.

The Serum Institute has tied up with British-Swedish pharmaceutical company AstraZeneca and Oxford University to produce a vaccine in India. The vaccine is seen as offering one of the best hopes for many developing countries because of its cheaper price and ability to be transported and stored at normal temperatures. Bharat Biotech in Hyderabad and Zydus Cadila in Ahmedabad are also working on a vaccine.

India has not signed a deal for a coronavirus vaccine yet so it is unclear when it will be available for use in the country. Availability of the vaccine in India will be subject to approval by domestic regulators, and the Indian government agreeing to purchase them. So far, many other nations including the United States, United Kingdom, the European Union, Australia and Israel have made deals to buy millions of doses of the vaccine.