“Mischievous and ill-conceived. Indian vaccine producer responds to trial volunteer complaint | Science

By Sanjay KumarDec 2, 2020 5:15 PM

ScienceCOVID-19 reports are supported by the Pulitzer Center and the Heising-Simons Foundation.

An Indian is suing one of the world’s largest vaccine makers after falling seriously ill during a trial of a COVID-19 vaccine developed by the University of Oxford and AstraZeneca. The patient developed a neurological disease after being vaccinated last month and is claiming 50 million rupees ($ 680,000) in damages from the Serum Institute of India (SII), which produces the vaccine in India.

But SII fought back harshly: In a November 29 statement, it called the allegations “malicious and false” and said it could seek damages of up to 1 billion rupees under the scheme. a counter-lawsuit claiming damage to reputation. The volunteer was “specifically told by the medical team that the complications he suffered were unrelated to the vaccine trial he underwent,” the company said.

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The case dominated the news in India for days, but the crucial facts are still obscure; neither SII nor the Indian government’s regulator provided details. Some critics have questioned why the trial was not halted when the adverse event occurred, as another trial of the same vaccine was. Others fear that SII’s backlash against the trial volunteer could undermine already fragile public confidence in clinical trials.

Based on other studies, AstraZeneca reported that its vaccine was between 62% and 90% effective, although the results raised questions as it appeared to work better in patients who were accidentally given a lower dose during from their first injection. SII has reached an agreement to produce the vaccine on a large scale – tens of millions of doses per month – with support from the Bill & Melinda Gates Foundation and Gavi, the Vaccine Alliance. The company is currently testing its version, called Covishield, with 1,600 participants at 17 sites across nine Indian states.

The trial participant, a 40-year-old business consultant from Chennai, sent SII a legal opinion on November 21 claiming he had developed severe neurological disease on October 11, 10 days after receiving his first dose of vaccine. He spent 15 days in hospital, including 8 days in intensive care, suffering from an acute neuroencephalopathy which left him “totally disoriented”, according to the complaint, to such an extent that he could no longer recognize his relatives. . He is much better now but is still not fully recovered, his wife told reporters.

SSI CEO Adar Poonawalla told reporters during a press briefing on November 28 that there was “no hospitalization” among the trial participants. But the trial’s lead investigator, SR Ramakrishnan of the Sri Ramachandra Institute of Higher Education and Research, admitted in interviews that the subject was critically ill and had received the study vaccine. , not a placebo. Based on an X-ray examination of his brain, Ramakrishnan determined that his illness was not the result of the vaccination, he reportedly said. The new times of the straits. A local ethics committee approved this assessment, Ramakrishnan said. (Ramakrishnan did not answer questions from Science and appeals to the chairman of the ethics committee were not answered.)

In its Nov. 29 statement, SII agreed that “there is absolutely no correlation with the vaccine trial and the health of the volunteer,” but provided no details. It also did not explain why the trial was not stopped when the adverse event occurred. Such breaks are not uncommon: Vaccination was stopped in the AstraZeneca trial in more than 23,000 people on two occasions after the occurrence of a suspected serious side effect. In the SSI study, “the results of the initial causal assessment did not require interruption,” said Balram Bhargava, director general of the Indian Council for Medical Research, a co-sponsor of the study.

In a new statement posted to Facebook yesterday, SII said Ramakrishnan, the trial data oversight and security council, and an ethics committee “have been independently approved and evaluated [the adverse event] as a matter unrelated to the vaccine trial ”, and that“ all reports and data related to the incident ”have been sent to regulatory authorities. India’s Central Pharmaceutical Standards Supervisory Organization has not publicly discussed the matter and has not responded Sciencerequests from.

“Done well, the investigation of a serious adverse event could have been completed in just 3 days,” says retired virologist Thekkekara Jacob John, formerly at Christian Medical College in Vellore. “If they weren’t sure, the study should have been stopped and the public informed.”

Asked whether the trial should have been suspended, Adrian Hill of the Jenner Institute at the University of Oxford, who helped develop the AstraZeneca vaccine, replied: “No comment, I don’t know the details of the case. “

Critics say the company’s threat to counterattack the patient sets a bad example, even though the man’s disease is deemed independent of the study vaccine. “Maybe there is a worse way to handle this, but I find it hard to imagine one,” Hilda Bastian, an independent evidence-based medicine expert wrote on her COVID-19 vaccine blog on Monday. PlOS.

Indian Health Secretary Rajesh Bhushan has so far dodged questions on the matter, saying the case is now before the courts. Malini Aisola, co-organizer of All India Drug ActionNetwork, says the government is using this argument “as a shield to avoid answering questions of great public interest”.

SII, which supplies vaccines against diseases such as polio, measles, hepatitis and tuberculosis to more than 160 countries, already produces 40 to 50 million doses of Covishield per month, and says it will soon be in able to increase it to 100 million. The company hopes to file an emergency vaccine clearance request in India within 2 weeks. After a November 28 visit by Indian Prime Minister Narendra Modi to the company’s headquarters in Pune, Poonawalla said he expected the Indian government to purchase between 300 and 400 million doses of Covishield by July 2021 SII also hopes to sell the vaccine widely in Africa. through the COVID-19 Global Vaccine Access Mechanism, better known as COVAX.