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KOCHI – Serum Institute of India has threatened to file a defamation lawsuit against a participant who reported having adverse reactions after receiving a dose of the company’s test Covid-19 vaccine during the clinical trial in India.
An official from the Indian Council for Medical Research (ICMR), a co-sponsor of the vaccine trial along with the Serum Institute, said the Controller General of Drugs of India (DCGI) is investigating whether the volunteer’s illness is related to the vaccine under study.
“The DCGI, the regulatory authority of India, will finally determine whether the vaccine is safe … Until it is known whether the serious adverse event is causally associated with the vaccine or not, we cannot make any decisions. That link is not yet established, “said Dr. Samiran Panda, head of the ICMR’s Division of Epidemiology and Communicable Diseases.
A 40-year-old trial participant was admitted to a Chennai hospital for 15 days in October after experiencing severe neurological reactions 10 days after receiving a dose of Covishield, as the vaccine made by the Serum Institute in Pune is called.
The vaccine technology was developed by the University of Oxford and UK-based AstraZeneca, and the Serum Institute is conducting a phase II / III trial in 1,600 human volunteers in India. The privately owned Indian company is the world’s largest vaccine manufacturer.
Dr. S. Ramakrishnan, the lead investigator who administered the vaccine in Chennai on October 1, confirmed with The Straits Times that the patient was treated from October 12 to 26 at the same hospital where he received the vaccine.
The man, a marketing consultant, was diagnosed after multiple tests with acute encephalopathy, which alters brain function and causes personality changes, memory loss, and decreased ability to reason or concentrate. The patient’s wife said that he is now recovering at home but is suffering from weakness and mild mood swings.
Dr Ramakrishnan said that after reporting the adverse event within 24 hours to the trial sponsors, they “unmasked the trial.”
He admitted that the patient had not received a placebo, but the study vaccine, but maintained that the disease was “not related to the vaccine” and that the local institutional ethics committee agreed with him in his initial evaluation report.
“When we discharged the patient, I told the family that radiologically there was no evidence that (the encephalopathy) was related to the vaccine,” added Dr. Ramakrishnan.
But the participant’s wife said the family was not informed.
“The hospital did a lot of testing and assumed all the costs, but they were trying to find some reason for my husband’s illness other than the vaccine. Even the hospital discharge summary did not mention the vaccine in the medication history,” she said .
The discharge summary, a copy of which ST has seen, lists existing gastroenteric problems and an anti-hair loss tablet that the patient has taken for a year, but not the test dose of Covid vaccine that the participant received 10 days before becoming ill. .
The participant’s family filed a legal notice against the company and India’s drug regulator on November 21, demanding compensation of Rs 50 million (S $ 903,850) and that the vaccine trial be stopped until the investigation show that it is safe.
Serum Institute on Sunday (November 29) dismissed the participant’s allegation as “malicious and ill-conceived.” In a statement, the company said it would seek damages in excess of one billion rupees.
Dr. T Jacob John, a prominent virologist and former professor at Christian Medical College, Vellore, said the Serum Institute’s statement was “completely out of place.”
“The company cannot prematurely declare that the adverse event is not vaccine related until the official agency completes its evaluation. The Covishield vaccine is one of the leading-edge vaccines in the world and will affect millions … The adverse event should have been in the public domain in mid-October when the man was hospitalized, “Dr. John said.
In September, after two participants in the AstraZeneca vaccine trial in the UK suffered adverse events, regulators around the world halted trials of the vaccine, including in India. They were resumed only after investigations concluded that adverse events in the UK were not related to the vaccine.
The Indian regulator even modified the consent forms for trials in India to include UK adverse events, for full disclosure.
“Why has the Indian regulator not been able to complete the adjudication of the event in over a month and a half and while it is pending, why not stop the trial, inform the participants and the public? asked Ms Malini Aisola, co-coordinator of All India Drug Action Network, a civil society organization.
On November 28, Adar Poonawalla, whose family founded the Serum Institute, held an online press conference after Prime Minister Narendra Modi visited the company’s facilities in Pune as part of a tour of three vaccine manufacturers in the country.
“Covishield vaccine supplies will be the first to be distributed in India, followed by Covax countries, primarily Africa,” said Mr. Poonawalla. The Covax Facility is a global procurement mechanism to develop and distribute new Covid-19 vaccines in 172 countries and is coordinated by the Gavi Vaccine Alliance.
This month, Bangladesh agreed to purchase 30 million doses of the candidate vaccine from the Serum Institute.
While he did not respond to questions about the adverse event, Mr. Poonawalla said his company was producing between 50 and 60 million doses of Covishield per month and was aiming to build facilities that can “handle more than one billion doses per month. year”.
They will apply to the Indian government for an emergency license in the next two weeks.
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