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‘Adverse Event’ Will Not Delay Serum Vaccine Plan: Center


Initial evaluations after the illness of a volunteer suggested that it was not necessary to stop the trial of the Oxford-AstraZeneca vaccine and that the incident will not affect the timelines for the emergency approval process in the country, senior officials said Tuesday: the The government’s first reaction to a controversy that seemed to dampen hopes for an early inoculation of the coronavirus.

The comments were made by the Union’s health secretary, Rajesh Bhushan, and the director of the Indian Medical Research Council, Dr. Balram Bhargava, at a weekly government briefing on Covid-19.

Officials also indicated that the country may not need to vaccinate the entire population of India to contain the spread of the disease. “I just want to make this clear that the government has never talked about vaccinating the entire country. It is important that we discuss these scientific issues, based only on factual information, ”Secretary Bhushan said when answering a question about when a vaccine can be provided to everyone in the country.

Explaining the comment, Bhargava, the director general of the ICMR, said that it may not be necessary to vaccinate the entire population if a “critical mass of people” is vaccinated and the chain of transmission of the virus is broken.

Early in the briefing, both officials addressed the controversy sparked by allegations by a Chennai man that clinical trials, sponsored by the Serum Institute of India, which makes the Oxford-AstraZeneca vaccine, left him with severe neurological symptoms.

The Oxford-AstraZeneca candidate vaccine is widely believed to be the first that could be licensed for use in people, with emergency approval expected in the coming months. India is targeting vaccines for 250-300 million healthcare workers and essential services personnel in its first phase of vaccinations, which it expects to end in June 2021.

“This event will not affect the schedules in any way. But since there is now a court case, we will not comment on details related to the case, “Bhushan said, before listing five safeguards that are part of clinical trials in India.

These, according to him, include monitoring by two independent groups of experts, an informed consent process, and a detailed investigation of the data and review of such incidents by regulators in India.

“The drug controller has the authority to not allow the vaccine trial to go to the next level if the data casts doubt on the candidate vaccine. Currently, the Serum Institute’s Covid-19 vaccine candidate vaccine has entered phase 3 of the phase 2/3 trials after receiving the necessary approvals after review of all relevant documents. Similarly, the Bharat Biotech vaccine candidate has also entered the phase 3 clinical trial stage after reviewing all the data they submitted, ”said Bhushan.

The volunteer who fell ill has sued the SII for $ 5 million rupees in damages, obtaining legal notice from the Pune-based vaccine manufacturer requesting $ 100 million rupees. The SII issued a new statement Tuesday, reiterating that the vaccine was safe and elicited an immune response and said its notice was intended to protect the company against attempts to smear it.

Adverse effects, as they are technically called, occur when trial volunteers develop serious illness after an inoculation and during the period for which they need to be monitored, usually two months. In this case, it has been said that the side effects experienced by the volunteer have not been related to the vaccine, although the detailed data is being studied.

“It is not necessary to inform all participants of all serious adverse events. Let’s be very clear that many serious adverse events are coincidental. In fact, that’s the case more often than causally related serious adverse events, for which, of course, information must be shared, ”said Dr. Gagandeep Kang, one of the leading researchers in the field of vaccines at India.

“In a trial that we did by way of illustration, we had 1,462 serious adverse events of which three were considered possibly related (and none of the three were hospitalized), with a similar rate of serious adverse events in intervention and placebo recipients.” .

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