THD NewsDesk, New Delhi: The Serum Institute of India is set to run Oxford University’s Covishield Vaccine phase 3 trials in India from next week. It has been issued with an approval notice by the Drugs Controller General of India (DCGI). Lately, trials for the vaccine were held off after an alert action as one of the UK volunteers exhibited unpropitious traits. The symptoms are yet to be associated with the vaccine.
In its notice, the Drugs Regulator General of India probed Serum Institute of not sending a detailed report in the UK. It also questioned propelling trials even after a case showed some severe symptoms.
The Serum Institute is enrolling recipients for phase 3 trials of the Covishield. Covishield is being developed jointly by Oxford University and pharmacy giant AstraZeneca. The vaccine was to be tested on 16,000 participants across 17 sites.
On Wednesday, The Serum Institute said, “We are going by DCGI’s direction, and so far we’re not told to pause the trials. If DCGI has any safety concerns, we will follow their instructions and abide by the standard protocols.”
Recently, the Pune based vaccine manufacturer stated that Indian trials did not manifest any issues at all. The company added that they “can’t comment much on the UK trials, but they have been paused for further review.”
An AstraZeneca representative had said that it is too basic information to ascertain the sick recipients’ diagnosis of new agency Reuters reported this information. In collaboration with Oxford University, AstraZeneca said that the recipient suffered “an unexplained illness,” and such lapses in drug trials are “routine.”
Michele Meixell, a spokeswoman, said in a statement, “This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials.”
New York Times had informed that a participant in the UK trials was diagnosed with transverse myelitis. It is a swelling of the spinal cord usually caused by infections, citing a person accustomed to it.
The volunteer’s severe health issues might be an obstacle to the development of the vaccine. Though, with recent developments made by the university and the pharma giant, one can be hopeful for the Covishield to succeed phase 3 trials.