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Serum Institute of India has applied to the Drug Controller General of India for an emergency use authorisation (EUA) on the Covid-19 vaccine developed by the AstraZeneca-OxfordUniversity combine, an official source confirmed.
This makes it the second company in India to do so, after multinational Pfizer approached the Indian regulator for EUA. It has received the nod in the UK.
Also read: Covid-19 vaccine will arrive in Delhi by December-end
Serum Institute has a collaboration with the AZ-Oxford University to produce and distribute their Covid-19 vaccine in India and other low- and middle-income countries. Currently, Serum is conducting late-stage trials on the vaccine in India. The AZ-Oxford vaccine is said to be best suited for Indian conditions in terms of storage and deployment.
Volunteer’s allegations
The application for an EUA comes even as vaccine-related concerns were raised recently be a volunteer who participated in an arm of the trial at a Chennai hospital. The volunteer’s family alleged that he had experienced serious adverse events, that they say was linked to the vaccine-trial. A legal notice on the volunteer’s behalf wanted the trial halted besides a compensation of ₹5 crore.
The volunteer’s lawyer R Rajaram told BusinessLine that they have received a response from Serum Institute saying that the volunteer’s experience was not linked to the vaccine trial. Meanwhile, the volunteer has also approached the DCGI for a copy of the expert committee report that reviewed the adverse event and cleared it saying it was not linked to the trial, the lawyer said, adding that the petitioner was keen on a legal recourse.
₹100-crore suit
While Serum Institute did not comment on the EUA filing, it has in the past refuted the volunteer’s allegations, maintaining that the trial participant’s medical condition was not linked to the vaccine. It countered the compensation claim with a ₹100-crore suit for damages against what it called “malicious” allegations.
Also read: The men behind the vaccines
Meanwhile, the Indian Council of Medical Research, a co-sponsor on the trial, has also said the adverse event was not linked to the vaccine. Health experts, though, have called for the DCGI to make a public statement on the issue, since it involved a vaccine that would be rolled out for mass use, once it gets regulatory clearance.
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