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The All India Drug Action Network (AIDAN) urged the federal government to withdraw permission to Covaxin
New Delhi: Questions are additionally being raised over the efficacy of the Covaxin, being developed by Bharat Biotech together with the Indian Council for Medical Research and the National Institute of Virology, with a number of feeling that the federal government had rushed in to clear the vaccines with out correct information on trials and security.
Congress chief Shashi Tharoor mentioned Covaxin has not but accomplished Phase 3 trials and its approval was untimely and might be harmful. He added that its use needs to be averted until the trials are full, and India can begin with the Oxford-AstraZeneca vaccine within the meantime. Congress chief Jairam Ramesh mentioned, “Bharat Biotech is a first-rate enterprise, but it is puzzling that internationally-accepted protocols relating to Phase 3 trials are being modified for Covaxin. Health Minister should clarify.”
Vaccine scientist Dr Gagandeep Kang mentioned she was “completely unaware of any data on efficacy of Bharat Biotech vaccine” including “it will be a stretch to say the vaccine will work against the UK strain of Covid.”
The All India Drug Action Network (AIDAN) urged the federal government to withdraw permission to Covaxin. “In gentle of the extreme issues arising from the absence of efficacy information and therefore the restricted regulatory evaluation of the vaccine candidate, the implications of public rollout of an untested product, and lack of transparency we urge the DCGI to rethink the suggestions of the SEC in granting the REU approval to Covaxin,” AIDAN mentioned in an announcement.
Responding to the doubts, Drugs Controller of India chief V.G. Somani mentioned: “We will never approve anything if there is slightest of safety concern. Vaccines are 110 per cent safe. Some side-effects like mild fever, pain and allergy are common for every vaccine. It (that people may get impotent) is absolute rubbish.”
AIIMS, New Delhi Director Dr Randeep Guleria hinted that Covaxin might be the back-up vaccine whereas Covishield would be the most important one. “I feel that in the coming days it is the Serum Institute vaccine that will be the main vaccine, Bharat Biotech only a back-up for emergency use in case of re-infection,” Dr Guleria advised a TV channel.
“By that their time they will get their dosage ready and by the time they will get the data which will be able to show that the Phase 3 data is robust and they have enough events to show that it is efficacious and it is safe, we will be able to have that vaccine available. But the first few weeks, it will be the Serum Institute vaccine which will be rolled out. It has 50 million doses available,” Dr Guleria added.
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