2 Congress leaders doubt efficacy, DCGI chief calls Covaxin 110% safe

New Delhi: Questions are also being raised over the efficacy of the Covaxin, being developed by Bharat Biotech along with the Indian Council for Medical Research and the National Institute of Virology, with several feeling that the government had rushed in to clear the vaccines without proper data on trials and safety.

Congress leader Shashi Tharoor said Covaxin has not yet completed Phase 3 trials and its approval was premature and could be dangerous. He added that its use should be avoided till the trials are complete, and India can start with the Oxford-AstraZeneca vaccine in the meantime. Congress leader Jairam Ramesh said, “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 said she was “completely unaware of any data on efficacy of Bharat Biotech vaccine” adding “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 government to withdraw permission to Covaxin. “In light of the intense concerns arising from the absence of efficacy data and hence the limited regulatory review of the vaccine candidate, the implications of public rollout of an untested product, and lack of transparency we urge the DCGI to reconsider the recommendations of the SEC in granting the REU approval to Covaxin," AIDAN said in a statement.

Responding to the doubts, Drugs Controller of India chief V.G. Somani said: “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 could be the back-up vaccine while Covishield will be the main 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 told 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.