Amid the raging debate over the efficacy of indigenous Covaxin, manufactured by Bharat Biotech in collaboration with the Indian Council of Medical Research and Pune’s National Institute of Virology, the Centre on Tuesday clarified why Covaxin has been given the emergency-use approval though its third phase trial is still going on.
As health secretary, Niti Aayog officials, ICMR director-general Balram Bhargava were present at the press meet, it was asked to them which vaccine they would take between Bharat Biotech’s Covaxin and Oxford-Serum Institute’s Covishield. Niti Aayog member (health) VK Paul answered the question and, holding health secretary Rajesh Bhushan’s hand, said, “I will take the vaccine which my ministry of health will specify for me with great affection, love and gratitude.”
“All scientific and statutory requirements have been made while giving this approval to vaccines. There is no doubt. These decisions are being taken by experts. Also remember, there is a context. These are not regular authorisation. No country is giving regular authorisation to any vaccine,” Niti Aayog member (health) VK Paul said.
Dispelling doubts over Covaxin, ICMR DG Balram Bhargava said safety, immunogenicity and efficacy reports are required for approval in a non-emergency situation. “Efficacy data is not required for emergency use approval. Immunogenicity data serves as a surrogate for efficacy data in such situation,” Bhargava said.
According to rules, phase two results of clinical data guide experts for approval, which Covaxin has. He also said there have been no safety concerns regarding Covaxin.
Covaxin has also been asked restricted use in clinical trial mode. Explaining this, Dr Bhargava said, “There has be consent from the trial participant and there will be follow up.”