In a significant development, Drugs Controller General of India (DCGI) on Sunday (January 3) formally approved Serum Institute's Covishield and Bharat Biotech's Covaxin for restricted use in India.

"Serum Institute and Bharat Biotech vaccines have to be administered in two doses. All the three vaccines have to be stored at 2-8° C. After adequate examination, CDSCO has decided to accept the recommendations of the Expert Committee and accordingly, vaccines of M/s Serum and M/s Bharat Biotech are being approved for restricted use in emergency situation and permission is being granted to M/s Cadila Healthcare for the conduct of the Phase III clinical trial," DCGI said in a press statement.

"Serum Institute of India, Pune has presented a Recombinant Chimpanzee Adenovirus vector vaccine (Covishield) encoding the SARS-CoV-2 Spike (S) glycoprotein with technology transfer from AstraZeneca/Oxford University. The firm submitted safety, immunogenicity and efficacy data generated on 23,745 participants aged ≥ 18 years or older from overseas clinical studies. The overall vaccine efficacy was found to be 70.42%," the DCGI said about Covishield.

"Bharat Biotech has developed a Whole Virion Inactivated Corona Virus Vaccine (Covaxin) in collaboration with ICMR and NIV (Pune), from where they received the virus seed strains. This vaccine is developed on Vero cell platform, which has well established track record of safety and efficacy in the country & globally. he firm has generated safety and immunogenicity data in various animal species such as mice, rats, rabbits, Syrian hamster, and also conducted challenge studies on non-human primates (Rhesus macaques) and hamsters. All these data has been shared by the firm with CDSCO. Phase I and Phase II clinical trials were conducted in approx 800 subjects and the results have demonstrated that the vaccine is safe and provides a robust immune response," the DCGI said about Bharat Biotech's Covaxin.

"We'll never approve anything if there's slightest of safety concern. Vaccines are 110 % safe. Some side effects like mild fever, pain & allergy are common for every vaccine. It (that people may get impotent) is absolute rubbish," said Dr VG Somani, Drug Controller General of India.

The DGCI granted the approval after a Subject Expert Committee of Central Drugs Standard Control Organisation (CDSCO) recommended these two vaccines for emergency use in India. It may be recalled that Covishield was recommended for emergency use on January 1, whereas Covaxin was recommended for restricted use on January 2. On Saturday, Union Health Minister Harsh Vardhan had said the vaccines would be given free of cost to priority groups in the first phase.