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 Intitute 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 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 Committe 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.
Prime Minister Narendra Modi has welcomed the DCGI decision and said that approval of two vaccines is a a decisive turning point to strengthen a spirited fight.
"DCGI granting approval to vaccines of Serum Institute and Bharat Biotech accelerates the road to a healthier and COVID-free nation. Congratulations India. Congratulations to our hardworking scientists and innovators," he said.
A decisive turning point to strengthen a spirited fight!
Congratulations to our hardworking scientists and innovators.
— Narendra Modi (@narendramodi) January 3, 2021
Reacting to DCGI's approval, Dr Poonam Khetrapal Singh, Regional Director WHO South-East Asia Region siad, “WHO welcomes the first emergency use authorization given to COVID-19 vaccine in the WHO South-East Asia Region. This decision taken today by India will help intensify and strengthen the fight against COVID-19 pandemic in the Region. The use of vaccine in prioritized populations, along with continued implementation of other public health measures and community participation will be important in reducing the impact of COVID-19".