COVID-19 vaccines of Serum Institue of India and Bharat Biotech have been granted permission for restricted use in emergency situation, said Drugs Controller General of India (DCGI) on Sunday.
“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,” said VG Somani, DCGI, during a media briefing today.
“We’ll never approve anything if there is slightest of safety concern. The vaccines are 100 per cent safe. Some side effects like mild fever, pain, and allergy are common for every vaccine. It (people may get impotent) is absolute rubbish,” he added.
The SEC of Standard Drug Organisation met on 1st and 2nd Jan and made recommendations in respect of proposal of restricted emergency approval of COVID-19 vaccine of SII, according to DCGI.
SII Pune has submitted safety immunogenicity and efficacy data generated on 23,745 participants aged more than or equal to 18 years or older from overseas clinical studies, he added.
The overall vaccine efficacy was found to be 70.42 per cent. Further SII was granted permission to conduct phase 2/phase 3 clinical trial on 1,600 participants within the country, according to DCGI.
“The firm also submitted the interim safety and immunogenicity data generated from this trial and the data was found comparable from the data from overseas clinical studies,” said Somani.
“After detailed deliberations, SEC has recommended for grant of permission for restricted use in an emergency situation subject to certain regulatory conditions. The clinical trial ongoing the country by the firm will continue,” he added.
Bharat Biotech has developed a vaccine named covaxin in collaboration with ICMR and the National Institute of Virology, from where they received the virus seed strains. This vaccine is developed on the Vero cell platform, which has a well-established track record of safety and efficacy in the country and globally.
Indin Prime Minister Narendra Modi congratulated the country as Drugs Controller General of India (DCGI) granted emergency use approval to Serum Institute of India and Bharat Biotech for their COVID-19 vaccines.
The 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 have 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 Phase III efficacy trial was initiated in India in 25,800 volunteers and to date, 22,500 participants have been vaccinated across the country and the vaccine has been found to be safe as per the data available to date.
The Subject Expert Committee (SEC) has reviewed the data on safety and immunogenicity of the vaccine and recommended for grant of permission for restricted use in an emergency situation in the public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains. The clinical trial ongoing within the country by the firm will continue, according to DCGI.
Accordingly, the firm has sought permission to conduct a Phase-III clinical trial in 26,000 Indian participants, which has been recommended by the Subject Expert Committee.
M/s Serum and M/s Bharat Biotech vaccines have to be administered in two doses. All the three vaccines have to be stored at 2-8° C, said DCGI.
