SII, Bharat Biotech's COVID-19 vaccines approved for restricted use in emergency situations

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 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 restructed emergency approval of COVID-19 vaccine of SII, according to DCGI. SII Pune has submitted safety immunogenisity 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 immunogenisity 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 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 National Institute of Virology, 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 and globally.

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 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 Phase III efficacy trial was initiated in India in 25,800 volunteers and till date, 22,500 participants have been vaccinated across the country and the vaccine has been found to be safe as per the data available till 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 emergency situation in 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.

M/s Cadila Healthcare Ltd., has developed a Novel Corona Virus-2019-nCov-Vaccine using DNA platform technology. The firm initiated Phase-I/II clinical trial in India in more than 1,000 participants which is ongoing. The interim data suggests that the vaccine is safe and immunogenic with three doses when administered intradermally. Accordingly, the firm has sought permission to conduct 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.