Drug Controller General of India (DCGI) on Sunday approved Serum Institute of India's 'Covishield' vaccine and Bharat Biotech's 'Covaxin' for emergency use against coronavirus. The development, eleven months after the first case of deadly coronavirus was detected in India, has paved the way for their roll-out and administration to millions. The vaccine will be first offered to one crore healthcare workers, along with two crore frontline and essential workers and 27 crores elderly, mostly above the age of 50 years with co-morbidities.
The expert panel has recommended granting permission for restricted emergency use of 'Covaxin' in "public interest as an abundant precaution, in clinical trial mode, especially in the context of infection by mutant strains.
This is a major relief for India which has the second-highest number of infections in the world, after the US. The Central government plans to vaccinate nearly 30 crore people in the first phase of the drive in the next six to eight months.
Here's the full statement by DCGI
The Subject Expert Committee of Central Drugs Standard Control Organisation (CDSCO) met on 1st and 2nd January 2021 and made recommendations in respect of a proposal for Restricted Emergency Approval of COVID-19 virus vaccine of M/s Serum Institute of India and M/s Bharat Biotech as well as Phase III clinical trial of M/s Cadila Healthcare Ltd. The Subject Expert Committee consists of domain knowledge experts from the fields of pulmonology, immunology, microbiology, pharmacology, paediatrics, internal medicine, etc.
M/s 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%. Further, M/s Serum was granted permission to conduct Phase-II/III clinical trials on 1600 participants within the country. The firm also submitted the interim safety and immunogenicity data generated from this trial and the data was found comparable with the data from the overseas clinical studies. After detailed deliberations, the Subject Expert Committee has recommended the grant of permission for restricted use in an emergency situation subject to certain regulatory conditions. The clinical trial ongoing within the country by the firm will continue.
M/s 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 the Vero cell platform, which has a well-established track record of safety and efficacy in the country & 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 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.
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 1000 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 a Phase-III clinical trial in 26000 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 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.
India gets coronavirus vaccines: Updates so far
The Subject Expert Committee, tasked with vetting the vaccine proposals, had recommended Oxford-Astra Zeneca's 'Covishield' and Bharat Biotech's indigenous 'Covaxin' for emergency use approval on January 1 and 2, respectively. The final call was to be taken by the DCGI.
The expert panel had recommended granting permission for restricted emergency use of 'Covaxin' in "public interest as an abundant precaution, in clinical trial mode, especially in the context of infection by mutant strains.
Pune-based Serum Institute of India has partnered with Oxford-AstraZeneca for conducting clinical trials and manufacturing 'Covishield', while Bharat Biotech has collaborated with the Indian Council of Medical Research (ICMR) for 'Covaxin'.
Serum and Bharat Biotech Pfizer had applied for the accelerated approval on December 6 and 7, respectively.
The UK and Argentina have already approved the Oxford-AstraZeneca vaccine. More than five crore doses of the vaccine have already been stockpiled by its manufacturer, Serum Institute of India.
Oxford-AstraZeneca vaccine will play a major role in India's plan to vaccinate its population against Covid-19 due to several factors -- low-cost, ease of storage and transport.
Serum Institute of India this week said it has stockpiled 40-50 million doses of its Covid-19 vaccine. India is likely to receive a majority of these 50 million doses.
As far as Bharat Biotech's Covaxin is concerned, it is India's first indigenous vaccine for coronavirus. The inactivated virus vaccine is being developed in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV).