In a huge fillip to the ‘Atmanirbhar Bharat’ and ‘Make in India’ campaigns, India’s scientific and medical community has gone beyond their line of duty and come up with the first indigenously developed vaccine for Covid-19. Hyderabad based Bharat Biotech’s vaccine, Covaxin has been given “restricted emergency use” approval by the Drug Controller General of India (DCGI). Serum Institute of India, Pune’s Oxford-AstraZeneca developed Covishield has also been granted ‘emergency use’ approval by the DCGI. Both the vaccines are safe, efficient, pocket friendly and suitable for India’s weather conditions. The Serum and Bharat Biotech vaccines have to be administered in two doses. All the three vaccines have to be stored between 2-8° C. The vaccination schedule is expected to be announced soon.
Prime Minister Narendra Modi has called the DCGI approval of Serum Institute of India and Bharat Biotech vaccines, a decisive turning point to strengthen a spirited fight against Corona.
In a series of tweets, the Prime Minister said, “A decisive turning point to strengthen a spirited fight! DCGI granting approval to vaccines of @SerumInstIndia and @BharatBiotech accelerates the road to a healthier and COVID-free nation. Congratulations India. Congratulations to our hardworking scientists and innovators.”
The Subject Expert Committee of Central Drugs Standard Control Organisation (CDSCO) met last week and made recommendations in respect of 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.
Serum Institute of India, Pune 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, Serum Institute was granted permission to conduct Phase-II/III clinical trial 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 Subject Expert Committee has recommended for the grant of permission for restricted use in emergency situation subject to certain regulatory conditions. The clinical trial ongoing within the country by the firm will continue.
Bharat Biotech has developed a Whole Virion Inactivated Corona Virus Vaccine (Covaxin) in collaboration with Indian Council of Medical Research and National Institute of Virology 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.
Bharat Biotech 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 approximately 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 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.
India’s Cadila Healthcare Ltd., too has developed a Novel Corona Virus-2019-nCov-Vaccine using DNA platform technology. Cadila 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 intra-dermally. Accordingly, firm has sought permission to conduct Phase-III clinical trial in 26000 Indian participants, which has been recommended by the Subject Expert Committee.
The Coronavirus pandemic threw up many challenges and opportunities. India seized the opportunity under the able leadership of Prime Minister Narendra Modi. Today has been able to successfully flatten the curve.
Script: Kaushik Roy; AIR: News Analyst