Following Pfizer, Serum Institute applies for emergency approval of its COVID vaccine in India!
Galatta | Dec 07, 2020, 02:30 pm
After months of being defenseless against the rampaging COVID-19 Novel Corona Virus Pandemic, our scientists and researchers had been struggling hard and racing against time to find a potential vaccine to eradicate it. Now, within a span of days, a number of vaccine candidates, which had all been in the crucial end-stage testing, have provided amazing results and proven very high efficacy against the deadly Virus! Recently, foreign pharma giants Pfizer and Moderna had announced that their vaccine candidates had returned high efficacy and Pfizer had also obtained Emergency Use Authorisation for their vaccine candidate in UK & Bahrain and had recently applied for the same in India!
Now, following Pfizer India applying for Emergency Use Authorisation (EUA) for their vaccine, Pune's Serum Institute of India (SII) has also applied for the EUA from the Drug Controller General of India (DCGI), for their COVID-19 vaccine candidate, which is being jointly developed by AstraZeneca and the Oxford University! This vaccine, which is being called Covishield, is currently undergoing four clinical studies, two of them happening in the UK and one each in India and Brazil. The Indian clinical studies are being conducted by the SII, in Pune. SII's application for EUA makes Covishield the first vaccine being tested in India, to apply for it.
Sources in the know state that the data from the four clinical studies of Covishield or the Oxford Vaccine as it is more popularly known, have shown the vaccine to be very efficacious against symptomatic and also very severe COVID-19 infections. SII feels that the Covishield test results are in line with other vaccine results and that it is safe and well-tolerated and can be effectively used to prevent any further spread of COVID-19. A statement in the application reveals that the benefit to risk ratio of Covishield strongly supports the widespread use of the vaccine. We also hear that the DGCI has placed the EUA application of Pfizer in front of a panel of experts, to examine the data of its clinical trials held abroad. Meanwhile, the procedures for getting the regulatory approvals in place for Covishield and the Covaxin, being developed jointly by ICMR and Bharat Biotech, are being put in place.