Serum Institute of India applies for emergency use approval of Covishield, becomes first Indian firm to do so
Serum Institute of India: On Sunday, Serum Institute of India became the first indigenous pharma firm to apply for emergency use of Covishield, the Covid-19 vaccine. SII applied to DCGI (Drugs Controller General of India), India’s drug regulator, seeking authorization for Oxford vaccine’s emergency use in India. This comes a day after DCGI approved emergency use of Pfizer’s Covid-19 vaccine, after it has already been approved by the UK and Bahrain.
Pune based Serum Institute is currently conducting phase 3 clinical trials of the Oxford-AstraZeneca vaccine, in collaboration with ICMR (Indian Council of Medical Research). The trials for Oxford vaccine are being carried out pan India at multiple centres, as is being done also the UK and Brazil.
Serum Institute, as conveyed by ICMR, has already completed manufacturing of 40 million vaccine doses. This was done after the institute had obtained at-risk manufacturing and stockpiling license from the DCGI.
In its authorization application to DCGI, SII has mentioned the high efficacy of Covishield against symptomatic and severe cases of Covid-19 is well established from data obtained through four independent clinical studies beign conducted – 2 in UK, 1 in Brazil and 1 in India. The sources from SII also said that the results are in accordance with other vaccines against Covid-19. It is expected that Covishield is going to be successful in reducing the mortality rates as well as morbidity rates.
Quoting the application, “In terms of safety, Covishield was well tolerated with respect to solicited adverse events and was not associated with an increased number of SAEs and deaths. A majority of solicited reactions were mild in severity and resolved without any sequelae. Therefore, Covishield is safe and well-tolerated and can be used effectively for prevention of COVID-19 in the targeted population. Thus, the benefit to risk ratio strongly supports the widespread use of Covishield.”
In contrast to other Covid-19 vaccines like Pfizer and Moderna that require extremely low temperatures for storage, Oxford vaccine is apt for Indian conditions for storage and distribution as it requires normal temperature of 2-8 C.