Serum Institute, Bharat Biotech Vaccines Not Cleared Yet, More Data Sought
New Delhi: Serum Institute of India (SII) and Bharat Biotech have not been granted emergency use authorisation of their coronavirus vaccine because of inadequate safety and efficacy data.
According to sources, a panel of experts have asked them to provide more data.
“Both proposals are not approved due to inadequate safety and efficacy data available currently. Both have been asked for more data,” NDTV quoted sources as saying.
Bharat Biotech sought permission from Drugs Controller General of India (DCGI) on Monday for emergency use authorisation of its COVID-19 vaccine Covaxin, which is being indigenously developed by the Hyderabad pharmaceutical firm in collaboration with Indian Council of Medical Research (ICMR). Pune-based SII, on the other hand, applied for emergency use authorisation of Oxford-AstraZeneca’s coronavirus vaccine.
The Subject Expert Committee of the Central Drugs Standard Control Organisation (CDSCO) met today to review the applications of Pfizer, Serum Institute of India and Bharat Biotech. Approvals are a long process and this is only the start, sources said.
The committee can only recommend, but the decision to approve vaccines is with the Drugs Controller General of India (DCGI), the health ministry said.
“It is standard practice for the government to hold several meetings. The process is expected to go on for one or two weeks,” sources in Serum Institute said on the development.