Serum Institute Seeks Drug Regulator's Approval Of Covovax As Covid Booster Dose: Report
The DCGI's office had raised a few queries, following which SII submitted a reply, flagging the current emerging situation caused by a new coronavirus variant.
New Delhi: The Serum Institute of India (SII) sought the Drugs Controller General of India (DCGI) approval for market authorisation of its Covid-19 vaccine Covovax, as a booster dose for those aged 18 years and above, who have taken two doses of Covishield or Covaxin, news agency PTI reported.
According to the report, Prakash Kumar Singh, director of government and regulatory affairs, SII, submitted an application for market authorisation of its heterologous booster dose of Covovax to DCGI on October 17.
Notably, the DCGI's office had raised a few queries, following which Singh submitted a reply, flagging the current emerging situation caused by a new coronavirus variant.
It is to be noted that Covovax was approved by the DCGI for a restricted emergency use in children aged seven to 11 years earlier in June.
The DCGI had also approved the vaccine for a restricted use in emergency situations in adults on December 28, last year and for those in the 12-17 age group, subject to certain conditions, on March 9.
Notably, Covovax, approved by European Medicines Agency for conditional marketing authorization, is manufactured through technology transfer from Novavax.
The vaccine was granted emergency-use listing by the World Health Organization (WHO) on December 2017, 2020.
In August 2020, US-based vaccine maker Novavax Inc. had announced a licence agreement with the SII for the development and commercialisation of NVX-CoV2373, its Covid-19 vaccine candidate, in India and low-and-middle-income countries.
Meanwhile, amid a surge in cases globally, Union Health Minister Mansukh Mandaviya on Thursday said in Lok Sabha that the states have been asked to ensure that people wear masks, maintain social distancing and use sanitisers in the wake of the festive and new year season.
“In the wake of festive & new year season, states are advised to make sure people wear masks, use sanitisers and maintain social distancing along with increasing awareness for precautionary doses,” Mandaviya said in Lok Sabha.
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