In a major development in the fight against novel coronavirus, the Subject Expert Committee of the Central Drug Standard Control Organisation on Friday recommended emergency use of Oxford-AstraZeneca’s vaccine candidate, ‘Covishield’. Now, it awaits the approval from Drug Controller General of India for the emergency use authorisation.
AstraZeneca and Oxford’s covid-19 vaccine candidate is developed by Pune based Serum Institute in India. World’s largest drug maker by volume, the Serum Institute had sought the regulatory approval earlier this month.
The piece of good news comes after the key meet of the 10-member Subject Expert Committee (SEC) of the Drug Regulator for the approval of coronavirus vaccine in India on Friday.
The (SEC) had earlier reviewed SII’s application seeking emergency use authorisation (EUA) for the shots on Wednesday and met again on Friday to clear it for the same.
“In terms of safety, Covishield was well tolerated with respect to solicited adverse events. The majority of solicited reactions were mild in severity and resolved without any sequelae. Therefore, Covishield is safe 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,” the EUA application signed by Prakash Kumar Singh, Additional Director, Government and Regulatory Affairs at Serum Institute of India (SII), as quoted by PTI stated.
As per the data provided by AstraZeneca on November 23, the he primary efficacy endpoint based on a pooled analysis showed that the vaccine was 70.4 per cent effective against the virus after following two dose regimen, The analysis also noted that the vaccine showed no adverse events in any of the participants.
Prime Minister Narendra Modi had visited the Pune-based company on November 28 to review vaccine development.
Meanwhile, recently, SII CEO Adar Poonwalla while briefing the media said that Covishield will be rolled out in the market very soon, adding that they have up to 40 to 50 million doses of the vaccine which are ready to be administered.