Indian government could approve Oxford-AstraZeneca's coronavirus vaccine by next week
The coronavirus vaccine, developed by the University of Oxford and AstraZeneca, is likely to get approval from the Indian government for emergency use by next week, two people privy to the development told Reuters. Serum Institute of India (SII), which is producing mass doses of the vaccine dubbed Covishield here, submitted the additional information sought by the government, the news agency added. Here's more.
On December 9, the Central Drugs Standard Control Organisation (CDSCO) reviewed the applications and asked for more information from all three companies — SII, Pfizer, and Bharat Biotech. The other two organizations have also sought emergency use authorization. SII has submitted the details. A government official said on Tuesday that they were still waiting for Pfizer's additional data. Bharat Biotech's response is also awaited.
Both sources told Reuters the Indian authorities were speaking with their British counterparts about the vaccine and there were "strong indications" that the vaccine will get approval next week. If India gives the green signal, it could become the first nation to approve Oxford-AstraZeneca's vaccine. This particular vaccine is considered the best option for lower-income countries as it's cheap and can be stored/transported easily.
Earlier this month, final-stage clinical trial data was published in The Lancet. The vaccine was found to be 62% effective when both doses were administered, and the efficacy increased to 90% when half a dose was given. "ChAdOx1 nCoV-19 (the vaccine) has an acceptable safety profile and has been found to be efficacious against symptomatic COVID-19 in this interim analysis of ongoing clinical trials."
Notably, Indian authorities are considering the two full-dose regimen, even if it was found to be less effective. A report in IE also said SII has given data. "Serum Institute of India has submitted additional data. The regulator's office, internally, will review these documents. Only then they will request the Subject Expert Committee (SEC) to meet," sources told the daily.
It should be noted that the approval for the vaccine in India was thought to be dependent on the UK's action. During the December meeting, an expert panel had directed SII to submit the conclusions of the British regulator. But the current request submitted by SII finds its roots in data of the clinical trials conducted in Brazil and the UK.
Meanwhile, authorities in the UK stated they were reviewing the vaccine, while adding that it won't be approved until it meets the standards of safety, quality, and efficacy. "Any vaccine must undergo robust clinical trials in line with international standards, with oversight provided by the Medicines And Healthcare Products Regulatory Agency," a spokesperson said. The Daily Telegraph claimed the approval in UK could come by December 28-29.
