Serum Institute of India demands for full market authorisation of Covisheld
On Friday, the CEO of Serum Institute of India Adar Poonawala confirmed that they have applied to the Indian authorities to get full market authorisation for Covershield as the vaccine rate has already exceeded 125 crore doses till now.
To produce the vaccines, SII partnered with the developer of the vaccines–AstraZeneca–and for the supply purposes, it tied up with the Indian government. The centre had given its nod to the vaccine’s emergence in January this year and hence the initiation of the vaccination drive in the country.
He said in his tweet, “Supplies of the COVISHIELD vaccine in India, have exceeded 1.25 billion doses. The government of India now has enough data for full market authorization,” as he tagged @SerumInstIndia @CDSCO_INDIA_INF (DCGI) and @MoHFW_INDIA for this permission.
In India, two vaccines– Covishield and Covaxin– were the first ones to get approval by the Drugs Controller General of India (DCGI) in January this year for emergency usage. Covaxin has been locally produced by Bharat Biotech, a Hyderabad-based company.
As of now, in the United States, Pfizer-BioNTech’s COVID-19 vaccine has been granted full USFDA approval on an individual who is 16 years of age and older making it the first vaccine to be removed from just emergence usage to full authorization. To back its argument, the firm submitted the conclusions of the phase-3 clinical study which was doen of 24,244 subjects from the UK, Brazil, and South Africa on June 8, 2021. Now CDSCO will go through the result and take a call on full market authorisation of Covershield in the country.