All the risks taken by Serum Institute have finally paid off, tweeted Adar Poonawalla, the chief executive of the Pune-based vaccine manufacturer, shortly after the country’s drug regulator cleared its Covishield vaccine for emergency approval in India. Mr Poonawalla reiterated that the “Covishield” vaccine — developed by Serum Institute of India in partnership with the Oxford University and pharma major AstraZeneca – is “safe and effective” against coronavirus and added that the vaccine “is ready to roll out in the coming weeks”.
Mr Poonawalla, CEO of the Serum Institute, said to be the world’s largest vaccine maker, had earlier said the “majority of the first 50 million doses will go to India”.
Happy new year, everyone! All the risks @SerumInstIndia took with stockpiling the vaccine, have finally paid off. COVISHIELD, India’s first COVID-19 vaccine is approved, safe, effective and ready to roll-out in the coming weeks. pic.twitter.com/TcKh4bZIKK
– Adar Poonawalla (@adarpoonawalla) January 3, 2021
Apart from Covishield, Bharat Biotech’s Covaxin has been granted permission for “restricted use”. Restricted use approval is normally only granted if there is sufficient evidence to suggest the drug is both safe and effective.
The Drug Controller General of India Dr VG Somani said both firms submitted data on their trial runs and both have been granted permission for “restricted use”. “We’ll never approve anything if there is slightest of safety concern. The vaccines are 100 per cent safe,” Dr Somani said.
Serum Institute of India’s Covishield was the first vaccinde to be recommended for “restricted use” by the the government-appointed panel on Friday. Covaxin, the coronavirus vaccine from Hyderabad-based Bharat Biotech, was recommended a day later, on Saturday.
A third vaccine – developed by American pharma giant Pfizer – had also applied for emergency fuse authorisation and is currently being reviewed by the panel. Sources, however, have said that the company has yet to present its data before the panel.
The Pfizer vaccine has already been rolled out in the UK, the US and some other countries.
The government on Saturday conducted a day-long trial run of the vaccine delivery system to check for potential problems once a vaccine is made available. The Health Ministry said dry runs were held in 116 districts, with nearly one lakh personnel undergoing necessary training.