Highlight
- Panel of government experts to review submissions from drug manufacturers
- Final approval with the drug regulator after expert recommendation
- Tomorrow second mock vaccination campaign
New Delhi:
Applications for emergency use approval for coronavirus vaccines submitted by the Serum Institute of India, Bharat Biotech, and Pfizer will be considered once again by a government-appointed panel of experts today.
Serum Institute, which is manufacturing the ‘Covishield’ vaccine developed by Oxford University and major pharmaceutical companies AstraZeneca and Bharat Biotech, which has partnered with the Indian Council for Medical Research (ICMR) for its ‘Covaxin’, made presentations to the panel on Wednesday. Pfizer had sought more time to present its data.
Once the vaccines are approved by the expert panel, the applications will be forwarded to the Comptroller General of Medicines of India (DCGI) for final approval. The government wants to start administering the vaccines starting this month.
Today’s meeting comes the day before an all-state immunization test. At an event Thursday, the Comptroller General of Drugs, Dr. VG Somani, said: “We will probably have a happy New Year with something in hand. That is what I can hint at.”
India, which has the second highest number of COVID-19 infections in the world after the United States, plans to inoculate 30 million people in the next six to eight months and the affordable Oxford vaccine is its best hope.
Although the Indian government has yet to sign a purchase agreement with the Serum Institute, the company says it will focus on its local market first and then export, mainly to countries in South Asia and Africa.
The world’s largest vaccine maker has already produced about 50 million doses of the Oxford-AstraZeneca injection and plans to increase it to 100 million by March next year, Poonawalla said Monday.
Earlier this week, the UK approved the University of Oxford’s AstraZeneca vaccine for human use, the second coronavirus vaccine licensed for deployment in Britain after the Pfizer-BioNTech attacks.
Like the Pfizer-BioNTech jabs, Covishield is similar in requiring two doses, but is easier to administer as it does not require extremely low temperatures for storage. It is also cheap and easy to mass produce.
In an ongoing early-phase trial, Bharat Biotech’s vaccine candidate, Covaxin, was shown to be safe and elicited immune responses and is currently part of a late-phase trial.
(With inputs from agencies)
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