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Pharmacovigilance is vital as more vaccines become available and new side-effects seen
As India grapples with a vaccine shortage, the Drug Controller General of India has formally approved another vaccine candidate Sputnik V under emergency use authorisation. Since January, India’s vaccination strategy has hinged almost entirely on Covishield the AstraZeneca vaccine and to a very limited extent, Covaxin. Another significant move by the government is in allowing foreign-made vaccines approved by regulatory agencies in the U.S., the U.K., Europe, Japan or those that find mention in the World Health Organization’s list of approved emergency use vaccines which can avoid conducting a local clinical trial but opt for a parallel bridging trial post-approval. Last year, Pfizer had approached Indian regulators for permission but a sticking point was over this question of the conduct of local trials. It is important to note that bridging trials are critical. A vaccine that ....

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