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Accelerated approval for Pfizer, SII vaccines?

Pfizer world headquarters in New York City, USA. Pfizer is one of two COVID vaccine candidate manufacturers to request emergency use authorisation in India. Image credit: Jim.henderson, Public domain, via Wikimedia Commons
Pfizer world headquarters in New York City, USA. Pfizer is one of two COVID vaccine candidate manufacturers to request emergency use authorisation in India. Image credit: Jim.henderson, Public domain, via Wikimedia Commons

Following the requests by both Pfizer and the Serum Institute of India (SII) for emergency use authorisation for their respective COVID-19 vaccine candidates, the Union Government is considering an accelerated approval process.

“We are in the process of reviewing,” said a senior government official quoted by Reuters. “It is an accelerated reviewing process, which is there for Serum too. All applications are accelerated. It is the need of the hour.” 

Pfizer’s vaccine candidate has shown much promise, with an efficacy of approximately 95 percent based on phase-III trial data. The SII, meanwhile, is producing Covishield, the vaccine made by AstraZeneca and the University of Oxford, in India. Reports indicate the SII has already manufactured forty million doses of the vaccine. Both have requested emergency use authorisation from the Drug Controller General of India. 

Prime Minister Narendra Modi has spoken out on the importance of a vaccine. “As per my recent discussion with scientists, I hope there will be no more delay now,” he said. However, the Prime Minister did add “there should be no carelessness in following COVID prevention measures.” Last month, he visited three of the facilities in India involved in producing vaccine candidates, including the SII in Pune, Maharashtra. 

The Union Government has earmarked US$7 billion for vaccination against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the novel coronavirus which causes COVID-19. A group of between 250 and 350 million people are prioritised for receipt of the vaccine. A vaccination drive against the disease will commence as soon as scientists give the go-ahead, Modi said earlier this month. 

“Our scientists are very confident of succeeding in their endeavour of developing a vaccine against COVID-19,” the Prime Minister has said. “There are names of vaccines from different countries doing the rounds in the market, but the world is keeping a watch on having the cheapest and safest vaccine. That is why, it is natural that the world is watching India.”

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