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Coronavirus vaccine update: Pfizer applies for emergency approval, 10 things to know

Pfizer's CEO Albert Bourla confirmed the company's application and said in a video statement,  'It is with great pride and joy - and even a little relief - that I can say that our request for emergency use authorization for our COVID-19 vaccine is now in the FDA's hands.'

twitter-logoBusinessToday.In | November 21, 2020 | Updated 15:16 IST
Coronavirus vaccine update: Pfizer applies for emergency approval, 10 things to know
Pfizer Inc and BioNTech have confirmed that they have formally asked US FDA for emergency use authorisation of their COVID-19 vaccine

Pfizer Inc and its German partner BioNTech have confirmed that they have formally asked the American Food and Drug Administration (FDA) for emergency use authorisation of their COVID-19 vaccine. Pfizer became the first company to do so in the US or Europe as the coronavirus continues to wreak havoc across the world.

Here are 10 facts about the Pfizer vaccine:-

The announcement by the American pharmaceutical company for the application to the US FDA for emergency use comes just after Pfizer reported final trial results which showed that their vaccine has an efficacy rate of 95 per cent.

The US agency declined to predict how long it would take to study the vaccine data, although both Pfizer Inc and US Health Secretary Alex Azar have said the FDA could authorise the vaccine in the first two weeks of December.

 As per European Commission president Ursula von der Leyen, the European Union (EU) could also move quickly on the Pfizer/BioNTech vaccine, perhaps as soon as the second half of December.

Pfizer's CEO Albert Bourla confirmed the company's application and said in a video statement,  "It is with great pride and joy - and even a little relief - that I can say that our request for emergency use authorization for our COVID-19 vaccine is now in the FDA's hands."

Also Read: Sleepy drug regulators mute witness to Covid vaccine one-upmanship; leave investors, patients at grave risk

The application also includes safety data on around 100 kids in 12 to 15 years of age. The firm said 45% of US trial participants are 56-85 years old.

The US FDA has said that it would hold a meeting of the advisory committee on December 10 where members would discuss the COVID-19 vaccine, which has been developed with breathtaking speed -- just 10 months after the genetic code of the novel coronavirus was first sequenced.

Pfizer earlier said during its initial analysis that the vaccine had shown 90 per cent efficacy but the final assessment involving 170 confirmed cases of COVID-19 showed 95 per cent efficacy.

Pfizer, which is testing its experimental vaccine based on messenger RNA, or mRNA, was the first to announce preliminary results from its Phase 3 trial.

Pfizer's vaccine shots, once they reach the vaccination centers, must be thawed from -70 degree celsius and injected within five days, if not then they go bad. Hence its distribution will be a challenge for India or poor countries with a scarcity of resources.

 Pfizer's announcement was followed by Moderna that its vaccine, also an mRNA vaccine, had been shown to be highly protective with an efficacy rate of 94.5 per cent. Pfizer's CEO Bourla said he was relieved to see that another vaccine was also successful and hoped there were many more, because the global need for Covid

Also Read : Coronavirus updates: 46,232 new COVID-19 cases in India; death toll mounts to 1.32 lakh

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