2 min read.Updated: 21 Nov 2020, 11:16 AM IST Edited By Meghna Sen
In a major step toward providing protection against the deadly virus, Pfizer became the first to do so in the US or Europe as the Covid-19 pandemic rages around the world
Pfizer's application to the FDA comes days after the global drugmakers reported final trial results that showed the vaccine was 95% effective in preventing Covid
At a time when we all are desperately waiting for a vaccine to curtail the spread of the novel coronavirus, the American pharmaceutical company confirmed that Pfizer Inc and its German partner BioNTech have formally asked the US Food and Drug Administration (FDA) for emergency use authorisation for their Covid-19 vaccine.
This was the first such application in a major step toward providing protection against the deadly virus. Pfizer Inc became the first to do so in the US or Europe as the Covid-19 pandemic rages around the world.
1) Pfizer's application to the US Food and Drug Administration (FDA) for emergency use authorisation of its Covid-19 vaccine comes just days after the global drugmakers reported final trial results that showed the vaccine was 95% effective in preventing coronavirus with no major safety concerns.
2) Confirming the application, Pfizer Chief Executive Officer Albert Bourla 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."
"This is a historic day; a historic day for science and for all of us," the Pfizer CEO added.
Albert Bourla further said, "It took just 248 days to get from the day we announced our plans to collaborate with BioNTech to our FDA submission date."
3) 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.
4) The US FDA has said that it would hold a meeting of the advisory committee on 10 December at which 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.
5) "The FDA recognizes that transparency and dialogue are critical for the public to have confidence in COVID-19 vaccines," the organization's head Stephen Hahn said in a statement.
6) The agency declined to predict how long it will 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.
7) As per the 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.
8) In an earlier statement, CEO Bourla had said, "Filing in the US represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential."
9) The BioNTech-Pfizer vaccine shots and another one being developed by the US-based drugmaker Moderna have taken the lead in the global chase for a Covid-19 vaccine.
10) However, there are important differences between the vaccines.
Pfizer's needs to be stored at -70 degrees Celsius (- 94 degrees Fahrenheit) while Moderna's only needs -20 degrees Celsius (-4 Fahrenheit), more akin to a regular freezer.
While the Pfizer-BioNTech doses are much smaller -- 30 micrograms to Moderna-NIH's 100 micrograms -- probably lowering production costs per dose.
The BioNTech-Pfizer vaccines have lifted hopes for an end to the novel coronavirus pandemic that has infected 57,909,991 people and caused 1,377,745 deaths worldwide since the outbreak started.
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