At a time when we are all desperately waiting for a vaccine to reduce the spread of the new coronavirus, the American pharmaceutical company confirmed that Pfizer Inc and its German partner BioNTech have formally applied to the US Food and Drug Administration (FDA ) an emergency use authorization. for your Covid-19 vaccine.
This was the first app of its kind in a big step toward protecting against the deadly virus. Pfizer Inc became the first to do so in the US or Europe as the Covid-19 pandemic spreads around the world.
Here’s your 10-point cheat sheet for this story:
1) Pfizer’s application to the U.S. Food and Drug Administration (FDA) for emergency use authorization of its Covid-19 vaccine comes just days after global drug manufacturers reported the results end of trials showing that the vaccine was 95% effective in preventing coronavirus without greater safety. concerns.
2) Confirming the request, Pfizer CEO Albert Bourla said in a video statement: “It is with great pride and joy, and even some relief, that I can say that our emergency use authorization request for our COVID-19 vaccine is now in the hands of the FDA. “
- “This is a historic day; a historic day for science and for all of us,” added the Pfizer CEO.
- Albert Bourla further said: “It took just 248 days from the day we announced our plans to collaborate with BioNTech until our submission date to the FDA.”
3) The app also includes safety data for around 100 children between the ages of 12 and 15. The firm said 45% of trial participants in the United States are between 56 and 85 years old.
4) The US FDA has said that it would hold an advisory committee meeting on December 10 where members would discuss the Covid-19 vaccine, which has developed with impressive speed, just 10 months after the genetic code of the novel. The coronavirus was sequenced for the first time.
5) “The FDA recognizes that transparency and dialogue are critical to public confidence in COVID-19 vaccines,” the organization’s director, 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 Secretary of Health Alex Azar have said the FDA could authorize the vaccine in the first two weeks from December.
7) According to the President of the European Commission, Ursula von der Leyen, the European Union (EU) could also advance rapidly on the Pfizer / BioNTech vaccine, perhaps in the second half of December.
8) In a previous statement, CEO Bourla had said, “The US unveiling 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 the efficacy profile. and safety of our vaccine, which gives us confidence in its potential. “
9) Injections of the BioNTech-Pfizer vaccine and another being developed by the US-based pharmaceutical company Moderna, have taken the lead in the global search for a Covid-19 vaccine.
10) However, there are important differences between vaccines.
- Pfizer’s should be stored at -70 degrees Celsius (-94 degrees Fahrenheit), while Moderna only needs -20 degrees Celsius (-4 Fahrenheit), more like a normal freezer.
- While the Pfizer-BioNTech doses are much smaller, 30 micrograms versus Moderna-NIH’s 100 micrograms, they probably reduce production costs per dose.
BioNTech-Pfizer vaccines have raised hopes of ending the new coronavirus pandemic that has infected 57,909,991 people and caused 1,377,745 deaths worldwide since the outbreak began.
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