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FDA: Authorization Pfizer-BioNTech COVID-19 Vaccine

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Temi: Coronavirus

Authorization Pfizer BioNTech COVID 19 Vaccine

FDA Authorization Pfizer-BioNTech COVID-19 Vaccine

FDA, 11 Dec 2020

Download - FDA Pfizer BioNTech COVID-19 Vaccine Letter of Authorization

On December 11, 2020, the U.S. Food and Drug Administration issued the first emergency use authorization (EUA) for a vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. The emergency use authorization allows the Pfizer-BioNTech COVID-19 Vaccine to be distributed in the U.S.

Emergency Use Authorization Status: Authorized
Name: Pfizer-BioNTech COVID-19 Vaccine
Manufacturer: Pfizer Inc.

Authorized Use

For the prevention of 2019 coronavirus disease (COVID-19) for individuals 16 years of age and older

Common Side Effects

The most commonly reported side effects, which typically lasted several days, were pain at the injection site, tiredness, headache, muscle pain, chills, joint pain, and fever. Of note, more people experienced these side effects after the second dose than after the first dose, so it is important for vaccination providers and recipients to expect that there may be some side effects after either dose, but even more so after the second dose. Learn more.
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Cumulative Incidence Curvers for the Firt COVID-19 Occorrence After Dose 1 (FDA Briefing Document)

Vaccine Pfizer
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Lettura del grafico (FDA Briefing Document)

Il grafico ha 2 curve, la prima azzurra rappresenta il numero di persone che hanno ricevuto una dose di vaccino al giorno 0 fino al 112 e l’altra rossa rappresenta il numero di persone che hanno ricevuto un vaccino placebo (nello stesso periodo).

Dal grafico si evince, che, fino a 14 giorni, le curve sono quasi sovrapponibili: 21 casi tra i vaccinati e 25 casi tra quelli non vaccinati. Da questo punto il sistema immunitario dei vaccinati comincia a produrre anticorpi contro COVID-19. Le curve dei due gruppi (nessuno dei partecipanti sa a quale gruppo appartiene) divergono notevolmente.

Tra i vaccinati, dal giorno 14 fino al 112 (arco temporale di 3 mesi e 22 gg), si ammalano solo altre 29 persone; tra i non vaccinati se ne ammalano altri 250 nello stesso arco temporale di somministrazione. E' stata somministrata una sola dose.

FDA

Collegati

Scarica questo file (Vaccine Pfizer 2020.png)Vaccine Pfizer 2020FDAEN112 kB(471 Downloads)
Scarica questo file (Meeting-Briefing-Document-FDA.pdf)Meeting-Briefing-Document-FDAFDA Oct 2020EN1158 kB(203 Downloads)
Scarica questo file (Pfizer BioNTech COVID-19 Vaccine Letter of Authorization.pdf)Pfizer BioNTech COVID-19 Vaccine Letter of AuthorizationFDA 11 Dec 2020EN420 kB(503 Downloads)
Scarica questo file (Pfizer-BioNTech COVID-19 Vaccine EUA Fact Sheet for Recipients.pdf)Pfizer-BioNTech COVID-19 Vaccine EUA Fact Sheet for RecipientsFDA 11 Dec 2020EN196 kB(202 Downloads)

Tags: Coronavirus