COVID-19 Vaccine (Pfizer-BioNTech)/it

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Generalità

Il vaccino COVID-19 Pfizer-BioNTech è un vaccino a base di mRNA approvato negli Stati Uniti per prevenire l'infezione sintomatica da COVID-19. Il Pfizer-BioNTech è stato il primo vaccino COVID-19 ad essere approvato per la distribuzione negli Stati Uniti, ed è stato autorizzato per uso di emergenza dalla United States Food and Drug Administration (FDA) l'11 dicembre 2020.

Il regime di dosaggio approvato è un’iniezione intramuscolare somministrata in due dosi, 30 μg ciascuna, a 21 giorni di distanza. Il vaccino è approvato per individui di età pari o superiore a 16 anni.

Il vaccino è destinato a prevenire il malessere da COVID-19, causato dal severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2). Il vaccino Pfizer‑BioNTech mira alla spike glicoproteina (S) del SARS‑CoV‑2.[¹]

Caratteristiche cliniche

Somministrazione

  • Tipo: antigene spike glicoproteina (S) del SARS‑CoV‑2 codificato da RNA e formulato in nanoparticelle lipidiche (LNP).
  • Forme di dosaggio: 2 dosi da 30 μg ciascuna, somministrate a 21 giorni di distanza.
  • Vie di somministrazione: Intramuscolare
  • Nomi commerciali comuni: Pfizer‑BioNTech COVID‑19 Vaccine, Pfizer Vaccine

Dosaggio negli adulti

Il dosaggio negli adulti del vaccino è di 2 dosi da 30 μg ciascuna, somministrate a 21 giorni di distanza.

Dosaggio pediatrico

Il vaccino COVID‑19 Pfizer‑BioNTech è stato approvato solo per individui di età pari o superiore a 16 anni. Tuttavia, il dosaggio negli individui di 16‑17 anni è lo stesso del dosaggio negli adulti.

Special Populations

Pregnancy Rating

Non è chiaro l’effetto del vaccino nelle donne in gravidanza, poiché la gravidanza era un criterio di esclusione dallo studio di fase 3 per questo vaccino.[²]

Lactation risk

Renal Dosing

  • Adult:
  • Pediatric:

Hepatic Dosing

  • Adult:
  • Pediatric:

Controindicazioni

  • Allergia alla classe/farmaco

Reazioni avverse

Serious

Common

Pharmacology

  • Half-life:
  • Metabolism:
  • Excretion:

Mechanism of Action

Comments

Vedi anche

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  • COVID-19 Vaccine (Pfizer-BioNTech)
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External Links

References

1. ↑ FDA Briefing Document, Pfizer-BioNTech COVID-19 Vaccine, <https://www.fda.gov/media/144245/download>, December, 2020. Accessed 21 December 2020 2. ↑ FDA Briefing Document, Pfizer-BioNTech COVID-19 Vaccine, <https://www.fda.gov/media/144245/download>, December, 2020. Accessed 21 December 2020

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