Pfizer, BioNTech Receive US FDA Approval & Authorization for Omicron KP.2-adapted Covid-19 Vaccine

Pfizer, BioNTech Receive US FDA Approval & Authorization for Omicron KP.2-adapted Covid-19 Vaccine

By, Admin 24 August 2024

Overview

Pfizer Inc. and BioNTech SE announced that the US Food and Drug Administration (FDA) has approved the supplemental Biologics License Application for individuals 12 years of age and older (COMIRNATY  (Covid-19 Vaccine, mRNA), and granted emergency use authorization for individuals 6 months through 11 years of age (Pfizer-BioNTech Covid-19 Vaccine) of the companies’ Omicron KP.2-adapted 2024-2025 Formula Covid-19 vaccine. This season’s vaccine is for use as a single dose for most individuals 5 years of age and older. Individuals 5 years of age and older with certain kinds of immunocompromise previously vaccinated with Pfizer and BioNTech Covid-19 vaccines or children under the age of 5 who have not already completed a three-dose series with previous formulas of a Covid-19 vaccine may be eligible to receive additional doses.

About KP.2 Adaptation

  • The KP.2 adaptation is based on guidance from the FDA, which stated that KP.2 is the preferred strain of the JN.1 lineage for Covid-19 vaccines for use in the US during the 2024-2025 fall and winter season, if feasible.  
  • Staying up to date on vaccinations in line with the Centers for Disease Control and Prevention (CDC) recommendations remains important, particularly in light of Covid-19 cases on the rise again.  
  • This season’s Pfizer and BioNTech Covid-19 vaccine will begin shipping immediately and be available in pharmacies, hospitals, and clinics across the US beginning in the coming days.

Behind the Approval

  • The approval is based on the full body of previous clinical, non-clinical, and real-world evidence supporting the safety and effectiveness of the Covid-19 vaccines by Pfizer and BioNTech. 
  • The application also included manufacturing and non-clinical data showing that the KP.2-adapted vaccine generates a substantially improved response against currently circulating Omicron JN.1 sublineages, including KP.2, KP.3 and LB.1, compared with the companies’ Omicron XBB.1.5 adapted Covid-19 vaccine .3

Covid Vaccines by Pfizer and BioNTech

  • The Covid-19 vaccines by Pfizer and BioNTech are based on BioNTech’s proprietary mRNA technology and were developed by both companies. 
  • BioNTech is the Marketing Authorization Holder for COMIRNATY and its adapted vaccines (COMIRNATY (Covid-19 Vaccine, mRNA); COMIRNATY Original/Omicron BA.1; COMIRNATY Original/Omicron BA.4-5; COMIRNATY Omicron XBB.1.5; COMIRNATY JN.1; COMIRNATY KP.2) in the United States, the European Union, the United Kingdom, and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries.

Pfizer-BioNTech Vaccine

Pfizer-BioNTech Covid-19 Vaccine (2024-2025 Formula) is FDA authorized under Emergency Use Authorization (EUA) to prevent coronavirus disease 2019 (Covid-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 6 months through 11 years of age.

Authorization by FDA under EUA

  • Emergency uses of Covid-19 vaccines from BioNTech and Pfizer, including Pfizer-BioNTech Covid-19 Vaccine (2024-2025 Formula), have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (Covid-19) in individuals 6 months of age and older. 
  • Emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical products under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.

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