Indication and Authorized Use of Pfizer & BioNTech's COVID-19 vaccines.
Emergency uses of the vaccines have not been approved or licensed by the US Food and Drug Administration (FDA) but have been authorized by the FDA under an Emergency Use Authorization (EUA) to prevent COVID-19 in individuals aged 6 months and older for the Pfizer-BioNTech COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent. The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.
For more information, please see the full Prescribing Information and EUA Fact Sheets for Vaccination Providers available at cvdvaccine-us.com.
Medical Update on Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)
Rajeev M Nepal, PhD
Medical Director,
Pfizer mRNA Vaccines,
Medical & Scientific Affairs, USA
Date and Time:
14 November 2022
12:00 pm – 1:00 pm EST
15 November 2022
5:00 pm – 6:00 pm EST
16 November 2022
3:00 pm – 4:00 pm EST
COVID-19 and COVID-19 mRNA Vaccine-Related Myocarditis
Santiago Lopez, MD
Medical Director,
Pfizer mRNA Vaccines,
Medical & Scientific Affairs, USA
Date and Time:
29 November 2022
12:00 pm –1:00 pm EST
01 December 2022
4:00 pm –5:00 pm EST
Neutralization of Omicron Sublineages with the Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)
Rajeev M Nepal, PhD
Medical Director,
Pfizer mRNA Vaccines,
Medical & Scientific Affairs, USA
Date and Time:
13 December 2022
12:00 pm – 1:00 pm EST
14 December 2022
5:00 pm – 6:00 pm EST
15 December 2022
3:00 pm – 4:00 pm EST
Effectiveness of COVID-19 mRNA Vaccines, Bivalent (Original and Omicron BA.4/BA.5) Against Omicron Sublineages
Rajeev M Nepal, PhD
Medical Director,
Pfizer mRNA Vaccines,
Medical & Scientific Affairs, USA
Date and Time:
11 January 2023
12:00 pm – 1:00 pm EST
12 January 2023
5:00 pm – 6:00 pm EST
17 January 2023
3:00 pm – 4:00 pm EST
Select Bivalent COVID-19 Vaccine Information Presented at Recent FDA Advisory Committee Meeting
Rajeev M Nepal, PhD
Medical Director,
Pfizer mRNA Vaccines,
Medical & Scientific Affairs, USA
Date and Time:
13 February 2023
12:00 pm – 1:00 pm EST
14 February 2023
5:00 pm – 6:00 pm EST
15 February 2023
3:00 pm – 4:00 pm EST
COVID-19 Vaccination: Considerations for Pediatric Patients
Maria D. McColgan, MD, MSEd
Medical Director,
Pfizer mRNA Vaccines,
Medical & Scientific Affairs, USA
Date and Time:
27 February 2023
12:00 PM – 1:00 PM EST
28 February 2023
5:00 PM – 6:00 PM EST
01 March 2023
3:00 PM – 4:00 PM EST
