Authorized use of Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)


Pfizer-BioNTech COVID-19 Vaccine, Bivalent has not been approved or licensed by FDA, but has been authorized for emergency use by FDA, under an EUA to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals aged 6 months of age and older. The emergency use of this product is 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 most recent Fact Sheets, please visit www.cvdvaccine-us.com

Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5): Authorization and Recommendation Updates

Elizabeth Thoburn, MPH
Medical Director,
Pfizer mRNA Vaccines,
Medical & Scientific Affairs, USA

Date and Time:

26 April 2023

12:00 pm – 1:00 pm EST

27 April 2023

4:00 pm – 5:00 pm EST

Select COVID-19 Vaccine Updates from February ACIP Meeting

Rajeev M Nepal, PhD
Medical Director,
Pfizer mRNA Vaccines,
Medical & Scientific Affairs, USA

Date and Time:

22 March 2023

12:00 pm – 1:00 pm EST

23 March 2023

4:00 pm – 5:00 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

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

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

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

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

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