Studies in Additional Populations

Studies in Additional Populations

The Pfizer-BioNTech COVID-19 vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years 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. Please see EUA Fact Sheet at www.cvdvaccine.com.

Pregnant Women

In February 2021, Pfizer and BioNTech dosed the first participant in a global Phase 2/3 study to further evaluate the safety, tolerability, and immunogenicity of the Pfizer-BioNTech COVID-19 vaccine in preventing COVID-19 in healthy pregnant women 18 years of age and older.

What are the objectives of the Phase 2/3 study in pregnant women?

The Phase 2/3 clinical trial will evaluate the safety and immune response in healthy pregnant women 18 years of older between 24-34 weeks of their pregnancy. We plan to enroll approximately 4,000 participants at more than 130 global sites within the U.S. Canada, Brazil, Chile, Mozambique, South Africa, U.K. and Spain. Each woman will participate in the study for approximately 7 to 10 months.

Why is it important to conduct a separate study in pregnant women?

We need to continue to gather the evidence on safety and efficacy to potentially support the use of the vaccine by important subpopulations. In general, pregnant women are considered a vulnerable population given the unique changes that happen to their bodies during pregnancy. The safety of some vaccines during pregnancy, however, is well documented and supported from multiple randomized clinical trials and observational studies that have demonstrated vaccines such as tetanus, Tdap, and Influenza to be safe for use during pregnancy.

 

Children Under 12

In March 2021, Pfizer and BioNTech dosed the first healthy children in a global Phase 1/2/3 continuous study to further evaluate the safety, tolerability, and immunogenicity of the Pfizer-BioNTech COVID-19 vaccine in children 11 years to 6 month old.

What is the design of the study in children 11 years to 6 months?

The Phase 1/2/3 dose-escalation study in healthy children six months old to 11 years will evaluate the safety, tolerability, and immunogenicity of the Pfizer-BioNTech COVID-19 vaccine on a two-dose schedule (approximately 21 days apart) in three age groups:

  • Children ages 5 to 11 years
  • 2 to 5 years
  • And 6 months to 2 years
    • Children younger than 6 months of age may subsequently be evaluated, once an acceptable safety profile has been established.

What are the endpoints of the study?

The primary endpoints of the study are to evaluate the safety and immunogenicity of the Pfizer-BioNTech COVID-19 vaccine in children under 12. Vaccine effectiveness in the study will be inferred through immunobridging to the 16-25-year-old population from the pivotal Phase 3 trial.

How many children are you planning to enroll?

Younger children, who make up a significant portion of the total global population, will play a critical role in our continued fight against COVID-19. The Phase 1/2/3 study will enroll 4,644 children 6 months to 11 years old in the United States and Europe.

  • Children younger than 6 months of age may subsequently be evaluated, once an acceptable safety profile has been established.

Do children need to be vaccinated in order for the world to reach herd immunity against SARS-CoV-2?

Children under the age of 15 account for 26% of the global population. We believe successfully vaccinating children will contribute to protection against COVID-19 if the vaccine proves to be effective in that population.

When can we expect results from this study? When will children be able to receive the vaccine?

We anticipate results from this study will be available in the second half of 2021.

If safety and immunogenicity is confirmed, and pending agreement with and endorsement from regulators, we hope to receive authorization for vaccination of these younger kids by early 2022.