What Can You Tell Me About Potential COVID-19 Vaccines in Children? Hear About Some of Pfizer’s Research

Since early summer 2021, cases of COVID-19 in children have been rising in the U.S., and as the Delta variant has become the dominant strain, cases continue to grow each day. Pfizer has been working to determine and evaluate the preferred vaccine dose to provide protection against COVID-19 in children.

Bill Gruber, MD, Senior Vice President of Clinical Research and Development at Pfizer, is Board Certified in Pediatrics and Pediatric Infectious Diseases and has more than 35 years of experience in vaccine development. He has a passion for the welfare of children and prevention of infectious diseases, and here he shares an inside look at the recent late-stage pediatric study.

A: Our late-stage Phase 2/3 study for kids 5-11 years old showed the Pfizer-BioNTech COVID-19 vaccine generated a strong immune response that compares well to what we saw in people between the ages of 16 to 25 years old in our Phase 3 landmark study. The data from the Phase 2/3 study also showed that our vaccine was well tolerated in kids 5-11 years old, with side effects generally similar to or lower than what we saw in the 16 to 25 year old group.

While the immune responses we saw in the study in the 5-11 year old group predicts that the vaccine is likely to provide protection, we have not had enough cases to determine efficacy. 

A: From the beginning of the pandemic we have strived to determine a vaccine dose that provides protection against COVID-19 in adults and children. In this study we intended to find a dose level that was well tolerated and still produced a high immune response in kids 5-11 years old. We believe that a dose level of 10 ug, one third of the dose used in people 12 and older, did just that.

A: We have not seen any cases of myocarditis or pericarditis in our clinical trials. However, we are aware of the rare reports of myocarditis, especially in young males, following vaccination. According to health authorities this is an extremely rare side effect, and it is important to note that health authorities continues to strongly encourage COVID-19 vaccinations for those eligible. We’ll also continue to monitor this through pharmacovigilance.

A: We have already begun sharing data with the U.S. Food and Drug Administration (FDA) and we plan to submit to request Emergency Use Authorization in kids 5-11 years old as soon as possible.

A: We expect to potentially have some data for kids 2-4 years old in the fourth quarter of this year and kids between 6 months and 2 years old sometime after that. Provided that the data demonstrate safety and immunogenicity, and in agreement with regulators, we could potentially submit the data to request EUA shortly after the data readouts.

A: Rolling out vaccine doses to this age group is not expected to impact the supply agreements that Pfizer and BioNTech have in place with governments and non-government organizations (NGOs) around the world. From day one, our goal has been to provide fair and equitable access to the vaccine to everyone, everywhere.