The American Academy of Pediatrics (AAP) is asking federal officials to include children in COVID-19 vaccine trials.1 On September 29, 2020, Sara Goza, MD, president of the AAP, wrote a letter addressed to U.S. Department of Health and Human Services (HHS) Secretary Alex Azar and Food and Drug Administration (FDA) Commissioner Steven Hahn, MD stating, “Children must be included in vaccine trials to best understand any potential unique immune responses and/or unique safety concerns.”2
Currently, none of the COVID-19 vaccines in clinical development are being tested in children under the age of 18 years.3
The letter goes on to state, “It would also be less than desirable to have one or more SARS-CoV-2 vaccines licensed or available under Emergency Use Authorization (EUA) at a time when no data have been collected on the safety, tolerability, dose, and regimen for children.”4
The AAP is also asking federal officials to include individuals in the trials who reflect the racial and ethnic diversity of the U.S. population and include pregnant women and individuals with underlying poor health conditions.5
AAP Blames Mistrust of COVID-19 Vaccines on Anti-Vaccination Movement
In the letter to HHS and the FDA, AAP officials blame the “vocal, well-established and growing anti-vaccination movement” for spreading “fear mistrust and misinformation” about COVID-19 vaccine candidates. The letter states:
Unfortunately, fear, mistrust, and misinformation about a potential SARS-CoV-2 vaccine is being spread from a vocal, well-established, and growing anti-vaccination movement. For a SARS-CoV-2 vaccine to be effective in controlling the pandemic, it must not only be safe and effective, but must also be embraced by medical providers and the public. For this to occur, Americans must have trust and confidence in the processes by which these vaccines are being tested for both safety and efficacy, and in the transparency of the scientific basis for licensure and recommendations for use. If that trust is jeopardized, mistrust of SARS-CoV-2 vaccines could become widespread and result not only in reduced uptake of SARS-CoV-2 vaccines but also in decreased confidence in all vaccines.6
Pfizer Submits Amended Protocol to FDA to Include Children in Clinical Trials
On Sept. 12, 2020, Pfizer, Inc. of New York City, New York and BioNTech SE of Mainz, Germany announced that they had submitted an amended protocol to the FDA to expand the enrollment of their Phase 3 pivotal COVID-19 vaccine trial to include approximately 44,000 participants, which also allows for the enrollment of new types of populations.7
The proposed expansion would allow the companies to increase trial population diversity and include adolescents as young as 16 years of age and people with chronic, stable HIV (human immunodeficiency viruses), Hepatitis C or Hepatitis B infection, as well as provide additional safety and efficacy data.8
1 Kemp K. AAP to feds: Children must be included in SARS-CoV-2 vaccine trials. AAP Publications Oct.1, 2020.
3 Downey K. Time to include children in COVID-19 vaccine trials, experts say. Healio Oct. 4, 2020.
4 See Footnote 1.
7 Pfizer and BioNTech Propose Expansion of Pivotal COVID-19 Vaccine Trial. Pfizer, Inc. Sept. 12, 2020.