On Oct. 14, 2020, Pfizer, Inc. of New York City, New York announced it had received approval by the U.S. Food and Drug Administration (FDA) to enroll children in the Phase 3 human clinical trial on its experimental messenger RNA (ribonucleic acid) BNT162b1 vaccine for COVID-19. The trial, which last month was expanded to include adolescent children as young as 16 years old with chronic health conditions such as HIV, hepatitis C and hepatitis B among its 44,000 participants, will now also include children as young as 12 years of age.1 2 3 4
“I think this is a really big deal. Without clinical trials actually done in children, the only way to actually extend the use of the COVID-19 vaccine into children would be to rely on the adult data,” said L.J. Tan, PhD, chief strategy officer for the Immunization Action Coalition of Saint Paul, Minnesota. “I would hope that the other vaccine manufacturers with COVID-19 vaccines, would follow Pfizer’s example and go down to [age] 12.”1 5
According to the FDA, “The epidemiology and pathogenesis of COVID-19, and the safety and effectiveness of COVID-19 vaccines, may be different in children compared with adults.” 6
Pfizer and BioNTech Will Be First to Test COVID-19 Vaccine on Children in U.S.
The move by Pfizer and its partner on the BNT162b1 vaccine, BioNTech SE of Germany, comes on the heels of a letter written by Sara Goza, MD, president of the American Academy of Pediatrics (AAP) to U.S. Department of Health and Human Services (HHS) Secretary Alex Azar and FDA Commissioner Steven Hahn, MD asking them to include children in COVID-19 vaccine trials. Dr. Goza’s letter, dated Sept. 29, 2020, stated:
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.7 8
Pfizer will reportedly be the first company to test its COVID-19 vaccine on children. A team at the Vaccine Research Center at Cincinnati Children’s Hospital was scheduled to begin testing the BNT162b1 vaccine on children 16-17 years old last week and is expected to soon begin enrolling children 12-15 years of age.9
AstraZeneca/University Oxford Will Experiment on Children 5-12 Years of Age
AstraZeneca plc and the University of Oxford in the United Kingdom are currently conducting a Phrase 3 clinical trial in the U.K. on its experimental AZD1222 (formerly ChAdOx1 nCoV-19) involving more than 12,000 participants broken out into 11 subgroups. One of those subgroups will consist of children 5-12 years of age. AstraZeneca’s CEO, Pascal Soriot, said last month that testing on children had not yet begun.2 10
On Sept. 8, 2020, AstraZeneca/University of Oxford haulted their Phase 3 trials in the U.K and the United States due to suspected very serious adverse reaction in a female participant. On Sept. 9, Soriot said the woman had suffered symptoms consistent with a rare but serious neurological disorder called transverse myelitis, which causes inflammation of the spinal cord.11
AstraZeneca/University of Oxford have since resumed their Phase 3 trial in the U.K. after Britain’s Medicines Health Regulatory Authority (MHRA) said it was safe to do so, but their Phrase 3 in the U.S. remains on hold pending an investigation by the FDA. “We are continuing to work with the FDA to facilitate review of the information needed to make a decision regarding resumption of the U.S. trial,” said Michele Meixell, spokesperson for AstraZeneca.12 13
Pfizer/BioNTech’s COVID-19 Vaccine Has Provoked Reactions in Phase 1/2 and Phase 3 Trials
Pfizer and BioNTech have also had some problems with their BNT162b1 vaccine. The companies reported that more than 50 percent of the adult participants in the Phase 1/2 human trials of the BNT162b1 vaccine conducted in May-June 2020 experienced adverse events following vaccination. Two trial participants suffered severe reactions.14 15 16
More recently, Pfizer/BioNTech reported that two participants in their Phase 3 trial experienced adverse events, including fever, headaches, and exhaustion after receiving the BNT162b1 vaccine. According to CNBC, one of the participants “woke up with chills, shaking so hard he cracked a tooth after taking the second dose.”17 18
1 Aubrey A. Will Kids Get A COVID-19 Vaccine? Pfizer To Expand Trial To Ages 12 And Up. NPR Oct. 13, 2020.
2 Maddipatla M, Burger L. Pfizer to enroll kids as young as 12 in COVID-19 vaccine study. Reuters Oct. 13, 2020.
3 Sblendorio P. Pfizer to test coronavirus vaccine in kids as young as 12 after getting FDA approval. New York Daily News Oct. 14, 2020.
4 Reuters. Pfizer, BioNTech propose expanding COVID-19 vaccine trial to 44,000 volunteers. CGTN Sept. 13, 2020.
5 L.J. Tan, MS, PhD. Immunization Action Coalition.
6 Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry. U.S. Department of Health and Human Services June 2020.
7 Kemp K. AAP to feds: Children must be included in SARS-CoV-2 vaccine trials. AAP Publications Oct.1, 2020.
8 TVR Staff. AAP Wants Children Enrolled in COVID-19 Vaccine Clinical Trials. The Vaccine Reaction Oct. 11, 2020.
9 Fox M. Pfizer to start testing its Covid-19 vaccine in children as young as 12. CNN Oct. 13, 2020.
10 Reuters. AstraZeneca is still waiting for FDA go-ahead to resume U.S. trial. CNBC Sept. 24, 2020.
11 Cáceres B. AstraZeneca Halts, Resumes COVID-19 Vaccine Trial After Serious Neurological Event. The Vaccine Reaction Sept. 14, 2020.
12 Holden M. AstraZeneca resumes UK trials of COVID-19 vaccine halted by patient illness. Reuters Sept. 12, 2020.
13 Wahlberg D. COVID-19 vaccine trial at UW Health still on hold as Trump, FDA clash on approval rules. Wisconsin State Journal Oct. 9, 2020.
14 Cáceres M. Pfizer/BioNTech’s COVID-19 Vaccine Causes Adverse Reactions in Over Half of Clinical Trial Volunteers. The Vaccine Reaction July 18, 2020.
15 Herper M. Covid-19 vaccine from Pfizer and BioNTech shows positive results. STAT July 1, 2020.
16 Mulligan MJ, et al. Phase 1/2 Study to Describe the Safety and Immunogenicity of a COVID-19 RNA Vaccine Candidate (BNT162b1) in Adults 18 to 55 Years of Age: Interim Report. medRxXiv July 1, 2020.
17 Farr C, Lovelace B. Coronavirus vaccine trial participants report day-long exhaustion, fever and headaches — but say it’s worth it. CNBC Oct. 1, 2020.
18 Volkman E. Report: Moderna and Pfizer Vaccine Trial Participants Report Serious Side Effects. The Motley Fool Oct. 5, 2020.