Letter from the American Academy of Pediatrics
August 5, 2021
Janet Woodcock, MD
Acting Commissioner
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Dear Dr. Woodcock:
On behalf of the American Academy of Pediatrics (AAP), a non-profit professional organization
of more than 67,000 primary care pediatricians, pediatric medical subspecialists, and pediatric
surgical specialists dedicated to the health, safety, and well-being of all infants, children,
adolescents, and young adults, I write to urge the Food and Drug Administration (FDA) to
continue working aggressively towards authorizing safe and effective COVID-19 vaccines for
children under age 12 as soon as possible.
Pediatricians and the families they care for have been anxiously awaiting a vaccine that can be
used in children 11 years of age and younger, and especially so now given the rise of the hyper
infectious Delta variant. The Delta variant is surging at extremely alarming ratesin every
region of America. This surge is seriously impacting all populations, including children. The
AAP and the Children’s Hospital Association have been tracking COVID cases in children since
the start of the pandemic. Last week saw the largest week-over-week percentage increase in
pediatric COVID-19 cases since the start of the pandemic. The data show 71,726 COVID cases in
children reported last week, almost double the 38,654 reported in the previous week. Simply
stated, the Delta variant has created a new and pressing risk to children and adolescents across
this country, as it has also done for unvaccinated adults.
As the numbers of children infected with the Delta variant have increased, not surprisingly the
proportion of COVID-19 cases occurring in the United States among children is also increasing,
in large part due the current ineligibility of children under 12 years of age to receive COVID
vaccines. Since the pandemic began, children have represented 14.3% of total cumulated cases.
However, for the week ending July 29, children were 19.0% of reported weekly COVID-19 cases.
The higher proportion of cases in this population means this age group could be contributing in
driving continued spread of COVID-19. Sadly, over 350 children have died of COVID since the
start of pandemic and millions of children have been negatively impacted by missed schooling,
social isolation, and in too many cases, the death of parents and other caregivers.
We understand that the FDA has recently worked with Pfizer and Moderna to double the
number of children ages 5-11 yearsincluded in clinical trials of their COVID-19 vaccines. While
we appreciate this prudent step to gather more safety data, we urge FDA to carefully consider
the impact of this decision on the timeline for authorizing a vaccine for this age group. In our
view, the rise of the Delta variant changes the risk-benefit analysis for authorizing vaccines in
children. The FDA should strongly consider authorizing these vaccines for children ages 5-11 years based on
data from the initial enrolled cohort, which are already available, while continuing to follow safety data from
the expanded cohort in the post-market setting. This approach would not slow down the time to authorization
of these critically needed vaccines in the 5–11-year age group.
In addition, as FDA continues to evaluate clinical trial requirements for children under 5 years, we similarly
urge FDA to carefully consider the impact of its regulatory decisions on further delays in the availability of
vaccines for this age group. Based on scientific data currently available on COVID-19 vaccines, as well as on 70
years of vaccinology knowledge in the pediatric population, the Academy believes that clinical trials in these
children can be safely conducted with a 2-month safety follow-up for participants. Assuming that the 2-month
safety data does not raise any new safety concerns and that immunogenicity data are supportive of use, we
believe that this is sufficient for authorization in this and any other age group. Waiting on a 6-month follow-up
will significantly hinder the ability to reduce the spread of the hyper infectious COVID-19Delta variant among
this age group, since it would add 4 additional months before an authorization decision can be considered.
Based on the evidence from the over 340 million doses of COVID-19 doses administered to adults and
adolescents aged 12-17,as well as among adults 18 and older, there is no biological plausibility for serious
adverse immunological or inflammatory events to occur more than two months after COVID-19 vaccine
administration.
While there is justifiable concern about reported cases of myocarditis in younger adults and adolescents
receiving a mRNA COVID-19 vaccine, these events are extremely rare, and, if they were to occur, they would
most likely happen within four weeks of receiving the vaccine. In even rarercases this might present at six
weeks, but not longer. In addition, data on the severity of reinfections of COVID-19 do not seem to prime a
more adverse immunological response, which lessens the concern that there would be a late negative adverse
effect of COVID vaccination.
The Academy appreciates all the work that the FDA has done to ensure that safe and effective COVID-19
vaccines are available to the American public. We urge your continued dedication to help ensure that COVID19 vaccinesfor children can be authorized as swiftly as possible so that children of all ages can benefit from
them.
Sincerely,
Lee Savio Beers, MD, FAAP
President
LSB/pmj
https://downloads.aap.org/DOFA/AAP%20Letter%20to%20FDA%20on%20Timeline%20for%20Authorization%20of%20COVID-19%20Vaccine%20for%20Children_08_05_21.pdf
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