The purpose of an Emergency Use Authorization, as outlined by the FDA, is to provide "a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current COVID-19 pandemic." This very action has allowed for the rapid distribution of life-saving vaccines to adults in the US as well as adolescents ages 12 and up. We are deeply concerned about news reports stating that the FDA may delay its consideration of an EUA for a COVID-19 vaccine in children under 12.  Children have no protection against SARS-CoV-2 and as highly transmissible variants spread, we are seeing an alarming rise in pediatric cases of COVID-19 across the country.

On 8/5/2021, the American Academy of Pediatrics issued a statement urging the Food and Drug Administration  to continue working aggressively towards authorizing safe and effective COVID-19 vaccines for children under age 12 as soon as possible, given rapidly rising pediatric infections and hospitalizations due to the Delta variant of SARS-Cov2 in the United States. On 8/16/2021, the American Academy of Family Physicians issued a similar statement.

As of August 19, over 4.5 million children in the United States have tested positive for COVID-19 since the onset of the pandemic. Over 180,000 pediatric COVID-19 cases were added the past week, a continuing substantial increase.  After declining in early summer, child cases have steadily increased since the beginning of July and now comprise 18.0% of reported weekly COVID-19 cases.  Up to 1.9% of child COVID-19 cases resulted in hospitalization. 4404 cases of Multisystem Inflammatory Syndrome in Children (MIS-C) have been documented in the United States, of which 37 cases were fatal. 430 children in the United States died of COVID-19 since the beginning of the pandemic, 134 of them under the age of 5. There were 24 pediatric deaths in the week of 8/19, the most since the beginning  of the pandemic  (exceeding the previous record by 10).  The weekly pediatric mortality in the US  is expected to rise over the next few weeks as it is a lagging indicator. 

We call on the members of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the Food and Drug Administration (FDA), and members of the Advisory Committee on Immunization Practices (ACIP) to act in the best interest of children and not delay the evaluation of applications for an EUA for vaccination of children under age 12.

Our reasons are as follows:

*With the emergence of highly contagious variants and repeal of most, if not all, mitigation measures in many areas, COVID-19 poses an imminent risk to unvaccinated people, including children < 12. 

*Serious illness exceeds that of many other childhood diseases, even though COVID-19 has been considered a disease of adults.

*Delaying potentially life saving vaccinations for children under 12 is unethical given our extensive knowledge that any serious vaccine related events will likely occur shortly after vaccination (i.e. within 2 months).  Delaying evaluation of data submitted for EUA or waiting for full approval will add time, leading to more infections and disease  in this age group.  If more safety data is indicated, opening more trial sites to increase the sample size and thereby the power to detect severe side effects would be the optimal course of action (additional references here​, here and here).

*Unvaccinated children are at risk for long-covid   (additional references here and here).

*Unvaccinated children remain at risk for long term sequelae of COVID-19, many of which are unknown (additional reference here).

*From a public health standpoint, delaying EUA leaves a large reservoir of vulnerable individuals who will continue to transmit the virus and allow for mutations that may evade the vaccines (additional reference here).

*Healthcare inequities are likely to worsen without rapid availability of vaccines for children.

For all of these reasons, we believe it is imperative to promptly evaluate the application for EUA for vaccination of children under 12 when presented.  Unless there is a safety concern that is as yet unknown to those outside of the FDA or Pfizer, it is simply unethical to withhold vaccine access based on theoretical risks when the actual risk of infection is much higher.  Giving well-informed parents access to vaccination for their children without delay will provide benefits which far outweigh the risks. The decision whether or not to vaccinate a child should account for individual and regional differences, and for many American children, the choice to vaccinate will be clear. To deprive parents of this option would be a grave error.

Sincerely,

Stephanie Camaglia Reznick, MD, Board Certified in Internal Medicine

Jennifer Belasco, MD, MS

Sasha Shapiro, MD, Board Certified in Internal Medicine

Katya Shpilberg,  MD, Board Certified Radiologist with CAQ in Neuroradiology

Sara Schroder, MD, FAAP, Board Certified Pediatrician

Kristina Lehman, MD

Marina Khrizman, DO, Board Certified Pediatric Neurologist

Eve Bloomgarden, MD, Board Certified Endocrinologist, Chief Operating Officer IMPACT