top of page

USA Vaccine Approval for Children aged 5-11 Years

Updated: 5 days ago

By Erica Hayes

LCK Support Group Team USA

29 October 2021




Vaccine approval for children 5-11 in the United States


Though many look at the childhood risk from COVID as being relatively low or unlikely compared to that of adults - parents of kids who have developed Post-COVID related conditions have learned first-hand how this virus can turn a life upside down. Many Long Haulers both young and old are forced to make adjustments to their everyday living thanks to newly acquired limitations and disability of varying degree.

Long Haulers struggle to find support from the outside world; doctors and schools lack both awareness and viable solutions to the problems they are facing.



We have not been given answers as to if our loved ones will ever recover, and the only certainty we have moving forward, is prevention.



For those of us with children 5-11 years old who were either slow to recover from COVID, or are still battling disabling symptoms, the approved use of the Pfizer vaccine for children 5-11 has been long awaited. We are unsure how our children will handle reinfection and are petrified of the possibility that things could get worse.




Pfizer Vaccine for Kids 5-11



ree

On September 20th, Pfizer-BioNTech announced the success of their vaccines safety and efficiency in preventing COVID-19 infections in children 5-11 years old.[1] They then approached the FDA seeking Emergency Use Authorization (EUA) based on trial data collected from children who participated. During their studies, Pfizer distributed two smaller doses of the vaccine, 21 days apart, to 1,518 children participating in the study [1] Additionally, another 750 children received two placebo saline shots, totaling to 2,268 trial participants.


This is not unlike the trial for children ages 12-18 that included 2,260 participants with a 1:1 placebo ratio that was approved May 10, 2021.

Approval Process

On Tuesday October 26th, the FDA’s Vaccines and Related Biological Products Advisory Committee met in a day-long meeting to review the data from Pfizer’s trial and cast their vote for approval.





The question at hand was proposed:


“Based on the totality of scientific evidence available, do the benefits of the Pfizer-BioNTech COVID-19 Vaccine when administered as a 2-dose series outweigh its risks for use in children 5-11 years of age?”[2]



Pfizer’s trial showed that the vaccine was safe in this age group and provided effective protection from contracting COVID-19 for 90.7% of trial participants.[3] Though typical milder side effects that have been observed in other cohorts were observed, such as sore arms, rashes, and fevers, researchers observed no cases of myocarditis and zero deaths.


FDA committee member discussion revolved around weighing the risks and benefits based on the small trial sample. The panel made note that the benefits are clearly greater in areas where community spread is greater and talked extensively about the fluidity of the pandemic. Committee members expressed that making the vaccine available for children who are at higher risk was a large motive in their decision.


Also discussed was the lack of diversity within the trials, which included only 5.9% Black or African American and only 5.9% Asian.[3]



Relevant to Long COVID Kids, 8.8% of the trial consisted of children who had previously tested positive for COVID-19.[3]



EUA amendment request for Pfizer-BioNTech COVID-19 Vaccine for use in children 5 through 11 years of age



The session concluded with a vote to move forward with EAU approval for the Pfizer vaccine in the 5-11 group.



Another panel of experts advising the Centres for Disease Control and Prevention (CDC) will make its own recommendations and offer guidelines on the vaccines use among this age group next week.


“The safety profile and immunogenicity data in children aged 5 to 11 years vaccinated at a lower dose are consistent with those we have observed with our vaccine in other older populations at a higher dose.” .[1] - Dr. Ugur Sahin, CEO and co-founder of BioNTech




Attempts to Calculate the Risk to Children


“The case rates among children ages 5 to 11 is near the highest of any age group,” said Dr. Doran Fink, Clinical Deputy Director of the Division of Vaccines for the Food and Drug Administration, FDA.


The American Academy of Paediatrics and the Children’s Hospital Association reported that 26 children have died from COVID-19 in the US in the last week, and over 90 child deaths have been reported in the past month.[7]


And while recognition of Long COVID in children is growing [4], studies that attempt to quantify the percentage of kids who have lingering symptoms post-covid [5] have recently been under fire. An Australia retrospective study attempted to expose previous studies limitations and poke holes in their validity, criticizing the loose definition of Long COVID itself, missing control groups, and inconsistent follow-ups [6]. While peer review and research vigour is essential, the timing of this study and how the media has latched onto its findings is unfortunate for those looking to weigh risks, and even more so those who are suffering with Long COVID.

While this portion of research appears to have taken a step back, the CDC is regularly updating their website with key points, clinical considerations, assessment, and treatment for those with Long COVID.





References [1] PFIZER AND BIONTECH ANNOUNCE POSITIVE TOPLINE RESULTS FROM PIVOTAL TRIAL OF COVID-19 VACCINE IN CHILDREN 5 TO 11 YEARS


[2] Vaccines and Related Biological Products Advisory Committee October 26, 2021 Meeting Announcement OCTOBER 26, 2021


[3] Vaccines and Related Biological Products Advisory Committee Meeting

October 26, 2021


[4] Case report and systematic review suggest that children may experience similar long-term effects to adults after clinical COVID-19

November 2020


[5] Cross-Sectional Survey on Long Term Sequelae of Paediatric COVID-19 among Italian Paediatricians

September 2021


[6] How Common Is Long COVID in Children and Adolescents?


[7] Children and COVID-19: State Data Report

A joint report from the American Academy of Paediatrics and the Children’s Hospital Association

Summary of publicly reported data from 49 states, NYC, DC, PR, and GU

Version: 10/21/21




LongCovidKids.org is a patient-led advocacy and support organisation led by Sammie Mcfarland for families of children with Long Covid. Our story started with a short film on the long-lasting symptoms of Covid in children.


We are supporting research with The Long Covid Kids Study with PeopleWith


Each Sunday we send out a newsletter providing a weekly round-up of statistics, the latest reports in the media, current research, and LCK news. Read previous issues and SIGN UP




If your child experiences any symptoms that indicate they are unwell, it COULD be COVID-19, and you should get them a test to help identify if it is a current Covid infection. Please see our Frequently Asked Questions page for more information.




Comments

bottom of page