1. What are the risks of COVID Disease in children aged 5-11?
    • Approximately 1.9 million children aged 5-11 have been diagnosed with COVID during the pandemic (out of 6 million total pediatric cases).  Approximately 38% of children have already contracted COVID at least once. Risk of complications seem lower in age 5-10 than any other age group with around 30 out of every 100,000 children in this range being hospitalized (>8,000 total).   94 children have died in this age group since the beginning of the pandemic and 66 have died since October 2020.  Around 2300 children have developed MIS-C in this age group and up to 8-9% have symptoms of fatigue and “long COVID” beyond 12 weeks.   The cognitive impact on school absenteeism is also an important aspect of COVID exposures and disease.

www.cdc.gov/coronavirus/2019-ncov/covid-data/covid-net/purpose-methods.html

www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-11-2-3/03-COVID-Jefferson-508.pdf

  • When did COVID-19 vaccines become available to children 5-11?
    • In September 2021, Pfizer became the first manufacturer to complete a clinical trial of COVID-19 vaccination in children 5 years to 11 years.   The FDA reviewed the evidence of safety and efficacy in late October and authorized Emergency Use Authorization (EUA) based on the initial study.   The CDC then met and recommened use in the United States in early November.  Currently, Pfizer is the only vaccine available for children 5-11 and is only allowed as a EUA, not full approval.  Details on the public study information are found here:  see: FDA event material
  • Is the vaccine the same as the one for adolescents and adults?
    • Not exactly.  The vaccine is the same Pfizer mRNA vaccine encased in lipoprotein, however only 1/3 of the adult dose is used in children.   The product has been packaged differently to avoid confusion.  The same as the adult product, there are two doses given at least 3 weeks apart.    There is currently no approval for any boosters.
  • Tell me more about the study that is the basis for this EUA?
    • This study C45910007 initially enrolled 2268 children aged 5-11 for phase 1, 2 and 3 trial (www.fda.gov/media/153447/download, section 7).    Approximately 1500 received the COVID-19 Pfizer vaccine and around 750 received the placebo (saline injection).   There were two primary endpoints evaluated, safety and immune reactivity.  A secondary endpoint of effectiveness was also added.   Patients were followed up to 3 months out and all symptoms and reactions were documented for safety.   The safety profile was shown to be similar to adults although less frequent (see below #5).   The immune responsiveness of the vaccine was evaluated by immunobridging.   This required blood draws to determine if the antibody levels in children reached the similar levels in adults.  The antibody levels were similar to adult comparisons at 1 week and 2 months after vaccine, indicating good immune response.   The efficacy endpoint was studied by following patients in study to see if they contracted COVID.  The real-world data showed 3 cases of COVID in the larger vaccinated arm compared with 16 cases in the smaller placebo arm.  This calculated to a 90% efficacy in preventing infection over that time.
  • What side effects occurred with the vaccine and how might my child feel after the vaccine?
    • The side effects seen for the child vaccine were the same as the adult vaccine.  However, they tended to occur less frequently for children.  For instance, adults had fever 18% of the time after the second dose, whereas children only had fever about 6% of the time.   Other noted side effects were site redness, soreness, headache, chills and fatigue.  There were no cases of anaphylaxis or serious side effects observed in the clinical trial.
  • Was the study large enough to identify all safety concerns?
    • As noted above, the study size for this age group was relatively small compared to a full vaccine FDA approval.   The size is due to the urgency of the pandemic and the narrow age range.  If there was not a global pandemic, there would be a bigger trial and there would be no EUA, only a full FDA approval.  
    • The study was large enough to identify the vast majority of significant side effects to the vaccine.    However, extremely rare reactions are still possible.   Over the next 3 months we suspect any rare effects will be identified in the surveillance process, as was done to find the myocarditis in the summer.   The possibility of rare vaccine side effects must be balanced with the risk of rare severe outcomes of COVID infection itself as well as the risk of spread to more vulnerable populations.
  • What do we know about heart complications such as myocarditis after receiving the vaccine?
    • Investigators and regulators are particularly interested in watching for heart effects of the vaccine.   It was found that in adolescents there was a higher incidence of myocarditis (heart inflammation) around the time of vaccination versus those who had not been vaccinated.   The highest incidence of this was in males 16-17 years who developed myocarditis at a rate of about 1 in 10,000.   There was hospitalization but no fatalities in some of those cases.
    •  In the trial of 5-11 year old participants, there were no cases of myocarditis.   However, since the initial study group only had around 1500 children who received the vaccine, it is not powered high enough to find rare side effects.  So if the vaccine it does cause myocarditis, all we know is that the rate would be at least smaller than 1 in 1500. Another 1500 participants were added and are being followed, but are less than 1 month out from their 2nd dose.

FDA Myocarditis Presentation

  • Can I wait to see how the first few months go first?
    • Yes.   If you are considering the vaccine but want to see a larger number of doses given before moving forward, waiting 2-3 months will accomplish that goal.   This strategy is less risky when disease burden is low like it is in November.  However, if numbers rise so does risk.
  • If my child has already had COVID, do they still need a vaccine?
    • There is insufficient data to know whether native (natural) infection with any strand of COVID is sufficient to reduce illness and spread in children 5-11.   It is possible, if not likely, that native infection is quite protective against severe COVID.   Data in adults indicates that vaccination after illness is particularly effective at driving up antibody levels far beyond native infection alone.   Yet correlating that with risk reduction is still unclear.
  • How long after my child has COVID should I wait to get the vaccine?
    • Your child can receive the vaccine as soon as their quarantine period ends. There is no known benefit to waiting until 3-6 months after illness.
  • If my child already had COVID, will their side effects be more severe?
    • The study in children 5-11 only enrolled children who had not previously been infected with COVID, so vaccine response in previously infected children is unknown.  Adults who received vaccine and boosters had no significant increase in side effects if they had previously had COVID, which is what we anticipate in children.
  • If the complications of COVID 19 are usually mild, why should I vaccinate my child?
    • There are a few reasons why families are considering this vaccine.  The complications of COVID include severe illness, hospitalization and rarely death.  MIS-C is a rare but frightening cascade of organ failure that can occur 2-6 weeks after COVID infection.   “Long COVID” is also a growing concern involving fatigue, headaches and nervous system sequalae.   School absenteeism from quarantine and illness is also a reason.    Additionally, children increasingly play a major role in transmitting virus since the Delta variant arrived and vaccinating them is likely to reduce spread to higher risk populations.
  • My child is healthy without underlying conditions.   Are they at risk?
    • General risks are outlined in question 1 above.  About 30-32% of 5-11 year olds who have been hospitalized or died from COVID-19 have no significant underlying health conditions.   For instance, of the 66 children who have died in the last year from COVID, around 20 had no obesity, immunodeficiency, or chronic lung disease. 
  • How does this vaccine handle variants of COVID-19 such as the Delta variant?
    • In the immunobridging phase, the Delta neutralizing antibodies were strong, indicating likely effectiveness.   Additionally, the 90% efficacy was calculated during the surge of Delta variant.    While the vaccine seems very effective at Delta, it is hard to know how well the vaccine will protect against any future mutations.
  • Why is Heritage Pediatrics offering the vaccine for children?
    • Offering any product without full FDA approval requires careful consideration.   We have many families who are very anxious to receive protection for their families with this vaccine.   The preliminary data from this trial combined with the experience in older children has led us to feel comfortable offering this vaccine to those families who desire it.   We believe that the risk of serious side effects from vaccination are very low while the risk of COVID disease complications is also low, but more frequent.   Therefore, we support families who desire to receive this vaccine during the EUA phase.
  • What does Heritage Pediatrics recommend for my child 5-11 years?
    • According to the available evidence, the modest benefits of the vaccine outweigh the remote risks.  We recommend that each family consider their situation, risk factors, community spread, and value systems to determine if this vaccine is right for you.   Our physicians and staff have vaccinated their own children to reduce transmission, reduce rare COVID complications, reduce school absenteeism, and because we feel that the risk of vaccination is exceedingly small based on the available evidence.
  • Where else can I find answers?
  • Where else can I get vaccine for my child besides your office?
    • Most local retail pharmacies such as CVS, Walgreens and HEB will offer it to all ages down to 5 years
    • You can also register online for a Metro Health Location here
    • CDC Vaccine Finder
    • We only have resources at this time for Heritage Pediatrics patients. All others seeking vaccination may consider the above alternatives