Important Updates on COVID-19 vaccine for 5-11
Will you offer the COVID-19 vaccine in your office?
Yes, we will have COVID-19 shot clinics similar to our flu vaccine clinics. Stay tuned for another email with specific clinic dates. We will also post on our website banner at 411pediatrics.com and on Instagram @411Pediatrics. We know you are excited, and we are too. But, we do NOT have the specific 5-11 year-old pediatric vaccine in our possession yet. So we are NOT making a waiting list for vaccine appointments. See more below…
Is the Pfizer vaccine approved for ages 5—11?
Almost. The FDA (Food and Drug Administration) advisory panel met on October 26 to review the study result findings. The 18 member panel voted overwhelmingly (17 yes, 1 abstention) to approve the vaccine for use in ages 5-11 based on the benefits of vaccination vs the potential risk of infection and risk of adverse side effects with vaccination. But, this is not the end of the regulatory process.
Next steps: the FDA itself has to approve emergency use authorization (which could happen in the next few days). Then, the CDC (Centers for Disease Control) advisory committee will meet (tentatively November 2-3) to make formal recommendations. Finally, Dr Rochelle Walensky, Director of the CDC, needs to sign off after that.
When will the Pfizer vaccine be available for ages 5-11 in your office?
We have pre-ordered 300 doses from the Texas Department of State Health Services (DSHS) for our initial shipment but there is no confirmed shipment date yet due to the regulatory process currently underway. We do not know when it will arrive, but trust us, you will hear as soon as we do know.
While it is tempting to simply use the adult formulation of the vaccine and draw up 1/3 of the volume for the younger children, it ‘has not been studied’ and is discouraged by DSHS. Yes, we have thought about it as we have that vaccine in the office already, but will follow the protocol so we can remain state vaccine providers!
What are the current stats for kids and COVID-19 infection?
Based on data from the American Academy of Pediatrics, Children’s Hospital Association, and the Centers for Disease Control, about 6.2 million children have tested positive for COVID-19 infection, more than 65,000 have been hospitalized, and 718 have died. About 70% of the children hospitalized for COVID-19 infection have pre-existing health conditions such as obesity, diabetes, asthma/chronic lung disease, heart disease and immunosuppression.
In the week ending October 14, there were 131,000 new cases in children, and kids now represent 25% of all new COVID-19 infections in the United States. Children ages 5—11 represent 39% of pediatric COVID-19 infections under 18 years of age.
Most children recover within 1-2 weeks but some will have long term symptoms lasting weeks or months. Since May 2020, there have been 5217 reported cases of Multisystem Inflammatory Syndrome in Children (MIS-C) and 46 deaths. Half of those cases were in children ages 5—13.
The FDA advisory panel that met on October 26 commented that about 40% of the pediatric population in ages 5-11 may have already had symptomatic or asymptomatic COVID-19 disease.
What are the results of the Pfizer vaccine study for ages 5—11?
2268 children participated in this study and most were followed for at least two months after receiving the second dose. There are an additional 2369 children who have yet not completed the follow up portion of the study at the time of application to the FDA. Of the participants, 2/3 received the vaccine and 1/3 received the placebo. Groups were given different doses of the vaccine (10, 20, and 30 mcg) to determine the lowest dose needed to mount adequate antibodies with the least unpleasant side effects (pain at the injection site, fatigue, headache). The 10 mcg dose (1/3 the adult dose) was just as effective as the higher doses in the 5—11-year-olds with only mild side effects, so this will be the recommended dose in this age group. There were no cases of myocarditis, severe allergic reaction or death.
Note: the risk of myocarditis in older age groups (12 and up) is so rare, it would be difficult to detect in the number of kids involved in this study. The FDA advisory committee commented that it is critical to follow the safety data once vaccination is widespread in this age group but that myocarditis (from any cause) is very uncommon in children who have not gone through puberty yet.
Over 90% of children were protected against symptomatic infection during the course of the study. There were 19 cases of COVID-19 infection but only 3 of those were in the vaccinated group (16 were in the placebo group).
Here is the FDA briefing document if you want the in-depth analysis.
If my 10-year-old weighs the same as my 12-year-old, why is the vaccine dose 1/3 strength?
Key point: younger children mount a more robust immune response to vaccinations than older kids and adults because the immune system gets old (and a little weaker) as we get older.
The vaccine dosing is based on the AGE of the child (and the age of their immune system), NOT on the WEIGHT of the child. So even if a 10-year-old weighs the same as a 12-year-old, the 10-year-old will still get the lower dose of Pfizer vaccine.
Is the vaccine schedule the same for kids as adults?
Yes, it is 2 doses given 21 days apart.
Is there any other place vaccine will be available for 5—11-year-olds?
Austin Public Health plans to offer some vaccine clinics through the local school districts. Pharmacies may also offer the vaccine for certain age groups.
Where can I get more information about the vaccine and safety data?
Since we have covered most of these questions on past newsletters, you can always review the news blog on our website at 411pediatrics.com. The American Academy of Pediatrics also has a helpful link here with answers to frequently asked questions.
We will be in touch soon….Happy Halloween!