Expert FDA Panel recommends COVID vaccine in children 5-11.
An expert panel of the FDA recommended that the Pfizer vaccine be approved for children ages 5 to 11 on October 26th. The Pfizer dose for younger children would be one-third of the strength given to people 12 and older, with two shots given three weeks apart. On November 2nd and 3rd, the FDA will review the expert panel (ie, subcommittee) recommendations and will likely approve the vaccine for children. The CDC will likely quickly approve the Pfizer vaccine in children. This means that by November 4th, children 5 - 11 could start being vaccinated against COVID.
What is the data supporting vaccinating children? This blog is an attempt to help parents make an educated decision around vaccinating their children against COVID, and to sift through the hard to understand the known and unknowns, and rumors floating around the web.
Why vaccinate?
8,300 children between 5 and 11 have been hospitalized in the US with Covid-19 and nearly 150 have died since the pandemic’s onset. Between August and early October, COVID-19 outbreaks have closed 272 school districts, affecting 2,074 schools, including several here in Maine. Some 1,069,116 students and 68,718 teachers have been affected. There has been a disproportionate effect on children of color. * , **
An explanation of the hard data:
The initial Pfizer data included 2,268 children who received 10 microgram (μg) doses administered 21 days apart, using one-third the dose given to adults. One child received the placebo for every two who received the vaccine. The trial was primarily constructed to compare the amount of neutralizing (ie, good) antibodies induced by the vaccine in children as compared to those in age groups 16 – 25 years. The data clearly demonstrated equal efficacy in both groups, with similar side effect profiles.***,
For the October 26th discussion, an additional study was added to bring the total sample size to 3,100 children. About half of those children were tracked for two months or more, and half for under a month. This data focused on actual COVID disease prevention. The Pfizer vaccine was found to be 90.7% efficacious in protecting the children from getting symptoms of COVID-19. Here are the numbers: 3 children who got the vaccine tested positive for COVID-19, while 16 in the placebo group tested positive during that period.**
Study Limitations:
The sample size is small – data from 3,100 children is the primary basis for these recommendations.
There has been no long term follow up –- children in the study have been followed for around two months.
Potential Complicating Factors and Downsides:
Approximately, 40% of children ages 5-11 have likely had the disease and have some amount of protection already against the disease. It is unclear what interactions this could have with the vaccine, synergistic or otherwise.
While most side effects from the vaccines have been mild (body aches, mild fever and malaise), there a true if very low risk of myocarditis (heart inflammation) following the mRNA vaccines. See below for further discussion.
Risk of Heart Inflammation Following COVID Vaccine versus COVID Infection:
Myocarditis literally means heart inflammation.
People with COVID have a 16-fold increased chance of getting myocarditis versus people without COVID. During March 2020–January 2021, the risk for myocarditis was 0.146% among patients with COVID-19 and 0.009% among patients without COVID-19. Children, however, have a 37-fold increased risk of getting myocarditis with COVID 19 than the peers who never get COVID. ******
By contrast, risk of developing myocarditis from a mRNA vaccine is thought to be approximately 0.000025% based on two studies including 7.5 million people in Israel. The highest concentration was among males ages 16 – 25, although cases were spread out among all ages and genders.*****
In almost all cases of myocarditis associated with mRNA vaccines, the symptoms are mild and resolve with time and minimal treatment. The same is not true of COVID myocarditis, which can be associated with Multisystem Inflammatory Syndrome (MIRS). MIRS is a rare condition that causes fever, loss of blood pressure and damage to different organs including the liver. Over the past year, the CDC recorded more than 5,200 cases of MIS-C and 46 deaths, mostly in children ages 5 to 13 years. **
The risk of COVID vaccine myocarditis is hoped to be decreased in the 5 – 11 year old age range for two reasons. Experts have said that the decreased dosing for children could diminish the risk of the heart-related side effects. Second, the general risk of myocarditis in this age group is lower within the population, who do not have COVID.
Researchers observed no cases of myocarditis in studies of young children submitted by Pfizer to the FDA. But Dr. Leslie Ball, a medical officer at the FDA, said the studies seeking emergency use authorization were not large enough to necessarily pick up an uncommon side effect like myocarditis.
Why do I recommed the vaccine in children ages 5 – 11 (and vaccinating my own kids!)?:
The first tenets of medicine are do no harm, and the treatment of the disease should not be worse than the disease. The mRNA COVID vaccine seems to carry very low risk of harm versus benefit.
Having your child vaccinated for COVID can help restore a more normal life.
The vaccine helps prevent or reduce the spread of COVID in everyone.
Getting vaccinated for COVID-19 can help stop other variants from emerging.
Do I think every child ages 5 – 11 should be vaccinated immediately?
I think parents should be aware that there are risks and benefits of the COVID vaccine in children ages 5 – 11.
FDA scientists did extensive modeling to predict how the benefits and risks would play out, and found that the balance was highly dependent on how much virus is circulating. During peak infections, the benefits of protecting children from the disease outweigh the small risks of complications from the vaccine, but in one model, which assumed very low prevalence of COVID-19 in the community, the risk of myocarditis, estimated from rates occurring among older children, offset any potential benefit of the vaccine.
My best recommendation is to talk to your pediatrician, ask questions and make sure you are comfortable with the information you have to make the decision.
Here in Maine, the risk of getting COVID is as high as it has ever been since the pandemic began. To me, this suggests the benefit of getting children vaccinated outweighs the risk.
* https://www.nytimes.com/2021/10/26/us/coronavirus-briefing-what-happened-today-kids-children-pediatric-vaccine.html
** https://time.com/6110640/fda-panel-recommends-covid-19-vaccine-for-children-5-11-years-old/
*** https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-positive-topline-results
**** https://www.cdc.gov/vaccines/basics/test-approve.html
***** https://www.nature.com/articles/d41586-021-02740-y
****** https://www.aappublications.org/news/2021/08/31/covid-myocarditis-risk-children-083121
