To have a conversation about the pediatric COVID vaccine, we must start by congratulating parents. The Biden administration announced on November 17 that in the first 10 days after the FDA emergency use authorization, 2.6 million kids aged 5-11 had their first COVID vaccine shot. That is 9.8 percent of the 5-11 year olds in the United States! It took three months for 10 percent of adults to receive their first vaccine. Impressive!
This has been a tiresome pandemic. We are all weary, and the announcement that pediatric patients ages 5-11 would be vaccinated was met by many with jubilance and enthusiasm. Of course, there are also parents who have questions and concerns. We are all careful with our children, perhaps more careful than we are with ourselves.
The U.S. has suffered through 46.9 million cases of COVID and 760,000 deaths. We are in the fourth wave of cases, with the third being the summer surge. The scientific response has been remarkable. The development of a safe and effective vaccine within 11 months – from January 2020 to December 2020 – was record-breaking.
In adults, we know the safety profile. Over 7 billion doses of the COVID-19 vaccine have been administered globally, and over 440 million doses administered in the U.S. The results from post-vaccine safety monitoring has been incredibly reassuring. We have seen very few serious adverse events and no long-term side effects from a vaccine that saves lives and prevents hospitalizations.
The burden of disease has disproportionately affected adults, and older adults at that, so why are we vaccinating our children?
Many children have suffered from COVID disease; in kids less than 18 years old, we have seen over 5 million cases, over 66,000 hospital admissions, 5,500 cases of MIS-C (multisystem inflammatory syndrome in children), and over 900 deaths in the past 15 months. We are vaccinating to prevent disease, hospitalizations, and death.
“Vaccinating our children is also an important step in protecting the vulnerable in households and the wider community.”
Vaccinating our children is also an important step in protecting the vulnerable in households and the wider community. By decreasing the amount of virus in the community, we decrease risk of death to older adults who may contract serious COVID illness even if vaccinated. We know that children transmit disease, and that vaccines prevent transmission. The best way to protect the elderly and unvaccinated children under five years old is to surround them with vaccinated children and adults.
Perhaps as important, we are vaccinating our children so they can resume a normal, happy childhood of activities and social gatherings. We are all aware of how difficult and isolating this pandemic has been. Children are meant to develop emotionally, intellectually, and physically in group situations: on sports teams, in classrooms, in groups of other children. We want our children back in school and developing into the social creatures that they are. With vaccination, we enable social gatherings. Vaccination also prevents the inconvenience of quarantine; in most settings, being vaccinated allows our children to stay in school and in activities even if exposed to a COVID-positive friend. Delightful!
“We are vaccinating our children so they can resume a normal, happy childhood of activities and social gatherings.”
Is the vaccine safe?
Parental hesitations often revolve around this concern, with questions arising about the speed with which the vaccines have been developed. To clarify, the Pfizer trial contained 2,268 children, two-thirds of whom received the COVID vaccine and one-third of whom received placebo. The pediatric COVID Pfizer vaccine contains one-third of the adult dose (at 10 mcg). There were no incidences of myocarditis or any severe adverse effects post-vaccination. The most common side effects were fever and local redness and swelling on the arm. However the study did not have enough children – it was not “sufficiently powered” – to determine if the more rare side effects, such as myocarditis, will occur when millions of children become vaccinated. While this raises legitimate questions, it is reassuring that other countries (Israel, for example) have already vaccinated children safely without significant side effects, and that the millions of American 12-13 year olds who have been vaccinated have done so safely.
Another central question that parents have is on efficacy: “Does it work?”
The answer is, in a word: yes. The efficacy of the Pfizer vaccine study reported 91 percent efficacy on preventing COVID disease in children. These are similar statistics to immunocompetent adults.
Are there unanswered questions?
Yes, of course. There are studies testing if the 10-mcg dose will be adequate for the 12-15 year-old age group; we may be able to give these teens a lower dose than the 30-mcg dose currently recommended. As a country, we track side effects efficiently and study them well. We will learn more about any potential rare side effects via the VAERS (“Vaccine Adverse Event Reporting System”), but given the vaccine proven safety profile, the mortality and morbidity of COVID disease (including long COVID and MIS-C) are far worse. The Pfizer trial data for children under the age of five years old has yet to be announced; the dose may be as low as 3 mcg. We do not yet know the dose and timing for “booster” doses in teens nor children.
This pandemic has been an exercise in patience and has carried much suffering. We have learned much – both about COVID disease and about ourselves, globally and locally – in the past two years. The EUA of the pediatric Pfizer vaccine for 5-11 year olds is a welcome step forward.