Recently, Pfizer announced findings from clinical trials that showed their COVID-19 vaccines are safe for children ages 5-11. Right now, the Pfizer vaccine is only FDA-authorized for children 12 and older.
When can we expect to see Emergency Use Authorization (EUA) for Pfizer vaccines for 5-11 year-olds? Is it safe? What do we know about COVID-19 and children?
Children will receive a smaller dose
The Pfizer clinical trial included 2,268 children ages 5-11. One-third of these children received a placebo; two-thirds received two doses of the vaccine three weeks apart. Children who received the vaccine got 10 micrograms per shot, compared to the 30 micrograms dosage for people 12 and older.
Data from the trial show that children who received the vaccine exhibited a strong immune response a month after their second dose. These children tolerated the vaccine and experienced only mild side effects, like what is expected from the adult vaccine. The most common side effects were fatigue, fever and muscle aches.
Pfizer submits data for FDA emergency authorization
On Sept. 20, Pfizer announced that it is preparing to share the trial results with the FDA in hopes of securing Emergency Use Authorization. If Pfizer is approved for EUA, children in this age group could start getting vaccinated by Halloween. Pfizer will continue collecting data on the vaccine’s efficacy to get full FDA approval.
COVID-19 cases spike in children, teens
According to the American Academy of Pediatrics, children now account for 1 in 5 COVID-19 cases in the U.S. As the delta variant surges, hospitalizations among children have spiked. One CDC study found that children and teen hospitalizations increased by five times between June and August.
In August alone, 30,000 children were hospitalized with COVID-19, according to the New York Times. Emergency use authorization of the Pfizer vaccine for children 5-11 could help bring these numbers back down.
Effects of COVID-19 on children
Some parents worry about the possibility of their child developing myocarditis from the vaccine. Myocarditis is inflammation of the heart muscle. However, a recent study from Israel showed that COVID-19 is more likely to cause myocarditis than the vaccine.
Some children infected with COVID-19 have also developed multisystem inflammatory syndrome, or MIS-C as a complication. MIS-C can affect a child’s organs and can be deadly, though most children recover with medical care.
- Stomach pain
- Skin rash
- Bloodshot eyes
If your child is showing signs of MIS-C, get in touch with their pediatrician right away.
What about children younger than 5?
Pfizer is also testing the vaccine in children younger than 5 years old. Three micrograms seem to be sufficient for this age group, according to Dr. Yvonne Maldonado, who led the Stanford University Pfizer vaccine trial.