Pediatric COVID-19 vaccines are here. What do parents need to know?
Now that the Food and Drug Administration has granted Emergency Use Authorization for a COVID-19 vaccine for children ages 5 to 11 years old and the vaccine is being rolled out across the country, here are some key points about Pfizer-BioNTech’s mRNA pediatric vaccine.
About 28 million children in the United States, including an estimated 1.7 million in Florida, are now eligible for the vaccination, with only those younger than 5 excluded.
Pediatricians recommend that parents vaccinate their children to protect them from the disease, decrease spread to families and ensure that they can stay in school without having to quarantine after an exposure.
CDC modeling suggests that vaccinating 5- to 11-year-old children will reduce the spread of COVID-19 in the United States by 8% between November and March 2022, while helping to reduce the impact of a new variant, if one emerges, but would not block its spread.
Where can I get the vaccine?
Among the first providers to administer doses in South Florida were retail pharmacies, where parents can schedule an appointment online.
Children’s hospitals, pediatricians in private practice and schools also will be providing the vaccine for newly eligible children, with efforts ramping up this week.
The CDC is directing parents to the website vaccines.gov to find a local provider.
What did the research show about the vaccine?
Clinical trials of the pediatric vaccine showed a strong immune response in children but had fewer participants than the adult vaccine trials.
Initially, the trial was limited to 2,268 children — 1,518 of whom received two doses spaced three weeks apart. The other 750 children received a placebo. The study assessed safety, antibody response and effectiveness for at least two months after the second dose.
An additional 2,379 vaccinated children 5 to 11 years old were followed for up to 2 1/2 weeks after their second dose.
Pfizer said the trial showed the vaccine is 91% effective at preventing symptomatic COVID-19, with a total of 19 cases reported in the study (16 among children who received a placebo, and 3 cases in those who received the vaccine). There were no cases of severe COVID-19, hospitalization or death.
What about side effects?
Adverse effects reported in the trials were similar to those reported among older children and adults, such as a sore arm, fatigue and headache.
But the rate of more serious side effects, such as myocarditis, a rare condition that causes inflammation of the heart muscle, is not known. The study did not include enough children to assess the risk adequately, but no cases of myocarditis were reported in the vaccine trials among 3,082 vaccinated children with at least seven days of followup.
For pediatricians like Dr. Lisa Gwynn with the University of Miami Health System, the vaccine trial’s takeaway for parents who may be undecided about vaccinating their young children is fairly simple.
“Basically, the benefits outweigh the risks,” she said. “There weren’t any serious complications at all.”
The CDC will continue to monitor young children who receive the vaccine using a different reporting system than the one used for adolescents and adults, the Vaccine Adverse Event Reporting System or VAERS.
For kids 5 to 11 years old, the CDC will use a system called V-Safe, which is a symptom and side-effect tracker that can also be used by the agency to contact individuals after vaccination.
What’s the difference between adult, pediatric vaccine?
The Pfizer vaccine authorized for 5- to 11-year-old children is about one-third of the dose given to those 12 and older, said Brian McKee, pharmacy director for Memorial Healthcare System, which includes Joe DiMaggio Children’s Hospital. McKee said providers won’t be able to just dilute an adult vaccine to produce the pediatric formula, however, because the dilution requirements are different.
The pediatric vaccine will also have a longer storage life than the vaccine given to adolescents and adults.
The vaccine for those 12 and older can only be kept in the freezer for two weeks or an ultra cold freezer for nine months or in the refrigerator for 31 days, McKee said. The pediatric vaccine can be stored in an ultra cold freezer for six months or in the refrigerator for 10 weeks.
“This will expand access to locations in provider offices,” McKee said.
Doctors and scientists do not yet know how long vaccine protection will last in children 5 to 11 years old, or whether a booster will be needed.
Because the pediatric vaccine was granted emergency use authorization and not full FDA approval, federal regulators, including the CDC, will continue to monitor the vaccine for safety.
Combating vaccine misinformation
For some providers, the biggest challenge in vaccinating children may be persuading their parents that it’s worth the risk, said Dr. Aniruddh Setya, a pediatric gastroenterologist with KIDZ Medical Services, a physician specialty group in South Florida.
“The problems I normally face is with the teenagers and a lot of misinformation on TikTok about vaccines causing flares of other diseases. This is not anti-vaxxers,” he said.
Setya said any risk associated with the vaccine will be far less than the potential danger of getting infected. Even though children are less likely than adults to have severe illness from COVID-19, Setya said there’s no reason to “wait and see” either.
“When parents say it’s the fear of unknown,” he said, “I tell them, ‘Well, we don’t know anything about COVID either.
“I’d rather put my belief in science than the chance that I won’t get it.”
This story was originally published November 8, 2021 at 4:37 PM with the headline "Pediatric COVID-19 vaccines are here. What do parents need to know?."
