USA TODAY International Edition
Panel ‘ very comfortable’ with kids’ shots
Here’s what to know with approval expected soon
Parents eager to vaccinate their kids are waiting as federal agencies review data from trials showing Pfizer- BioNTech’s COVID- 19 vaccine is safe and effective for children.
The vaccine is fully approved for people 16 and older, and it’s authorized under emergency use for children 12 to 15 years old.
Last Tuesday, an advisory committee to the Food and Drug Administration voted to recommend the vaccine to kids ages 5 to 11. With this first step down, the vaccine is likely to be available to eligible children across the country by the middle of this week.
What do doctors suggest?
The American Academy of Pediatrics says it won’t issue a formal recommendation until after an independent panel to the Centers for Disease Control and Prevention completes its evaluation of the data.
But many health experts are going on the record recommending children ages 5 to 11 get the Pfizer- BioNTech vaccine as soon as it becomes available.
“As pediatricians, our sole purpose is to take care of children and protect them,” said Dr. Stan Spinner, vice president and chief medical officer at Texas Children’s Pediatrics and Texas Children’s Urgent Care. “We feel very comfortable ( with this vaccine). If we didn’t, we wouldn’t be recommending it.”
Hundreds of kids ages 5 to 11 have been hospitalized with COVID- 19, and 94 have died this year, the FDA says. It was the eighth- leading cause of death in the age group over the past year.
Children appear to be just as likely as adolescents and adults to catch COVID- 19 and pass it on, health experts say. Though they seem to be less likely to become seriously ill, health experts urge parents not to take that chance.
Why should my kid get a vaccine?
Even with a mild infection, children are still at risk for developing a dangerous immune overreaction called multisystem inflammatory syndrome in children. COVID- 19 has led to more than 5,000 cases of the condition; the average age is 9.
Children are less likely to have longterm symptoms of COVID- 19 than adults, experts say, but they still can suffer from so- called long- haul COVID.
Recent data shows children are as likely to get infected by the delta coronavirus variant as adults, and about 50% of infections in children are asymptomatic.
“The last point for why to vaccinate children now is to really allow kids the freedom to be kids,” said Dr. Emmanuel Walter Jr., professor of pediatrics at Duke University School of Medicine and chief medical officer of the Duke Human Institute.
Has FDA approved kid shots?
Though a federal advisory committee voted to recommend Pfizer- BioNTech’s vaccine for ages 5- 11, the Food and Drug Administration has yet to authorize it.
The agency is expected to sign off on emergency use authorization in the next few days. But even after that, it will not mean the vaccine is “approved” for kids.
Emergency use authorization allows Pfizer- BioNTech to provide safety and effectiveness data after tracking trial participants for an average of two months instead of the usual six months.
The only age group that has official approval from the FDA is people 16 and older. Teenagers and children ages 12 to 15 have also been authorized to get the vaccine under emergency use.
Even after signing off on emergency use authorization, two more steps remain before the vaccine will become available to children. Another independent panel of experts, advising the CDC, will review data on the safety and effectiveness of the Pfizer vaccine during meetings Tuesday and Wednesday.
If the panel gives the vaccine its approval, CDC Director Rochelle Walensky will need to add her support before vaccines become available, which is likely as soon as the middle of this week.
What’s the schedule, dosing?
The vaccine would be given to ages 5 to 11 in two shots, administered three weeks apart, at one- third of the dose given to adults and adolescents.
The adult dose of the Pfizer- BioNTech vaccine is 30 micrograms; the companies propose a 10- microgram dose in children ages 5 to 11.
The only difference in the children’s vaccine is the addition of tri- sucrose, already used in several other vaccines. It makes the vaccine easier to dilute and remain stable in a refrigerator.
What did vaccine study show?
The FDA’s Vaccines and Related Biological Products Advisory Committee met last Tuesday.
Pfizer presented its studies among about 5,000 5- to 11- year- olds, which showed the vaccine was found to be safe with no severe side effects or dangerous allergic reactions.
In a subset of the children, the vaccine was found to be more than 90% protective against symptomatic COVID- 19. Of 19 children in the study found to be infected with the coronavirus, only three received the active vaccine, compared with 16 who received a placebo.
In one of the studies, of about half the children, more than 11% had obesity and nearly 8% had asthma. Both groups appeared just as well protected from the vaccine as children without those conditions.
Side effects for kids?
The trials showed children experienced the same types of mostly minor side effects seen in adolescents and young adults.
Many of those ages 5 to 11 had sore arms, fatigue, headaches, muscle pain, chills and low- grade fevers that lasted a day or two.
One of the reasons researchers decreased the normal vaccine dose from 30 to 10 micrograms in children is to reduce the severity of side effects, said Jason Gallagher, clinical professor at Temple University’s School of Pharmacy and a clinical pharmacy specialist in infectious diseases at Temple University Hospital.
Health experts say parents can give their children over- the- counter medicine to relieve any mild to moderate side effects. The CDC does not recommend medications before vaccination in anticipation of side effects, because they might affect how the vaccine works.
Will vaccinated kids need masks?
Until a vaccine is available to children, public health experts have said that the best thing parents can do to protect their children besides getting vaccinated themselves is to encourage kids to wear masks indoors in public.
CDC guidance recommending fully vaccinated people to wear masks inside could remain in place even after children 5 to 11 can get their shots, health experts say.
Kids under 5?
The companies are also studying their vaccine in children ages 2 to 5, and 6 months to age 2, but those trials are not yet complete. Younger children are being tested on a 3- microgram dose. Pfizer has reported it may have data by the end of the year. The company will have to submit the data for FDA and CDC review. The timing “is going to depend on what the data show,” O’Leary said. “I think that people’s best guess is early 2022, but there’s a lot of uncertainty around that guess.”