RALEIGH, N.C. — With Pfizer officially requesting emergency use authorization from the Food and Drug Administration, the process has started for the company’s COVID-19 vaccine to be authorized for children ages 5 to 11.
Currently, the Pfizer vaccine is authorized for emergency use only in those age 12 to 15. It received full approval from the FDA for those age 16 and up in August.
The FDA is expected to grant emergency use authorization, or EUA, for younger children in the next few weeks.
But should you have your child vaccinated? And what are the potential side effects? Here’s what you need to know.
In the Pfizer trial for young children, 2,268 children ages 5 to 11 participated. Of those, two-thirds were given two doses of the vaccine, like adults, three weeks apart. The other third received placebos.
The trial found that the vaccine “demonstrated a favorable safety profile and elicited robust neutralizing antibody responses.”
The Pfizer vaccine uses mRNA, a method of instructing immune cells how to produce antibodies against SARS-CoV-2, the virus that causes COVID-19.
The company said the antibody response is comparable to that seen in adults.
A study from the N.C. Department of Health and Human Services in late August found that those unvaccinated are four times as likely to contract COVID-19 and 15 times more likely to die from the disease, The News & Observer reported.
When will it be authorized?
The FDA tentatively scheduled a meeting on Oct. 26 to consider an EUA for Pfizer’s vaccine to be administered to children ages 5 to 11. A ruling is expected by the end of the month, The New York Times reported.
The Centers for Disease Control and Prevention could recommend the vaccine for that age group in early November, according to The New York Times report.
Why should I get my child vaccinated?
Dr. David Wohl, infectious disease specialist at the University of North Carolina at Chapel Hill, said the highly contagious delta variant has affected children more than earlier strands of the virus.
The week ending Sept. 19 was the third week in a row that those younger than 18 made up a third of all new COVID-19 cases statewide, Dr. Mandy Cohen, DHHS secretary, said at a press conference in September.
Earlier in the pandemic, when cases were peaking over the winter, cases in children made up about 10 percent from week to week.
“In the earlier part of the pandemic, children were very unlikely to get severely ill but were considered perhaps a source of infection to others,” Wohl said. “More children are now getting severely ill due to the delta variant than they were in previous periods.”
Delta is a mutation of the coronavirus that’s more than twice as contagious as the original strand, according to the CDC.
In the week of Sept. 26, those younger than 18 accounted for about a quarter of new cases, DHHS data show.
Pfizer cited similar figures nationwide from late September when it announced its EUA request on Twitter.
As of Oct. 7, seven people younger than 18 had died due to COVID-19 in North Carolina since the pandemic started. Four of those deaths were reported since delta started surging in early July.
During August, at the height of the delta surge, pediatric intensive care units were full across the Triangle due to COVID-19 patients, The News & Observer reported.
“I have a 17-year-old and a 22-year-old. They’ve been vaccinated,” Wohl said. “If I had a younger child, I would vaccinate them.”
What are the side effects in young children?
The most notable risk of side effect in any age group post-vaccination is myocarditis, a condition in which an immune system response causes inflammation of the heart muscle, causing chest pain, shortness of breath and feelings of a pounding heart.
But a study from the New England Journal of Medicine found myocarditis post-vaccination to still be extremely rare — one to five cases per 100,000 people vaccinated.
The CDC says myocarditis post-vaccination is more common after the second dose of either mRNA vaccine and more often occurs in young males, though it is still extremely rare.
”It’s so rare that very, very few clinicians have seen this or heard about it,” Wohl said.
The study from the New England Journal of Medicine found that of the 21 cases of myocarditis from vaccination, 19 were males. The median age was 25.
But myocarditis from a COVID-19 infection is up to 11 times more common in those unvaccinated, the study found.
No causal link between the mRNA vaccines, from Pfizer and Moderna, and deaths have been found, according to CDC. A causal relationship between the Johnson & Johnson vaccine and deaths caused by blood clots has been deemed plausible, though extremely rare.
“We have to put this all in context. If we focus too much on the very, very rare events, it drowns out the substantial benefits of these vaccines, and I think there is an agenda. On the one hand, we have a balance. We want people to know about the side effects. We want people to be informed. We don’t want to brush anything under the rug. Clearly, people should do their homework. They should know about it,” Wohl said. “But the risks we’re talking about are so minuscule.”
“Can you give me the list of side effects that have ever occurred per 100,000 people or a million people with the tetanus shot, or the hepatitis B shot or the shingrix shot? They don’t do that. Yet for these vaccines we have, and the scrutiny that’s being placed, I think, on one hand is appropriate, but on the other hand, I think can be distracting,” he said.
Other potential side effects of the vaccine include severe allergic reactions such as anaphylaxis. Other reactions include rash, itching, hives or swelling of the face. But these treatable side effects typically occur within 15 minutes of vaccination.
Other side effects reported are pain where the shot was injected, fatigue, headache, muscle and joint pain, chills and fever.
The CDC continues to recommend the COVID-19 vaccine for anyone age 12 and older.
“With half of humanity now vaccinated, we know a lot about their safety,” Wohl said. “There’s really very limited reason not to vaccinate a child in this age range. Certainly if there’s been a history of adverse reactions of some sort to other vaccines, to components that are shared between these vaccines and another vaccine. Those are extremely, extremely rare. But I can’t think of a broad group of people who are in this age group who should not get vaccinated.”
How much would vaccinations in this age group improve the overall rate?
According to 2020 population estimates from the CDC, there are 892,945 children in North Carolina ages 5 to 11 that would become eligible for the Pfizer vaccine if authorized by the FDA.
Those children are among the 4,956,746, based on the 2020 population estimates, that are unvaccinated in North Carolina.
As of Friday, 54 percent of all North Carolinians and 63 percent of those eligible, ages 12 and up, are fully vaccinated.
Is this the same vaccine given to adults?
The vaccine that would be given to children ages 5 to 11 would be one-third of the dose given to those age 12 and up.
This may require more or less dilution with each shot, or a different vial or syringe may be used, The New York Times reported.
Young children would still be given two doses, given three weeks apart.
Ben Sessoms, The News & Observer