The vaccine is safe, extremely effective for kids, and crucial to defeating the virus that has plagued North Carolina since early 2020.
Perhaps parents of young children can now exhale.
A key Centers for Disease Control and Prevention panel gave the final go-ahead Tuesday for children 5-11 years old to get the Pfizer COVID-19 vaccine. Approval from the federal agency’s director followed hours later Tuesday.
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North Carolina health officials say they are well-prepared for the rollout, and could start delivering the doses by the end of this week.
Dr. Mandy Cohen, the head of NC’s Department of Health and Human Services, said in a news conference on last week that the state was slated to get 400,000 doses this week, and had established 750 locations across the state’s 100 counties, including in underserved communities, where people can get their shots.
“There is plenty of supply,” Cohen said
But parents no doubt have questions about the safety and effectiveness of the vaccine for their younger children. So here’s what you need to know:
Is It Safe?
In its review process of the clinical trials for 5-11 year olds, the FDA found that the side effects were “mostly mild or moderate” and were in line with what was seen with older recipients. The most common side effects included fatigue, headache and a sore arm.
“There were no serious adverse events related to the vaccine,” the FDA found.
And that included the most concerning adverse side effect so far, myocarditis. Myocarditis, the inflammation of the heart muscle, is a rare but potentially serious side effect associated with the mRNA vaccines, of which Pfizer is one.
It is most common, several studies and health officials say, in males aged 16 to 30. But it is “exceedingly rare” overall, said Dr. Emmanuel Walter Jr., a pediatrician and chief medical officer at the Duke Human Vaccine Institute who helped lead the clinical trials reviewed by FDA
Most importantly, Walter and other health officials say, the risk of developing myocarditis is far, far greater from a COVID infection than it is from getting the vaccine.
“Not all myocarditis is the same,” Walter said in a news conference last week. “Myocarditis from COVID is usually quite severe and makes people quite ill and causes a prolonged hospitalization,” he said. “The myocarditis that we’ve been seeing after vaccine is generally fairly mild,” he added, “and is easily treated once it’s recognized.”
More than 3,000 children got the vaccine in the trial. None of them got myocarditis.
Is It Effective?
The trial showed that the vaccine was 90.7% effective in preventing symptomatic COVID-19 in the 5-11 year olds, the FDA said. Like all the COVID vaccines, it was even better at preventing severe illness.
Also like the original doses of the Pfizer vaccine, the doses for 5-11 year olds will come in two shots given three weeks apart. But each shot will be only a third of the dosage given to every other age group.
The height, weight and other physiological differences among such a wide age range shouldn’t affect the effectiveness of the vaccine, Walter said.
“You might have some small 5-year-olds and some rather large 12-year-olds,” Walter said, “but the immune response will be adequate for those kids.”
Where Can You Get the Shot?
The vaccines will go in large part to pharmacies and pediatricians’ offices where parents will be most comfortable, Cohen said. NC health officials are also working to ensure the vaccines are distributed fairly throughout the state’s 100 counties. There will also be some mass-family oriented events throughout the state, she said.
Parents in NC can go to myspot.nc.gov to find a location offering the vaccine.
Do Kids Really Need the Vaccine?
Younger children are less likely to develop severe illnesses from a CVOID infection, but because the Delta variant is so much more contagious than earlier strains, far more children are getting infected. Which means far more have also been going to the hospital.
“With this current delta surge,” Walter said, “children now account for about 25%of reported cases of COVID.”
He added: “When I last looked the other day there had been 750 deaths from COVID in children under age 18, [in the U.S.] and 160 deaths in this age group for which we’re now considering approval or authorization of the vaccine.”
Those numbers, he said, are much higher than the death toll from the flu in a typical year.
So far, children ages 12-17 remain the least vaccinated age group in North Carolina.
Though the overall number of cases and hospitalizations are decreasing now, the CDC says that all but two NC counties are still seeing high or substantial spread of COVID-19. Vaccinating 5-11 year olds, who make up 20% of the state’s population, is a huge part of the plan to bring overall transmission rates down.
“Right now every unvaccinated person is another foothold allowing this virus to regain strength,” Gov. Roy Cooper said last week.
While the Pfizer vaccine is the only one approved so far for children, federal officials are also looking at preliminary data from Moderna’s trials in the same age-group. Trials are also underway now for vaccines in younger children. Walter said those results could be available soon and that he expected they could be approved sometime early next year.