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Vaccine experts, in a public meeting Tuesday, will weigh the safety and benefits of Pfizer’s COVID-19 vaccine for school-age children.
Based on the independent panel’s recommendations, the Food and Drug Administration and the Centers for Disease Control and Prevention could authorize the shot for the nation’s 28 million children ages 5 to 11 by next week, with smaller needles and a dose that is about one-third of an adult’s dose.
Families would be able to get the shot at pediatricians’ offices, pharmacies and possibly school clinics. With a regular dosing schedule, children could be fully vaccinated by Christmas.
How effective is the Pfizer COVID-19 vaccine for young kids?
An analysis by FDA scientists, released Friday night, concluded that in almost every scenario the vaccine’s benefit for preventing hospitalizations and death from COVID-19 would outweigh any serious potential side effects in children. But agency reviewers stopped short of calling for Pfizer’s shot to be authorized, the Associated Press reported.
A Pfizer study, which has not been peer-reviewed, found that kid-size doses of its COVID-19 vaccine appear safe and nearly 91% effective at preventing symptomatic infections in 5- to 11-year-olds, the Associated Press reported. The shots could begin in early November — with the first children in line fully protected by Christmas — if regulators give the go-ahead.
In an interview with, Dr. Philip Huang, the director of Dallas County Health and Human Services, said that the early data is very encouraging and shows that the vaccine is extremely effective. He said “there’s no question” about the benefit of vaccination for children and their families.
“It’s an exciting time to help protect those who have not been able to be protected thus far,” Dr. Seth Kaplan, a Frisco physician and past president of the Texas Pediatric Society, told The News last week. “This is our chance to really get ahead … and protect the community because as long as there continues to be a reservoir of unvaccinated individuals, the chances of it spreading to more vulnerable members of the community remain higher.”
Dr. Sonja Rasmussen, a University of Florida professor of pediatrics and epidemiology, told the Associated Press that Pfizer’s data is “really reassuring’’ and predicted the FDA and CDC will sign off on the shots. She said it was encouraging to see that the vaccine was effective with a one-third dose. That reduces the chance of sore arms, fever and other mild effects that can occur with any immunization, Rasmussen said.
“I don’t see any red flags here that would have people concerned,’’ said Rasmussen, who wasn’t involved in the research. The results are good news for “so many families out there that are waiting to have the vaccine before the holidays.’’
A Pfizer study tracked 2,268 kids in that age group who got two shots three weeks apart of either a placebo or the low-dose vaccine. Each dose was one-third the amount given to teens and adults.
Researchers calculated the low-dose vaccine was nearly 91% effective, based on 16 COVID-19 cases in youngsters given dummy shots versus three cases among vaccinated children. There were no severe illnesses reported among any of the youngsters, but the vaccinated ones had much milder symptoms than their unvaccinated counterparts.
In addition, young children given the low-dose shots developed coronavirus-fighting antibody levels just as strong as teens and young adults who got regular-strength vaccinations.
For a slightly older age group — teenagers — there have been positive results, researchers said. The CDC reported that the Pfizer vaccine was 93% effective against hospitalization for COVID-19 among 12- to 18-year-olds, The New York Times reported.
How safe is the Pfizer COVID-19 vaccine for young kids?
Dr. James Cutrell, an associate professor of medicine in the division of infectious diseases at UT Southwestern, said during a Dallas Morning News virtual event, that the vaccine appears to be quite effective in kids but that the FDA advisory panel will be looking closely at the safety of the vaccine
Kids aren’t typically at high risk of severe symptoms with COVID-19, so the safety of the vaccine is vitally important. Cutrell said that the FDA is looking for any rare side effects, such as myocarditis, the inflammation of the heart that has been seen in some young men.
Cutrell said that the current data suggests that even given this rare side effect, the vaccine is still beneficial. He noted that COVID-19 can cause heart issues and other severe side effects.
A review by FDA scientists, released Friday night, found no new or unexpected side effects. Those that did occur mostly consisted of sore arms, fever or achiness. However, FDA scientists noted that the study wasn’t large enough to detect extremely rare side effects.
At the urging of federal regulators, Pfizer and Moderna are expanding the size of their clinical trials for children ages 5 to 11 — a precautionary measure designed to detect rare side effects, The New York Times reported.
Researchers estimated that for every million vaccinated boys ages 12 to 17 in the U.S., the shots might cause a maximum of 70 myocarditis cases, but they would prevent 5,700 infections, 215 hospitalizations and two deaths. Studies have also shown that the risk of heart problems after COVID-19 is much higher than after vaccination, according to reporting by Apoorva Mandavilli of The New York Times.
“Hopefully, parents will be comforted by the level of rigor in the studies and the data showing how safe the vaccine is in children,” said Dr. Oni Blackstock, a primary care and HIV physician who recently served as assistant commissioner at the New York City Health Department. Blackstock added that she will be getting her 8-year-old son vaccinated as soon as the shots become available.
What do doctors and researchers say about COVID-19 risks for young kids?
Children run a significantly lower risk than older people of getting seriously ill from COVID-19. By some measures, the risks for unvaccinated kids look similar to the risks for vaccinated people in their 50s, wrote journalist David Leonhardt of The New York Times.
Still, at least 708 youngsters in the U.S. have died from the virus, most of them ages 5 to 18, according to the CDC.
In August and September, COVID-19 ranked as the sixth leading cause of death for children ages 5 to 14, according to an analysis from the Kaiser Family Foundation. Six million U.S. children have been infected, 1 million of them since early September amid the spread of the more contagious delta variant, the American Academy of Pediatrics says.
“While children are less likely to develop severe illness from COVID-19, they are still at risk. In early September, children accounted for nearly 30% of coronavirus cases, and the highly contagious delta variant has sent more children into hospitals and intensive care units in the past few weeks than at any other time during the pandemic,” wrote journalists Tara Parker-Pope and Dani Blum of The New York Times.
“Unvaccinated children, even if they do not become ill, can spread the virus to family members, teachers and others they interact with regularly, including grandparents or others who are at higher risk for severe disease or death,” Parker-Pope and Blum wrote.
Pediatric hospitalizations for COVID-19 rose over the summer as the delta variant spread across the country, increasing nearly five-fold, according to a CDC study.
“When this pandemic started, there was this myth that kids don’t get sick, die or get hospitalized,” Dr. Sangeeta Elhence, a pediatrician at Lake Lewisville Pediatrics, told The News last week. “But the delta variant has totally changed that.”
“Children are still becoming infected because we have not implemented safety protocols adequately or equitably throughout the country,” said Cecilia Tomori, the director of global public health and community health at Johns Hopkins School of Nursing. “Vaccination is the best protection that the children themselves will have.”
Health officials believe that expanding the vaccine drive will not only curb the alarming number of infections in children but also reduce the spread to vulnerable adults.
Erin Carlson, the director of graduate public health programs at the University of Texas at Arlington, told The News that children can transmit to other members of their household, including their caregivers. And that can have tragic consequences: A recent study published in the journal Pediatrics reported that more than 140,000 U.S. children, or about 1 in 500 children, have lost a caregiver during the pandemic.
“It’s very important to slow that chain of transmission by getting [kids] vaccinated,” Carlson said.
Vaccinating children could also help schools stay open and kids get back on track academically, and contribute to the nation’s recovery from the pandemic, the Associated Press reported.
How will the Pfizer COVID-19 vaccine be administered to young kids?
The process of getting shots into children’s arms probably won’t look like it did for adults. In other words, officials said, there probably won’t be mass vaccination sites.
The Associated Press reported that more than 25,000 pediatricians and primary care providers have already signed on to administer COVID-19 vaccine shots to kids. That is in addition to the tens of thousands of pharmacies that are already administering shots to adults. Hundreds of school- and community-based clinics will also be funded and supported by the Federal Emergency Management Agency to help speed putting shots into arms.
Carlson emphasized the need to deliver information and the vaccines in ways that parents trust. She described local pharmacies and pediatricians’ offices as “places we know, we’ve been [to], we trust, we feel comfortable going, and we feel comfortable asking questions.”
The CDC discussed the option of vaccination clinics at schools, but stopped short of endorsing that as a primary way to get kids vaccinated, the AP reported. The guidance also warns health care providers to only use doses that have been prepared especially for kids, and not try to fraction adult doses.
It’s not clear yet how school clinics may play a role in this vaccine rollout, but public health experts say that these efforts will be important.
“We just simply cannot overlook the role that school nurses play in access to health care,” Carlson said. “When you have somewhere between 1 in 3 and 1 in 5 families at any given point in Texas who have no access to health care because they don’t have access to health insurance, the school nurse is the key health care provider [for those kids].”
Tomori said, “Many people don’t actually see health care providers regularly. So the community-based approach and the school-based approach [are] a much more effective way and much more equitable way of getting vaccination to people.”
Tomori added that the expanded eligibility for children could help with mobilizing vaccinations in the adolescent age group. “This would be a great opportunity to do outreach to families and communities,” she said.
There should be more than enough shots. The U.S. has bought 65 million doses of the Pfizer pediatric shot — expected to be one third the dosage for adults and adolescents — according to officials. They will ship in smaller packages of about 100 doses each, so that more providers can deliver them, and they can be stored for up to 10 weeks at standard refrigeration temperatures, the Associated Press reported.