- A clinical trial showed that the Pfizer-BioNTech COVID-19 vaccine is safe and effective for younger adolescents.
- The Pfizer-BioNTech COVID-19 vaccine has been approved for people over the age of 16.
- The pharmaceutical companies are now asking the FDA to allow vaccinations in children as young as 12.
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Drugmaker Pfizer Inc. and German partner BioNTech asked the Food and Drug Administration (FDA) on April 9 to expand the emergency approval of their COVID-19 vaccine to include its use in adolescents ages 12 to 15.
This comes a week after the drugmakers said in a news release that a phase 3 clinical trial found that the vaccine is safe and effective and produced robust antibody responses in this age group.
The Pfizer-BioNTech vaccine is currently approved in the United States for use in people 16 years or older. This is the age range included in initial clinical trials of the vaccine.
If the FDA expands the emergency use authorization (EUA) to include younger adolescents, it will move the United States closer to achieving herd immunity, according to experts.
Dr. Christina Johns, senior medical advisor for PM Pediatrics, says this is a very exciting development, both for protecting children and for ending the pandemic.
“This means we are one step closer to vaccinating the rest of the population that we need to vaccinate in order to get closer to herd immunity,” she said, “so that we can really defeat this virus.”
The companies plan to request similar authorizations in other countries in the coming weeks, reports Reuters, including in Canada, where the vaccine is approved for use in people 16 years or older.
The Pfizer-BioNTech study of 2,260 younger adolescents released last month found that the vaccine had 100 percent efficacy against symptomatic infection in children ages 12 to 15. This study used the same two-shot regimen that is being used in adults.
The study also found that younger adolescents who received the vaccine produced more coronavirus antibodies than 16- to 25-year-olds in an earlier study. Vaccine side effects were similar to what was seen in this older age group.
The initial clinical trial in people age 16 and older found that the vaccine had 95 percent efficacy at preventing symptomatic COVID-19. Updated data from this trial showed that 6 months after the second dose, the vaccine efficacy remained high, about 91 percent.
While vaccine trials in children were slow to get started, several are now underway.
Pfizer’s pediatric study is enrolling children 6 months to 11 years old. Moderna has an adolescent trial in progress and is recruiting children 6 months to 11 years old for another study. Johnson and Johnson recently expanded testing of its vaccine to include adolescents 12 to 17 years old.
Earlier this month, the University of Oxford paused a trial in children and teens of the vaccine it co-developed with AstraZeneca as regulators review rare cases of blood clots in adults who received the vaccine.
While there’s a good chance that the FDA will grant an EUA for the Pfizer-BioNTech vaccine for younger adolescents before school starts in the fall, results from the other trials will not be available for several months.
An estimated 3.5 million coronavirus infections have occurred in American children, according to the American Academy of Pediatrics (AAP). This represents 13.5 percent of all U.S. cases.
However, “the silver lining of this pandemic is that children are not nearly as affected [by COVID-19] as are adults, especially the elderly,” said Dr. Federico Laham, medical director of pediatric infectious diseases at Orlando Health Arnold Palmer Hospital for Children.
Children’s risk of dying from COVID-19 is very low — under 0.03 percent. The most common complication of the disease, multisystem inflammatory syndrome in children (MIS-C), is also uncommon, occurring in 3,185 children, with
Vaccinating children, though, comes with other benefits.
“Our coverage rate for the COVID-19 vaccines is far from ideal,” said Laham. “Even though there are now more opportunities in the community to get vaccinated, many people have still not signed up to get vaccinated for a number of reasons.”
Herd immunity, also known as community immunity, is the point at which enough people in a population are protected from the virus to block its spread effectively.
Herd immunity also indirectly protects people who have a lower immune response to vaccination — such as those who are immunocompromised — or who can’t be vaccinated for health reasons such as an allergy to the vaccine.
Scientists estimate that to reach herd immunity for the coronavirus, 70 to 90 percent of Americans would need immunity to the virus, either through vaccination — which is the safer route — or through natural infection.
With children making up about 22 percent of the population in the United States, reaching herd immunity without vaccinating children is unlikely.
“Children are definitely part of the puzzle when it comes to transmission in the community,” said Laham. “We do know that they are less likely to transmit the virus, but they do transmit.”
In recent weeks, there has been growing concern that as the country opens and up and vaccines are authorized only for adults, children may be become infected with the B.1.1.7 coronavirus variant, which was first identified in the United Kingdom and is now
So far, there is no indication that this variant makes children sicker. It’s also unclear whether children might spread this variant more easily.
Experts say that vaccinating children — and their teachers — by the end of summer could also allow children to return to in-person school. This will be critical to children’s well-being, says the AAP.
“If we can get the majority of middle and high school students vaccinated over the summer months,” said Johns, “then I think school in the fall can look a lot more like it did before the pandemic.”