Pfizer said Monday that its COVID-19 vaccine works for children ages 5 to 11 and that it will shortly request a U.S. approval for this age group – a key step towards starting vaccinations for young people.
The vaccine, manufactured by Pfizer and its German partner BioNTech, is already available to anyone aged 12 and over. But now that kids are back in school and the extra-infectious delta variant is causing a huge spike in childhood infections, many parents are eagerly awaiting vaccinations for their youngest children.
For primary school children, Pfizer has tested a much lower dose — a third of the amount found in every vaccine made today. However, after taking the second dose, children aged 5 to 11 have antibodies to coronavirus as high as teens and young adults, Dr. Bill Gruber, senior vice president of Pfizer, told The Associated Press.
The pediatric dosage has also been found to be safe, with similar or fewer temporary side effects such as pain in the arms, fever, or pain experienced by adolescents, he said.
“I think we really hit the middle ground,” said Gruber, who is also a pediatrician.
Gruber said the companies intend to apply to the FDA by the end of the month for emergency use in this age group, and then file applications with European and UK regulators shortly thereafter.
Earlier this month, FDA chief Dr. Peter Marks told AP that once Pfizer releases the results of its research, his agency will evaluate the data “hopefully within a few weeks” to decide if the injections are safe and effective enough for young children.
Many Western countries have so far vaccinated children at least 12 years of age, awaiting evidence that the dose is correct and that it is safe for young children. But last week, Cuba began immunizing children as young as two with homemade vaccines, and Chinese regulators have approved vaccinations of two of its brands before age three.
Although children are at a lower risk of severe illness or death than older adults, more than 5 million children in the United States have tested positive for COVID-19 since the start of the pandemic, and at least 460 children have died, according to the American Academy of Pediatrics. The incidence of children has skyrocketed as the delta variant spread throughout the country.
“I feel an urgent need” to make the vaccine available to children under 12, Gruber said. “There is a deferred demand for parents so they can get their children back to normal.”
In New Jersey, 10-year-old Maya Huber asked why she couldn’t get vaccinated like her parents and both teenage brothers. Her mother, Dr. Nisha Gandhi, an intensive care physician at Englewood Hospital, included Maya in the Pfizer study at Rutgers University. But the family did not weaken the camouflage and other virus protection measures until they knew whether Maya received a real vaccine or a fake vaccine.
As soon as she knows that she is under protection, Maya’s first goal is to “spend the night with all my friends.”
Maya said it was exciting to participate in the study, even though she was “very afraid” of getting hit. But “after you get it, at least you feel happy you did it and you feel relieved it didn’t hurt,” she told AP.
Pfizer said it studied the lower dose in 2,268 kindergarten and primary school children. The FDA has called for a so-called immune bridge study: evidence that young children develop antibody levels that have already been shown to be protective in adolescents and adults. This was announced by Pfizer on Monday in a press release, not in a scientific publication. Research is still ongoing. continues, and there have not yet been enough COVID-19 cases to compare rates between vaccinated and placebo recipients – something that may provide additional evidence.
The study is not large enough to detect any extremely rare side effects, such as inflammation of the heart, which sometimes occurs after the second dose, mostly in young adults. FDA Marks said pediatric research needs to be large enough to rule out any higher risk to young children. Pfizer’s Gruber said that once the vaccine is approved for young children, they will be closely monitored for rare risks like everyone else.
The second US vaccine manufacturer, Moderna, is also looking into vaccinations for primary school children. Pfizer and Moderna are also studying young children up to 6 months of age. Results are expected later this year.