Pfizer seeking FDA approval to vaccinate children ages 5 and up

(CN) — A lower dose of the Pfizer-BioNTech Covid-19 vaccine has proved highly safe and effective in kids ages 5 to 11, the pharmaceutical companies said Monday alongside highly anticipated trial results that show the vaccine produced robust antibody responses in children.

“These trial results provide a strong foundation for seeking authorization of our vaccine for children 5 to 11 years old, and we plan to submit them to the FDA and other regulators with urgency,” Albert Bourla, CEO of Pfizer, said in a statement Monday. The companies are expected to ask the Food and Drug Administration for emergency use authorization for this age group by the end of September and soon after seek similar authorizations from European and British regulators.

“We are eager to extend the protection afforded by the vaccine to this younger population, subject to regulatory authorization, especially as we track the spread of the Delta variant and the substantial threat it poses to children,” Bourla continued, noting that pediatric cases of the novel coronavirus have risen since July by about 240% in the U.S., largely driven by the delta variant’s spread.

Neal Goldstein, an assistant professor of epidemiology at Drexel University, said in a phone call Monday that vaccinating school-age children will be an important next step in bringing the pandemic under control. As in-person classes resume, more community transmission is naturally occurring, he noted.

“For a while now, we've seen that children can get sick, and they can spread Covid to others, not only other adults, but other children,” said Goldstein, pointing to research that suggests children are less likely than adults to “super spread,” in other words transmit the virus to many other people.

Goldstein also noted the importance of studying the effectiveness of vaccines in children in trials prior to having children roll up their sleeves.

“Children are not just small adults,” Goldstein explained. “As such, they need their own clinical trials to that weighs the benefits of any kind of medical intervention.

“With them being a vulnerable group," he continued, "there are more protections that need to be put in place, and more rigor and more and more scrutiny that's brought to the to the trial.” Goldstein added that such interventions are typically first proven safe and effective in adults, then teenagers, then children and infants.

Through three trial phases, Pfizer and BioNTech said Monday that they administered a two-dose regimen of the vaccine to approximately 4,500 children between the ages of 6 months and 11 years old in the United States, Finland, Poland and Spain. Vaccine doses were given roughly three weeks apart to three age groups: those age 5 to 11 years; those age 2 to 5 years; and those age 6 months to 2 years.

Those age 5 to 11 years, around 2,268 of the participants, were given around a third of the amount of vaccine already approved for children 12 and older. The results of the study showed that these children still developed antibody levels as strong as teenagers and young adults after two shots. The companies determined how big of a dose to give the children based on the early study results, and noted that children were enrolled in trials “with or without prior evidence of SARS-CoV-2 infection.”

The study is still ongoing as the companies continue to monitor for enough Covid-19 cases to compare infection rates between children who were vaccinated and those where were given a placebo.

Eager to expand its vaccine’s availability to even younger populations of children, the companies said Monday that it could have trial results surrounding whether its vaccine is safe and effective in those under 5 years old as soon as later this year. Children under 5 years old have received an even lower dose dose of the vaccine in trials, around a third of the portion allocated for elementary-age children.

The Pfizer-BioNTech vaccine has now been available to adults for since December 2020, and to children 12 and older since May 2021. Amid the ongoing surge of the virus's more infectious delta variant, however, the United States is averaging around 300 Covid-19 cases in every 100,000 people, according to the Centers for Disease Control and Prevention data. All states are seeing high transmission rates.

Cases have continued to climb back to levels not seen since the fall of 2020 since many children resumed school in August. Becky Pringle, president of the National Education Association, noted in an email Monday that she is hopeful that FDA authorization of the Pfizer-BioNTech’s vaccine for elementary-aged children will make in-person education safer for all those in the school system. 

“Students, parents, and educators alike know that in-person education works best, which is why the National Education Association welcomes early reports about promising Covid-19 vaccine trial results for children as young as 5 years of age,” she said. “NEA looks forward to the day when all students, including those in elementary schools, are eligible for safe and effective COVID-19 vaccines, as that will greatly enhance this country’s ability to ensure that schools truly are the safest place in any community.”

Data showed that the dose level in children 5 to 11 also caused similar or fewer temporary side effects, like soreness at the injection site, fevers or aches, as compared with side effects experienced by teens.

Still, Goldstein expects there might be an initial wave of hesitancy to the vaccine for children 5 through 11.

“We see this with adults, and we will see this with children — mainly because of parents making the decision on behalf of their children,” the epidemiologist said. “We'll also see that different children may not be eligible for vaccination. For example, if they are immunocompromised.”

Goldstein further noted that some subgroups of the 5-11 age group may receive vaccines at lower rates than others.

“But we may see the availability and lack of access to vaccination being a factor here, for example, if a parent needs to take their child to a clinic to be vaccinated and that parent can't get off of work. There may just be barriers to getting vaccinated that if the vaccine clinic was offered at the school itself may help to alleviate some of those things.”

While children were shown in the early days of the pandemic to be less susceptible to Covid-19, cases among them have risen with the rise of the delta variant. In the United States, data collected by the American Academy of Pediatrics indicate that more than 5 million children have tested positive for the virus during the pandemic and at least 460 children have died. A study released last week by the Centers for Disease Control and Prevention revealed that more than three-quarters of all coronavirus deaths in children and adults under 21 were among minorities.

In other countries, like China and Cuba, young children are already being vaccinated. Cuba cleared its state-developed vaccine for those as young as 2 years old earlier this month while China has given the OK to two vaccine distributors for children as young as age 3.

Moderna is expected to release trial results in how its two-shot vaccine works in elementary school-aged children later this year.

Follow Alexandra Jones on Twitter

Follow @@lexandrajones

Subscribe to Closing Arguments

Sign up for new weekly newsletter Closing Arguments to get the latest about ongoing trials, major litigation and hot cases and rulings in courthouses around the U.S. and the world.

Email *

Submit