FDA OKs Pfizer Coronavirus Vax For Kids 5 to 11

LONG ISLAND, NY — Children ages 5 through 11 could soon be eligible to receive the Pfizer-BioNTech COVID-19 vaccination, after the U.S. Food and Drug Administration authorized the emergency use Friday.

The Centers for Disease Control and Prevention has to green light the effort before shots can be administered to children.

The authorization was based on the FDA’s "thorough and transparent evaluation" of the data that included input from independent advisory committee experts who "overwhelmingly" voted in favor of making the vaccine available to children in the age group, the FDA said.

The move will open the doors for vaccinations for 28 million children in the United States. The CDC's advisory committee on immunization practices will meet next week to discuss.

According to the FDA, in terms of effectiveness, immune responses of children 5 through 11 years of age were comparable to those of people 16 through 25. In addition, the vaccine was found to be 90.7 percent effective in preventing COVID-19 in children 5 through 11, the FDA said.

The vaccine’s safety was studied in about 3,100 children age 5 through 11 who received the vaccine and no serious side effects have been detected in the ongoing study, the FDA said.

“As a mother and a physician, I know that parents, caregivers, school staff, and children have been waiting for today’s authorization. Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy,” said Acting FDA Commissioner Janet Woodcock, M.D. “Our comprehensive and rigorous evaluation of the data pertaining to the vaccine’s safety and effectiveness should help assure parents and guardians that this vaccine meets our high standards.”

The Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age is administered as a two-dose primary series, three weeks apart, but is a lower dose — 10 micrograms — than that used for individuals 12 years of age and older, which 30 micrograms.

In the U.S., COVID-19 cases in children 5 through 11 years of age make up 39 percent of cases in individuals younger than 18 years of age, the FDA said. According to the CDC, about 8,300 COVID-19 cases in children 5 through 11 years of age resulted in hospitalization. As of Oct. 17, 691 deaths from COVID-19 have been reported in the U.S. in individuals less than 18 years of age, with 146 deaths in the 5 through 11 age group.

The FDA said Friday that it has determined the Pfizer vaccine has met the criteria for emergency use authorization. Based on scientific evidence, the known and potential benefits of the Pfizer-BioNTech COVID-19 vaccine in individuals down to 5 years of age outweigh the known and potential risks, the FDA said.

According to the FDA, the effectiveness data to support the EUA in children down to 5 years of age is based on an ongoing randomized, placebo-controlled study that has enrolled approximately 4,700 children 5 through 11 years of age.

The study is being conducted in the U.S., Finland, Poland and Spain.

Children in the vaccine group received two doses of the Pfizer-BioNTech COVID-19 vaccine containing 10 micrograms of messenger RNA per dose. The FDA analyzed data that compared the immune response of 264 participants from this study to 253 participants 16 through 25 years of age who had two higher doses of the vaccine in a previous study which determined the vaccine to be effective in preventing COVID-19.

The FDA also discussed the available safety data to support the EUA, which includes more than 4,600 participants — 3,100 vaccine, 1,538 placebo — ages 5 through 11 years enrolled in the ongoing study. In this trial, a total of 1,444 vaccine recipients were followed for safety for at least two months after the second dose.

Commonly reported side effects in the clinical trial included sore arms, redness and swelling, fatigue, headache, muscle and/or joint pain, chills, fever, swollen lymph nodes, nausea and decreased appetite. More children reported side effects after the second dose than after the first dose. Side effects were generally mild to moderate in severity and occurred within two days after vaccination, and most went away within one to two days, the FDA said.

Some concerns have been expressed due to the fact that the FDA and CDC safety surveillance systems have previously identified increased risks of myocarditis, or inflammation of the heart muscle, and pericarditis — inflammation of tissue surrounding the heart — following vaccination with Pfizer-BioNTech COVID-19 vaccine, particularly following the second dose, and with the observed risk highest in males 12 through 17 years of age.

To that end, the FDA said it conducted its own benefit-risk assessment using modeling to predict how many symptomatic COVID-19 cases, hospitalizations, intensive care unit admissions and deaths from COVID-19 the vaccine in children 5 through 11 years of age would prevent versus the number of potential myocarditis cases, hospitalizations, ICU admissions and deaths that the vaccine might cause. The FDA’s model predicts that overall, the benefits of the vaccine would outweigh its risks in children 5 through 11.

In recent days, Gov. Kathy Hochul urged parents to call their pediatricians to set up appointments before the "crush of interest" ensues.

With the holiday season approaching, beginning with Halloween, the CDC released new guidance recently on how to stay safe with the delta variant still a concern.

"Hopefully, this will be the last Halloween when parents should have to worry about trick-or-treating or head to the mall and wonder if Santa has been vaccinated," Hochul said. "We know the answer is within our reach."

Earlier in October, Pfizer-BioNTech asked the U.S. Food And Drug Administration to green light the use of its two-dose COVID-19 vaccine in children between the ages of 5 to 11.

Hochul said that could happen as soon as early-to-mid November.

"I expect there could be a crush of interest in this," she said. "I want to be sure doctors' officers are ready."

Hochul planned to speak to the New York State chapter to the American Academy of Pediatrics and set up engagement webinars with pediatricians. Schools, she said, are also the answer; the state is focusing on connecting schools to provider partners and community organizations, providing outreach and educational materials, and planning for ways to vaccinate kids, including in schools.

"We want to make this as easy as possible," Hochul said.

To parents, she said, "Make your pediatrician appointments now — you don't want the first available appointment to be in February."

Hochul said mass vaccinations sites will be opened but as a mother, she understood that most parents would feel more comfortable with their own pediatrician.