Pfizer/BioNTech Announces Child COVID-19 Vaccine Trial Results

A 15-year-old receives the Pfizer-BioNTech vaccine against the CCP virus in Bloomfield Hills, Michigan, on May 13, 2021. (Jeff Kowalsky/AFP via Getty Images)

Pfizer/BioNTech announced the results of a clinical trial of 5 to 11-year-old children, the pharmaceutical company announced Friday.

The news was released as the company has submitted information to the U.S. Food and Drug Administration (FDA). Pfizer/BioNTech is currently seeking emergency authorization to administer the coronavirus vaccine to children.

Children participating in the clinical trial received a dose of 10 micrograms, an amount that was one-third of the adult dose.

A total of 2,268 children from ages 5 to 11-years-old were included in the trial. Twice as many were given the child-level dose of the vaccine compared to others who received a placebo. Among those who received the placebo, 16 tested positive for COVID-19. Three cases were recorded among those who were administered the trial vaccine.

Pfizer’s clinical trial in those 5 to 11 years old was not primarily designed to measure efficacy against the virus. Instead, it compared the amount of neutralizing antibodies induced by the vaccine in the children to the response of older recipients in their adult trial. The company claims its COVID-19 vaccine usage in children 5-11 years old showed a 90.7 percent efficacy rate.

The Mayo Clinic has also said that there have been reported cases of myocarditis and pericarditis after COVID-19 vaccination, “particularly in male adolescents and young adults age 16 and older.” Myocarditis is the inflammation of the heart muscle, while pericarditis is the inflammation of the lining outside the heart.

A White House Fact Sheet released Wednesday provided an update on advanced plans for COVID-19 vaccinations for children 5 to 11.

“The potential authorization of the first COVID-19 vaccine for children ages 5-11, which is currently under consideration by the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC), would be another major milestone in our efforts to build on this historic progress and protect even more Americans,” the fact sheet said.

The plan included several steps in anticipation of the vaccine’s approval for young children. First, the Biden administration “has procured enough vaccine to support vaccination for the country’s 28 million children ages 5-11 years old.”

Another focus in the fact sheet said that more than 25,000 pediatric and primary care provider sites will be made available to distribute the coronavirus vaccines to children.

The plan’s third focus emphasized building public trust. An educational effort for parents and families will seek to provide detailed information regarding vaccines and the risks of COVID-19 as part of the effort.

The FDA met earlier this month to discuss coronavirus vaccines for younger children. Another meeting is expected next week to discuss the latest information from Pfizer/BioNTech, though details have not yet been confirmed.

For now, the vaccines remain unauthorized for use among young children.

“The FDA has not yet authorized a COVID-19 vaccine for children 5 to 11 years of age, and CDC’s ACIP has not yet made a recommendation on vaccinating this age group,” the Centers for Disease Control and Prevention (CDC) website notes.

Even if the Pfizer/BioNTech vaccine is soon approved, many American parents will have concerns or choose not to have their children vaccinated. The controversy may continue to lead to additional concerns, such as the recent walkout in California after Democrat Gov. Gavin Newsom added a new requirement for children 12 and older to be vaccinated to attend public schools in the state.

According to the CDC, since April, there has been an increase in reports of both myocarditis (heart inflammation) and pericarditis (inflammation of the tissue surrounding the heart) after COVID-19 vaccination with the Pfizer-BioNTech and Moderna vaccines, particularly in adolescents and young adults.

Reuters and Jennifer Margulis contributed to this report.