FDA authorizes emergency use of the Pfizer COVID-19 vaccine for children ages 5 through 11

Photo: Roberto Jimenez Mejias/Getty Images

The U.S. Food and Drug Administration on Friday authorized the emergency use of the Pfizer-BioNTech COVID-19 vaccine for children ages 5 through 11.

The Centers for Disease Control and Prevention must sign off on the vaccines before they can be distributed, but that could begin as early as this week. The CDC's Advisory Committee on Immunization Practices will meet Tuesday to discuss further clinical recommendations, the FDA said.

The vaccine will be administered as two doses three weeks apart. Each is a third of the dose used for individuals ages 12 and older. 

Authorization was based on the 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 this age group, the FDA said.

WHY THIS MATTERS

Vaccinating younger children against COVID-19 brings the United States closer to returning to a sense of normalcy, said Acting FDA Commissioner Dr. Janet Woodcock.

The vaccine is 90.7% effective in preventing COVID-19 in children 5 through 11, according to the FDA. The immune responses of children in this age group are comparable to those of individuals ages 16 through 25. The vaccine's safety was studied in approximately 3,100 children ages 5 through 11, and no serious side effects were detected.

In the U.S., COVID-19 cases in children 5 through 11 years of age make up 39% of cases in individuals younger than 18 years of age. According to the CDC, approximately 8,300 COVID-19 cases in children 5 through 11 years of age resulted in hospitalization. 

As of October 17, 691 deaths from COVID-19 were reported in the U.S. in individuals younger than 18, with 146 deaths in the 5 through 11 age group.  

The FDA has determined that, based on the totality of scientific evidence available, the known and potential benefits of the Pfizer vaccine in individuals down to 5 years of age outweigh the known and potential risks. 

THE LARGER TREND

Vaccine hesitancy in the United States remains a concern for healthcare officials looking to reach herd immunity against the coronavirus.  An estimated 57.8% of the population, as of October 26, is fully vaccinated, according to the Mayo Clinic.

Regarding all of the COVID-19 vaccines available, serious adverse events after vaccination are rare but may occur, according to the CDC, reporting on October 26. These include anaphylaxis, thrombosis with thrombocytopenia syndrome (TTS) after the Johnson & Johnson's vaccination, Myocarditis, and Pericarditis.

Reports of death after COVID-19 vaccination are rare. More than 414 million doses of COVID-19 vaccines were administered in the United States from December 14, 2020, through October 25. During this time, the Vaccine Adverse Event Reporting System (VAERS), which is a self-reporting system, received 9,143 reports of death (0.0022%) among people who received a COVID-19 vaccine.

The FDA requires healthcare providers to report any death after COVID-19 vaccination to VAERS, even if it's unclear whether the vaccine was the cause. Reports of adverse events to VAERS following vaccination, including deaths, do not necessarily mean that a vaccine caused a health problem, the CDC said.

ON THE RECORD

"The FDA is committed to making decisions that are guided by science that the public and healthcare community can trust," said Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research. "We are confident in the safety, effectiveness and manufacturing data behind this authorization.

"As part of our commitment to transparency around our decision-making, which included our public advisory committee meeting earlier this week, we have posted documents today supporting our decision and additional information detailing our evaluation of the data will be posted soon. We hope this information helps build confidence of parents who are deciding whether to have their children vaccinated." 
 

Twitter: @SusanJMorse
Email the writer: susan.morse@himssmedia.com