May 26, 2022, 8:45 a.m. News Staff — The AAFP, following an expedited review of the evidence, has approved a pair of actions taken last week by the FDA and CDC regarding the amendment of an emergency use authorization for the Pfizer-BioNTech COVID-19 vaccine in children.
On May 19, CDC Director Rochelle Walensky, M.D., endorsed a recommendation from the agency’s Advisory Committee on Immunization Practices to allow a single booster dose of the vaccine in children ages 5 through 11 years at least five months after completion of a primary series of the vaccine.
“Vaccination with a primary series among this age group has lagged behind other age groups, leaving them vulnerable to serious illness,” said Walensky. “With over 18 million doses administered in this age group, we know that these vaccines are safe, and we must continue to increase the number of children who are protected. I encourage parents to keep their children up to date with CDC’s COVID-19 vaccine recommendations.”
Walensky’s endorsement followed an 11-1 vote (with one abstention) from ACIP earlier in the day to approve a measure stating that a single booster dose of the vaccine should be recommended for children ages 5 to 11 years at least five months after the primary series of COVID-19 vaccinations has been completed.
The CDC also announced that it has strengthened its recommendation that people age 50 years and older, and individuals 12 years and older with certain immunocompromising conditions (such as solid organ transplantation or living with conditions that are considered to have an equivalent level of immunocompromise), should receive a second booster dose of either the Pfizer-BioNTech or Moderna COVID-19 vaccine at least four months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine.
“It is important to remember that COVID-19 can cause serious illness in children and that vaccination is the best defense against serious COVID-19 infection,” Pamela Rockwell, D.O., of Ann Arbor, Mich., the AAFP’s liaison to the ACIP, told AAFP News.
“Since 2020, COVID-19 has been a significant cause of death in children ages 5 to 11 years with over 4.8 million cases and over 15,000 hospitalizations in this age group to date,” Rockwell added. “Data presented at the ACIP meeting clearly showed that booster doses in this age group can help prevent further serious illnesses and death due to COVID-19 infection. I recommend all children age 5 years and older and all adults be vaccinated with a COVID-19 primary vaccination series and receive a booster dose when eligible.”
The CDC’s endorsement followed a May 17 regulatory action from the FDA to amend the EUA for the Pfizer-BioNTech vaccine.
“The FDA is authorizing the use of a single booster dose of the Pfizer-BioNTech COVID-19 vaccine for children 5 through 11 years of age to provide continued protection against COVID-19,” explained FDA Commissioner Robert Califf, M.D., in a news release issued the same day. “Vaccination continues to be the most effective way to prevent COVID-19 and its severe consequences, and it is safe. If your child is eligible for the Pfizer-BioNTech COVID-19 Vaccine and has not yet received their primary series, getting them vaccinated can help protect them from the potentially severe consequences that can occur, such as hospitalization and death.”
The FDA’s May 17 action further amended an EUA issued by the agency on Jan. 3, 2022.
Under the Jan. 3 EUA, the FDA authorized the use of a single booster dose of the Pfizer-BioNTech vaccine for administration in individuals ages 12 to 15 years at least five months after completing primary vaccination. The May 17 action expands the use of a single booster dose to include children ages 5 through 11 years.
The latest actions by FDA and CDC come amid recent increases in COVID-19 cases and hospitalizations throughout much of the United States. According to the CDC’s COVID Data Tracker, there was an average of 106,358 cases of COVID-19 per day for the week ending May 21, 2022, compared with a low of 46,644 cases per day for the week ending April 23.
More than 83 million cases of COVID-19 have occurred in the United States, and more than 1 million deaths have been attributed to the disease, as of May 25.
In related news, the FDA on May 23 revised two meeting dates for the Vaccines and Related Biological Products Advisory Committee with regard to COVID-19 vaccines. Under the new schedule
These dates are based on expected completion of EUA submissions.