The American Academy of Pediatrics (AAP) has issued a strong response following a decision by a federal advisory committee to remove COVID-19 vaccines from the recommended routine immunization schedules for healthy children and pregnant people. The AAP warns that this move disregards established scientific review processes and could increase health risks for vulnerable populations.
“This decision bypasses a long-established, evidence-based process used to ensure vaccine safety and ignores the expertise of independent medical experts, including members of CDC committees who are examining the evidence regarding the vaccine to make recommendations for the fall,” said Sean T. O’Leary, M.D., M.P.H., FAAP, chair of the AAP Committee on Infectious Diseases.
The statement comes after Health and Human Services Secretary Robert F. Kennedy Jr. announced the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) will no longer recommend routine COVID-19 vaccination for healthy children and pregnant people.
The announcement bypassed the CDC’s usual process, which involves review and voting by an independent panel of vaccine experts. Historically, the CDC director has almost always deferred to this panel before making changes to vaccine recommendations.
Kennedy’s move was announced via a video statement on X alongside FDA Commissioner Martin Makary, M.D., M.P.H., and NIH Director Jay Bhattacharya.
Kennedy cited a lack of any clinical data to support the repeat booster strategy in children as a key rationale for the change.
While the risk of severe COVID-19 is lower in healthy children than in adults, vaccination still provides meaningful protection, especially for those with underlying health conditions or other risk factors.
Clinical trials and real-world data show that COVID-19 vaccines are effective in preventing symptomatic infection and, more importantly, severe illness and hospitalization in children. Vaccination also reduces the risk of long COVID in children.
Major medical organizations, including the American College of Obstetricians and Gynecologists, continue to recommend COVID-19 vaccination for pregnant people, emphasizing that the benefits far outweigh any potential risks.
Vaccination during pregnancy is highly effective at reducing the risk of severe illness, hospitalization, and death from COVID-19. It also lowers the risk of adverse outcomes such as stillbirth and preterm birth. Additionally, antibodies generated by the vaccine can cross the placenta, providing newborns with some protection during their first months of life, a period when they are particularly vulnerable to severe COVID-19.
Kennedy, who has been critical of the COVID-19 vaccine that was funded by the first Trump administration, called for new vaccines to undergo placebo testing earlier this month.
The new policy would mandate that, before vaccines can be authorized for use in people, they must be tested in studies where half of the participants receive a placebo, typically a saline injection, allowing researchers to directly compare outcomes between those who receive the vaccine and those who do not.
Placebo-controlled trials are a standard method for establishing the safety and efficacy of new vaccines, but many experts caution that using placebos is ethically questionable when an effective vaccine is already available.
The FDA followed this line of thinking by mandating large, randomized, placebo-controlled clinical trials placebo-controlled trials for the evaluation of any new COVID-19 vaccines. This decision could affect the availability of COVID vaccines next fall.
The mRNA-based vaccines (such as Pfizer-BioNTech and Moderna) showed efficacy rates of about 94–95% in preventing symptomatic COVID-19 in large phase III trials. Adenovirus-vectored vaccines (such as AstraZeneca and Johnson & Johnson) also performed well, with efficacy rates ranging from 66% to over 80%, depending on the specific vaccine and population studied.
Real-world studies have confirmed these high levels of protection. For example, three doses of mRNA vaccines provided nearly 89% effectiveness against death from COVID-19 and about 77% effectiveness against hospitalization, even during periods when more transmissible variants were circulating. Booster doses have been shown to restore waning immunity to robust levels.
Vaccinated individuals who do become infected are less likely to develop Long COVID compared to those who are unvaccinated.
The FDA will continue to approve updated COVID-19 vaccines for seniors (65+) and individuals with underlying medical conditions that increase the risk of severe illness, such as diabetes, obesity, or immunocompromise. Pregnant people with additional risk factors may still be eligible for vaccination, but the government will no longer issue a blanket recommendation for all pregnancies.
Major medical organizations, including the American College of Obstetricians and Gynecologists, continue to recommend COVID-19 vaccination for pregnant people, emphasizing that the benefits far outweigh any potential risks.
Vaccination during pregnancy is highly effective at reducing the risk of severe illness, hospitalization, and death from COVID-19. Additionally, antibodies generated by the vaccine can cross the placenta, providing newborns with some protection during their first months of life, a period when they are particularly vulnerable to severe COVID-19.
