News
Article
Author(s):
The change is poised to impact countless individuals who may have sought a COVID-19 vaccine this upcoming respiratory season.
The CDC is set to alter its COVID-19 vaccine guidance, no longer recommending that healthy children and pregnant women receive routine COVID-19 vaccinations, according to an announcement from Health and Human Services Secretary Robert F. Kennedy Jr; National Institutes of Health Director Jay Bhattacharya, MD, PhD; and FDA Commissioner Marty Makary, MD, MPH, posted on X (formerly Twitter).1,2
Image Credit: © Katherine Welles - stock.adobe.com
“As of today, the COVID[-19] vaccine for healthy children and healthy pregnant women has been removed from the CDC recommended immunization schedule,” Kennedy said in the announcement.1
Previously, the CDC recommended that everyone 6 months and older receive a routine COVID-19 vaccine, which has been proven effective at reducing the risk of severe illness, hospitalization, and death. The announcement comes on the heels of a new framework implemented by the FDA regarding future COVID-19 vaccine guidance, which will prioritize recommendations for older adults and high-risk groups while requesting new randomized trials investigating the vaccine in a healthy cohort of adults.3,4
It remains to be seen what the impacts of this announcement will be, especially for healthy children and pregnant women who may have intended to receive a routine COVID-19 vaccination this year. Children 17 years or younger are less likely to become seriously ill with COVID-19, with patients from this age group accounting for only 1.5% of those treated in the hospital for COVID-19 between 2020 and 2024. Pregnant individuals often experience mild COVID-19 symptoms while recovering from their infection quickly.5,6
However, even if children are at lower risk of severe disease, other risks are linked to COVID-19 infection, including multisystem inflammatory syndrome in children (MIS-C), which can cause widespread inflammation throughout the organs, or post-COVID-19 syndrome—known as long COVID—which can linger for weeks or months in any infected person regardless of their age.5
Furthermore, the changes induced by pregnancy—including those to the immune system, lungs, and heart—make pregnant individuals at increased risk of getting seriously ill due to COVID-19. The CDC lists pregnancy as an underlying condition that increases a person’s risk of severe illness from COVID-19, corroborated by extensive systematic reviews. According to one such review, conducted by Wei et al, infection with SARS-CoV-2 in pregnancy was associated with increased risk of preeclampsia, preterm birth, and stillbirth compared with noninfected individuals. Additionally, compared with mild COVID-19, severe COVID-19 in pregnancy was associated with gestational diabetes and low birth weight.6-8
For now, access to COVID-19 vaccines for patients in these populations should remain unchanged. Although the CDC will no longer recommend the COVID-19 vaccine for these groups, health care providers may choose to recommend the vaccine for these patients anyway, based on the litany of solid evidence backing their use in these populations. Pharmacists and health care providers should check with local and state health authorities regarding their next steps in vaccinating healthy children or pregnant individuals. In addition, pharmacists will play an important role in counseling patients and their caregivers regarding the shifting guidance and options for the future.
Impacts on the manufacturing process of new COVID-19 vaccines may also be seen. Manufacturers and investigators may need to alter current trial designs of new COVID-19 vaccine candidates to align with the new CDC recommendations, which will be referred to when considering future FDA approvals of these vaccines. Additionally, the FDA has previously authorized numerous COVID-19 vaccines under emergency authority for use in healthy children and pregnant individuals. It remains to be seen if these population-specific authorizations will be revoked or altered in any way.