• Officials from the Trump administration have decided to stop advocating COVID-19 vaccinations for individuals below 65, pregnant individuals, and healthy children.

  • New versions of the COVID-19 vaccine must now pass placebo-controlled clinical trials before they are approved, potentially restricting their availability.

  • Health experts criticize the decision to remove pregnant individuals and children from the recommended vaccination groups as lacking foresight.

This autumn, if you are under 65 and in good health, you might find it challenging to receive a COVID-19 vaccine.

On the social media platform X, the Secretary of Health and Human Services, Robert F. Kennedy Jr., stated that the CDC would no longer suggest the updated COVID-19 vaccines for healthy pregnant women and children.

Following a statement by the FDA in a New England Journal of Medicine article, the CDC revised its guidelines, reserving COVID-19 vaccines primarily for older adults and those with underlying health conditions.

“The swift creation of various COVID-19 vaccines in 2020 was a significant achievement in science, medicine, and regulation. However, the value of additional doses for low-risk individuals, who may have received several vaccine doses or experienced multiple COVID-19 infections—or both—is not well defined,” noted the FDA officials.

Monica Gandhi, MD, a medical professor at the University of California, San Francisco, agrees that not everyone requires vaccination. However, she believes the recommendations should cover a broader group.

“Excluding healthy pregnant women from those who need the vaccine was not a preference of mine,” Gandhi expressed to Healthline.

“While I concur that healthy children with prior immunity do not need the vaccination, those without such immunity should be vaccinated against COVID-19,” she added.

Moreover, FDA representatives have directed vaccine manufacturers to focus their COVID-19 vaccines on the LP.8.1 strain, a variant of Omicron first identified in July 2024.

Yet, they have also demanded that new vaccines undergo placebo-controlled clinical trials, a process not previously required for recent vaccine updates. As a result, the approval of new vaccines could take years.

Gandhi has raised ethical concerns regarding this new requirement.

“The initial COVID-19 vaccine trials, such as those for Moderna and Pfizer, were placebo-controlled because no prior vaccines were available, making the use of a placebo ethical,” she explained.

“Now that we have established COVID-19 vaccines, it would be unethical to compare a new vaccine to a placebo in vulnerable individuals, like the elderly, when a prior vaccine formulation could serve as a control,” she concluded.

Vaccination During Pregnancy Offers Critical Protection

Despite the new guidelines, the CDC still identifies pregnancy as a condition that elevates the risk of severe COVID-19, alongside other health issues like asthma and diabetes.

A study published in JAMA in April 2025 showed that maternal mortality rates in the U.S. remained stable from 2000 to 2020 but surged in 2021 during the peak of the COVID-19 outbreak.

Reports also suggest that COVID-19 heightens the risk of complications during pregnancy and that pregnant individuals are more likely to experience severe illness from the virus.

G. Thomas Ruiz, MD, a senior OB-GYN at MemorialCare Orange Coast Medical Center in California, commented on the elevated risks during pregnancy due to the immune-compromised state it induces.

“The updated recommendations are both shortsighted and irresponsible,” he told Healthline.

The American College of Obstetricians and Gynecologists (ACOG) also voiced their concerns.

“We are deeply troubled and disappointed by the HHS’s decision to no longer recommend COVID-19 vaccines during pregnancy,” said ACOG president Steven Fleischman, MD. “As practitioners, we’ve seen how severe COVID-19 can be for pregnant women and their newborns, who rely on maternal antibodies from the vaccine for protection.”

William Schaffner, MD, an expert in infectious diseases and a professor at Vanderbilt University in Tennessee, also supports vaccination during pregnancy.

“The vaccine not only protects the mother but also extends some protection to the newborn through the placenta during the first months of life,” he explained to Healthline.

Vaccinations Recommended from Six Months Onward

In 2022, the CDC included the COVID-19 vaccine in its immunization schedule for children starting at six months of age.

The agency emphasizes that vaccination can prevent serious illness in children, with a recommendation for everyone aged six months and older.

The American Academy of Pediatrics noted that during the 2024-2025 respiratory virus season, over 11,000 children were hospitalized due to COVID-19, with the majority being under five years old.

“Removing these recommendations could deprive families of their choice,” stated Sean O’Leary, MD, chair of the AAP Committee on Infectious Diseases. “It could affect insurance coverage and accessibility. It’s clear that pregnant women, infants, and young children are at a higher risk of hospitalization from COVID, and the vaccine’s safety is well-documented.”

Danelle Fisher, MD, a pediatrician at Providence Saint John’s Health Center in Santa Monica, CA, mentioned she would continue to recommend the COVID-19 vaccine to parents.

“I believe these new guidelines aren’t scientifically grounded. COVID-19 remains a threat in these groups, which concerns me,” Fisher commented to Healthline.

She also expressed worry about vaccine availability due to the new guidelines, potentially affecting those parents who choose to vaccinate their children.

“This is a major worry for me,” she added. “We can only recommend what we have available to offer.”

Availability of COVID-19 Vaccines This Autumn

The revised U.S. policy on COVID-19 vaccinations aligns more closely with European standards.

Experts warn that the new guidelines may make it difficult for younger, healthy Americans to obtain the updated vaccine if they choose to do so.

They also note that vaccine producers might reduce production due to the new restrictions.

Additionally, insurance companies might not cover the vaccination costs for those who do not fall under the CDC and FDA guidelines, experts explained to Healthline.

The CDC lists the current price for Pfizer or Moderna COVID-19 vaccines at about $150.

However, Ruiz mentioned that the price could skyrocket to between $500 and $1,000.

“This could make the vaccine prohibitively expensive,” he stated.

He fears that the cost, coupled with the new guidelines, could deter many from getting vaccinated.

“The vaccine should be accessible to anyone who desires it,” he remarked.

Ruiz, along with Schaffner, will continue to recommend updated vaccines, especially during the respiratory virus season.

“Certainly, anyone in a high-risk category should take advantage of the protection offered by the COVID vaccine this fall. COVID hasn’t gone away, and we expect another surge this winter,” Schaffner added.

Fisher emphasized that vaccines for COVID-19, influenza, and other diseases are simply practical choices.

“I’d rather prevent a disease than deal with its consequences,” she noted.