New federal guidance surrounding COVID vaccine authorization could make it more difficult for many people to be inoculated against the circulating — and, now, seasonally spiking — coronavirus.
Under the approval for the updated COVID-19 vaccines issued this week by the Food and Drug Administration, adults younger than 65 who are otherwise healthy would need to consult with a healthcare provider before getting the shot.
It’s the latest move by U.S. Health and Human Services Secretary Robert F. Kennedy Jr., a vaccine skeptic, and his allies aimed specifically at COVID vaccines, which were developed during President Trump’s first term in an effort dubbed Operation Warp Speed.
It also came just hours before the Trump administration said it had fired the director of the U.S. Centers for Disease Control and Prevention, Susan Monarez, who was just confirmed to the post by the U.S. Senate 29 days earlier.
Monarez was forced out after Kennedy and other officials asked her if she was aligned with efforts to change vaccine policy, and she declined to agree without consulting her advisors, the Washington Post reported Wednesday.
“Secretary Kennedy and HHS have set their sights on weaponizing public health for political gain and putting millions of American lives at risk,” Monarez’s attorneys, Mark S. Zaid and Abbe David Lowell, said in a statement posted on social media. “When CDC Director Susan Monarez refused to rubber-stamp unscientific, reckless directives and fire dedicated health experts, she chose protecting the public over serving a political agenda.”
White House press secretary Karoline Leavitt said the lawyers’ comments “made it abundantly clear … that she was not aligned with the president’s mission to Make America Healthy Again.”
“So the president fired her, which he has every right to do,” Leavitt said.
Sen. Bill Cassidy (R-La.), a physician who chairs the Senate’s Health committee and was a critical vote in confirming Kennedy as HHS secretary, urged that the Sept. 18 meeting of the CDC’s Advisory Committee on Immunization Practices be indefinitely postponed given the upheaval at the agency.
“If the meeting proceeds, any recommendations made should be rejected as lacking legitimacy given the seriousness of the allegations and the current turmoil in CDC leadership,” Cassidy said in a statement.
That committee, as well as the CDC director, plays a major role in setting vaccine recommendations for the American public. Kennedy fired all 17 of the panel’s members earlier this year, replacing them in some cases with people who have criticized vaccines and spread misinformation, according to the Associated Press.
The moves come as COVID activity has increased this summer both in California and nationwide, with waning immunity from earlier vaccinations and previous infections cited as one factor.
In a post on X, Kennedy said the guidance would “keep vaccines available to people who want them, especially the vulnerable,” while demanding additional research.
“The American people demanded science, safety, and common sense,” he wrote. “This framework delivers all three.”
Some public health experts, however, criticized the move — saying it does not make sense to change the authorization guidelines this way.
“The nightmare continues,” said Dr. Peter Chin-Hong, an infectious disease expert at UC San Francisco. He said that requiring people to speak with a healthcare provider before getting a COVID-19 vaccine is “completely wrong” and a “barrier,” and he expects it will make it harder for those who don’t have a regular healthcare provider to get vaccinated.
Further reducing vaccine coverage will make it easier for COVID to spread, critics say — putting more people at risk not just of acute illness, but potentially of the enduring syndrome known as long COVID.
And while the FDA guidance does not require higher-risk individuals to themselves consult with a physician before getting a COVID vaccine, it does not extend that same latitude to younger adults — even those who regularly interact with, or take care of, older or sicker individuals. This, too, could needlessly expose at-risk Americans, critics say.
The Infectious Diseases Society of America on Wednesday said the FDA’s decision “completely contradicts the evidence base, severely undermines trust in science-driven policy and dangerously limits vaccine access, removing millions of Americans’ choice to be protected and increasing the risk of severe outcomes from COVID.”
The CDC, which like the FDA falls under Kennedy’s purview, earlier this year began requiring parents of healthy children to talk with a healthcare provider before getting the COVID vaccine for their youngsters.
Chin-Hong said he had heard that this policy had led some pharmacists to stop vaccinating those children.
“They don’t want to do it,” Chin-Hong said, “because they don’t know, in this environment, if they would be considered a ‘healthcare provider.’ ”
In a rebuke to the CDC’s guidance, the American Academy of Pediatrics last week said it recommends infants and children ages 6 months to 23 months get the updated COVID vaccine, since they are at high risk of severe illness. The vaccine should also be offered to children age 2 and older if their parent wishes, according to the organization.
In the face of the continued push to alter federal vaccine guidance, some CDC officials did resign Wednesday, including Dr. Demetre Daskalakis, director of the National Center for Immunization and Respiratory Diseases. He criticized recent changes in the CDC immunization schedule for children, as well as pregnant women.
“All of these moves are chilling, but they all are consistent in one thing, which is really increasing doubts and confusion about vaccines in general and public health,” Chin-Hong said.
The CDC had long urged pregnant women to stay up-to-date on COVID-19 vaccines but, earlier this year, began saying it offers “no guidance” as to whether healthy pregnant women should get the vaccine. The American College of Obstetricians and Gynecologists last week recommended that people receive the updated COVID-19 vaccine at any point during their pregnancy.
The new CDC policy, critics contend, has made it more difficult for pregnant women to get vaccinated.
In a resignation message posted on X, Daskalakis wrote that recent changes in the CDC immunization schedule for adults and children “threaten the lives of the youngest Americans and pregnant people.”
“I have never experienced such radical non-transparency, nor have I seen such unskilled manipulation of data to achieve a political end rather than the good of the American people,” Daskalakis said of efforts to support Kennedy’s directives regarding vaccine policy.
“The intentional eroding of trust in low-risk vaccines favoring natural infection and unproven remedies will bring us to a pre-vaccine era where only the strong will survive and many if not all will suffer,” he wrote.
California health officials and medical organizations criticized the new COVID-19 vaccine policy, which marks a significant departure from the CDC’s previous recommendation that everyone age 6 months and older get an updated COVID-19 vaccination every autumn.
“Doctors and patients need clear science-based vaccine recommendations. Unfortunately, changes in federal immunization policy have created uncertainty about who should take certain vaccines, and on what schedule they should be administered,” the California Department of Public Health said in a statement to The Times.
“Vaccination is considered one of public health’s greatest achievements, preventing the spread of serious illnesses, reducing hospitalizations and saving lives,” the department said.
Doctors were already concerned that the federal changes would promote confusion and uncertainty — especially if the messaging is inconsistent.
“A patient may hear one message in the national news, another one from their insurance provider, and a third from their local pharmacy or their public health clinic, and that patchwork of information can create real confusion,” Dr. Jen Brull, president of the American Academy of Family Physicians, said in a webinar Wednesday. “Confusion often translates into hesitation, which results in missed opportunities for protection. … The path to vaccination can feel unnecessarily complicated.”
Here’s what you need to know:
How can healthy, younger adults get a COVID vaccine, if they want?
Wednesday’s change in COVID vaccine policy means that healthy people under age 65 will need to consult with their healthcare provider before getting the 2025-26 COVID vaccination, according to HHS.
The Infectious Diseases Society of America said that physicians “can still provide COVID vaccines off-label, and IDSA strongly urges doctors to continue recommending and administering vaccination to their patients based on the best available science.”
But that option isn’t necessarily universally available. IDSA noted that “pharmacists’ ability to provide off-label vaccines may be severely constrained, underscoring the vital role of physicians and other clinicians in maintaining access.”
Why did the FDA do this?
On social media Wednesday, Kennedy said the guidance rescinds the emergency-use authorizations for the COVID vaccines that allowed them to be broadly and quickly administered during the height of the pandemic.
One of his goals is “to demand placebo-controlled trials from companies,” he wrote.
Kennedy has long disparaged vaccines in general and the COVID shots in particular.
Other health experts have said seeking additional testing for COVID vaccines is unnecessary, given the extensive testing done before they were first distributed, and their track record since.
Kennedy has also canceled contracts and pulled funding from efforts to develop vaccines using mRNA technology — the same technology used to develop most of the COVID vaccinations administered in the U.S., and that has been credited with saving millions of lives.
In announcing and explaining that decision, Kennedy said federal health officials were prioritizing the development of “safer, broader vaccine strategies.”
Who can get updated COVID vaccines without first talking to a healthcare provider?
The FDA approved the 2025-26 COVID vaccines for seniors age 65 and up, and younger people with at least one health condition that puts them that at high risk for severe COVID should they get infected, according to the Department of Health and Human Services.
Such factors include obesity, diabetes, heart conditions, chronic lung disease, kidney disease and immunocompromising conditions.
Wednesday’s announcement of the FDA’s vaccine approvals for the 2025-26 formula was issued by the three manufacturers of COVID vaccines in the United States: Moderna, Pfizer and Novavax.
Officially, the FDA “approved” the updated 2025-26 vaccine for only certain groups of people. The Department of Health and Human Services said the FDA was making these changes as hospitalizations and deaths from COVID-19 had declined dramatically.
Pharmacies and health systems sometimes don’t start administering the updated COVID vaccine until after the CDC’s Advisory Committee on Immunization Practices meets and makes a recommendation, typically around the beginning of fall. That recommendation is then considered by the CDC director, who typically endorses it or, rarely, makes her or his own recommendation.
Cassidy, the Republican senator, said the CDC’s ACIP meeting should not take place “until significant oversight has been conducted.”
“Serious allegations have been made about the meeting agenda, membership, and lack of scientific process being followed for the now announced September ACIP meeting,” Cassidy said in a statement. “These decisions directly impact children’s health.”
So what does this mean for me?
Local health officials and healthcare organizations are still scrambling to understand the implications.
CVS said it expected to receive the updated 2025-26 COVID-19 vaccines in the coming days.
“We’ll administer FDA-authorized COVID-19 vaccines in states where legally permitted at CVS Pharmacy and/or MinuteClinic to meet our patients’ needs,” said spokesperson Amy Thibault.
Kaiser Permanente was still reviewing the details of the FDA’s approval.
“We will also review the CDC’s clinical guidance when it is released and evaluate other sources of clinical recommendations, including relevant medical societies, to ensure safe and effective administration of the COVID vaccine,” according to a statement from Kaiser spokesperson Terry Kanakri. “Vaccination continues to be one of the safest and most effective ways to protect against illness and reduce the severity of illness from COVID.”
Kaiser, Kanakri added, “is committed to making the 2025-26 COVID vaccine available at no cost to children and adults for protection from severe illness from COVID.”
