FDA Guidelines on COVID-19 Vaccines Are Throwing Those Most at Risk Into Despair

When the Food and Drug Administration approved updated COVID-19 vaccines on August 27, 2025, it also imposed new restrictions on who is eligible to get them. The new restrictions have created widespread confusion and concern, as well as a series of shakeups in government and public health institutions.

“The [FDA’s] new recommendations are acting as a bureaucratic deterrent against people getting the vaccine, exacerbating the problem of record lows in rates of COVID vaccination last year,” evolutionary epidemiologist and fellow Truthout contributor Rob Wallace told me. The changes come as COVID-19 infections are rising, according to data from the Centers for Disease Control and Prevention (CDC).

The new guidelines officially limit vaccine approval to people older than 65 and those older than 6 months who are immunocompromised or live with another qualifying health condition, such as asthma, diabetes, or heart disease. Previously, the vaccines were recommended for most adults to protect against severe illness, hospitalization, and death. The change means fewer people will get vaccinated and more will die of COVID-19, a preventable disease that has killed more than 1.2 million Americans since January 2020, according to the CDC.

Disabled and aging Americans, communities of color, and low-income communities are the most vulnerable to premature death under the new guidance. “We are feeling very dehumanized and like our lives don’t matter,” Debra, a Missouri resident who lives with chronic illness and is using only her first name to protect the identities of her children, told Truthout.

Getting the updated COVID-19 vaccine is one important way to limit your risk of contracting the virus or transmitting it to others in your community, who may be at higher risk of severe illness, according to medical researchers. Even if you have been vaccinated against COVID-19 in the past, “The SARS-CoV-2 virus regularly lurches in evolution out from underneath the coverage of a previous year’s vaccine,” Wallace explained to Truthout. “That’s why we need regular boosters, including this year’s.”

Research has shown that available vaccines are not a perfect solution and work best when paired with other preventative measures, especially wearing an N95 or KN95 mask during surges, in medical settings, while traveling, or in other crowded or poorly-ventilated settings.

The FDA’s new prohibitive guidelines around COVID-19 vaccines are the latest in a series of moves furthering Secretary of Health and Human Services Robert F. Kennedy Jr.’s anti-vaccine and eugenicist agenda. Kennedy took to X/Twitter on August 27, 2025, to laud the new vaccine guidance, claiming it fulfilled his promise to “end covid vaccine mandates.” He has also installed anti-vaccine activists in important positions within his administration, ordered a review of the child vaccine schedule, and often repeated disinformation about vaccines and autism.

Kennedy also claimed in his August 27 post to X/Twitter that COVID-19 vaccines would remain “available to people who want them, especially the vulnerable.” But the reality is that even those labeled high-risk, including disabled and aging Americans, are now struggling to access a vaccine. “I have been inquiring at Walgreens, CVS, and Albertsons about availability, [and] the vague answer is ‘two to three weeks’ based on the ‘lack of approvals,’ even though [the vaccines] have been approved for my age group,” Dane Madsen, a 67-year-old resident of Nevada, told Truthout.

Many of the nation’s largest retail pharmacies are not offering the vaccines at all or are only administering them to individuals with a prescription in dozens of states and Washington, D.C. CVS Pharmacy cited the “current regulatory environment” as the reason for these policies at its stores. Stephanie, a North Carolina resident who is using only her first name to avoid harassment from anti-vaccine relatives and neighbors, told Truthout she was unable to find the vaccines at any local branch of six department stores and retail pharmacies, including CVS, Walgreens, and Walmart: “Ultimately, this year, nobody in my family is likely to get a COVID vaccine.”

Debra told Truthout her local CVS refused to vaccinate her 5-year-old, even though the child has asthma, which is on the CDC’s list of qualifying conditions. “There’s a lot of misinformation, and nobody seems to know what’s going on,” she said. She now plans to take her child to a CVS MinuteClinic, where others have reported that the on-site nurse practitioners have helped them overcome access barriers.

Some patients are seeking Nuvaxovid, a non-mRNA vaccine against COVID-19 developed by Novavax, which has been shown to produce fewer and milder short-term side effects than Pfizer’s mRNA vaccine. Christina Gleason, who takes immunosuppressant medications for Sjogren’s disease, told Truthout she experienced “lengthy symptom flares that have lasted up to a month” after receiving mRNA vaccines in the past, but only mild discomfort with Nuvaxovid.

This year, Novavax and Sanofi, the company responsible for Nuvaxovid commercialization in the U.S., have provided little information on when the updated Nuvaxovid vaccine will be available. On September 10, 2025, New York Times reporter Maggie Astor shared on Bluesky that Sanofi had not yet shipped Nuvaxovid, but the company planned to begin doing so the following week.

“It is completely unclear when any pharmacies will have it in [and] the communications have been so poor,” Elana Levin, who is looking for Nuvaxovid in New York, told Truthout. Novavax and Sanofi did not respond to Truthout’s requests for comment.

Even if Gleason were willing to risk a symptom flare, she said she has been unable to schedule a vaccine appointment at her local Walmart in Upstate New York. There is no way to indicate that she is immunocompromised using the store’s online scheduler, and the site tells her she is ineligible based on her age. “It’s been a major stressor, wondering if, when, and how I can get the updated vaccine,” she told Truthout.

Some who spoke to Truthout said they feared they could suffer consequences for checking a box to confirm they meet the criteria to receive a COVID-19 vaccine if they misunderstood the requirements. Matthew Cortland, a public health expert who has published a series of explainers on COVID-19 vaccine access issues in their newsletter, wrote in one that, in the vast majority of cases, pharmacies will not ask patients how they meet the criteria or to provide documentation.

“A pharmacy is not a court of law,” Wallace, the epidemiologist, echoed to Truthout.

Once a person has located an updated COVID-19 vaccine and secured an appointment, there’s the issue of cost. Those who are uninsured or underinsured can expect to be charged around $200 for the vaccine after the Bridge Access Program, which had helped cover those costs, sunset last year. A course of Paxlovid, an antiviral medication prescribed to treat COVID-19 in those at high risk of severe illness, now costs more than $1,400 out-of-pocket. The costs of vaccines and treatments fall hardest on those in low-income communities, who already face a higher risk of serious illness if infected.

“I can’t afford it,” Amanda Finley told Truthout. Finley has been uninsured since her position at the Internal Revenue Service was eliminated in one of the supposed cost-cutting sprees of the so-called Department of Government Efficiency (DOGE). Instead of booking an appointment at Walgreens, she plans to wait to see if the Missouri Department of Health will offer a free vaccine clinic near her. She does not drive, meaning she cannot easily travel to find a vaccine.

Finley is eager to find an updated vaccine after she contracted COVID-19 twice in 2020, before vaccines were available, which developed into long COVID. She is one of more than 20 million Americans who have been diagnosed with the illness, which can present with various symptoms, including chronic fatigue, brain fog, heart palpitations, and joint pain. Scientists are only beginning to understand the condition, and most doctors struggle to treat it. The risk of developing long COVID increases with every COVID-19 infection, and vaccines reduce long COVID risk.

Recognizing the potential harm to patients and the nation’s public health, the announcement of this year’s more restrictive guidelines around COVID-19 vaccines sparked outrage among CDC staff. President Donald Trump fired Director Susan Monarez the same day the guidance was announced, although she had been on the job less than a month, after she accused Kennedy of “sabotage.”

Some medical societies have also voiced opposition to the new rules or issued their own recommendations, including the American Academy of Pediatrics and the American College of Obstetrics and Gynecologists. A group of infectious disease experts at the University of Minnesota is developing alternative vaccine recommendations. Coalitions of states on the West Coast and across New England also plan to issue their own guidance.

On September 4, 2025, during a Senate Finance Committee hearing, federal lawmakers on either side of the aisle also condemned Kennedy’s efforts to limit vaccine access. Many called for his resignation. Meanwhile, state lawmakers in several states, including Colorado, Massachusetts, Minnesota, New Mexico, New York, and Pennsylvania, have issued orders for health insurers to cover state-endorsed vaccines or for pharmacies to waive prescription requirements, or taken other measures to ameliorate barriers.

For those in states that have not taken action, some public health experts, including Cortland, have suggested individuals contact their governor and state representatives to urge them to do so, as well as call Senators and Members of Congress to pressure them to force Kennedy’s resignation. The People’s CDC, a coalition of scientists and public health experts, has urged individuals to submit personalized comment to the CDC before a deadline on the evening of September 13, 2025, to advocate for expanding vaccine access in face of “one of the largest public crises in decades.”

This story was originally published by Truthout.