vaccines

Could COVID-19 mRNA vaccines also fight cancer? | Drugs News

The mass-produced COVID-19 vaccines built using the mRNA model – which were rapidly manufactured during the global pandemic – could also help the immune system recognise and attack cancer tumours, new studies have shown.

Studies in mice and an analysis of medical records of cancer patients – who received mRNA shots for COVID-19 before starting immunotherapy for cancer treatment – revealed a startling pattern: the vaccinated patients lived significantly longer than those who had not received the shots.

A team of researchers from the University of Florida and the University of Texas MD Anderson Cancer Center presented the results this week at the European Society for Medical Oncology Congress in Berlin and published in the peer-reviewed journal, Nature.

The results, they say, reveal that the mRNA vaccines do not just prevent infection – they also “wake up” and prompt the body’s immune system to fight tumours.

The discovery has come at a time when US President Donald Trump’s administration has slashed funding for mRNA research.

So, why is this being touted as groundbreaking? What does it mean for cancer patients? And how did the COVID-19 pandemic become the medium for this unlikely discovery?

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A nurse loads a syringe with the child’s dose of the Pfizer COVID-19 vaccine prior to vaccinating a Jackson Public School student at a vaccination station in Jackson, Mississipi, US, on February 16, 2022 [Rogelio V Solis/AP]

What is an mRNA vaccine?

Unlike traditional vaccines, which used weakened or inactive parts of a virus to trigger the immune system to build a defence, mRNA vaccines deliver a small strand of genetic code known as “messenger RNA” directly into the body’s cells.

The cell reads this blueprint as an instruction to manufacture a spike protein which mimics that of the virus, and display it on its surface, effectively waving a red flag that alerts the immune system to build a defence.

The body then creates antibodies and memory cells trained to recognise and attack that protein spike if it ever appears again.

This is an area of research which has been going on for some years, most notably by paediatric oncologist Elias Sayour, the Stop Children’s Cancer/Bonnie R Freeman Professor for Pediatric Oncology Research at the University of Florida, in the United States.

The COVID-19 pandemic presented a particular opportunity to study the implications of mRNA for cancer treatment as the world moved en masse to vaccinate the population.

When Sayour’s former student, oncologist Adam Grippin, examined clinical data of more than 1,000 patients treated between August 2019 and August 2023 at the MD Anderson Cancer Center, he found a striking pattern.

People who had received a COVID-19 mRNA vaccine within 100 days of starting immunotherapy lived significantly longer than those who received the same medical treatment but did not have the vaccine.

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Medical staff transport a body of a patient who died of COVID-19 at the morgue of the city hospital 1 in Rivne, Ukraine, October 22, 2021 [File: Evgeniy Maloletka/AP]

How much longer did people live with the vaccine?

For patients with advanced lung cancer, the median survival rate nearly doubled if they had the vaccine, rising from 20.6 months to 37.3.

More strikingly, the survival improvements were most pronounced in patients with immunologically “cold” tumours – meaning that the mRNA vaccine appeared to “wake up” the immune system in patients with these harder-to-treat cancers – turning “cold” tumours into ones the immune system could more easily recognise and attack.

The researchers noted that their findings were consistent across varying factors, such as different vaccine manufacturers, doses and time of vaccination.

The researchers also compared the survival rates in a smaller group of patients receiving immunotherapy for metastatic melanoma, the most advanced stage of a type of skin cancer. In the study, 43 patients had an mRNA COVID vaccine and 167 did not.

Patients who did not receive the vaccine had a median survival of just more than two years. By contrast, those who were vaccinated before starting treatment had not yet reached their median survival point more than three years into follow-up, the research found.

How does it work?

The researchers discovered that mRNA vaccines work like an alarm for the body’s defence system.

When the vaccine is given, it puts the immune system on alert, making it more likely to notice cancer cells that it might have ignored before. Once the immune system is activated, it begins to attack these cells.

But cancer cells fight back. They produce a protein called PD-L1, which works as a shield that “hides” them from the immune system. However, there are drugs known as immune checkpoint inhibitors that can block this shield.

When both the vaccine and these drugs are used, it creates the ideal situation – the immune system is active and alert, and the cancer’s defences are down, Grippin explained.

While the researchers said that they do not yet fully understand the mechanisms, the findings suggest that mRNA vaccines can be used to re-programme immune responses to cancer.

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A technician inspects anti-cancer drugs in vials at a lab of a pharmaceutical company in Lianyungang, Jiangsu province, China, on March 13, 2019 [File: Stringer/Reuters]

What does this mean for cancer patients?

These findings are preliminary. If, however, the study is validated in clinical trials, it could have huge implications for the treatment of cancer.

“These vaccines produce powerful anti-tumour immune responses that are associated with massive improvements in survival for patients with cancer,” Grippin said.

“The implications are extraordinary – this could revolutionise the entire field of oncologic care,” said Sayour. “We could design an even better nonspecific vaccine to mobilise and reset the immune response, in a way that could essentially be a universal, off-the-shelf cancer vaccine for all cancer patients.”

Grippen, who co-led the study with Steven Lin, professor of radiation oncology, said his team is launching a Phase 3 clinical trial to confirm the initial results and investigate whether COVID mRNA vaccines should be made part of the standard of care for patients.

What did scientists find in tests with mice?

In the mouse experiments, researchers found that injecting an mRNA COVID vaccine directly into a tumour made dendritic cells – a type of white blood cell – more alert.

Once the dendritic cells picked up on presence of the tumour, they sent out signals that attracted T cells to come and attack it. In some mice, this helped slow the growth of the cancer.

But there’s a big catch. Not everyone naturally has T cells that are capable of killing cancer cells. For some people, their immune system can tell that a tumour is dangerous, but their specific T cells do not know how to destroy it.

That’s one reason why immunotherapies – treatments that boost the immune system to fight cancer – work for some patients but not for others.

Having an mRNA COVID vaccine will not make your body produce new tumour-fighting T cells. What it might do, based on this early research, is make dendritic cells more likely to notice a tumour and effectively deploy the T cells.

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Why Trump is seeking to remove aluminium from vaccines? | Donald Trump News

Health officials in the United States are reviewing whether to remove aluminium from some common vaccines, as part of the Trump administration’s escalating attacks on vaccines.

The Department of Health and Human Services has reduced some vaccine access. The agency scaled back COVID-19 vaccine recommendations, approved COVID-19 vaccines for fewer people and aimed to remove the preservative thimerosal from US vaccines. Experts told PolitiFact scientific research did not support its removal.

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During a September 22 news conference, in which US President Donald Trump told people not to take Tylenol during pregnancy, he also mentioned another objective. “We want no aluminium in the vaccine,” he said. The administration was already in the process of removing aluminium from vaccines, he added.

About two weeks later, on October 8, the US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices, or ACIP, announced a new working group focused on the childhood vaccine schedule. Its discussion topics include vaccine ingredient safety and aluminium adjuvants.

Robert Malone, an ACIP member who has opposed COVID-19 vaccines, told Axios he expected the ACIP would determine there was “a lot of evidence” of “issues” with aluminium in vaccines. The committee would likely vote to re-categorise vaccines containing aluminium adjuvants so that people would have to discuss with their doctor before getting them, Malone told Axios.

That could have far-reaching ramifications. Here’s what to know about aluminium in vaccines.

A: Small amounts of aluminium are sometimes included in vaccines as adjuvants, or substances that boost the body’s immune response to the vaccine to ensure protection from infection.

That boost means people can get fewer vaccine doses in smaller quantities.

Q: When used, how much aluminium is in a vaccine?

A: Vaccines with aluminium adjuvants usually contain less than 1mg aluminium per dose, according to the Children’s Hospital of Philadelphia.

That is a pretty abstract number. To help make it more concrete: a milligram is one-thousandth (1/1,000th) of 1g. One gram is about the weight of a raisin or a stick of gum. Imagine cutting one of those items into 1,000 equal pieces. One of the pieces would be about 1mg.

Here is another way to think about it.

People come in contact with and consume aluminium all of the time. It is one of the most abundant metal elements in the Earth’s crust, according to the US Geological Survey. It is naturally occurring in soil, air and water. Food is the main way people are exposed to aluminium. The average adult eats 7mg to 9mg of aluminium per day, according to the CDC.

A baby in its first six months might receive a total of about 4.4mg of aluminium from recommended vaccines. In the same period of time, a breastfed infant would ingest about 7mg of aluminium from breastmilk, and a formula-fed baby would ingest about 38mg from formula.

Q: How long have vaccines contained aluminium?

A: Aluminium adjuvants have been used in vaccines for more than 70 years, the CDC said.

“Aluminium is one of our oldest adjuvants; it’s been used in vaccines since the 1920s,” said Dr Peter Hotez, a Baylor College of Medicine professor and codirector of Texas Children’s Hospital Center for Vaccine Development.

Q: How do we know it’s safe to include small amounts of aluminium in vaccines?

A: Every vaccine’s safety and efficacy are tested in animal studies and human clinical trials before the US Food and Drug Administration (FDA) licenses it for public use. Every vaccine containing adjuvants has been tested, and health agencies continuously monitor their safety, the CDC said.

Over several decades of use, vaccines with aluminium adjuvants have been proven safe, the FDA said.

Vaccines containing aluminium have been “given to billions of people worldwide now”, said Dr Kawsar Talaat, a professor at Johns Hopkins Bloomberg School of Public Health.

A growing body of research has also found that aluminium adjuvants do not cause aluminium toxicity or other adverse outcomes.

Q: Do aluminium adjuvants have any risks?

A: Rarely, some people have allergic reactions to aluminium in the same way they might have allergic reactions to other substances, Talaat said.

In 2022, researchers published a retrospective, observational study on more than 325,000 children that found an association between vaccine-related aluminium exposure and persistent asthma. Association is not the same as causation, meaning the study did not prove a link between aluminium in vaccines and asthma.

Experts from the CDC and the American Academy of Pediatrics encouraged more research on the subject because the backwards-looking observational study did not prove causation and also had limitations, including that it excluded many children who developed asthma before they turned two years old.

A 2025 study found no increased risk of asthma associated with childhood exposure to aluminium-absorbed vaccines.

Q: Which vaccines contain aluminium adjuvants?

A: At least 25 vaccines approved for use in the US have aluminium adjuvants, the CDC says. That includes vaccines that protect against HPV, hepatitis A and B and diphtheria, tetanus, and acellular pertussis (whooping cough).

Q: Which vaccines do not contain aluminium adjuvants?

The CDC’s list of vaccines without adjuvants includes vaccines against COVID-19, Ebola, meningococcal, polio and rabies. Additionally, most seasonal flu shots and the vaccine against measles, mumps and rubella do not contain aluminium adjuvants.

Q: Can we remove aluminium from vaccines?

A: Not quickly. If it could be done at all, it would take years to develop, test and license new, aluminium-free vaccines. Many of the vaccines with aluminium adjuvants do not have aluminium-free formulas.

“A vaccine is licensed based on all of its ingredients and the exact manufacturing process,” Talaat said. “If you were to take an ingredient out of a vaccine, you would have to start all over with the clinical trials and the manufacturing, and it is highly possible that some of these vaccines wouldn’t work without the aluminium in there.”

Although other adjuvants exist, they are newer and often more scarce than aluminium, which is abundant.

An immediate ban on aluminium in vaccines would drastically reduce people’s ability to protect themselves and others against numerous diseases.

“I think we’d see outbreaks of vaccine-preventable diseases,” Talaat said.

Q: Why do people think aluminium in vaccines is causing autism?

A: A 2011 study said vaccines with aluminium adjuvants “may be a significant” contributing factor to the rising number of autism diagnoses in kids, Nature reported.

A year later, a World Health Organization vaccine safety committee called the 2011 study “seriously flawed”. The 2011 study and another by the same authors compared vaccines’ aluminium content and autism rates in several countries, the WHO group said, but that cannot be used to establish a causal relationship.

“We studied aluminium, and have no link between aluminium and autism,” Talaat said.

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Massachusetts joins Illinois in making insurance cover COVID-19 vaccines

Sept. 17 (UPI) — Massachusetts says that all citizens should be vaccinated to protect against the COVID-19 virus as the Bay State will now force insurance providers to cover vaccines approved by the state.

On Wednesday, the Massachusetts Department of Public Health released its COVID-19 vaccine guidelines through 2026 that suggested all state residents get a COVID-19 shot, including children ages 6, and particularly those at higher risk of exposure, with a weakened immune system or pregnant.

“We are not going to let Donald Trump or Robert Kennedy take away your ability to make your own health care decisions,” said Gov. Maura Healey.

The decision by Massachusetts came as the Food and Drug Administration under U.S. Health and Human Services Robert F. Kennedy Jr. approved in August its most recent round of COVID shots but federally limited their use.

Healey said earlier this month that Massachusetts will begin to require health insurance companies to cover state-recommended vaccines and became the first U.S. state to do so, followed by Illinois in an executive order Friday by Gov. JB Pritzker, a Democrat.

Executive actions in Illinois and Massachusetts could be the first in a series of other similar acts by governors to create a coalition to set vaccine policy separate of federal authorities.

“Massachusetts will continue to lead with science and protect access to life-saving vaccines,” Healey, 54, said Wednesday in a statement.

Notably, the Healey administration’s plan was backed by the nonprofit entities Blue Cross Blue Shield of Massachusetts and the Massachusetts Association of Health Plans.

The newly issued state guidelines stand in stark contrast to federal recommendations by the Trump administration and Centers For Disease Control and Prevention.

Massachusetts health officials said the state acted on an “extensive review of current scientific data” consistent with widely respected groups such as the American Academy of Pediatrics.

The commonwealth’s Public Health Commissioner Robbie Goldstein reiterated Wednesday that vaccines remain the “most effective public health intervention of the past century,” adding that vaccine use has “saved millions of lives.”

Goldstein stated its guidelines were “grounded in evidence and science, driven by equity and shaped by the lived experiences” of Massachusetts’ 351 communities.

On Monday, Healey called Kennedy a “walking conspiracy theorist who is denying people vaccines and the healthcare they want and need” during a speech to Massachusetts Democrats as she hailed her administration’s new vaccine coverage mandate for insurance conglomerates.

A recent study indicated that in 2022 and 2023 more than 1.5 million “missing Americans” died due to COVID-19 in excessive deaths that could have been averted.

But on Wednesday Healey said the state was taking this action “so the people of Massachusetts know that you will continue to be able to get the vaccines you want and need — no matter what happens at the federal level.”

Also on Wednesday, ex-CDC Director Susan Minaret appeared on Capitol Hill to testify in front of lawmakers over her termination by Kennedy due to allegations that she refused to allow all decisions to be approved by political staff.

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Massachusetts governor forces health insurance to cover vaccines

Massachusetts Gov. Maura Healey said Friday that COVID-19 vaccines must be covered by insurance and available in drug stores. File Photo Amanda Sabga/EPA

Sept. 5 (UPI) — Massachusetts is the first state to force health insurance companies to cover vaccines recommended by the state’s department of public health.

The law will require that insurance companies not solely follow recommendations by the Centers for Disease Control and Prevention, which has seen recent changes to its vaccine recommendations by Health and Human Services Department Secretary Robert F. Kennedy Jr.

Last week, the Food and Drug Administration narrowed the list of people to whom it recommends the COVID-19 vaccine, drawing criticism from the Senate at Thursday’s hearing questioning Kennedy about that and other decisions.

“Massachusetts has the best health care in the world,” Gov. Maura Healey said in a statement Friday. “We won’t let Donald Trump and Robert Kennedy get between patients and their doctors. When the federal government fails to protect public health, Massachusetts will step up. The actions we are announcing today will make sure people can continue to get the vaccines they need and want in Massachusetts.”

On Wednesday, a group of states with Democrat governors — California, Oregon and Washington — announced plans to form a public health alliance to offer “evidence-based immunization guidance,” The Hill reported.

Healey said earlier this week that her state will join other Northeastern states to create a similar coalition to set vaccine policy.

Blue Cross Blue Shield of Massachusetts and the Massachusetts Association of Health Plans have said they support the action by Healey.

“Today’s action ensures that everyone who should get a vaccine will get one, and their insurance will cover it,” Insurance Commissioner Michael Caljouw said in a statement. “Our collective commitment — state government working with our health insurance companies — is important as we enter the fall season.”

The governor, in the press release, outlined a three-step plan:

The Division of Insurance and Department of Public Health issued a bulletin that requires insurance carriers in Massachusetts to continue to cover vaccines recommended by the Massachusetts Department of Public Health.

The governor has taken steps to ensure that Massachusetts residents who want the COVID vaccine can get it at pharmacies.

Massachusetts is leading efforts to create a public health collaboration with states in New England and across the Northeast committed to safeguarding public health.

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Some vulnerable seniors can’t get COVID vaccines amid case spike

Seniors in some parts of the country say they are being denied COVID-19 vaccinations amid an ongoing spike in cases, leading to rising frustration over new Trump administration policies that are making it harder to get the shots.

Matthew D’Amico, 67, of New York City, said a Walgreens declined to administer COVID-19 vaccines to him and his 75-year-old wife on Friday because they didn’t have a prescription. They’re trying to get vaccinated ahead of a trip.

“I can’t believe we can’t get” the vaccine, D’Amico said in an interview. “I’ve been inoculated a number of times and never had to get a prescription. And it’s just very frustrating that this is where we are.”

He’s not alone in his exasperation. Under the leadership of the vaccine skeptic Health and Human Services Secretary Robert F. Kennedy Jr., federal agencies have effectively made it more difficult to get vaccinated against COVID-19 this year. The Food and Drug Administration has only “approved” COVID-19 vaccines for those age 65 and up, as well as younger people with underlying health conditions.

That means across the country, people younger than 65 interested in getting the COVID-19 vaccine must now either consult with a healthcare provider or “attest” to a pharmacy that they have an underlying health condition. It’s a potential hurdle that can make getting the vaccine more difficult and, some health experts worry, prompt even more Americans to eschew getting vaccinated.

As D’Amico can attest, though, being part of a group for whom the COVID vaccine is “approved” doesn’t necessarily guarantee easy access.

“For me to go to my primary [healthcare provider] now and get a prescription, it’s just kind of ridiculous,” D’Amico said.

At least some people younger than 65 are encountering pharmacy staff asking probing questions about their medical conditions.

That happened Friday at a CVS in Orange County, according to 34-year-old Alex Benson, who takes medication that can suppress his immune system.

Besides just protecting himself, he wanted to get vaccinated as he has family members who are at high risk should they get COVID — his mother is immunocompromised, and his mother-in-law had open-heart surgery on Thursday night.

Benson said an employee asked why he thought he was eligible for the vaccine.

“They asked me for either a prescription or they wanted to know … why I felt I needed the vaccination,” Benson said. At one point, a staffer offered to call his doctor to get an authorization for the vaccine.

Benson said he was alarmed by the questions, and started to “feel kind of some desperation to plead my case to the pharmacist.” Another CVS staffer later came over and said further answers weren’t necessary and simply attesting he was eligible was good enough. He eventually got the vaccine.

Still, he felt the experience was dismaying.

“I think easy access should be the policy,” Benson said. “I tend not to get too political, but it seems just rather juxtaposed to me that an anti-regulation administration is using regulation in this way. They’re supposed to be removing barriers to healthcare.”

The vaccine chaos comes as COVID-19 is either increasing or starting to hit its late summer peak. According to data released Friday, there are now 14 states with “very high” levels of coronavirus detected in their wastewater — California, Texas, Florida, North Carolina, Indiana, South Carolina, Alabama, Louisiana, Connecticut, Utah, Nevada, Idaho, Hawaii and Alaska, as well as the District of Columbia.

Dr. Elizabeth Hudson, the regional physician chief of infectious diseases for Kaiser Permanente Southern California, said data continue to show an increase in coronavirus cases.

“Over this past week, we’ve seen an increase in the number of outpatient COVID cases, and even a smattering of inpatient cases,” Hudson said. “It appears that we may be nearing the top of the wave, but it may be another two weeks or so until we truly know if we’re there.”

The rate at which coronavirus lab tests are confirming infection also continues to rise statewide and in the Los Angeles area. For the week ending Aug. 30, California’s COVID test positivity rate was 12.83%, up from 7.05% for the week ending Aug. 2. In L.A. County, the positive test rate was 14.83%, up from 9.33%.

Other data, however, suggest some areas may have reached their summer COVID peak.

In Orange County, the COVID positive test rate was 13.1%. That’s below the prior week’s rate of 18%, but still higher than the rate for the week that ended Aug. 2, which was 10.8%.

In San Francisco, the test positivity rate has been hovering around 9% for the last week of reliable data available. It’s up from 7% a month earlier.

In addition, wastewater data in L.A. County show coronavirus levels declined slightly from the prior week.

“It’s too early to know if this decrease in wastewater viral concentrations is the first sign that COVID-19 activity is peaking or is regular variation typical of this data source,” the L.A. County Department of Public Health said.

COVID hospital admissions in California are increasing — with the latest rate of 3.93 admissions per 100,000 residents, up from 2.38.

But they remain relatively low statewide and in L.A. County. The number of L.A. County residents seeking care for COVID-related illness, or who have been hospitalized, “is quite a bit lower than during summer surges in 2023 and 2024,” the public health department said.

A relatively mild summer wave, however, could mean that the annual fall-and-winter COVID wave might be stronger. In July, the state Department of Public Health said that scientists anticipate California would see either a stronger summer COVID wave or a more significant winter wave.

The current confusion over federal COVID vaccine policy has been exacerbated by the chaos at the U.S. Centers for Disease Control and Prevention, where Kennedy earlier this year fired everyone on the influential Advisory Committee on Immunization Practices, and orchestrated the firing of CDC Director Susan Monarez just 29 days after she was confirmed to the post by the Senate.

Some of Kennedy’s handpicked replacements on the ACIP have criticized vaccines and spread misinformation, according to the Associated Press. And the new interim CDC director — Jim O’Neill, a Kennedy deputy — is a critic of health regulations and has no training in medicine or healthcare, the AP reported.

The CDC hasn’t issued its own recommendations on who should get vaccinated, and that inaction has resulted in residents of a number of states needing to get prescriptions from a healthcare provider for at least the next couple of weeks. In some cases, that’s true even for seniors, as D’Amico found out.

As of Friday, CVS said people need a prescription to get a COVID-19 vaccine, sometimes depending on their age, in Arizona, Florida, Georgia, Louisiana, Maine, North Carolina, New Mexico, New York, Pennsylvania, Utah, Virginia and West Virginia, as well as the District of Columbia.

CVS couldn’t even offer the COVID-19 at its pharmacies in Nevada as of Friday; they were only available at the company’s MinuteClinic sites, according to spokesperson Amy Thibault.

CVS said it expects to offer COVID-19 vaccines without prescriptions at its pharmacies in New Mexico, Nevada, New York and Pennsylvania “soon,” due to recent regulatory changes in each state.

“Right now, all patients in all states need to attest to being eligible for the vaccine in order to schedule an appointment online,” Thibault said. If an adult says they have no underlying health conditions, but do have a prescription from a healthcare provider for “off-label” use of the vaccine, they can get the shot, Thibault confirmed.

On Thursday, Hawaii joined California, Washington and Oregon in launching the West Coast Health Alliance: an interstate compact meant to provide science-based immunization guidance as an alternative to the CDC.

“Together, these states will provide evidence-based immunization guidance rooted in safety, efficacy, and transparency — ensuring residents receive credible information free from political interference,” according to a statement from Gov. Gavin Newsom’s office.

The statement suggested that the Trump administration was essentially “dismantling” the CDC.

“The absence of consistent, science-based federal leadership poses a direct threat to our nation’s health security,” the statement said. “To protect the health of our communities, the West Coast Health Alliance will continue to ensure that our public health strategies are based on best available science.”

It was not immediately clear, however, whether the formation of the West Coast Health Alliance would make it easier for people to get COVID-19 vaccines at the nation’s largest pharmacy retailers, where many people get their shots.

Mainstream medical groups, such as the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists, are also offering their own recommendations to advise individuals and families on what vaccines they should get.

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Who can get updated COVID-19 vaccines in the US now? | Health News

Winter is approaching in the United States and COVID-19 cases are rising. Questions about accessing protective vaccines are swirling.

Nearly five years since the first US patient was vaccinated to help stem what was then a raging coronavirus pandemic, doctors, patients and pharmacists are navigating a radically different public health landscape.

The US Food and Drug Administration (FDA) on August 27 announced it had approved some COVID-19 vaccines – but for far fewer people than in years past.

If you tried to schedule a COVID-19 vaccine this week, your pharmacy’s online scheduler might have told you it isn’t available yet.

Meanwhile, leading medical organisations disagree with the government’s latest COVID-19 vaccine guidance.

If all that leaves you wondering about your ability to get a COVID-19 shot, you’re not alone. It’s confusing.

We sought answers.

Q: Who can get a COVID-19 vaccine?

First, what we do know: The FDA approved the 2025-26 vaccines for anyone age 65 and older and any person six months and older who has at least one underlying health condition that increases their risk of severe COVID-19 infection.

So, people in those groups should be able to schedule vaccinations as soon as healthcare providers who are authorised to administer the vaccine receive it – likely in the next few weeks.

Q: I don’t fit into those categories. Am I banned from getting a COVID-19 vaccine?

Not “banned”, per se. But it may require more legwork on your end. You’ll need to consult your doctor, who can legally prescribe a COVID-19 vaccine for you even if you don’t fall within the categories the FDA specified.

“Physicians can prescribe medications and vaccines that are beyond the label, beyond the licence,” said Dr William Schaffner, Vanderbilt University Medical Center professor of infectious diseases.

That’s true for adults and children – and the practice of prescribing medications and vaccines for “off-label” use is fairly common in paediatrics, he said.

Q: OK, so will insurance still cover COVID-19 vaccinations under these new rules?

If you’re in one of the two FDA-approved categories, the outlook is probably better than if you’re not.

Federal law requires that most health insurance plans fully cover vaccines recommended by the US Centers for Disease Control and Prevention and its vaccine advisory committee.

Here’s the rub: Because the CDC hasn’t yet adopted 2025-26 COVID-19 vaccine recommendations, whether the shots will be covered by insurance is a grey area.

The CDC’s panel of experts, the Advisory Committee on Immunisation Practices (ACIP), had planned to vote on updated COVID-19 vaccine recommendations at its June meeting, but did not. And it’s unclear when or if the ACIP will vote on the recommendations.

But there could be another avenue for people to get insurance-covered COVID-19 vaccines. The CDC’s vaccine recommendations typically include a provision for what’s known as “shared clinical decision making”, Schaffner said.

That means, for example, “If you were 52 years old and otherwise healthy, but you nonetheless wanted to get the vaccine, you could discuss that with your doctor – shared clinical decision-making – and you could receive the vaccine, and insurance companies would honour that,” he said.

That provision could be important for healthy people who want to avoid COVID-19 infection because they are close contacts with or care for people with high-risk conditions.

But again, without CDC recommendations, “We don’t know if that provision is still there,” Schaffner said.

To confirm whether your insurance will cover your COVID-19 shot, Schaffner recommends talking to your doctor and, potentially, your insurance provider. But first, give it a little more time: healthcare providers themselves are still working out the details.

Q: If my insurance doesn’t cover vaccination, how much might it cost?

Vaccine manufacturers report that COVID-19 vaccines cost about $142, according to the CDC’s price lists. It’s unclear whether that would be the out-of-pocket cost for patients receiving a COVID-19 vaccine not covered by insurance.

Q: Are COVID-19 vaccines still recommended during pregnancy? And if I’m pregnant and want one, what can I do? 

Health and Human Services Secretary Robert F Kennedy Jr in May announced he had unilaterally removed COVID-19 vaccines from the recommended immunisation schedule for healthy children and pregnant women. The health-focused news outlet STAT reported that no one from the CDC or ACIP was consulted before Kennedy announced this change. Vaccine experts called the move concerning and unprecedented.

Removing the vaccines from the immunisation schedule could limit vaccine access by reducing insurance companies’ coverage of the shot. But again, by consulting with your doctor, you might still be able to access it. Some pharmacies also might be able to provide it, because the CDC lists pregnancy as a factor that increases the risk of severe COVID-19 infection.

Q: Is there anyone who should not get the COVID-19 shot?

Broad health guidance always comes with exceptions. For example, people who have had “a very severe adverse reaction to a previous COVID-19 vaccine” should not get this season’s version, Schaffner said. You should discuss your health situation with your physician for personalised guidance.

Q: Why is the outlook for COVID-19 vaccines so different this year?

In short, Kennedy has long been broadly critical of vaccinations and, now that he’s in charge of the nation’s healthcare policy, has taken actions to overhaul their regulation and distribution.

Typically, the CDC recommends vaccines based on guidance from ACIP. ACIP’s recommendations become CDC policy if they’re adopted by the CDC director. This year, Kennedy fired all 17 members of ACIP and replaced them with new members, many of whom have expressed anti-vaccine views. CDC Director Susan Monarez was fired on August 27 amid a dispute with Kennedy over vaccine policy.

In previous years, the CDC recommended annual COVID-19 vaccines for everyone aged six months and older. The committee still hasn’t issued COVID-19 vaccine recommendations for this year.

Q: Aren’t there some medical organisations that recommend COVID-19 vaccinations for most people, though? 

Yes. In recent months, professional organisations have issued their own recommendations that contradict new messaging from the federal government.

The American Academy of Pediatrics recommends routine COVID-19 vaccines for all children aged six months to 23 months and for children aged two to 18 in some situations, including if they’re at high risk of COVID-19, have never been vaccinated against it or live in a household with people who are high risk.

And the American College of Obstetricians and Gynecologists recommends that anyone pregnant or lactating receive updated or “booster” COVID-19 vaccines.

Dr Tina Tan, president of the Infectious Disease Society of America, said the FDA’s decision to limit the COVID-19 vaccine’s approval “contradicts the evidence base, severely undermines trust in science-driven policy and dangerously limits vaccine access”.

Q: What qualifies as an underlying health condition that puts someone at higher risk? 

The FDA and HHS did not point us to a list of health conditions that meet the high-risk requirements.

The CDC’s website catalogues a number of underlying conditions that it said demonstrate “a conclusive increase in risk for at least one severe COVID-19 outcome”. They included: chronic lung diseases, cancer, certain chronic kidney and liver diseases, diabetes, some disabilities, heart conditions, HIV, physical inactivity, primary immunodeficiencies and some mental health conditions.

Q: But I clicked on those lists and both say ‘pregnancy and recent pregnancy’ are risk factors. How do I square that with the latest changes?

You’re right. These lists are inconsistent with the messaging coming from top HHS officials. Again, the American College of Obstetricians and Gynecologists continues to recommend COVID-19 vaccines for people who are pregnant and lactating. Talk to your doctor.

Q: Is this season’s COVID-19 vaccine formula different from last season’s?

Yes. After the FDA passed its recommendations to vaccine manufacturers in May, the COVID-19 vaccines were updated to target the viral strain expected to circulate this year. The changes align with the World Health Organization’s recommendations.

Q: When will the updated COVID-19 shots be available? 

Since the FDA’s approval, updated vaccines are set to start shipping immediately and might even be available now in some pharmacies. Pfizer said it was shipping immediately and would be available across the US “in the coming days”. Sanofi, the company distributing the Novavax non-mRNA vaccines, said its vaccine should be available “in the early fall”.

But what that means for how quickly you can access it could depend on where you live, your age and your health. (See next question.)

Q: Where can I get the updated COVID-19 shots? 

We knew you were going to ask. And we wish we had a straightforward answer.

If you typically get your COVID-19 shots at a local pharmacy, it might not be that easy this year.

As of August 29, the scheduling apps for Walgreens and CVS notified patients in some locations that they could not schedule a COVID-19 vaccine appointment because of state restrictions, inventory or the need for a prescription.

In 18 states and Washington, DC, pharmacists’ authority to administer vaccines is linked to the CDC’s recommendations, said Brigid Groves, the American Pharmacists Association’s vice president of professional affairs. The states are: Colorado, Connecticut, Georgia, Iowa, Kentucky, Maine, Maryland, Massachusetts, Montana, Nevada, New Jersey, New Mexico, North Carolina, Oregon, Pennsylvania, South Carolina, Virginia and West Virginia.

That means even though the FDA has issued its approval, in those 19 places, pharmacists cannot administer it because it isn’t on the CDC immunisation schedule yet, Groves said.

The American Pharmacists Association has asked those states’ governors to issue executive orders granting pharmacists broader authority to administer vaccines.

In the other 32 states, with some exceptions, it’s possible that a pharmacy can administer the updated COVID-19 shots for patients who fall within the FDA-approved categories of recipients.

If you are getting it “off label”, however, because you don’t have one of those underlying conditions, you might need to get it straight from your prescribing doctor.

One caveat: if ACIP votes on recommendations for COVID-19 vaccines that include giving them to healthy people through the “shared clinical decision making” process, Groves said pharmacists would be able to vaccinate almost anyone. That’s because pharmacists are considered clinicians who can conduct that shared decision-making.

Q: When might ACIP vote on COVID-19 vaccine recommendations? 

The committee has a September 18-19 meeting scheduled, according to the CDC’s website. A meeting agenda hasn’t been published yet.

Q: How will a pharmacy know if I have an underlying condition?

Typically, pharmacies ask patients to self-attest whether they have an underlying condition, Groves said. For example, a person who is under age 65 but has severe asthma would self-attest to that when making a vaccine appointment. So far, all signs point to that self-attestation still being the case.

Q: When is the best time to get vaccinated? 

During fall and winter months, when COVID-19 infections are typically expected to spike alongside other respiratory infections.

Q: What do the administration’s vaccine changes mean for future COVID-19 vaccines?

Kennedy recently cancelled $500m in funding for mRNA vaccine development. Two of the most effective COVID-19 vaccines are mRNA. Some companies had been researching combined mRNA flu and COVID-19 shots, and those projects’ status is unclear.

The FDA also recently announced that vaccine makers seeking approval for future COVID-19 vaccines, or boosters, would need to conduct new randomised clinical trials of healthy populations. That move, combined with the decision to narrow the FDA’s vaccine approval for certain segments of the population, is expected to limit COVID-19 vaccine access.

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FDA signs off on new COVID vaccines but limits who will get them

Aug. 27 (UPI) — The federal government signed-off on the latest round of COVID-19 vaccines, but new limits were set on which Americans can get them after U.S. Health and Human Services Secretary Robert F. Kennedy Jr. fulfilled many of his promises to reshape U.S. vaccine policy.

The U.S. Food and Drug Administration on Wednesday ended its authorization for the broad use of COVID-19 shots, clearing them only for patients at higher risk of severe illness, and those age 65 and older — or younger adults with at least one underlying health condition who would qualify.

“The emergency use authorizations for Covid vaccines, once used to justify broad mandates on the general public during the Biden administration, are now rescinded,” Kennedy stated early Wednesday afternoon in a post on X.

Kennedy said the American people “demanded science, safety and common sense,” and he claimed this new framework “delivers all three.”

But this new action is likely to complicate access, observers say, and prompts questions on insurance plan coverage.

According to Kennedy, vaccine shots still will be available for patients but only after they consult with a doctor.

On Wednesday, both Moderna and Pfizer confirmed its vaccines were approved for use in adults age 65 and older and those age 5 through 64 with at least one underlying condition.

However, it remains to be seen how easily it can be obtained for patients without higher risk health factors.

Previous U.S. vaccine policy suggested an annual COVID-19 shot for people age 6 months and older.

The American Academy of Pediatrics, the nation’s leading pediatrics association, recently recommended children as young as 6 months old be inoculated against COVID-19 in a departure with Trump administration guidelines.

The COVID-19 vaccine shots must be voted on by a panel of the Centers for Disease Control and Prevention.

Earlier this year Kennedy, a known skeptic of long-used and effective vaccines, gutted the CDC panel and named widely-known vaccine critics to sit in place.

On Wednesday the chief of America’s Frontline Doctors, a right-wing group known to spread false and unsubstantiated claims, cheered Kennedy’s actions on the U.S. coronavirus vaccine policy switch.

“Mandates are dead. Freedom wins,” Dr. Simone Gold, AFD’s president, said on social media.

However, a noted television medical analyst offered advice to those still on the fence on getting another COVID-19 shot.

“If you want to know if you or members of your family should get vaccinated, my recommendation is to solicit advice from your doctor, not the federal government,” Dr. Jonathan Reiner, a professor at the D.C.-based George Washington School of Medicine & Health Sciences and its director of Cardiac Catheterization Laboratories, stated on X.

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RFK Jr. is dismantling trust in vaccines, the crown jewel of American public health

When it comes to vaccines, virtually nothing that comes out of Robert F. Kennedy Jr.’s mouth is true.

The man in charge of the nation’s health and well being is impervious to science, expertise and knowledge. His brand of arrogance is not just dangerous, it is lethal. Undermining trust in vaccines, he will have the blood of children around the world on his hands.

Scratch that.

He already does, as he presides over the second largest measles outbreak in this country since the disease was declared “eliminated” a quarter century ago.

“Vaccines have become a divisive issue in American politics,” Kennedy wrote the other day in a Wall Street Journal essay, “but there is one thing all parties can agree on: The U.S. faces a crisis of public trust.”

The lack of self-awareness would be funny if it weren’t so tragic.

Over the past two decades or so, Kennedy has done more than almost any other American to destroy the public’s trust in vaccines and science. And now he’s bemoaning the very thing he has helped cause.

Earlier this month, Kennedy fired the 17 medical and public health experts of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices — qualified doctors and public health experts — and replaced them with a group of (mostly) anti-vaxxers in order to pursue his relentless, ascientific crusade.

On Thursday, at its first meeting, his newly reconstituted council voted to ban the preservative thimerosal from the few remaining vaccines that contain it, despite many studies showing that thimerosal is safe. On that point, even the Food and Drug Administration website is blunt: “A robust body of peer-reviewed scientific studies conducted in the U.S. and other countries support the safety of thimerosal-containing vaccines.”

“If you searched the world wide, you could not find a less suitable person to be leading healthcare efforts in the United States or the world,” psychiatrist Allen Frances told NPR on Thursday. Frances, who chaired the task force that changed how the Diagnostic and Statistical Manual of Mental Disorders, or DSM, defines autism, published an essay in the New York Times on Monday explaining why the incidence of autism has increased but is neither an epidemic nor related to vaccines.

“The rapid rise in autism cases is not because of vaccines or environmental toxins,” Frances wrote, “but is rather the result of changes in the way that autism is defined and assessed — changes that I helped put into place.”

But Kennedy is not one to let the facts stand in the way of his cockamamie theories. Manufacturers long ago removed thimerosal from childhood vaccines because of unfounded fears it contained mercury that could accumulate in the brain and unfounded fears about a relationship between mercury and autism.

That did not stop one of Kennedy’s new council members, Lyn Redwood, who once led Children’s Health Defense, the anti-vaccine group founded by Kennedy, from declaring a victory for children.

“Removing a known neurotoxin from being injected into our most vulnerable population is a good place to start with making America healthy again,” Redwood told the committee.

Autism rates, by the way, have continued to climb despite the thimerosal ban. But fear not, gullible Americans, Kennedy has promised to pinpoint a cause for the complex condition by September!

Like his boss, Kennedy just makes stuff up.

On Wednesday, he halted a $1-billion American commitment to Gavi, an organization that provides vaccines to millions of children around the world, wrongly accusing the group of failing to investigate adverse reactions to the diptheria vaccine.

“This is utterly disastrous for children around the world and for public health,” Atul Gawande, a surgeon who worked in the Biden administration, told the New York Times.

Unilaterally, and contrary to the evidence, Kennedy decided to abandon the CDC recommendation that healthy pregnant women receive COVID vaccines. But an unvaccinated pregnant woman’s COVID infection can lead to serious health problems for her newborn. In fact, a study last year found that babies born to such mothers had “unusually high rates” of respiratory distress at or just after birth. According to the CDC, nearly 90% of babies who were hospitalized for COVID-19 had unvaccinated mothers. Also, vaccinated moms can pass protective antibodies to their fetuses, who will not be able to get a COVID shot until they are 6 months old.

What else? Oh yes: Kennedy once told podcaster Joe Rogan that the 1918 Spanish flu epidemic was “vaccine-induced flu” even though no flu vaccine existed at the time.

He also told Rogan that a 2003 study by physician scientist Michael Pichichero, an expert on the use of thimerosal in vaccines, involved feeding babies 6 months old and younger mercury-contaminated tuna sandwiches, and that 64 days later, the mercury was still in their system. “Who would do that?” Kennedy demanded.

Well, no one.

In the study, 40 babies were injected with vaccines containing thimerosal, while a control group of 21 babies got shots that did not contain the preservative. None was fed tuna. Ethylmercury, the form of mercury in thimerosal, the researchers concluded, “seems to be eliminated from blood rapidly via the stools.” (BTW, the mercury found in fish is methylmercury, a different chemical, which can damage the brain and nervous system. In a 2012 deposition for his divorce, which was revealed last year, Kennedy said he suffered memory loss and brain fog from mercury poisoning caused by eating too much tuna fish. He also revealed he has a dead worm in his brain.)

Kennedy’s tuna sandwich anecdote on Rogan’s podcast was “a ChatGPT-level of hallucination,” said Morgan McSweeney, a.k.a. “Dr. Noc,” a scientist with a doctorate in pharmaceutical sciences, focusing on immunology and antibodies. McSweeney debunks the idiotic medical claims of non-scientists like Kennedy in his popular social media videos.

Speaking of AI hallucinations, on Tuesday, at a congressional committee hearing, Kennedy was questioned about inaccuracies, misinformation and made up research and citations for nonexistent studies in the first report from his Make America Healthy Again Commission.

The report focused on how American children are being harmed by their poor diets, exposure to environmental toxins and, predictably, over-vaccination. It was immediately savaged by experts. “This is not an evidence-based report, and for all practical purposes, it should be junked at this point,” Georges C. Benjamin, executive director of the American Public Health Assn. told the Washington Post.

If Kennedy was sincere about improving the health of American children he would focus on combating real scourges like gun violence, drug overdoses, depression, poverty and lack of access to preventive healthcare. He would be fighting the proposed cuts to Medicaid tooth and nail.

Do you suppose he even knows that over the past 50 years, the lives of an estimated 154 million children have been saved by vaccines?

Or that he cares?

@rabcarian.bsky.social
@rabcarian



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FDA sets new rules for COVID vaccines in healthy adults and children

Annual COVID-19 shots for healthy younger adults and children will no longer be routinely approved under a major new policy shift unveiled Tuesday by the Trump administration.

Top officials for the Food and Drug Administration laid out new requirements for yearly updates to COVID shots, saying they’d continue to use a streamlined approach that would make vaccines available to adults 65 and older as well as children and younger adults with at least one health problem that puts them at higher risk.

But the FDA framework urges companies conduct large, lengthy studies before tweaked vaccines can be approved for healthier people. In a framework published Tuesday in the New England Journal of Medicine, agency officials said the approach still could keep annual vaccinations available for between 100 million and 200 million adults.

The upcoming changes raise questions about people who may still want a fall COVID-19 shot but don’t clearly fall into one of the categories.

“Is the pharmacist going to determine if you’re in a high-risk group?” asked Dr. Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia. “The only thing that can come of this will make vaccines less insurable and less available.”

The framework, published in the New England Journal of Medicine, is the culmination of a series of recent steps scrutinizing the use of COVID shots and raising major questions about the broader availability of vaccines under President Trump.

For years, federal health officials have told most Americans to expect annual updates to COVID-19 vaccines, similar to the annual flu shot. Just like with flu vaccines, until now the FDA has approved updated COVID shots when manufacturers provide evidence that they spark just as much immunity protection as the previous year’s version.

But FDA’s new guidance appears to be the end of that approach under Health and Human Services Secretary Robert F. Kennedy, who has filled the FDA and other health agencies with outspoken critics of the government’s handling of COVID shots, particularly their recommendation for young, healthy adults and children.

Tuesday’s update, written by FDA Commissioner Marty Makary and FDA vaccine chief Vinay Prasad, criticized the United States’ “one-size-fits-all” approach and states that the U.S. has been “the most aggressive” in recommending COVID boosters, when compared with European countries.

“We simply don’t know whether a healthy 52-year-old woman with a normal BMI who has had COVID-19 three times and has received six previous doses of a COVID-19 vaccine will benefit from the seventh dose,” they wrote.

Outside experts say there are legitimate questions about how much everyone still benefits from yearly COVID vaccination or whether they should be recommended for people at increased risk. An influential panel of advisors to the Centers for Disease Control and Prevention is set to debate that question next month.

The FDA framework announced Tuesday appears to usurp that advisory panel’s job, Offit said. He added that CDC studies have made clear that booster doses do offer protection against mild to moderate illness for four to six months after the shot even in healthy people.

Perrone and Neergaard write for the Associated Press. The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.

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