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FDA approves updated COVID-19 shots with limits for some kids and adults

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FDA approves updated COVID-19 shots with limits for some kids and adults
TECH

TECH

FDA approves updated COVID-19 shots with limits for some kids and adults

2025-08-28 04:42 Last Updated At:04:51

WASHINGTON (AP) — U.S. regulators approved updated COVID-19 shots Wednesday but limited their use for many Americans — and removed one of the two vaccines available for young children.

The new shots from Pfizer, Moderna and Novavax are approved for all seniors. But the Food and Drug Administration narrowed their use for younger adults and children to those with at least one high-risk health condition, such as asthma or obesity. That presents new barriers to access for millions of Americans who would have to prove their risk — and millions more who may want to get vaccinated and suddenly no longer qualify.

Additionally, Pfizer’s vaccine will no longer be available for any child under 5, because the FDA said it was revoking the shot’s emergency authorization for that age group.

Parents will still be able to seek out shots from rival drugmaker Moderna, the other maker of mRNA vaccines, which has full FDA approval for children as young as 6 months. But the company’s Spikevax vaccine is only approved for children with at least one serious health problem.

The revamped vaccines target a newer version of the continuously evolving virus and are set to begin shipping soon. But it could be days or weeks before many Americans know if they’ll be able to get one, with access dependent on decisions by federal health advisers, health insurers, pharmacies and state authorities.

The new restrictions — previewed by FDA officials in May — are a break from the previous U.S. policy, which recommended an annual COVID-19 shot for all Americans 6 months and up.

The approach reflects heightened skepticism about the ongoing risks of COVID-19 and the need for yearly booster shots from Health Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary, both outspoken critics of wide-scale vaccinations.

“The American people demanded science, safety, and common sense. This framework delivers all three,” Kennedy wrote on social media.

Novavax's shot is only open to people 12 or older, not younger children, and carries the same risk-based restrictions that are now in place for Moderna and Pfizer. It's the nation's only traditional, protein-based COVID-19 vaccine.

The new limits "can’t help but create barriers to vaccinations” and cause confusion for patients, doctors and pharmacists, said Dr. William Schaffner, a Vanderbilt University vaccines expert.

Some medical groups, including the American Academy of Pediatrics, have objected to the restrictions, saying they may block vaccine access for families who want to protect their children. Last week, the group offered its own recommendations for kids, saying annual shots are strongly recommended for children ages 6 months to 2 years and advised for older children.

In his post Wednesday, Kennedy said the shots will be "available for all patients who choose them after consulting with their doctors.”

But Americans are likely to confront a number of logistical hurdles.

Insurers typically base their vaccine coverage decisions on the recommendations of a panel of advisers to Centers for Disease Control and Prevention, but some say they will also look to medical professional groups, including the American Medical Association.

Earlier this year, Kennedy replaced the entire CDC panel, naming several doctors and researchers who have repeatedly questioned the safety of commonly used vaccines and ingredients. The panel is expected to meet in September, but no agenda has been released.

Depending on the panel’s advice, Americans under age 65 could be expected to provide documentation of a serious medical problem before they can get a shot. Also complicating the rollout is the fact that pharmacists — who administer most COVID-19 shots — typically aren’t expected to collect that kind of information. And laws governing their ability to administer routine vaccinations vary by state.

Access could also be complicated for healthy adults and children who are interested in getting a shot for extra protection.

If the latest vaccines aren’t covered by their insurance, those patients could be required to pay $150 or more out of pocket if they want one. If they aren't considered high-risk, they might also have to find a doctor or other health professional willing to give the shot “off label." Many pharmacists might be reluctant to give the shots outside of FDA's instructions.

“This makes things much more complicated, and when things get complicated we see vaccine uptake go down,” said Andy Pekosz, a virologist at Johns Hopkins University.

The updated shots target coronavirus subtypes that are closely related to some newly emerging cousins. Pfizer and Moderna said they expect their shots to be available within days. Novavax's vaccine is expected in the early fall, a spokesman said.

Shots from all three companies were initially made available under the FDA’s emergency use authorization, an expedited process to quickly review vaccines, drugs and other countermeasures during the pandemic. Pfizer had not yet sought full approval for its doses designed for children under 5, which is the reason that Moderna will be the only provider of shots for that age group this year.

In addition to revoking emergency use of Pfizer’s vaccine in young children, Kennedy said Wednesday the government also pulled remaining authorizations for all other COVID-19 vaccines and another therapy from the pandemic years, convalescent plasma, which was used to treat hospitalized patients before the first antiviral drugs became available.

COVID-19 vaccines do a good job preventing severe disease, hospitalization and death, which remain a bigger risk for seniors, young children and people with underlying health risks.

Preliminary data from the CDC estimates 47,500 Americans died from COVID-related causes last year.

Some experts worried that fewer vaccinations could increase the strain on hospitals over the winter, when cases tend to accelerated.

“Down the line, this will really stress our health workforce,” said Amanda Jezek, of the Infectious Diseases Society of America. “The public health impacts here are very worrisome.”

Associated Press journalists Mary Conlon, Lauran Neergaard and Mike Stobbe contributed to this story.

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.

FILE - Pfizer signage is displayed at the Pfizer NYC Headquarters, Thursday, April 10, 2025, in New York. (AP Photo/Yuki Iwamura, File)

FILE - Pfizer signage is displayed at the Pfizer NYC Headquarters, Thursday, April 10, 2025, in New York. (AP Photo/Yuki Iwamura, File)

MINNEAPOLIS (AP) — A federal officer shot a man in the leg in Minneapolis after being attacked with a shovel and broom handle, further heightening the sense of fear and anger radiating across the city a week after an immigration agent fatally shot a woman in the head.

Smoke filled the street Wednesday night near the site of the latest shooting as federal officers wearing gas masks and helmets fired tear gas into a small crowd while protesters threw rocks and shot fireworks. Minneapolis Police Chief Brian O’Hara said during a news conference that the gathering was an unlawful assembly and “people need to leave.”

Things later began to quiet down at the scene, and by early Thursday fewer demonstrators and law enforcement officers were there.

Such protest scenes have become common on the streets of Minneapolis since a federal agent fatally shot Renee Good on Jan. 7 amid a massive immigration crackdown that has seen thousands of officers sent into the Twin Cities. Agents have yanked people from cars and homes and been confronted by angry bystanders who are demanding that officers pack up and leave.

Minneapolis Mayor Jacob Frey described the situation as not “sustainable.”

“This is an impossible situation that our city is presently being put in and at the same time we are trying to find a way forward to keep people safe, to protect our neighbors, to maintain order,” he said.

Frey described a federal force that is five times as big as the city’s 600-officer police force and has “invaded” the city, scaring and angering residents, some of whom want the officers to “fight ICE agents.” At the same time, the police force is still responsible for their day-to-day work to keep the public safe.

The Department of Homeland Security says it has made more than 2,000 arrests in the state since early December and is vowing to not back down.

In a statement describing the events that led to Wednesday's shooting, Homeland Security said federal law enforcement officers stopped a person from Venezuela who was in the U.S. illegally. The person drove away and crashed into a parked car before taking off on foot, DHS said.

After officers reached the person, two other people arrived from a nearby apartment and all three started attacking the officer, according to DHS.

“Fearing for his life and safety as he was being ambushed by three individuals, the officer fired a defensive shot to defend his life,” DHS said.

The two people who came out of the apartment are in custody, it said.

O’Hara said the man shot was in the hospital with a non-life-threatening injury.

The shooting took place about 4.5 miles (7.2 kilometers) north of where Good was killed. O’Hara's account of what happened largely echoed that of Homeland Security.

Earlier Wednesday, a judge gave the Trump administration time to respond to a request to suspend its immigration crackdown in Minnesota, while the Pentagon looked for military lawyers to join what has become a chaotic law enforcement effort in the state.

“What we need most of all right now is a pause. The temperature needs to be lowered," state Assistant Attorney General Brian Carter said during the first hearing in a lawsuit filed by Minnesota and the cities of Minneapolis and St. Paul.

Local leaders say the government is violating free speech and other constitutional rights with the surge of law enforcement. U.S. District Judge Katherine Menendez gave the U.S. Justice Department until Monday to file a response to a request for a restraining order.

Justice Department attorney Andrew Warden suggested the approach set by Menendez was appropriate.

The judge is also handling a separate lawsuit challenging the tactics used by Immigration and Customs Enforcement and other federal officers when they encounter protesters and observers. A decision could be released this week.

During a televised speech before Wednesday's shooting, Gov. Tim Walz described Minnesota as being in chaos, saying what's happening in the state “defies belief.”

“Let’s be very, very clear, this long ago stopped being a matter of immigration enforcement,” he said. “Instead, it’s a campaign of organized brutality against the people of Minnesota by our own federal government.”

CNN, citing an email circulating in the military, says Defense Secretary Pete Hegseth is asking the military branches to identify 40 lawyers known as judge advocate general officers or JAGs, and 25 of them will serve as special assistant U.S. attorneys in Minneapolis.

Pentagon spokesperson Kingsley Wilson appeared to confirm the CNN report by posting it on X with a comment that the military “is proud to support” the Justice Department.

The Pentagon did not immediately respond to emails from The Associated Press seeking more details.

It’s the latest step by the Trump administration to dispatch military and civilian attorneys to areas where federal immigration operations are taking place. The Pentagon last week sent 20 lawyers to Memphis, U.S. Attorney D. Michael Dunavant said.

Mark Nevitt, an associate professor at Emory University School of Law and a former Navy JAG, said there's concern that the assignments are taking lawyers away from the military justice system.

“There are not many JAGs but there are over one million members of the military, and they all need legal support,” he said.

Jonathan Ross, the Immigration and Customs Enforcement officer who killed Good, suffered internal bleeding to his torso during the encounter, a Homeland Security official told The Associated Press.

The official spoke to AP on condition of anonymity in order to discuss Ross’ medical condition. The official did not provide details about the severity of the injuries, and the agency did not respond to questions about the extent of the bleeding, exactly how he suffered the injury, when it was diagnosed or his medical treatment.

There are many causes of internal bleeding, and they vary in severity from bruising to significant blood loss. Video from the scene showed Ross and other officers walking without obvious difficulty after Good was shot and her Honda Pilot crashed into other vehicles.

She was killed after three ICE officers surrounded her SUV on a snowy street a few blocks from her home.

Bystander video shows one officer ordering Good to open the door and grabbing the handle. As the vehicle begins to move forward, Ross, standing in front, raises his weapon and fires at least three shots at close range. He steps back as the SUV advances and turns.

Homeland Security Secretary Kristi Noem has said Ross was struck by the vehicle and that Good was using her SUV as a weapon — a self-defense claim that has been deeply criticized by Minnesota officials.

Chris Madel, an attorney for Ross, declined to comment on any injuries.

Good’s family, meanwhile, has hired a law firm, Romanucci & Blandin, that represented George Floyd’s family in a $27 million settlement with Minneapolis. Floyd, who was Black, died after a white police officer pinned his neck to the ground in the street in May 2020.

The firm said it would conduct its own investigation and publicly share what it learns.

Associated Press reporters Julie Watson in San Diego, Rebecca Santana in Washington, Ed White in Detroit, Giovanna Dell’Orto in Minneapolis and Graham Lee Brewer in Oklahoma City contributed.

A protester yells in front of law enforcement after a shooting on Wednesday, Jan. 14, 2026, in Minneapolis. (AP Photo/John Locher)

A protester yells in front of law enforcement after a shooting on Wednesday, Jan. 14, 2026, in Minneapolis. (AP Photo/John Locher)

Tear gas surrounds federal law enforcement officers as they leave a scene after a shooting on Wednesday, Jan. 14, 2026, in Minneapolis. (AP Photo/John Locher)

Tear gas surrounds federal law enforcement officers as they leave a scene after a shooting on Wednesday, Jan. 14, 2026, in Minneapolis. (AP Photo/John Locher)

Protesters shout at law enforcement officers after a shooting on Wednesday, Jan. 14, 2026, in Minneapolis. (AP Photo/Abbie Parr)

Protesters shout at law enforcement officers after a shooting on Wednesday, Jan. 14, 2026, in Minneapolis. (AP Photo/Abbie Parr)

Law enforcement officers stand amid tear gas at the scene of a reported shooting Wednesday, Jan. 14, 2026, in Minneapolis. (AP Photo/Adam Gray)

Law enforcement officers stand amid tear gas at the scene of a reported shooting Wednesday, Jan. 14, 2026, in Minneapolis. (AP Photo/Adam Gray)

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