Moderna says FDA refuses its application for new mRNA flu vaccine

posted in: All news | 0

By LAURAN NEERGAARD and MATTHEW PERRONE

WASHINGTON (AP) — The U.S. Food and Drug Administration is refusing to consider Moderna’s application for a new flu vaccine made with Nobel Prize-winning mRNA technology, the company announced Tuesday.

Related Articles


Close Maduro ally pardoned by Biden once again a target of US criminal investigation


Privacy activists call on California to remove covert license plate readers


U.S. citizens and legal residents sue over aggressive immigration raid at Idaho horse racing track


Immigrant rights groups seek to dismiss a Republican lawsuit to exclude noncitizens from US census


Trump administration plans to hold back grant money for some Democratic-led states

The news is the latest sign of the FDA’s heightened scrutiny of vaccines under Health Secretary Robert F. Kennedy Jr., particularly those using mRNA technology, which he has criticized before and after becoming the nation’s top health official.

Moderna received what’s called a “refusal-to-file” letter from the FDA that objected to how it conducted a 40,000-person clinical trial comparing its new vaccine to one of the standard flu shots used today. That trial concluded the new vaccine was somewhat more effective in adults 50 and older than that standard shot.

The letter from FDA vaccine director Dr. Vinay Prasad said the agency doesn’t consider the application to contain an “adequate and well-controlled trial” because it didn’t compare the new shot to “the best-available standard of care in the United States at the time of the study.” Prasad’s letter pointed to some advice FDA officials gave Moderna in 2024, under the Biden administration, which Moderna didn’t follow.

According to Moderna, that feedback said it was acceptable to use the standard-dose flu shot the company had chosen — but that another brand specifically recommended for seniors would be preferred for anyone 65 and older in the study. Still, Moderna said, the FDA did agree to let the study proceed as originally planned.

The company said it also had shared with FDA additional data from a separate trial comparing the new vaccine against a licensed high-dose shot used for seniors.

The FDA “did not identify any safety or efficacy concerns with our product” and “does not further our shared goal of enhancing America’s leadership in developing innovative medicines,” Moderna CEO Stephane Bancel said in a statement.

It’s rare that FDA refuses to file an application, particularly for a new vaccine, which requires companies and FDA staff to engage in months or years of discussions.

Moderna has requested an urgent meeting with FDA, and noted that it has applied for the vaccine’s approval in Europe, Canada and Australia.

In the last year, FDA officials working under Kennedy have rolled back recommendations around COVID-19 shots, added extra warnings to the two leading COVID vaccines — which are made with mRNA technology — and removed critics of the administration’s approach from an FDA advisory panel.

Kennedy announced last year that his department would cancel more than $500 million in contracts and funding for the development of vaccines using mRNA.

FDA for decades has allowed vaccine makers to quickly update their annual flu shots to target the latest strains by showing that they trigger an immune response in patients. That’s a far more efficient approach than running long-term studies tracking whether patients get the flu and how they fare. In an internal memo last year, Prasad wrote that the streamlined method would no longer be permitted – leading more than a dozen former FDA commissioners to pen an editorial condemning the statements.

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.

Grieving mother demands answers nearly 2 years after Florida deputy fatally shot airman

posted in: All news | 0

FORT WALTON BEACH, Fla. (AP) — The mother of a U.S. Air Force airman shot and killed by a Florida sheriff’s deputy nearly two years ago says she doesn’t want people to forget about her son and is still seeking accountability so it doesn’t happen to someone else.

Related Articles


US’s largest public utility says it now doesn’t want to close two coal-fired plants


FBI search of Georgia offices tied to probe of possible 2020 election ‘defects,’ affidavit says


US-Canada bridge brouhaha deepens as White House says Trump could amend a permit for the project


US to expand passport revocations for parents who owe child support, AP sources say


Trump administration takes down a rainbow flag at the Stonewall National Monument

Senior Airman Roger Fortson, 23, was shot to death by a deputy responding to a disturbance call at Fortson’s apartment in Fort Walton Beach, where he lived while based at nearby Hurlburt Field. The May 2024 encounter was captured on body camera video.

At a Tuesday news conference in Florida, prominent civil rights attorney Ben Crump, who is representing Fortson’s family in an ongoing federal lawsuit, said it was his mother’s decision to hold the media briefing.

“She is deeply hurt and concerned that time has allowed her son’s name and his life to fade from public consciousness,” Crump said.

“We are not here to litigate facts or comment on ongoing legal proceedings,” he added. “We are here because silence, delay and distance have a human cost for families who are left to grieve while waiting for answers.”

Okaloosa County Sheriff Eric Aden fired Deputy Eddie Duran, 38, who fatally shot Fortson after being directed to Fortson’s apartment while responding to a domestic violence call. Duran was charged with manslaughter with a firearm, a first-degree felony punishable by up to 30 years in prison. It’s a rarely seen criminal case filed against a Florida law officer.

FILE – Attorney Ben Crump, center left, speaks during a news conference with Chantemekki Fortson, mother of slain U.S. Air Force senior airman Roger Fortson, June 3, 2024, in Atlanta. (AP Photo/Brynn Anderson, File)

Two Florida attorneys representing Duran did not immediately respond to requests for comment Tuesday.

Fortson’s mother, Chantimekki Fortson, said she still has many unanswered questions about the case.

“I need to know what happened to my baby,” she said.

“I have to try to learn how to live life without Roger,” she added. “I don’t think I’m going to ever learn that.”

Crump added that Fortson’s mother wants to know: “How could it have been prevented and how can we make sure that it doesn’t happen to anyone else’s family?” he said.

Fortson’s family is from Georgia. Hundreds of Air Force members in dress blues mourned Fortson at his funeral outside Atlanta.

Don Lemon Hires Federal Prosecutor Who Quit Over Immigration Crackdown

posted in: All news | 0

MINNEAPOLIS — The federal prosecution of journalist Don Lemon took an unlikely turn Tuesday.

Facing charges over his presence at a church protest challenging the immigration crackdown in Minnesota, Lemon has hired as one of his defense lawyers a veteran criminal litigator who, until just weeks ago, was helping lead the prosecutor’s office that has charged Lemon with felonies.

Joseph H. Thompson, a former senior federal prosecutor who resigned from the U.S. attorney’s office in Minnesota in mid-January over the Justice Department’s handling of the immigration operation, has joined Lemon’s defense team, according to a court filing.

Thompson’s appointment is the latest plot twist in a high-profile case that has been anomalous from the start. By representing the most prominent of nine defendants charged in the church protest case, Thompson will face off against a department that employed him for nearly 17 years. Thompson will work alongside Lemon’s lead defense lawyer, Abbe Lowell.

The government’s investigation began after Lemon, a former CNN anchor who now works as an independent journalist producing content for a YouTube show, accompanied protesters who disrupted the Sunday morning service at Cities Church in St. Paul, Minnesota, on Jan. 18. Demonstrators targeted the church because one of its pastors, David Easterwood, is a senior official with U.S. Immigration and Customs Enforcement in the state. Easterwood was not at the service.

Lemon, 59, met with protest organizers at the parking lot of a grocery store, followed them into the church and livestreamed as they chanted “ICE out!” and “Hands up, don’t shoot!”

In a video of the protest Lemon posted on social media, he is seen interviewing worshippers as well as protesters inside the church, at one point saying, “We are not part of the activists, but we’re here reporting on them.”

That night, Harmeet Dhillon, the assistant attorney general for civil rights, issued a statement calling Lemon’s role in the protest “pseudojournalism” that was not protected under the First Amendment.

Days later, a federal magistrate judge signed arrest warrants for three of the protesters but declined to sign off on warrants for the arrest of Lemon and four other people. The chief federal judge in Minnesota, Patrick Schiltz, agreed with the magistrate judge, saying the government had not produced evidence that Lemon had broken the law.

Senior Justice Department officials took the unusual step of appealing Schiltz’s refusal to sign off on Lemon’s arrest by asking an appeals court to do so, calling the possibility of future protests during church services a “national security emergency.” The appeals court declined that request.

Late last month, a federal grand jury indicted Lemon along with another independent journalist, Georgia Fort, and seven other individuals who attended the demonstration.

The nine defendants are charged with conspiring to violate religious freedoms at a house of worship, and with injuring, intimidating and interfering with the exercise of religious freedoms at a place of worship. Both charges are felonies under a 1994 law passed mainly to protect abortion clinics from violence.

Attorney General Pam Bondi called Lemon’s conduct unlawful, referring to the demonstration as a “riot” that terrified congregants. After Nekima Levy Armstrong, one of the protest organizers, was arrested late last month, the White House posted a photo of her arrest that was manipulated to make Levy Armstrong, who is Black, appear to have darker skin, and to falsely portray her as disheveled and crying.

According to the indictment, Lemon “stood in close proximity” to a pastor during the protest “in an attempt to oppress and intimidate him.” At one point, it adds, Lemon “caused the pastor’s hand to graze” his. The indictment says Lemon and the demonstrators did not immediately leave the church at the request of its leaders.

Lemon, who has been a vocal critic of the Trump administration’s deportation push, has called the charges against him “an unprecedented attack on the First Amendment and a transparent attempt to distract attention from the many crises facing this administration.”

The aggressiveness with which the Justice Department has pursued the church protest case has unsettled career prosecutors, according to several people familiar with events at the U.S. attorney’s office in recent days. Several of them, who spoke on the condition of anonymity because they were not authorized to speak publicly, have noted that the indictment does not include the names of any career prosecutors at the U.S. attorney’s office in Minnesota as would be common in a civil rights criminal case.

Thompson, who had been the second in command at the U.S. attorney’s office in Minnesota, resigned Jan. 13 along with several colleagues after clashing with leaders at the Justice Department over its handling of the investigation into the killing of a Minneapolis woman, Renee Good, by an ICE agent.

Thompson and other career prosecutors sought to investigate the legality of the shooting of Good. But senior department leaders overruled him and instead sought to investigate Good’s partner, examining her possible links to groups protesting ICE operations in the state.

Thompson, who kept a low profile since resigning, this week started a law firm with Harry Jacobs, a fellow former federal prosecutor who also resigned in protest.

Thompson’s move to represent a defendant prosecuted by his former office reflects the wider tumult at the Justice Department, which has seen an exodus of career prosecutors as they said they found themselves pressured to investigate and prosecute President Donald Trump’s perceived enemies.

Other surprising partnerships have emerged. Last summer, Rascoe Dean, the deputy chief of the criminal division at the U.S. attorney’s office in Nashville, Tennessee, joined the legal team representing Kilmar Abrego Garcia, the Salvadoran immigrant who has come to symbolize Trump’s aggressive deportation agenda. Dean quit his job as a prosecutor after Abrego Garcia was indicted.

This article originally appeared in The New York Times.

Privacy activists call on California to remove covert license plate readers

posted in: All news | 0

By GARANCE BURKE and BYRON TAU

More than two dozen privacy and advocacy organizations are calling on California Gov. Gavin Newsom to remove a network of covert license plate readers deployed across Southern California that the groups believe feed data into a controversial U.S. Border Patrol predictive domestic intelligence program that scans the country’s roadways for suspicious travel patterns.

Related Articles


U.S. citizens and legal residents sue over aggressive immigration raid at Idaho horse racing track


Immigrant rights groups seek to dismiss a Republican lawsuit to exclude noncitizens from US census


Trump administration plans to hold back grant money for some Democratic-led states


Why the words ‘Armenian genocide’ matter after Vance social media reference is deleted


Republican lawmakers grill telecom officials over phone records access in Trump investigation

“We ask that your administration investigate and release the relevant permits, revoke them, and initiate the removal of these devices,” read the letter sent Tuesday by the Electronic Frontier Foundation, Imperial Valley Equity and Justice and other nonprofits.

An Associated Press investigation published in November revealed that the U.S. Border Patrol, an agency under U.S. Customs and Border Protection, had hidden license plate readers in ordinary traffic safety equipment. The data collected by the Border Patrol plate readers was then fed into a predictive intelligence program monitoring millions of American drivers nationwide to identify and detain people whose travel patterns it deems suspicious.

AP obtained land use permits from Arizona showing that the Border Patrol went to great lengths to conceal its surveillance equipment in that state, camouflaging it by placing it inside orange and yellow construction barrels dotting highways.

The letter said the groups’ researchers have identified a similar network of devices in California, finding about 40 license plate readers in San Diego and Imperial counties, both of which border Mexico. More than two dozen of the plate readers identified by the groups were hidden in construction barrels.

They could not determine of the ownership of every device, but the groups said in the letter that they obtained some permits from the California Department of Transportation, showing both the Border Patrol and Drug Enforcement Administration had applied for permission to place readers along state highways. DEA shares its license plate reader data with Border Patrol, documents show.

The letter cited the AP’s reporting, which found that Border Patrol uses a network of cameras to scan and record vehicle license plate information. An algorithm flags vehicles deemed suspicious based on where they came from, where they were going and which route they took. Agents appeared to be looking for vehicles making short trips to the border region, claiming that such travel is indicative of potential drug or human smuggling.

Federal agents in turn sometimes refer drivers they deem suspicious to local law enforcement who make a traffic stop citing a reason like speeding or lane change violations. Drivers often have no idea they have been caught up in a predictive intelligence program being run by a federal agency.

The AP identified at least two cases in which California residents appeared to have been caught up in the Border Patrol’s surveillance of domestic travel patterns. In one 2024 incident described in court documents, a Border Patrol agent pulled over the driver of a Nissan Altima based in part on vehicle travel data showing that it took the driver six hours to travel the approximately 50 miles between the U.S.-Mexican border and Oceanside, California, where the agent had been on patrol.

“This type of delay in travel after crossing the International Border from Mexico is a common tactic used by persons involved in illicit smuggling,” the agent wrote in a court document.

In another case, Border Patrol agents said in a court document in 2023 they detained a woman at an internal checkpoint because she had traveled a circuitous route between Los Angeles and Phoenix. In both cases, law enforcement accused the drivers of smuggling immigrants in the country unlawfully and were seeking to seize their property or charge them with a crime.

The intelligence program, which has existed under administrations of both parties, has drawn scrutiny from lawmakers since the AP revealed its existence last year.

The California Department of Transportation and the office of Newsom, a Democrat, did not immediately respond to requests for comment.

Courts have generally upheld license plate reader collection on public roads but have curtailed warrantless government access to other kinds of persistent tracking data that might reveal sensitive details about people’s movements, such as GPS devices or cellphone location data. Some scholars and civil libertarians argues that large-scale collection systems like plate readers might be unconstitutional under the Fourth Amendment.

“Increasingly, courts have recognized that the use of surveillance technologies can violate the Fourth Amendment’s protections against unreasonable searches and seizures. Although this area of law is still developing, the use of LPRs and predictive algorithms to track and flag individuals’ movements represents the type of sweeping surveillance that should raise constitutional concerns,” the organizations wrote.

CBP did not immediately respond to a request for comment, but previously said the agency uses plate readers to help identify threats and disrupt criminal networks and their use of the technology is “governed by a stringent, multi-layered policy framework, as well as federal law and constitutional protections, to ensure the technology is applied responsibly and for clearly defined security purposes.”

DEA did not immediately respond to a request for comment.

Burke reported from San Francisco. Tau reported from Washington.

Contact AP’s global investigative team at Investigative@ap.org or https://www.ap.org/tips/.