The Brief

The Food and Drug Administration intends to get tougher on vaccine approvals, as top officials raised concerns about the risk of COVID vaccines for children.

Speaking on Fox News Saturday morning, FDA Commissioner Marty Makary said the agency would no longer "rubber-stamp new products that don't work," claiming it made a "mockery of science."

Makary's comments came the day after FDA's top vaccine regulator, Dr. Vinay Prasad, told his team the agency would change its annual flu vaccine framework, update vaccine labels to be "honest," and make other changes to how it reviews vaccines, according to contents of an internal email reviewed by NPR and reported on first by a PBS News Hour correspondent and later by The Washington Post.

Prasad wrote that the FDA would also no longer authorize vaccines for pregnant women without stricter requirements. And for pneumonia vaccines, manufacturers will have to prove they reduce disease rather than show they generate antibodies. He also raised questions about giving multiple vaccines at the same time, which is standard practice.

The changes could make it much more difficult and expensive for vaccines to get approved, further limiting the availability of vaccines, which are considered among the safest and most effective tools for protecting people against infectious diseases.

While all vaccines carry some risks, most public health experts argue the current process for vetting vaccines before marketing has long assured that the benefits of vaccines outweigh their risks. Studies required after vaccines are approved and surveillance systems, including the Vaccine Adverse Event Reporting System (VAERS), also flag potential safety issues once vaccines are in use.

FDA says an analysis links COVID shots to some deaths

Makary said on Fox News that 10 children had died from the COVID shot during the Biden administration, but did not offer specifics about how the FDA came to that conclusion. Millions of children have received the vaccine. 

Officials with the Department of Health and Human Services and Food and Drug Administration didn't immediately respond to requests for comment on the COVID analysis and changes to vaccine review standards.

According to the FDA email from Prasad, he told the agency's biostatistics and pharmacovigilance team to analyze 96 reported deaths from 2021 to 2024, and they determined 10 children died "after and because of" the COVID vaccine. But Prasad said the true number was likely higher.

Dr. Paul Offit, who directs the Vaccine Education Center at the Children's Hospital of Philadelphia, said in a text message that Prasad has not shared the evidence that these vaccines killed 10 children.

"Because he doesn't provide any evidence, he is asking us to trust him on an important issue," Office said. "All this will do is scare people unnecessarily. At the very least, he should provide all the evidence he has so that experts in the field can review it and decide whether he has enough data to prove his point."

Dr. Jesse Goodman, a professor at Georgetown University who held Prasad's job at FDA from 2003 until 2009, said in an email that the FDA's Center for Biologics Evaluation and Research, which oversees vaccine approval, has been "recognized globally as a gold standard regulator." Goodman defended "immunologic endpoints like antibody levels" for the accelerated approval of pneumonia and influenza vaccines. He said science supports their use and they are confirmed with studies after approval: "These approaches have helped provide children and adults with timely access to safe and effective vaccines, saving many lives."

Michael Osterholm, an epidemiologist at the University of Minnesota, reviewed the email from Prasad and challenged his statement that "COVID-19 was never highly lethal for children." Osterholm also questioned the FDA's latest analysis of adverse event reports attributing the 10 deaths to COVID vaccines.

"Prasad's email is filled with factual mistakes and misrepresents both the severity of COVID in children (1597 deaths in 2020-2022) and how the US responded to the first signals of possible vaccine-associated pediatric deaths in May 2021," Osterholm wrote in an email to NPR.

"While Prasad's email notes 10 such deaths, these cases have never been presented for review by the medical and public health communities or published in the medical literature," Osterholm continued. "Given the record of this Administration to misrepresent scientific data regarding vaccines, until these cases have been reviewed by an expert third party, like the National Academy of Science[s], we can not accept the fact they are vaccine-associated deaths."

Surveillance system collects vaccines reports

The FDA makes public data from the VAERS surveillance system co-sponsored by the Centers for Disease Control and Prevention. But the FDA cautions, "it is important to note that for any reported event, no cause and effect relationship has been established." In his email, Prasad wrote that "with case reports, causality is typically assessed on a subjective scale. In this scale ranging from certain to unlikely — certain, possible/likely, and probable are broadly considered as related to the product."

Makary said on Fox News that when the COVID shot was first rolled out, it was "amazing" for people at high risk of coming down with severe disease, but things have changed.

"Back in 2020, we saw a reduction in the severity of illness and lives saved, but now recommending that a 6-year-old girl get another 70 million COVID shots — one each year for the rest of her life — is not based on science. And so we're not going to just rubber stamp approvals without seeing some scientific evidence."

The claim is the latest move by Trump administration health officials questioning the safety and effectiveness of vaccines and how the government has regulated them. Health Secretary Robert F. Kennedy Jr. has long questioned vaccines.

The FDA restricted eligibility for the updated COVID vaccines in August after announcing the agency planned to require more evidence about the shots' safety and effectiveness going forward.

CDC committee will meet to review vaccine policies

The FDA email on vaccine policy comes just before the CDC convenes a crucial two-day meeting of that agency's influential Advisory Committee on Immunization Practices on Dec. 4-5. The committee is in the process of conducting a major review of how children are inoculated against dangerous infectious diseases such as measles, mumps, rubella, polio and hepatitis B.

Many public health experts are concerned the committee will upend the childhood vaccination schedule. It could move to delay the timing of some inoculations, space out vaccinations and call for the reformulation of some vaccines. Taken together, the moves could result in fewer children getting protected and the resurgence of once-vanquished diseases.

Asked about Makary and Prasad's claims that the COVID vaccine caused deaths among 10 children, Moderna, whose COVID vaccine is approved for children as young as 6 months old, pointed to a statement it made in September. The company says that multiple published, peer-reviewed studies from a variety of sources show its shot is safe and that it is "not aware of any deaths in the last year or pertinent new information from prior years."

Moderna says it monitors its vaccine's safety along with regulators in more than 90 countries. "With more than one billion doses distributed globally, these systems — including in national health systems across Europe, the United Kingdom, Canada, Australia and the U.S. — have not reported any new or undisclosed safety concerns in children or in pregnant women."

Pfizer did not immediately respond to requests for comment.
Copyright 2025 NPR

Updated March 21, 2026 at 17:36 PM ET

Robert Mueller, the former FBI director and special counsel who led the high-profile investigation into Russian interference in the 2016 election and the possible obstruction of justice by President Trump, died on Friday at 81.

"With deep sadness, we are sharing the news that Bob passed away," his family said in a statement Saturday shared with NPR. No cause of death was given.

Mueller had been diagnosed with Parkinson's disease four years ago, his family told The New York Times in August.

Trump, who openly despised Mueller and his investigation, celebrated his death on Saturday.

"Good, I'm glad he's dead," the president posted on social media. "He can no longer hurt innocent people!"WilmerHale, the law firm where Mueller served as a partner, remembered Mueller as a "friend" who was "an extraordinary leader and public servant and a person of the greatest integrity."

"His service to our country, including as a decorated officer in the Marine Corps, as FBI Director, and at the Department of Justice, was exemplary and inspiring," a spokesperson for WilmerHale told NPR in a statement. "We are deeply proud that he was our partner. Our thoughts are with Bob's family and loved ones during this time."

Former President Barack Obama on Saturday called Mueller "one of the finest directors in the history of the FBI, transforming the bureau after 9/11 and saving countless lives."

"But it was his relentless commitment to the rule of law and his unwavering belief in our bedrock values that made him one of the most respected public servants of our time," Obama wrote on social media. "Michelle and I send our condolences to Bob's family, and everyone who knew and admired him."

Path to public service

Born on Aug. 7, 1944 in New York City, Mueller was raised in Philadelphia and graduated from Princeton University in 1966. He received a master's degree in international relations from New York University.

Mueller, throughout his career, ran toward tough assignments. Following the lead of a classmate at Princeton, Mueller enrolled in the Marines and served in the Vietnam war. He earned the Bronze Star for rescuing a colleague. Mueller said he felt compelled to serve during that conflict, an idea he returned to throughout his life.

Law professor and former Justice Department lawyer Rory Little knew Mueller for many years.

"Bob is kind of a straight arrow, you know, wounded in Vietnam," Little said. "You keep wanting to hunt for where is the crack in that façade — 'Where is the real Bob Mueller?' — and after a while you begin to realize that's the real Bob Mueller. He is exactly who he appears to be. This kind of sour-faced, not a lot of humor, sort of all-business guy. That's him."

But with his closest friends, Mueller let down his guard. They teased him — saying Mueller would have made an excellent drill instructor on Parris Island, where Marine recruits are trained.

Instead, Mueller went to law school at the University of Virginia. He joined the Justice Department in 1976. There, he prosecuted crimes, big and small, for U.S. attorneys in San Francisco and Boston. He was a partner at Hale and Dorr, a Boston law firm now known as WilmerHale.

He later became a senior litigator prosecuting homicides at the U.S. attorney's office in Washington, D.C.

Head of the FBI

In 2001, President George W. Bush nominated him to serve as the director of the FBI. Mueller was sworn in a week before the Sept. 11 terrorist attacks.

"I had been a prosecutor before, so I anticipated spending time on public corruption cases and narcotics cases and bank robberies, and the like. And Sept. 11th changed all of that," Mueller told NPR during an interview in 2013.

He shifted the bureau's attention to fighting terrorism. He staffed up the headquarters in Washington. He pushed those agents to try to predict crimes and to act before another tragedy hit.

"He directed and implemented what is arguably the most significant changes in the FBI's 105-year history," said his former FBI deputy, John Pistole.

Along the way, Mueller drew some criticism when his agents erred. During the investigation of the deadly anthrax attacks, the bureau focused on the wrong man as its lead suspect.

Mueller left the bureau in 2013.

Return to the national spotlight

After Trump fired FBI Director James Comey, Mueller in May 2017 was appointed by then Deputy Attorney General Rod Rosenstein as special counsel to oversee the probe into Russian meddling in the 2016 election and possible connections to Trump associates.

Trump called the investigation "a witch hunt" and Republicans in Congress started to attack the investigators.

When then the investigation eventually concluded in March 2019 with the more than 400-page "Mueller report," the special counsel said the investigation did not establish that Trump's campaign or associates colluded with the Russian government to influence the 2016 election. The report did not take a position on whether Trump obstructed justice.

Mueller said the report spoke for itself. But Democrats wanted more and insisted he testify. A reluctant witness, Mueller once again fulfilled his duty. He was visibly older than at the time of his appointment and kept his testimony restrained.

He said Justice Department guidelines would not allow him to charge a sitting president with criminal wrongdoing. But he also refused to exonerate Trump.

"If we had had confidence that the president clearly did not commit a crime, we would have said so," Mueller later told Congress.

In the end, the team charged 37 people and entities, including former campaign chair Paul Manafort, national security adviser Michael Flynn and 25 Russians.

Trump went on to grant clemency to or back away from criminal cases against many of the people Mueller's investigators had charged.

Copyright 2026 NPR

At the Koreatown Senior and Community Center, people were used to seeing Keum-soon Lee arrive early. When she didn’t show up for the 11 a.m. group harmonica class at the center last Friday, people took notice. 

“She would always be there first,” said conductor Eun-young Kim. “If she couldn’t come, she would tell me ahead of time. This time, I didn’t receive any messages from her. I thought, something isn’t right.”

Kim tried calling and sending messages. She didn’t get a response.

Members of the center later learned that Lee, 73, was critically injured in a hit-and-run crash while biking home in Koreatown after attending early morning prayer at her church. She died in a hospital March 13 from her injuries, according to the Los Angeles Police Department.

“I was shocked,” said Jin-soon Baek, who has played with Lee for years. “We’ve been friends for a long time. We ate together, practiced together. She was like a sibling to me.

“She was so hardworking. Always the first one there to sign in for class. She’d walk ahead of me and I’d follow behind. That’s how it always was.”

Baek, who is in her 80s, said the two also shared something more personal: Both had cancer.

“I had cancer years ago, and she was going through treatment recently,” Baek said. “We understood each other.”

In January, Lee played with the harmonica ensemble at an LA Kings game. Lee spoke with a journalist about undergoing surgery and chemotherapy, and what the group meant to her. 

“I think I’ve almost fully recovered,” Lee told journalist Chase Karng at the hockey game. “Even while receiving chemotherapy, I felt encouraged when I heard that I could perform here.”

At the Koreatown Senior and Community Center, people were used to seeing Keum-soon Lee arrive early. When she didn’t show up for the 11 a.m. group harmonica class at the center last Friday, people took notice.

Lee was born in 1952 in South Korea and immigrated to the United States in 1998. She was an elder at Saehan Presbyterian Church in Pico Union and is survived by her husband, Sang-rae Lee, and son, Young-jo Lee.

The senior center, where Lee was a fixture and known as a reliable friend, has designated March 20 as a day of mourning.

On Friday, Lee’s church held a funeral service, where members of the harmonica ensemble performed the hymn, “Nearer My God to Thee,” in her memory.

“I usually don’t attend funeral services, but I had to come for hers,” said Alice Kim. “Whenever I came to church, I would see her watering the grass, bent over, and she would smile and say, ‘You’re here, Alice,’ and hand me the Sunday bulletin.”

In her eulogy, elder Gyu-sook Lee said the sudden loss has hit the congregation hard.

“She always greeted everyone with a warm smile,” she said. “She was the kind of person who always stepped forward first to do the hard work that no one else wanted to do. And when she took something on, she saw it through to the end.”

At the Koreatown Senior and Community Center, people were used to seeing Keum-soon Lee arrive early. When she didn’t show up for the 11 a.m. group harmonica class at the center last Friday, people took notice.

“She still had so many years ahead of her,” Baek said. “She was younger than us. Full of hope. It feels like it should have been me instead.”

According to police, Lee was riding through a crosswalk when a white Dodge Ram truck turning right struck her around 6:40 a.m. near Olympic Boulevard and Vermont Avenue. The driver briefly stopped, then drove away, authorities said.

Investigators found the truck and are looking into whether the driver was impaired on drugs or alcohol. The truck was seized and there was no information about the driver.

Kim, the conductor, said Lee was the first person to reach out to her when she started to lead the ensemble in September. 

“She sent me a message saying thank you for coming,” Kim said. “She was such a special person to me.” 

At Friday’s service, speaker after speaker described Lee as someone who was a light in every community she was part of. 

“The way she served the church behind the scenes became a lesson in faith for all of us. There isn’t a single part of this church that hasn’t felt her touch. Her warmth, her love, her dedication — I can still feel it,” Gyu-sook Lee said.

When Gilbert Lindsay became the first Black person elected to Los Angeles City Council in 1963, it gave the residents of the predominantly Black District 9 someone who understood the challenges they faced living in South Central. 

This area was the center of Black political power in LA because it was one of the few places in the city Black people were allowed to live and thrive due, in part, to housing restrictions. For the next 63 years, voters in this district — which includes historic South Central, Exposition Park and a small portion of downtown Los Angeles — consecutively chose a Black representative. 

That will end with Curren D. Price Jr., the current District 9 councilmember who can’t run again due to term limits. 

Twelve candidates announced campaigns in February to replace Price. Of them, six candidates have qualified to be on the June 2 primary election ballot, none of whom are Black. They include: Estuardo Mazariegos, Elmer Roldan, Jorge Hernandez Rosas, Jorge Nuño, Martha Sánchez and Jose Ugarte. 

The list is a reflection of the demographic shift of the area, but candidates also told The LA Local that it shows the strength of the district’s Black-Latino political coalition. And with the civil rights gains since the 1960s, while some locals are concerned that issues facing Black voters won’t get the attention they need, others who live in the district said they’re less concerned with what their representative looks like. Instead, they said they want someone who listens and gets things done. 

“As long as you do good in the community, we’re going to be happy,” said Dennis Anya, who works on Central Avenue and has lived in the district for nearly 40 years.

What the demographic shifts in District 9 mean for the June election

The upcoming election comes as the demographics have changed in District 9 and South LA. The Black population in South Los Angeles was 81% in 1965, according to a special census survey from November 1965 of South and East LA. 

As of 2021, District 9, specifically, is about 78% Latino and 13% Black, according to LA City Council population demographic data taken that year as part of a redistricting effort. 

Officials have predicted the district’s shift for years. Former City Councilmembers Kevin De León and Nury Martinez discussed the district’s future in the leaked 2021 audio — checkered with racist remarks — that the LA Times reported in 2022.“This will be [Price’s] last four years,” De Leon said at one point in the conversation, the transcript of which the LA Times published in full. “That eventually becomes a Latino seat.” 

Erin Aubry Kaplan, a writer and columnist who traces her family’s roots to South Central, told The LA Local that because District 9 has historically voted for a Black candidate, there is some anxiety amongst Black voters about losing Black representation in Los Angeles. 

“I would hope that whoever wins, will carry the interest of Black folk forward,” she said.

Manuel Pastor, a USC professor and co-author of “South Central Dreams: Finding Home and Community in South LA,” told The LA Local that traditionally, voters are older. While District 9 is now home to a younger, immigrant community, they may not vote at the same rate as older generations, and undocumented residents are ineligible to vote.  

Pastor said it’s likely for this reason that the current District 9 candidates are not emphasizing being Latino but are modeling their campaigns after other city leaders and focusing on Black-Latino solidarity. 

“Just because the demographics have changed, doesn’t mean that the voting population has changed,” Pastor said.  

Here’s what the candidates say about the transformation of District 9

Chris Martin, one of the two Black candidates who campaigned for the seat but did not qualify for the ballot, said he believes the city’s Black elected officials should have supported Black candidates in the race. Martin said he will challenge the city clerk’s decision on his nomination petition in court. 

“The story of Black political power in the city of Los Angeles is dying,” Martin said. “I felt like I had a good chance of keeping it alive.” 

When Gilbert Lindsay became the first Black person elected to Los Angeles City Council in 1963, it gave the residents of the predominantly Black District 9 someone who understood the challenges they faced living in South Central.

Michelle Washington, the other Black candidate who also did not qualify, did not respond to a request for comment.Price, the current District 9 councilmember, endorsed his deputy Jose Ugarte in the race and wrote in a statement that this election is about solidarity. 

“As a Black man who has served a majority-Latino district, I know that progress in South Central has always come from Black and Brown families moving forward together,” Price wrote. “We’ve had to fight harder for housing, safety, opportunity and the basic investments every neighborhood deserves. And when we’ve made gains, it’s because we stood united.”  

Five of the six candidates who qualified for the ballot told The LA Local that not having a Black candidate on the ballot doesn’t diminish the place of the district’s Black community. (Candidate Jorge Hernandez Rosas did not return requests for comment.) 

“It has always been a Black community and will always be a Black community. This isn’t about a passing of the baton or one community taking over another. It’s about building a solidarity movement,” Estuardo Mazariegos said. 

Elmer Roldan, who carries endorsements from LA Mayor Karen Bass and City Council President Marqueece Harris-Dawson, said the district needs a councilmember who won’t leave anyone behind.“We have to avoid at all costs contributing to Black erasure and Black displacement,” Roldan said.

Ugarte said that the major quality of life problems — like dirty streets and broken street lights — affecting the neighborhood’s Black and brown communities haven’t changed since he was a child living in the district. 

“The same issues are still here,” he said. 

Here’s what happens next

If you haven’t registered to vote and you want to receive a vote-by-mail ballot, you must register to vote by May 18.

Results from the primary election will be certified by July 2. If no candidate receives more than 50% of the vote, the top two candidates will move on to the general election on Nov. 3, according to the City Clerk’s website. 

The winner of District 9 will begin a four-year term Dec. 14.

The L.A. County Medical Examiner has released the cause of death for Emily Beutner, the daughter of former LAUSD Superintendent Austin Beutner.

The 22-year-old died from the effects of a combination of drugs, including two linked to the opioid known as kratom — mitragynine and 7-hydroxymitragynine — according to the statement released by the medical examiner Friday.

A county health official told our partner CBS L.A. that kratom products are sometimes sold as natural remedies but are illegal and unsafe.

The other two substances cited as causes of death were quetiapine and mirtazapine — the former is an antipsychotic medication, and the latter is used to treat depression, according to the Mayo Clinic.

The former Loyola Marymount University student was found alone and suffering from medical distress by L.A. County Fire Department personnel shortly after midnight in a field by a highway in Palmdale on Jan. 6. She was transported to a hospital and pronounced dead soon after.

After his daughter's death, Beutner dropped out of the L.A. mayoral race.

The Medical Examiner said the manner of death was ruled a suicide.

Resources

If You Need Immediate Help

• If you or someone you know is in crisis and need immediate help, call the Suicide Prevention Lifeline at 988 or go here for online chat.

If you or someone you know is experiencing a crisis, you can dial the mental health lifeline at 988.

Additional resources