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.
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Flies, rodents and other pests have been a persistent problem in Boyle Heights and nearby communities as millions of tons of food rot in a nearby burned-out warehouse. It’s gotten bad enough that L.A. Mayor Karen Bass is asking for action from the L.A. County Department of Public Health.

In a letter sent Tuesday to county Public Health Director Barbara Ferrer, Bass said she’s “concerned with County DPH’s pace in addressing this disaster” and the risks it posed to health and quality of life.

“Possibly the worst manifestation of these risks is the severe infestation of flies in Boyle Heights and neighboring communities,” Bass wrote.

LAist has asked the Department of Public Health for comment and will update this article when they respond.

The back-and-forth between jurisdictions

Bass wrote that the city of L.A., which does not have its own health department, is largely dependent on L.A. County for control of potentially disease-carrying vectors. The city has said elsewhere that its Sanitation Department did set about 250 rat traps in surrounding areas.

Bass’ letter says the county took its first steps to hold Lineage accountable for a fly infestation on July 17, ordering Lineage to remove flies and mosquitoes from the warehouse.

“Although I appreciate that County DPH has taken this first step, the County’s report only directs Lineage to eliminate flies from Lineage’s own property,” Bass’ letter to Ferrer states.

Bass urged the county to compel Lineage to address pests at neighboring properties “with aggressive measures to eliminate the flies and any other vectors.”

As for L.A. County’s Department of Public Health, a spokesperson told LAist on July 17 that it had itself directed the city and Lineage to address the pest situation.

“Los Angeles County Department of Public Health requested that both Lineage Logistics and the City of Los Angeles develop and implement a vector/insect control plan,” the statement reads.

Lineage’s part

According to Councilmember Ysabel Jurado, who represents Boyle Heights on the L.A. City Council and met with Lineage representatives on Monday, an inspector contracted by the company confirmed that the rotting food at the warehouse is serving as a breeding ground for flies. The infestation won’t go away without addressing the root cause, Jurado reported the contractor as saying.

“Removing waste, adding odor-control equipment, and conducting a pest inspection are important,” Jurado said in a statement. “But residents are asking a more fundamental question: Are conditions actually improving? They deserve evidence, timelines and accountability — not just a list of activities.”

Lineage has not yet presented its pest control plan to the public.

A ticking clock

The first day of instruction for L.A. Unified schools is Aug. 12, three days before the city’s current deadline to clear the warehouse — a deadline Lineage does not appear to be on track to meet.

That’s led many teachers and parents to raise the alarm about smells and pests that may very well still be around when school starts. An LAUSD spokesperson told Boyle Heights Beat that it is prepared to temporarily relocate nearby schools, as they did with summer programs during the warehouse fire.

Lineage meets deadline at last minute

Meanwhile, Lineage also faced a deadline of Tuesday to present a plan to air quality officials on how to address smells. A South Coast Air Quality Management District spokesperson said that the agency received a response from Lineage at 5 p.m. and is evaluating it.

L.A.’s homeless services agency has not completed any internal audits in years — and one that was started two years ago is still incomplete because management is taking months to provide responses, officials said Monday.

The delayed audit has been looking into why the L.A. Homeless Services Authority, known as LAHSA, failed to spend $7 million in federal dollars it was granted to house and serve people in need. The roughly six-page audit report hasn’t been released because it’s missing LAHSA management responses that were requested over two months ago, officials said.

Internal audits are considered critically important to protecting taxpayer dollars at every level of government. L.A. County auditors, for example, issued about 100 reports in a recent fiscal year.

“ We haven’t gotten anything,” said Erum Shahnawaz, LAHSA’s chief internal auditor, referring to the lack of response from LAHSA management at a meeting of the agency’s audit committee on Monday.

“That’s the only thing that's holding us from issuing the final report,” Shahnawaz said of the underspending audit.

That audit is examining a repeat problem. A previous, external audit in January 2022 found LAHSA had left $3.5 million in federal grants on the table by not using them.

Shahnawaz flagged management’s delays to the LAHSA Commissioner Justin Szlasa, Szlasa said. He chairs the commission’s audit committee, and has repeatedly called out LAHSA executives’ delays in providing information about taxpayer spending over the past year.

“ I've been trying to intervene and use whatever I can to try to help provide support,” said Szlasa as he described his attempts to get the auditor the answers needed to complete the report.

Szlasa was appointed to the commission by L.A. County Supervisor Kathryn Barger.

 “It shouldn't take us two months to receive a…management response to an internal audit,” Szlasa said at Monday’s meeting. He said the industry standard for internal audits is eight or nine weeks from start to finish. That compares to the two years — and counting — for LAHSA’s federal underspend audit.

“We haven't had a single internal audit completed here in the last couple of years, which is nuts,” Szlasa added. He called for internal audits to happen much more frequently.

Long delays to LAHSA audits also are not new. In November 2024, the county issued a widely-seen audit that included findings that LAHSA was failing to complete internal audits.

Half of LAHSA’s governing commission is appointed by L.A. Mayor Karen Bass and half appointed by each of the five county supervisors. Bass is also the only elected official on the commission. She served on the audit committee for several months last fall. Records show she was absent for all of the meetings during that time.

Janine Lim, LAHSA’s deputy chief financial officer, said management’s responses to the audit on underspending haven’t been provided yet because LAHSA leadership did not have clearly defined roles for who is supposed to coordinate responses to internal audits.

“ We need to work on clarifying that role internally,” Lim said.

 “The last two months have been probably some of the most stress-filled two months that we've had at LAHSA,” said Paul Rubenstein, chief of staff to LAHSA CEO Gita O’Neil, pointing to mass layoffs.

Szlasa said there’s not that much in the audit for management to respond to.

“It's like, six pages or less,” he said.

Szlasa said  another option is to “just say we've asked management for responses and we're awaiting management response. We can publish the results.”

In response, Shahnawaz said that if management doesn't have an updated timeline for a response, then she’ll go ahead and issue the report without the response.

Once they floated that idea, Lim committed to providing the responses by next Tuesday.

LAHSA’s leadership has downsized the internal audit team — dropping from a staff of three to just one in the agency’s proposed budget up for approval Friday.

Delays in getting access to financial records

The delayed responses from management are not the only thing that’s been slowing down audits, Szlasa said at the meeting.

LAHSA policy, approved by its governing commission, says internal auditors are “ authorized to access all organizational records, personnel, and systems necessary for conducting audits,” he said.

But the auditor has faced challenges in actually getting that access, Szlasa said — including delays in being allowed to view LAHSA’s databases that show contracts and financial payments.

 ”We finally were granted access, but it wasn't, it wasn't easy, it wasn't immediate. It was slow,” Szlasa said.

Many failed outside audits

The delays on the internal audit come even after LAHSA failed multiple external audits in recent years, which have found the agency — overseen by city and county elected officials — has neglected to properly track billions of dollars in spending.

Largely in response to earlier audits, L.A. County supervisors pulled funding from LAHSA and are having the county instead oversee it directly. L.A.’s mayor and City Council have continued to have LAHSA manage the city’s homeless spending while the council delays plans to start studying a possible plan to transition away city tax dollars.

Signatures under scrutiny

LAHSA is also in the midst of a different internal audit — expected to finish in late August or early September — examining whether top officials followed requirements when signing contracts and letting others sign. It was launched in the wake of LAist reporting that found LAHSA’s then-CEO Va Lecia Adams Kellum’s signature finalized a $2.1 million contract with her husband’s employer.

LAist also discovered Adams Kellum’s signature, as LAHSA’s CEO at the time, finalized a quarter-million-dollar contract between LAHSA and a longtime service provider she led up until two months earlier.

That contract was signed so soon after she left the service provider — St. Joseph Center — that the contract paperwork still listed her as one of St. Joseph Center’s points of contact and authorized signers.

She is currently under a state ethics investigation into whether her actions were an illegal conflict of interest.

When Bengara opened in Los Angeles' Arts District earlier this year, its owner and head chef had something special lined up in their kitchen arsenal.

It was genshiyaki, a rare traditional Japanese grilling method that dates back 1,500 years.

Chef and co-owner Tyler Burges had only encountered it once while traveling in Japan at a robatayaki spot in Fukuoka, a port city on the island of Kyushu.

Robatayaki, a style of slow, ember-cooked grilling rooted in Japan's rural coastal kitchens, usually centers on an open charcoal hearth. But the restaurant Burges visited had something even more noteworthy: a genshiyaki pit, a gentler, ambient method of cooking that uses radiant heat instead of direct flame.

Loving the unusually subtle, delicate flavor and texture it produced, he and head chef Phil Mireles decided to bring genshiyaki back to the U.S. and build their Arts District restaurant around it. The genshiyaki pit is a rare enough technique that Burges had to work with fabricator Phil Roxworthy for six months just to get the grill built to spec.

It's Burges' and Mireles' first L.A. project. The pair are also behind Smoke Door, their acclaimed Lake Tahoe restaurant, and Bengara brings a more casual, day-to-day take on the same fire-driven cooking.

All roads lead to the Arts District

Chef/owner Tyler Burges (left) and head chef Phil Mireles at Bengara.

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Wonho Frank Lee

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Courtesy Bengara

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Burges and Mireles both got their start at San Francisco's Saison and Angler under chef Joshua Skenes — who's now just down the street in L.A. at LYNX with fellow alum Brandyn Tepper.

Burges traces Bengara's DNA back to two mentors: Ron Siegel, who introduced him to Japanese ingredients and technique in his mid-20s, and Skenes, who taught him to cook with live fire. It was Skenes, Burges said, who showed him that fire didn't have to mean char and bravado.

"The one thing I loved about wood-fire cooking is you get this subtle, sweet barbecue flavor when you cook correctly over embers, and you don't cook directly over the fire," Burges said. "Most places, when you think about grilling something, you think of char, bold flavors, masculine flavors. But Chef Josh — it's like a master art, getting really delicate, subtle flavor using that grill method."

The uni kiritampo, Bengara's take on a traditional Akita-prefecture rice skewer, finished with scallion.

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Courtesy Bengara

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What sets the food apart

Take their luscious miso cod. On a normal grill, the marinade's sugars would blacken before the fish cooked through. On the genshiyaki pit, the cod sits at a distance from the embers, cooking gently until the very end, when it's given one last pass directly over the coals — what Burges describes as a final "kiss" of heat before it hits the plate.

To fuel genshiyaki's slower, ambient style, ordinary charcoal or wood is replaced with binchotan, an ultra-dense, pure-carbon hardwood charcoal traditionally made in Japan, which burns hotter and cleaner.

The signature dish

A perfect example of how this cooking style comes together is the uni kiritampo, the Akita prefecture rice skewer, reimagined with uni and cooked via genshiyaki — born of an offhand kitchen conversation with one of the restaurant's Japanese chefs about regional dishes cooked over fire.

Once they realized genshiyaki was the dish's original, historic cooking method, the rest fell into place.

"It's like the most delicious thing," Burges said. "I don't know why it never made it over to the United States earlier."

Bengara's Arts District dining room pairs industrial bones with warm, low lighting and long communal tables.

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Wonho Frank Lee

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Courtesy Bengara

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The chewy exterior, with just a hint of smoke, gives way to a creamy inside, like a caramelized custard, that’s topped with a decadent amount of uni, providing a semi-sweet finish — one memorable bite.

Tasting menu option

Bengara recently added a daily eight-course tasting menu ($98) that doubles as a greatest-hits tour of the kitchen — Toyosu carpaccio with chili coffee oil, pork belly "tacos" wrapped in mochi crepes, miso cod, Mary's half chicken, and handmade citrus soba, with optional wagyu and uni add-ons.

The price includes a beverage pairing, with a full non-alcoholic option alongside the boozy version. Walk-ins are welcome, and reservations can be booked via OpenTable.

Topline:

Why it matters: Museum officials said you will “likely experience high demand and long wait times in the queue" and thanked people for their patience.

LAist saw estimated wait times up to 6 hours, and it took a little more than 4.5 hours for this reporter to get through. On the bright side, there were still plenty of tickets left, including for the first day. Do not refresh the page or you may lose your spot.

The details: All tickets are timed entry. Tickets are $25 for adults and $21 for those 65 and older. Children, members, active-duty military, personal aides or attendants and EBT cardholders have free entry. Museum neighbors in the LM37 program will also be free, with that pass opening in August.

But how do I buy: Each person is limited to nine tickets, and you’ll have 20 minutes to check out once they’re added to your cart, according to the museum. You can find the link here.

What's next: The grand opening is Sept. 22.

Go deeper: How to secure Lucas Museum of Narrative Art tickets ahead of the fall opening