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

A crew of four moon-bound astronauts will remain on the ground for at least a month after NASA delayed the launch of the Artemis II mission. During critical pre-launch testing Monday, mission managers uncovered a number of issues that prevented the completion of the test.

NASA is now planning a March launch date for the four astronauts — three from the U.S. and one from Canada — on a ten-day mission to circle the moon and return to Earth, traveling farther than any humans have ventured into deep space.

Issues leading to that delay began about an hour into Monday's test, known as the wet dress rehearsal. As the team began fueling the rocket at the Kennedy Space Center in Florida, sensors picked up a hydrogen leak. Super-chilled hydrogen is used as the fuel for the massive Space Launch System (SLS) rocket.

Hydrogen is an efficient propellant for rockets — but its molecules are so tiny and light they can escape even the tightest of seals. Launch director Charlie Blackwell-Thompson said they had troubleshooted the initial leak, but when they began to pressurize the tank, another leak surfaced.

"And so as we began that pressurization, we did see that the leak within the cavity came up pretty quick," said Blackwell-Thompson.

(L/R) NASA Associate Administrator Amit Kshatriya, NASA Associate Administrator Lori Glaze, launch director Charlie Blackwell-Thompson, and manager of NASA's Space Launch System Program, John Honeycutt, hold a news conference on the Artemis II mission at Kennedy Space Center in Cape Canaveral, Fla., on Tuesday.

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Miguel J. Rodriguez Carrillo

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Hydrogen leaks plagued testing of NASA's Artemis I mission in 2022. Blackwell-Thompson said lessons learned from that uncrewed flight were utilized for Artemis II, but there's more investigation is needed.

The wet dress rehearsal uncovered other issues — including a problem with the Orion capsule, which will carry the crew to the moon. While no one was on board Monday, teams practiced preparing the spacecraft for its passengers. A valve that pressurizes the vehicle required additional attention and took more time to close the hatch than anticipated.

Teams also uncovered issues with cameras due to cold weather and audio dropouts across communication channels. "As always, safety remains our top priority, for our astronauts, our workforce, our systems and the public," said NASA administrator Jared Isaacman in a post on X, and that NASA will only launch when the agency is ready.

Work now begins to fix the issues. NASA will require another wet dress rehearsal before giving the "GO" to put astronauts on board. "All in all, a very successful day for us on many fronts," said Blackwell-Thompson. "Then, on many others, we got some work we've got to go do."

The earliest launch window for another attempt is March 6. NASA has additional launch opportunities on March 7, 8, 9 and 11.

The crew of NASA astronauts Reid Wiseman, Victor Glover, Christina Koch, and Canadian Space Agency astronaut Jeremy Hansen were released from quarantine and will remain in Houston, Texas. They'll re-enter quarantine about 14 days ahead of the next launch attempt and make the trip to the Kennedy Space Center six days before liftoff.

Artemis II is testing key systems of the Orion spacecraft, like its maneuverability and life support systems, ahead of the planned Artemis III mission that will take humans to the lunar surface. The Artemis II will mark the first time humans have returned to the moon since the final Apollo lunar mission in 1972.
Copyright 2026 NPR

A trial got underway Tuesday in a case alleging that Huntington Beach illegally dilutes the power of Latino voters with its at-large election system.

Cities across Orange County and elsewhere in California have faced similar challenges over the past decade. Most have settled out of court by adopting by-district elections, where voters only vote on a city council representative from their area, rather than requiring candidates to run citywide. A notable exception is Santa Monica — the city has been fighting a challenge to its at-large election system in court for nearly 10 years.

Now, Huntington Beach is following suit.

The case was brought by the nonprofit group Southwest Voter Registration Education Project and Victor Valladares, a Huntington Beach resident and Democratic Party activist. It’s being heard by Orange County Superior Court Judge Craig L. Griffin.

The argument against at-large city elections

The plaintiffs allege Latino voters can’t elect a candidate of their choice under the current system, in violation of the California Voting Rights Act. This alleged dilution of Latino voting power, they say, leads to poor representation and negative consequences for the city’s majority-Latino Oak View neighborhood.

“Their needs get ignored,” Kevin Shenkman, the plaintiffs’ lawyer, said during his opening statement Tuesday. “It is a natural result of the at-large election system.”

Latinos make up about 20% of the population in Huntington Beach. Under a draft map of electoral districts drawn up by demographer David Ely, a witness for the plaintiffs, the district that includes the Oak View neighborhood would be 40% Latino. Plaintiffs argued this would give residents more power to elect a city councilmember who represents their interests.

The city’s defense of at-large elections

In their opening argument, lawyers representing Huntington Beach argued that Latinos in Huntington Beach are spread across the city and politically diverse.

The city’s lawyers also argued that recent elections of Latino city council members, including MMA star Tito Ortiz in 2020 and Gracey Van Der Mark in 2022, prove the city’s current at-large election system doesn’t impede Latino residents’ ability to participate in the local political process.

“The system works, it’s not broken, and the evidence will show that at trial,” said Anthony Taylor, one of the attorneys representing Huntington Beach.

The trial is expected to last into next week.

Go deeper

• Why were AI-equipped police cameras installed in this majority Latino Huntington Beach neighborhood?
• Huntington Beach's controversial voter ID law is illegal
• Voting by district gives Latino candidates a boost in Orange County
• District elections mean big governing changes for many California cities

In a week when temperatures are 20 degrees above average in parts of Southern California, the L.A. County Board of Supervisors unanimously approved the county’s first heat action plan.

The plan lays out strategies to achieve three goals in coming decades: cooler outdoor spaces, cooler indoor spaces and better public education about the dangers of heat.

The blueprint, approved Tuesday, comes as L.A. County and the world are experiencing longer, hotter and deadlier heat waves as a result of pollution trapped in the Earth’s atmosphere. It’s one of the only such plans in the region dedicated to extreme heat.

Why it matters

Already, heat is responsible for the deaths of more than 200 people each year in L.A. County, as well as thousands of emergency room visits. Since the 1980s, summer temperatures, particularly in the valleys and inland areas, have risen on average 3 degrees, with expected increases as high as 8 degrees on average in certain areas, such as the Antelope Valley, according to the plan.

A graph from the new L.A. County Heat Action Plan.

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Courtesy LA County Chief Sustainability Office

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Unless global pollution is dramatically reduced, by 2050, average temperatures in L.A. County are expected to rise nearly 4 degrees. The valleys and inland regions will see the highest heat: The San Gabriel Valley could see the number of extreme heat days above 95 degrees go from 32 a year to 74. But coastal areas won’t be spared: Long Beach could see extreme heat days quadruple, from just four days on average above 95 degrees to 16, according to local projections.

Nights are getting hotter even faster, disrupting sleep and impacting health in ways we don’t yet understand — 41% of L.A. County residents who responded to a survey for the heat action plan reported trouble sleeping on very hot nights.

“We needed to develop an all-of-government framework for dealing with rising temperatures,” said Ali Frazzini, policy director with the county’s sustainability office.

Nights are heating up faster than days as a result of climate change, affecting our sleep and health in ways we don't yet fully understand.

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Courtesy L.A. County CSO

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An invisible threat

The plan includes goals for strategies such as replacing blacktop at schools, installing shade structures, and enforcing renter protections for safe indoor temperatures.

“There wasn't the same level of centralization and systems for responding to and adapting to heat as we see with some of our other hazards,” Frazzini said.

Unlike earthquakes or wildfires, heat is something of an invisible threat, she said — it’s ubiquitous, though experienced in unequal ways, and it doesn’t cause extensive property damage. It’s not confined to certain regions.

Despite being the leading weather-related cause of death in the U.S. and here in Southern California, heat is not officially recognized as a disaster at a state or federal level, which limits funding support for public health interventions. The county hopes the plan will unify its efforts across departments and draw more state and federal funding to protect public health.

Strategies to live in a hotter LA 

The plan builds on four years of work since 2021, when the county released its first climate vulnerability assessment.

“That assessment told us where our problems were and what they were, and this plan now tells us how to address them,” said Rita Kampalath, the county’s chief sustainability officer.

Most of the strategies highlighted in the plan are in progress, though many have faced serious delays. For example, one goal includes adding shade structures to all L.A. County bus stops by 2045 — county leaders have attempted to do this for decades, and progress has been extremely slow. Other goals include greening schools and planting trees in neighborhoods with the least shade. Efforts to green schools have faced stops and starts due to funding challenges and lack of planning, though there is progress. And planting trees where they’re most needed has proved to be a lot more difficult than it may seem.

Despite the challenges of implementing the ideas, V. Kelly Turner, a heat researcher at UCLA who served on an advisory group for the plan, said "one thing the L.A. County heat action plan gets fundamentally right is that it centers people and the everyday ways that heat becomes a disruptor to daily life."

Another unique aspect of the plan, she said, is that it used shade data, not only temperature data, to inform its strategies.

"Few cities around the world are using shade maps to systematically inform heat resilience planning," she said. "So, in that respect, the county's heat action plan is truly a leader."

Below are some selected facts and figures from the plan.

Goals for 2045:

• Install functional shade structures at 100% of L.A. County bus stops. 
• Achieve 20% tree canopy in unincorporated areas. 
• Replace 1,600 acres of pavement at schools and public spaces.
• Enforce new rules that require landlords to keep units below 82 degrees.
• Reduce energy burden for low-income households to 4% of monthly budget.
• Create 30% more county cooling centers for 234 regionwide by 2045, as well as support solar and battery installation at trusted indoor community spaces.