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CDC narrowly avoids making COVID-19 vaccine prescription-only

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CDC narrowly avoids making COVID-19 vaccine prescription-only

After a contentious discussion that at times referenced discredited theories, low-quality data and desperate pleas from physicians and patients to rely upon sound science, a key CDC committee opted Friday to weaken its existing recommendations on COVID-19 shots, while punting other vaccine decisions to a later date.

The Advisory Committee on Immunization Practices voted unanimously to pull back its current unequivocal recommendation that all adults get vaccinated against COVID-19 in favor of a process of “shared clinical decision making,” in which patients are encouraged to speak to a doctor, nurse or pharmacist first.

The group came extremely close to recommending that the COVID-19 vaccine be available by prescription only, with a 6-6 vote broken by chair Martin Kulldorff’s “no” vote. The group also postponed a vote on hepatitis B vaccination indefinitely, with some members arguing that a proposal to delay the first dose did not go far enough.

The two-day meeting’s chaotic atmosphere left even many close observers confused about what decisions the group actually made.

“What we’re seeing is what happens when individuals who don’t have a basic understanding about how vaccines are delivered are making these crucial policy decisions for the American public. They don’t know what they’re doing,” Dr. Sean O’Leary, chair of American Academy of Pediatrics’ Committee on Infectious Diseases, said Friday during a news conference over Zoom. “What we are getting from ACIP is confusion.”

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On Thursday, the committee voted that children under the age of four receive the measles, mumps and rubella (MMR) vaccine and the varicella, or chickenpox, vaccine in two separate shots given at the same time, instead of a single dose.

It was a relatively minor change. Many pediatricians already do this in order to reduce the risk of febrile seizures.

But the meeting’s tone and the decisions the committee appeared poised to make profoundly worried many physicians and public health officials.

“The damage isn’t just in today’s specific votes, it’s in legitimizing this framework where these laboratory-based studies and theories based on misrepresented findings are given equal standing with robust population-level safety data,” Dr. Jake Scott, an infectious disease specialist at Stanford University School of Medicine, said Friday. “Now every anti-vax group knows that they can package their claims and scientific-looking slides and cite some weird paper out of context, and then potentially get their concerns mandated into official medical documents.”

The COVID-19 discussion was led by Retsef Levi, a professor of operations management at MIT Sloan and the lone member of the committee with no biomedical or clinical degree.

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He began the discussion by making clear that the committee would take into account anecdotal evidence and unpublished reports in its decision making, together with rigorously researched data.

“We need to leverage all the relevant published and unpublished scientific, clinical and public health data, information and knowledge, including experiences from the field. We are going to focus on personalized risk benefit analysis, and we’re going to very much stay away from the narratives or the statements about ‘safe and effective,’” said Levi, who has stated that mRNA vaccines are deadly and should be pulled from the market. “We don’t believe that these are appropriate or scientific language to talk about the issues related to vaccination.”

At one point, a microphone caught someone in the meeting muttering “idiot” as Levi was talking. It was not clear who the speaker was.

The group voted unanimously to postpone any changes to hepatitis B vaccination. Vaccine skeptics appointed to the committee said that a proposal to delay the first dose by a month didn’t go far enough.

ACIP member Vicky Pebsworth, a nurse who serves as research director for the National Vaccine Information Center, an organization long criticized for promoting inaccurate information, criticized the CDC for glossing over side effects of hepatitis B vaccine such as fever, sleepiness and fussiness.

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“These are not trivial reactions,” Pebsworth said. “I personally think we should be erring on the side of caution and adopt a more prudent vaccination policy.”

Hepatitis B has been nearly eliminated since the vaccine was introduced in 1991.

Up to 85% of babies born to infected mothers become infected themselves, and the risk of long-term effects from the disease is higher the earlier the infection is acquired.

Infants infected in the first year of life have a 90% chance of developing chronic hepatitis B and 25% of those who do will die from complications such as liver cancer and cirrhosis, according to the American Academy of Pediatrics.

Side effects from the vaccine are extremely rare, CDC scientists told the committee Thursday, and those that do occur tend to be mild.

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Several committee members indicated they were unconvinced.

“There are gaps in what we know and understand about the effects of hepatitis B [vaccine], particularly on very young infants, and the conclusion that we know that it is safe is perhaps premature,” Pebsworth said.

At one point, she asked whether the irritability and fussing some babies showed at the time of the shot could be early symptoms of neurological problems stemming from the vaccine that hadn’t been studied.

At this, committee member Dr. Joseph Hibbeln pushed back.

“We have to vote on where there’s data of concrete harm or concrete benefit,” said Hibbeln, a psychiatrist who previously served as a section chief at the National Institutes of Health. “We’re going beyond data, and we’re turning into a discussion of speculation and possible clinical outcomes for which we have no data.”

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The American Academy of Pediatrics said in a news conference Thursday that it would continue to recommend that infants receive their first hepatitis B shot at birth.

America’s Health Insurance Plans, an association that includes major U.S. insurers such as Aetna, Humana, Kaiser Permanente, Cigna and several Blue Cross and Blue Shield groups, announced this week that its members would continue to cover all vaccines recommended by the CDC as of Sept. 1 through the end of 2026.

For most of its 61-year history, ACIP meetings have been dry, technical affairs in which committees of experienced physicians, public health officials and research scientists get deep into the weeds of vaccine and disease data.

The committee’s role in vaccine insurance coverage and availability in the U.S. is paramount. Insurers are only required to cover vaccines the CDC endorses, though they can choose to cover others as well. The committee’s recommendation has typically set the vaccine schedule followed by schools and physicians. It also determines what vaccines are covered by the CDC’s Vaccines for Children Program, which pays to immunize nearly half the nation’s children.

Previously, the committee collaborated year-round with expert working groups like the American Medical Assn., the American Academy of Pediatrics and the Infectious Diseases Society of America to craft its recommendations and guidelines. Members also served staggered terms, so that new people coming on always joined colleagues with previous experience, and often went through more than a year of vetting.

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But Kennedy fired the entire 17-member committee in June, and then informed medical groups they were no longer invited to review scientific evidence and advise the committee in advance of the meeting.

With the exception of Dr. Cody Meissner, who served on ACIP under presidents George W. Bush and Barack Obama, all of the members are new.

The lack of experience showed.

The group started the day by redoing a vote they’d hurriedly cast the previous afternoon on whether public funding would continue to cover the combined MMRV shot, as several members confessed to not fully understanding the text of the measure they’d voted on. In the new vote, they determined that it would not.

In August, Kennedy fired CDC Director Susan Monarez, who was appointed to the position by President Trump. On Wednesday, Monarez told a Senate committee that Kennedy fired her in part because she refused to sign off in advance on changes he planned to make to the vaccine schedule this month, without seeing scientific evidence for them.

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The ACIP’s recommendations become official only after the CDC director approves them. With Monarez out, that responsibility now goes to Health and Human Services Deputy Secretary Jim O’Neill, who is serving as the CDC’s acting director.

“This committee has focused on poorly done research that supports their preconceived anti-vaccine notions, rather than trying to truly weigh risks and benefits to get to the best decisions for American kids,” said Dr. Adam Ratner, a New York City pediatric infectious disease specialist. “This ACIP meeting demonstrates a sad deterioration of our public health systems, and real families and children will suffer as a result.”

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Emergency room visits during heat waves available to the public in ‘near-real time’ in L.A. County

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Emergency room visits during heat waves available to the public in ‘near-real time’ in L.A. County

For the first time, Los Angeles County residents can see how many people are ending up in emergency rooms, their bodies pushed past the limit, during heat waves.

The county Department of Public Health says its new Heat-Related Illness and Mortality Dashboard will provide heat illness counts in “near real time,” which means weekly. That might seem like a lag, but until now the data were only provided upon request and in ad hoc reports.

Heat is the leading cause of weather-related death in the United States and heat waves are only getting more frequent and intense as the climate changes.

Public health experts called the tracker a meaningful step toward assessing how well county programs are addressing heat risks.

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“It’s showing the county’s commitment to reducing the burden of heat on people’s health,” said David Eisenman, director of UCLA’s Center for Public Health and Disasters. “As the county puts more resources into that, this is a metric that allows the public to judge the effectiveness of the work.”

“There’s a handful of other places that also do this, but they’re all relatively new,” said Bharat Venkat, director of the UCLA Heat Lab, noting as examples Imperial and Riverside counties in California, Harris County in Texas and Maricopa County in Arizona. “It is very much welcome.”

The tracker takes heat illness data from patient complaints and doctor diagnoses provided by a countywide monitoring project that was previously available only to public health officials. The website says that what it provides is an undercount. The records often fail to count people when heat exacerbates more obvious health problems.

“Heat piggybacks off of preexisting health conditions,” Venkat said. “Say you go to the ER and you’re experiencing an intense psychotic episode, or a heart attack or a stroke. It’s very likely that the doctor is going to diagnose that as a psychotic episode, heart attack or stroke, and less likely that they’ll note that heat is contributing to that.”

Heat-related deaths are counted from death certificates, which present similar issues for undercounting. Those numbers will be reported monthly on the dashboard.

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L.A. County has a recently approved heat action plan that aims to educate the public and reduce indoor and outdoor temperatures with strategies such as opting for shade and air conditioning.

The new tracker breaks down daily heat-related emergency room visits and deaths by age group, geography, and race and ethnicity.

It shows that people over 65 are more vulnerable to heat illness. For Black residents, heat is disproportionately fatal. And people in the San Fernando, San Gabriel, and Antelope valleys see the most heat-related emergency room visits.

Kelly Turner, a professor of urban planning at UCLA, stressed that heat sickness tracks closely with social inequality and is preventable.

“A heat death or heat illness is dependent on who you are and what assets you have,” Turner said. “If you have air conditioning or not, if you work outside or you don’t, all of those factors factor in.”

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She noted that there is more risk in the San Fernando and San Gabriel valleys because of the combination of hotter days and more people who are unprotected. “When you map those two things on top of each other, you get a hot spot of vulnerability,” she said.

California already has a tool called CalHeatScore that uses historical hospital records and temperatures to forecast risk for different ZIP Codes in the state during heat events.

Public health officials hope to use the new dashboard to target messaging and public outreach when extreme heat strikes.

“If we’re having an extended heat event we can show that, ‘Hey, we’re having heat impacts’ as they’re happening,” said Dr. Nicole Quick, chief science officer at the L.A. County Department of Public Health.

Venkat said he would like to see the tool become more robust, in line with Maricopa County’s dashboard, widely viewed as the current gold standard for heat illness and mortality tracking. He said the Arizona county, which includes Phoenix, dives deeper into health records and conditions surrounding hospitalizations and deaths to better reflect the role of heat.

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“They do scene investigations and send someone out to take notes about where the body was found,” Venkat said. “What was going on? Did they have air conditioning? Were they outside? Did they have access to water? What medications were they taking? All those things provide important context.”

Eisenman said he would like to see the county train physicians on recording heat-related illness, as it has been “clear for a long time” that doctors don’t make the diagnosis enough.

“It would have to be more than just a handout or a few slides. You’d really have to have each institution make some effort to change physicians’ behaviors,” Eisenman said. He added that it probably hasn’t been done because of the costs involved.

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More middle-class Californians cancel health coverage after losing federal aid

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More middle-class Californians cancel health coverage after losing federal aid

Facing higher premiums and the loss of federal subsidies, 374,000 people with health insurance from the state marketplace known as Covered California canceled their coverage in the first three months of the year, according to government statistics.

The cancellations amount to 19% of those who had renewed their policies on the state marketplace during open enrollment, state officials said. Those cancellations are higher than in the past three years when they ranged from 13% to 15% of those who renewed.

Jessica Altman, executive director of Covered California, attributed the jump in cancellations to the expiration of enhanced federal subsidies that caused the cost of a plan to leap for most middle-class Californians.

“We expect coverage losses to increase through the year,” she said.

Overall, Covered California had 1.8 million enrollees in February, down from 1.94 million the year before — a decline of 7%.

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Altman said monthly enrollment numbers are delayed because consumers have a three-month grace period to resume their premium payments before the insurance carriers end their coverage for nonpayment.

This year, many middle-class Californians who depend on the state-run insurance marketplace created under the Affordable Care Act faced annual costs that were hundreds of dollars higher than last year because of the end of enhanced federal subsidies that began during the COVID-19 pandemic.

In 2021, Congress voted to temporarily boost the amount of subsidies Americans could receive for an ACA plan.

The law also expanded the program to families who had more money. Before that 2021 vote, only Americans with incomes below 400% of the federal poverty level — currently $62,600 a year for a single person or $128,600 for a family of four — were eligible for ACA subsidies. The 2021 vote eliminated the income cap and limited the cost of premiums for those higher-earning families to no more than 8.5% of their income.

On top of the loss of the enhanced federal subsidies, the average premium charged by insurers this year for a Covered California plan rose by more than 10% because of fast-rising medical costs.

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The decline in ACA plan enrollees, however, has been greater in some other states. California has tried to keep people insured by using state tax money to fill in the gap for lower-income families.

This year, the state budgeted $190 million for premium subsidies for people with incomes of up to 165% of the federal poverty level.

In his budget plan, Gov. Gavin Newsom proposed spending $300 million on those state subsidies in 2027. That would expand the subsidies to enrollees with incomes up to 200% of the federal poverty level, or $31,920 for an individual or $66,000 for a family of four.

“We may actually see a number of Covered California enrollees paying less in 2027” because of the additional state subsidies, Altman said.

In May, Newsom also proposed in his budget that an additional $27 million in state money be used to help enrollees pay for the cost of gender-affirming care. That amount is an increase to the $30 million that he earlier proposed be spent this year and next to defray those costs for Covered California enrollees, according to state officials.

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Last year, federal health officials enacted a rule that said the federally subsidized ACA plans could no longer cover gender-affirming care because it was no longer considered an “essential health benefit.”

Newsom’s proposed budget still faces debate in Sacramento and approval by the state Legislature.

The state marketplaces, created by the Affordable Care Act, also known as Obamacare, were meant to help those who don’t have access to an employer’s health insurance plan and have incomes too high to qualify for Medi-Cal, the government-paid insurance for the poor and disabled.

Because of the higher cost this year, more people are choosing the lower-priced Bronze plans. Those plans have higher co-pays and deductibles than the more expensive plans.

“We’re very concerned with the large shift to Bronze,” Altman said. “When you have higher cost-sharing, you’re more likely to defer care.”

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Political play or budget fix? Competition for JPL’s management comes at a fraught moment

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Political play or budget fix? Competition for JPL’s management comes at a fraught moment

Weeks after Trump administration officials announced that management of NASA’s Jet Propulsion Laboratory would open to competitive bidding for the first time, questions remain as to why Caltech could lose control of the lab its researchers founded in 1936.

On one hand, observers note, high-profile delays and cost overruns on significant recent JPL projects earned sharp criticism from NASA even before the 2024 presidential election.

On the other, the second Trump administration’s record of squeezing scientific funding and attacking institutions in Democrat-led states make it difficult to consider any action separate from the charged political atmosphere, analysts say.

“My first instinct is that this [competition] isn’t necessarily a bad thing. It’s not written in stone that Caltech must run JPL, and it wouldn’t be the worst thing to have some competition for running the place,” said Casey Dreier, chief of space policy at the non-profit Planetary Society.

“That said, that requires this contract evaluation to be fair and unbiased, and this administration has no credibility in such things,” he added. “The responsibility is on NASA to earn the trust and ensure such an evaluation is open and free from political meddling. That’s almost impossible.”

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JPL became part of NASA when the space agency was formed in 1958, and Caltech has been awarded the contract to run the institution outright ever since.

Its current 10-year contract with NASA, which is valued at up to $30 billion, runs through Sept. 30, 2028.

NASA Administrator Jared Isaacman announced the competition on May 22 as part of a slate of sweeping organizational changes at the space agency.

“When you step back, it is worth considering how many additional missions we could have undertaken with the resources lost to program cancellations and cost overruns over the years,” Isaacman wrote in a memo to staff. “That is the problem we must fix, so the American taxpayer and space-loving community can receive the highest scientific return on every dollar we spend at NASA.”

Competing the contract for JPL, the lone Federally Funded Research and Development Center (FFRDC) in NASA’s portfolio, was an effort to address cost-efficiency concerns, Isaacman wrote.

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“This process will take several years, and I do not anticipate it having any impact on the projects underway or the location of the facilities,” he wrote. “It does, however, provide an opportunity to evaluate management costs, overhead burdens, and ideally find ways to get after the science faster and more affordably.”

In a joint statement, Caltech President Thomas F. Rosenbaum and JPL Director Dave Gallagher said the competition was “no surprise” and that a team was already in place “to ensure we are positioned for success.”

In July, NASA’s Office of Procurement held an informational event for companies and institutions interested in the upcoming FFRDC contract.

The dozens of registered attendees included universities like USC, Texas A&M University and Georgia Tech, aerospace companies such as Boeing and Lockheed Martin and nonprofit corporations like MITRE, which manages several FFRDCs, and Universities Space Research Association, a university consortium founded by the National Academy of Sciences in 1969. (SpaceX, which has been awarded more than $13 billion in NASA contracts in the last decade, was not on the list.)

“Lockheed Martin has more than 50 years of deep space exploration success with JPL, supporting landmark missions to Jupiter, Venus, Saturn, Pluto, including nearly a dozen missions to Mars,” said Bob Behnken, VP of Exploration and Technology Strategy. “We look forward to building on that unmatched partnership in the years ahead. We are closely following NASA’s review and will continue to assess how we can best contribute to the agency’s mission.”

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Other attendees contacted by The Times declined to discuss their involvement.

Isaacman indicated that JPL could come under scrutiny even before he took over NASA. The billionaire entrepreneur referenced high costs at the La Cañada Flintridge institution in a memo prepared in advance of his confirmation hearings on his priorities for the space agency.

“Contract structure: Very expensive,” Isaacman wrote of JPL in a table outlining organizational issues at each of NASA’s centers. “Must increase the output and ‘time-to-science’ KPI.”

The institution has recently suffered a number of high-profile management stumbles.

After the JPL-managed Psyche mission to a metal-rich asteroid failed to meet its 2022 launch date, NASA commissioned an independent review that said internal reorganizations and personnel changes created distracted and uninformed managers and burned-out, stretched-thin staffers.

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After a 2023 independent review found there was “near zero probability” of the JPL-managed Mars Sample Return mission making its proposed 2028 launch date, and “no credible” way to bring rocks back from the Red Planet within the stated budget, Isaacman’s predecessor Bill Nelson put out a call for proposals to industry and all other NASA centers, forcing JPL to compete for its own project.

After Trump’s election, Nelson announced that the final decision would be in the next administration’s hands.

The White House pushed for massive cuts to NASA’s 2026 budget that Congress overturned, and has lobbied for similarly steep cuts again this year. JPL has instituted painful cost-cutting measures of its own, reducing staffing from roughly 6,500 employees in 2023 to 4,500 last year through layoffs and attrition.

Its struggles come at a point when NASA is enthusiastically embracing private industry. Last month the agency awarded several key contracts for its upcoming lunar missions to Jeff Bezos’s Blue Origin and other private companies.

Trump has also made no secret of his willingness to punish states that haven’t voted for him through job losses. In announcing his decision to move U.S. Space Command from Colorado to Alabama, Trump acknowledged that his loss in Colorado in three presidential elections played a part in the move.

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It’s impossible to consider any decision on JPL’s future separate from the administration’s track record of politically-motivated decisions, Dreier said.

“At the heart of this is why? Why now? If this is not just some rank political attack on California, what do they hope to gain from this?” Dreier said. “That deserves explanation, because the administration otherwise has no credibility here.”

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