Science
Pfizer Vaccine Effective in Children Under 5, the F.D.A. Says

The Meals and Drug Administration stated on Sunday that three doses of the Pfizer-BioNTech coronavirus vaccine seemed to be efficient in stopping Covid sickness in youngsters below 5, judging by the extent of virus-blocking antibodies the pictures induced.
The company’s analysis was posted on-line forward of Wednesday’s assembly of outdoor vaccine consultants, summoned to suggest how the F.D.A. ought to rule on purposes from each Pfizer and Moderna on vaccinating the nation’s youngest youngsters.
Some public well being consultants expect the F.D.A. to authorize each Moderna’s and Pfizer’s vaccines, providing dad and mom a selection between the 2. The Facilities for Illness Management and Prevention should additionally weigh in with its suggestions after the F.D.A. acts. Roughly 18 million youngsters youthful than 5 are the one People who aren’t but eligible for pictures.
In a workers evaluation, the F.D.A. stated the info submitted by Pfizer and its German companion, BioNTech, means that three doses are simpler than two. However the company stated it was exhausting to attract definitive conclusions as a result of there have been so few instances of Covid among the many 1,415 youngsters who acquired three doses of the vaccine through the scientific trial.
Pfizer has stated solely eight youngsters within the placebo group and two within the vaccinated group fell sick. The trial protocol stated 21 instances had been required to render a judgment on efficacy.
Thus far, the F.D.A. seems to view each Pfizer’s and Moderna’s requests for pediatric vaccines favorably. Dad and mom are so desirous to have a coronavirus vaccine for his or her youngest youngsters that some have stated they might settle for even low charges of effectiveness, so long as the vaccines had been secure.
In its evaluation of Pfizer’s information, the company stated that charges of hospitalization and dying on account of Covid amongst youngsters below 5 had been increased than amongst these age 5 to 17, “underscoring the good thing about an efficient Covid- 19 vaccine on this age group.”
The company additionally famous that amongst youngsters 5 or older, who’re already eligible for Pfizer’s vaccine, the pictures have helped forestall hospitalization and different critical outcomes, together with through the present 12 months, when the extremely contagious Omicron variant and its quickly evolving subvariants turned the dominant types of the virus.
“Given the uncertainty of the Covid-19 pandemic and probability of continued SARS-CoV-2 transmission through the ensuing months, deployment of the vaccine to be used amongst youngsters 6 months via 4 years of age will doubtless have a helpful impact on Covid-19-associated morbidity and mortality on this age group,” the F.D.A. stated. The company recognized minimal unintended effects.
On Friday, the F.D.A. stated Moderna’s coronavirus vaccine for kids below 6 was additionally efficient in stopping symptomatic an infection with out inflicting worrisome unintended effects. The 2 vaccines are primarily based on the identical kind of expertise, however the dosage and regimens differ. Moderna is proposing two doses at one-quarter the power of grownup doses. Pfizer is proposing three doses at one-tenth the power of grownup pictures.

Science
Federal contractors improperly dumped wildfire-related asbestos waste at L.A. area landfills

Federal contractors tasked with clearing ash and debris from the Eaton and Palisades wildfires improperly sent truckloads of asbestos-tainted waste to nonhazardous landfills, including one where workers were not wearing respiratory protection, according to state and local records.
From Feb. 28 to March 24, federal cleanup crews gathered up wreckage from six burned-down homes as part of the wildfire recovery efforts led by the U.S. Army Corps of Engineers and its primary contractor Environmental Chemical Corp.
However, prior to reviewing mandated tests for asbestos, crews loaded the fire debris onto dump trucks bound for Simi Valley Landfill and Recycling Center, and possibly Calabasas Landfill in unincorporated Agoura and Sunshine Canyon Landfill in Los Angeles’ Sylmar neighborhood, according to reports by the California Office of Emergency Services and Ventura County.
Later on, federal contractors learned those tests determined that the fire debris from these homes contained asbestos, a fire-resistant building material made up of durable thread-like fibers that can cause serious lung damage if inhaled.
The incident wasn’t reported to landfill operators or environmental regulators until weeks later in mid-April.
Many Southern California residents and environmental groups had already objected to sending wildfire ash and debris to local landfills that were not designed to handle high levels of contaminants and potentially hazardous waste that are often commingled in wildfire debris. They feared toxic substances — including lead and asbestos — could pose a risk to municipal landfill workers and might even drift into nearby communities as airborne dust.
The botched asbestos disposal amplifies those concerns and illustrates that in some cases federal contractors are failing to adhere to hazardous waste protocols.
“You have to wonder if they caught it here, how many times didn’t they catch it?” asked Jane Williams, executive director of the nonprofit California Communities Against Toxics. “It’s the continued failure to effectively protect the public from the ash. This is further evidence of that failure. This is us deciding those who work and live around these landfills are expendable.”
As of May 1, nearly 1 million tons of disaster debris has been taken to four landfills in Southern California. Simi Valley, an 887-acre landfill in Ventura County, has taken two-thirds of the tonnage. Several residents who live nearby voiced their disappointment ahead of the June 24 Ventura County Board of Supervisors vote to approve emergency waivers to allow fire debris to continue to be disposed of at Simi Valley Landfill — without a cap on tonnage — until Sept. 3.
“When I told my kids about the fire debris being dumped at the landfill, they asked me, why would anyone allow us to be exposed to this?” said Nicole Luekenga, a resident of nearby Moorpark, at the June 24 board meeting. “We are deeply concerned about the potential health risks from the fire debris being dumped at a residential landfill in our community. It feels as though profit and convenience are being prioritized over public safety, and that is unacceptable.”
An Environmental Chemical Corp. official acknowledged the lapse in asbestos protocols led to the improper disposal in February and March. He said the ash and debris from the six homes — four in Altadena, one in Pacific Palisades and one in Malibu — contained “trace amounts” of asbestos but did not elaborate on the specific type of building material that contained asbestos, or why the debris wasn’t flagged.
Asbestos has historically been used in a variety of construction materials — large and small — including roofing shingles, cement pipes, popcorn ceilings and insulation.
The company official said the improper disposal may have been due to a failure of either its workers or subcontractors to properly review paperwork. He also said he was unaware of any other cases in which asbestos or hazardous waste were improperly disposed. The Army Corps of Engineers declined to comment on the matter.
Environmental Chemical officials told Simi Valley Landfill that the asbestos should be presumed to be friable, a form of the fibrous mineral that is more easily broken down into smaller pieces and considered hazardous waste, according to an April letter from the landfill’s owner, Waste Management, to the Los Angeles Regional Water Quality Control Board.
During the time the asbestos waste was taken to the landfills, workers handling fire debris at Simi Valley Landfill had not been wearing protective masks or respirators, according to inspection reports. Typically municipal landfill workers don’t wear face coverings because they are mostly handling trash and nonhazardous waste.
But experts say protective masks are essential for protecting worker health at landfills. Landfill workers or hired contractors regularly drill pipelines extending hundreds of feet underground into the layers of the waste to extract gases that can build up when garbage decomposes. Experts say drilling into hazardous waste, such as asbestos waste, could expose workers to harmful substances if they aren’t wearing appropriate protective equipment.
During at least one visit in March, a Ventura County inspector found workers without masks in parts of the landfill designated for fire debris. Waste Management staff told the county inspector that mask-wearing was voluntary for employees. In April, county inspectors observed at least four workers constructing a new well in the fire debris area without respiratory protection, and another worker with only a cloth face mask.
High-filtration respirators are typically considered the best form of protection against asbestos. Protective masks, such as N95 masks, can guard against breathing in small particles, but should not be used to protect against asbestos.
Since learning about the asbestos-containing fire debris, local regulators have ordered the operators of Simi Valley Landfill to consult with safety professionals to determine the appropriate level of protective gear needed to protect against breathing in hazardous contaminants.
Army Corps officials had previously vowed that contractors would test for asbestos and take steps to segregate this waste and to take it to the appropriate disposal locations, such as Azusa Land Reclamation Co., a 300-acre landfill in the San Gabriel Valley that is also owned by Waste Management.
Waste Management officials said the company intends to leave the asbestos-containing waste in place, because attempting to excavate it could increase the likelihood that some of the toxic material would be released into the air. Nicole Stetson, district manager at Waste Management, urged the Los Angeles Regional Water Quality Board to ask Environmental Chemical what actions it would take to prevent more asbestos from inadvertently being dumped there.
The landfill staff “followed all relevant procedures during affected period and could not have prevented these events through any reasonable means,” Stetson wrote in a letter in April.
So far, regulators have been mum on whether any enforcement action has been taken after the lapse in hazardous waste protocols. The regional water board declined to comment. CalRecycle referred questions to local authorities that it partners with to provide oversight and ensure compliance.
The Army Corps of Engineers is more than halfway through its mission of clearing the wildfire debris from the vast majority of homes and schools that were razed in the Eaton and Palisades wildfires. So far, it has overseen the removal of fire debris from nearly 9,000 properties.
The wildfire ash and debris the Army Corps has moved from disaster sites to landfills probably contains elevated levels of toxic metals. For example, Nick Spada, a researcher with the UC Davis Air Quality Research Center, has collected dozens of ash samples from the burn scars and, in preliminary findings, found elevated levels of lead, arsenic, cadmium and antimony in the test materials.
Spada is sampling the air near Simi Valley Landfill in hopes of identifying the levels of dust pollution from the site. The air sampling will help determine the types of metals in the air along with the particle sizes. (Smaller particles can cause more health complications because after they are inhaled into lungs, some are tiny enough to enter the bloodstream.)
Spada said the forthcoming results should provide communities with important greater insight into public health risks associated with the wildfire debris that continues to be dumped there. But, beyond the community, Spada is also concerned with those who are the closest to the debris: the workers.
“I see our role as raising concerns and then exploring them and trying to help out our friends in the regulatory agencies and the government that are all working as hard as they can trying to get a handle on this massive tragedy,” he said. “I’m concerned about all the workers who are in the burn areas, who are doing this work without respirators. It’s really hot, so heat-related illnesses is a primary concern, as is respiration of these particles.”
Science
Column: RFK Jr. is dismantling trust in vaccines, the crown jewel of American public health

When it comes to vaccines, virtually nothing that comes out of Robert F. Kennedy Jr.’s mouth is true.
The man in charge of the nation’s health and well being is impervious to science, expertise and knowledge. His brand of arrogance is not just dangerous, it is lethal. Undermining trust in vaccines, he will have the blood of children around the world on his hands.
Scratch that.
He already does, as he presides over the second largest measles outbreak in this country since the disease was declared “eliminated” a quarter century ago.
“Vaccines have become a divisive issue in American politics,” Kennedy wrote the other day in a Wall Street Journal essay, “but there is one thing all parties can agree on: The U.S. faces a crisis of public trust.”
The lack of self-awareness would be funny if it weren’t so tragic.
Over the past two decades or so, Kennedy has done more than almost any other American to destroy the public’s trust in vaccines and science. And now he’s bemoaning the very thing he has helped cause.
Earlier this month, Kennedy fired the 17 medical and public health experts of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices — qualified doctors and public health experts — and replaced them with a group of (mostly) anti-vaxxers in order to pursue his relentless, ascientific crusade.
On Thursday, at its first meeting, his newly reconstituted council voted to ban the preservative thimerosal from the few remaining vaccines that contain it, despite many studies showing that thimerosal is safe. On that point, even the Food and Drug Administration website is blunt: “A robust body of peer-reviewed scientific studies conducted in the U.S. and other countries support the safety of thimerosal-containing vaccines.”
“If you searched the world wide, you could not find a less suitable person to be leading healthcare efforts in the United States or the world,” psychiatrist Allen Frances told NPR on Thursday. Frances, who chaired the task force that changed how the Diagnostic and Statistical Manual of Mental Disorders, or DSM, defines autism, published an essay in the New York Times on Monday explaining why the incidence of autism has increased but is neither an epidemic nor related to vaccines.
“The rapid rise in autism cases is not because of vaccines or environmental toxins,” Frances wrote, “but is rather the result of changes in the way that autism is defined and assessed — changes that I helped put into place.”
But Kennedy is not one to let the facts stand in the way of his cockamamie theories. Manufacturers long ago removed thimerosal from childhood vaccines because of unfounded fears it contained mercury that could accumulate in the brain and unfounded fears about a relationship between mercury and autism.
That did not stop one of Kennedy’s new council members, Lyn Redwood, who once led Children’s Health Defense, the anti-vaccine group founded by Kennedy, from declaring a victory for children.
“Removing a known neurotoxin from being injected into our most vulnerable population is a good place to start with making America healthy again,” Redwood told the committee.
Autism rates, by the way, have continued to climb despite the thimerosal ban. But fear not, gullible Americans, Kennedy has promised to pinpoint a cause for the complex condition by September!
Like his boss, Kennedy just makes stuff up.
On Wednesday, he halted a $1-billion American commitment to Gavi, an organization that provides vaccines to millions of children around the world, wrongly accusing the group of failing to investigate adverse reactions to the diptheria vaccine.
“This is utterly disastrous for children around the world and for public health,” Atul Gawande, a surgeon who worked in the Biden administration, told the New York Times.
Unilaterally, and contrary to the evidence, Kennedy decided to abandon the CDC recommendation that healthy pregnant women receive COVID vaccines. But an unvaccinated pregnant woman’s COVID infection can lead to serious health problems for her newborn. In fact, a study last year found that babies born to such mothers had “unusually high rates” of respiratory distress at or just after birth. According to the CDC, nearly 90% of babies who were hospitalized for COVID-19 had unvaccinated mothers. Also, vaccinated moms can pass protective antibodies to their fetuses, who will not be able to get a COVID shot until they are 6 months old.
What else? Oh yes: Kennedy once told podcaster Joe Rogan that the 1918 Spanish flu epidemic was “vaccine-induced flu” even though no flu vaccine existed at the time.
He also told Rogan that a 2003 study by physician scientist Michael Pichichero, an expert on the use of thimerosal in vaccines, involved feeding babies 6 months old and younger mercury-contaminated tuna sandwiches, and that 64 days later, the mercury was still in their system. “Who would do that?” Kennedy demanded.
Well, no one.
In the study, 40 babies were injected with vaccines containing thimerosal, while a control group of 21 babies got shots that did not contain the preservative. None was fed tuna. Ethylmercury, the form of mercury in thimerosal, the researchers concluded, “seems to be eliminated from blood rapidly via the stools.” (BTW, the mercury found in fish is methylmercury, a different chemical, which can damage the brain and nervous system. In a 2012 deposition for his divorce, which was revealed last year, Kennedy said he suffered memory loss and brain fog from mercury poisoning caused by eating too much tuna fish. He also revealed he has a dead worm in his brain.)
Kennedy’s tuna sandwich anecdote on Rogan’s podcast was “a ChatGPT-level of hallucination,” said Morgan McSweeney, a.k.a. “Dr. Noc,” a scientist with a doctorate in pharmaceutical sciences, focusing on immunology and antibodies. McSweeney debunks the idiotic medical claims of non-scientists like Kennedy in his popular social media videos.
Speaking of AI hallucinations, on Tuesday, at a congressional committee hearing, Kennedy was questioned about inaccuracies, misinformation and made up research and citations for nonexistent studies in the first report from his Make America Healthy Again Commission.
The report focused on how American children are being harmed by their poor diets, exposure to environmental toxins and, predictably, over-vaccination. It was immediately savaged by experts. “This is not an evidence-based report, and for all practical purposes, it should be junked at this point,” Georges C. Benjamin, executive director of the American Public Health Assn. told the Washington Post.
If Kennedy was sincere about improving the health of American children he would focus on combating real scourges like gun violence, drug overdoses, depression, poverty and lack of access to preventive healthcare. He would be fighting the proposed cuts to Medicaid tooth and nail.
Do you suppose he even knows that over the past 50 years, the lives of an estimated 154 million children have been saved by vaccines?
Or that he cares?
@rabcarian.bsky.social
@rabcarian
Science
Hims & Hers' ugly split with Wegovy maker weighs on the telehealth company's future
Hims & Hers, the high-flying telehealth company that rapidly ascended from a buzzy startup selling Viagra to a multibillion-dollar business with a Super Bowl ad, had a hard week.
The San Francisco company’s shares took a dive Monday after its partnership with Novo Nordisk crumbled. The Danish drugmaker abruptly ended its agreement to let Hims & Hers directly sell its popular weight-loss drug, prompting the companies to spar publicly.
Less than two months after agreeing to partner with Hims & Hers, Novo Nordisk accused the telehealth company of putting patient safety at risk through “deceptive” marketing and selling a knockoff version of its drug Wegovy. Hims & Hers fired back, alleging that Novo Nordisk was “misleading the public” and wanted to “control clinical standards and steer patients to Wegovy.”
The messy split is the latest hurdle facing Hims & Hers, a platform where people subscribe to get help for hair loss, improve sex, lose weight and address other health problems. The company aims to reach $6.5 billion in revenue by 2030. The tussle also highlights the tensions between telehealth platforms and pharmaceutical companies.
“The termination of this partnership suggests that Novo still views Hims’ marketing and sales tactics as a threat to branded Wegovy and indicates Novo considers Hims more of a competitor than a true partner,” Aaron DeGagne, a senior analyst of healthcare at PitchBook, said in a statement.
Hims & Hers’ stock price has swung wildly this year. The price had at one point soared more than 150% this year before the Novo split knocked off a nearly a third of its valuation on Monday. Its share price rose nearly 7% on Friday to end the week at $49.41.
Hims & Hers is disrupting the healthcare industry, testing the limits of regulations to make it easier to buy popular drugs at lower prices. Its showdown with Novo could help define how far it can go.
While Hims & Hers faces more legal risks after the breakup, some analysts said they don’t expect the fallout to heavily harm the company’s growth. The company is expanding beyond just treating weight loss. Still, Hims & Hers is losing a potential source of revenue.
“Even with all these revenue streams, the bigger concern (rightfully so) is the ability for these revenue streams to fill the expected hole that the end of the NovoCare partnership creates,” Michael Cherny, a senior research analyst at Leerink Partners, said in a note.
NovoCare is the pharmacy people were able to access on the Hims & Hers platform to buy the weight-loss drug.
Last year, Hims & Hers said in a letter to shareholders that the company expects its weight loss offerings will contribute at least $725 million of revenue in 2025 but that treatments outside of that category will make up the majority of its sales. Wegovy is just one weight-loss drug it offers.
Drug disruptor
Launched in 2017, Hims initially focused on treating men’s health issues such as hair loss and erectile dysfunction — concerns that people might feel too embarrassed to bring up in doctor visits. Instead, subscribers answer questions online, correspond with medical professionals virtually and get the prescribed drugs in visually pleasing packages delivered discreetly to their homes.
Andrew Dudum, one of the company’s co-founders and its chief executive, started Hims at venture studio Atomic in San Francisco. The startup, now known as Hims & Hers Health Inc., then expanded into women’s health, went public in 2021 and grew its workforce to more than 1,600 workers.
Hims & Hers’ annual revenue grew from $148.8 million in 2020 to $1.48 billion in 2024. The company also became profitable with its net income reaching $126 million in 2024, compared with a loss of $18 million in 2020. The company forecasts it will reach between $2.3 billion and $2.4 billion in revenue this year.
The company’s growth and 2.4 million-subscriber base was turbocharged as people looked for easier access and affordable options to the wildly popular weight-loss drugs Wegovy and Ozempic.
Despite strong results in the first quarter of this year, the company’s forecast for second-quarter revenue fell below analysts’ expectations. In May, Hims & Hers said it was slashing more than 4% of its workforce after signaling it would move away from selling cheaper alternatives to weight-loss drugs.
Its stock had initially surged in February after the company released a controversial Super Bowl ad promoting its treatment for weight loss. The ad marketed the telehealth platform as an affordable solution to a system that is “built to keep us sick and stuck.”
But the company’s aggressive marketing triggered backlash. Doctors, politicians and drugmakers quickly criticized the company for not disclosing the risks associated with the compounded drugs that Hims & Hers sometimes uses for weight loss.
With compounded drugs, licensed pharmacists alter, mix or combine ingredients of a drug to customize medicines. Though copying patented drugs is illegal, compounded knockoffs are allowed if they are tailored for a patient who might need something slightly different than what the patent-holding company produces. For example, a person might take a compounded drug if they’re allergic to a certain dye.
Taking compounded drugs comes with risks, according to the U.S. Food and Drug Administration. Unlike generics, they’re not approved by the FDA, a federal agency that verifies whether drugs are safe and effective .
Compounding drugs is also allowed when there’s a shortage of an FDA-approved drug, which has happened with Wegovy and Ozempic. But those drugs are no longer in shortage, and the FDA has warned the public about taking compounded drugs when it isn’t medically necessary.
Drug war erupts
The fallout between Hims & Hers and Novo Nordisk centers on its sales of compounded versions of Wegovy, a drug people inject to decrease hunger so they eat less and lose weight.
In April, the two companies teamed up to make obesity treatment more affordable and accessible. Starting at $599 per month, some people were able to get prescribed to Wegovy and a Hims & Hers membership. That was much cheaper than the previous cost of paying $1,999 per month for Wegovy on the Hims & Hers platform.
That partnership was short-lived. Novo Nordisk said this week that it’s cutting off Hims & Hers’ direct access to Wegovy.
“Hims & Hers Health, Inc. has failed to adhere to the law which prohibits mass sales of compounded drugs under the false guise of ‘personalization’ and are disseminating deceptive marketing that put patient safety at risk,” Novo Nordisk said in a statement.
Hims & Hers advertises a compounded drug that contains the same ingredients in Wegovy for $165 per month.
Novo Nordisk, citing its own investigation and a Brookings Institution report, said ingredients in knock-off drugs sold by telehealth entities and compounding pharmacies are manufactured in China and do not have FDA approval.
Novo Nordisk sells Wegovy through its pharmacy NovoCare and telehealth platforms LifeMD and Ro. On Thursday, the company also announced a partnership with WeightWatchers to sell Wegovy at a discounted price in July.
Dudum, Hims & Hers chief executive, said on social media site X that the telehealth provider would still provide a variety of treatments including Wegovy. The company says on its website that it works with pharmacies in Arizona and Ohio that are regulated.
“We refuse to be strong-armed by any pharmaceutical company’s anticompetitive demands that infringe on the independent decision making of providers and limit patient choice,” he said in the statement.
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