Tag: government organizations – us

Tracking the opioid crisis: Inside the DEA’s secret lab | CNN

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Watch CNN Films’ “American Pain” at 9 p.m. ET Sunday, February 5.



CNN
 — 

Sitting among the warehouses of Dulles, Virginia, is one of the US Drug Enforcement Administration’s forensic labs. It’s one of eight across the country where scientists analyze illegal drugs and try to stay ahead of what’s driving deadly overdoses.

Starting in the late 1990s with overprescribing of prescription narcotics, the opioid epidemic has continued to plague the United States for decades. What has changed is the type of drugs that have killed more than half a million people during the past 20 years.

CNN was granted rare access to the secret lab where the DEA tests seized illicit drugs to understand what’s coming next.

“The market is constantly changing, so we are trying to do everything we can from a science base to keep up with that,” Scott Oulton, deputy assistant administrator of the DEA’s Office of Forensic Sciences, told CNN Chief Medical Correspondent Dr. Sanjay Gupta.

Holding a white bag of fentanyl precursor powder – one of the chemicals used to make the opioid – Oulton explained that the illicitly made painkiller continues to be a dominant presence in the drugs officials are finding.

“This kilogram can be converted into fentanyl to make approximately 800 grams,” he said. “So it doesn’t take that much material, it’s fairly cheap, it’s inexpensive to obtain.”

Fentanyl is the deadliest drug in the United States, and it’s often found in combination with other illicit drugs, including cocaine and heroin. But increasingly, fentanyl is showing up in illicit pills disguised as common prescription drugs like oxycodone, hydrocodone, even Adderall.

Users buying drugs on the street that look like prescription pills may end up with a highly potent, potentially deadly drug they never intended to take.

“Over 99% of what we see are fake. They contain fentanyl,” Oulton says of the pills that the agency is seizing.

The 800 grams of fentanyl that Oulton held could be turned into 400,000 to 500,000 potentially lethal pills.

As more and more of these lethal pills circulate, the opioid epidemic is reaching more of the population.

Deena Loudon of Olney, Maryland, is among those living with its effects.

“I truly love sharing Matthew with the world,” Loudon says as she flips through pictures of her son.

One of her favorite memories is Matthew playing hockey – what Loudon calls his happy place.

Matthew Loudon's mom says he turned to drugs after struggling with anxiety.

But she also recalls his struggles with anxiety, which led him to turn to drugs. He started dabbling in them in the 10th grade. By the following year, his grades began to fall, and he couldn’t keep them high enough to stay in hockey.

“He was using Xanax to help self-medicate himself and I think to help get rid of some of that angst so he could live somewhat of a normal life,” Loudon said.

Matthew was always honest, almost to a fault, Loudon says. “He told me he tried everything. Like everything. Heroin, meth, crack, you name it, cocaine, whatever – until I guess he found what made him feel the best, and it was Xanax.”

And as much as a mother can worry, Loudon says, Matthew always tried to reassure her. “I know what I’m doing,” he would tell her.

She had heard about fentanyl showing up in pills in their area.

“But you don’t ever think it’s going to happen to you,” Loudon said.

She said they even had a conversation about fentanyl the day before he died. “I was sort of naive, wanting to stick my head in the sand and thinking ‘I bet he does know what he’s doing.’ ”

On November 3, 2020, she found 21-year-old Matthew on the floor of their basement.

Matthew’s autopsy report lists his cause of death as fentanyl and despropionyl fentanyl intoxication.

“I don’t say he overdosed. I say he died from fentanyl poisoning. … Truthfully, like, at the end of the day, to me, he was murdered, right? Because he asked for one thing. They gave him something different. And it took his life.”

For a parent, she said, the hardest thing is burying their child. It’s a pain she speaks out about in hopes of keeping other families safe.

“It’s Russian roulette,” she warns them. “You never know what you’re gonna get.”

The number of pills the DEA has seized skyrocketed in just three years, from 2.2 million in 2019 to 50.6 million in 2022.

The sheer volume of pills has been one of the biggest challenges for the DEA’s lab, Oulton says. As the fentanyl threat continues to grow, the Virginia facility is expanding to accommodate the analysis needed.

The lab can test for something as simple as the presence of fentanyl, but something called the purity of the pill also offers important insight. This means how much fentanyl is actually in one of these illicit pills.

“Lately, we’ve been seeing a purity increase over the last year, where we used to say roughly four out of the 10 seizures that we were receiving would contain a lethal dose of greater than 2 milligrams. As of October last year, we started reporting that we’ve seen an uptick. Now we’re saying that six out of 10 of the seizures that we’re receiving contain over 2 milligrams,” Oulton said.

He says they’re finding an average of 2.3 milligrams of fentanyl in each pill.

Two milligrams may be the cutoff for what is considered lethal, but Oulton says that doesn’t necessarily mean a pill with 1.99 milligrams of fentanyl can’t be deadly.

“One pill can kill” is his warning.

“The message I would like to send out is, don’t take it,” he said. “Don’t take the chance. It’s not worth your life.”

Oulton says he and his team are constantly finding new and different drugs and substances in pills – things they’ve never seen before.

One machine in the lab is almost the equivalent of an MRI in a medical office, showing the structure and detail of a pill.

“We will do what we call structural elucidation to determine that this is a different version of a fentanyl that’s got a new compound and molecule that’s been added to it,” Oulton said.

They’ve seen “hundreds and hundreds of unique combinations,” he said.

“We’ll see one that contains fentanyl, one with fentanyl and xylazine, one with fentanyl and caffeine, one with fentanyl and acetaminophen, and you don’t know what you’re getting.”

Xylazine, a veterinary tranquilizer, poses a unique problem. It’s not an opioid, so even when it’s mixed with fentanyl, drugs designed to reverse an opioid overdose may not work.

Narcan or naloxone, one of the more common overdose-reversing drugs, has become increasingly necessary as the prevalence and potency of illicit drugs increases. About 1.2 million doses of naloxone were dispensed by retail pharmacies in 2021, according to data published by the American Medical Association – nearly nine times more than were dispensed five years earlier.

Oulton wants to be clear: The problem Isn’t with pills prescribed by your doctor and dispensed by a pharmacy – it’s the pills on the illicit market.

Those, Matthew’s mother warns, are easy to get.

“The first pills [Matthew] got was in high school. And it was just flipping out, floating around, and it was easy for him to get his hands on,” she said.

Loudon’s message for parents now: Keep your eyes open.

“Just be mindful of what your children are doing. You just just have to keep your eyes open. And even sometimes, when you keep your eyes open, you can miss some of the warning signs, but I think a parent knows their child best, so just keep talking.”

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Mpox is almost gone in the US, leaving lessons and mysteries in its wake | CNN

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CNN
 — 

The US public health emergency declaration for mpox, formerly known as monkeypox, ends Tuesday.

The outbreak, which once seemed to be spiraling out of control, has quietly wound down. The virus isn’t completely gone, but for more than a month, the average number of daily new cases reported to the US Centers for Disease Control and Prevention has hovered in the single digits, plummeting from an August peak of about 450 cases a day.

Still, the US led the world in cases during the 2022-23 outbreak. More than 30,000 people in the US have been diagnosed with mpox, including 23 who died.

Cases are also down across Europe, the Western Pacific and Asia but still rising in some South American countries, according to the latest data from the World Health Organization.

It wasn’t always a given that we’d get here. When mpox went global in 2022, doctors had too few doses of a new and unproven vaccine, an untested treatment, a dearth of diagnostic testing and a difficult line to walk in their messaging, which needed to be geared to an at-risk population that has been stigmatized and ignored in public health crises before.

Experts say the outbreak has taught the world a lot about this infection, which had only occasionally been seen outside Africa.

But even with so much learned, there are lingering mysteries too – like where this virus comes from and why it suddenly began to spread from the Central and West African countries where it’s usually found to more than 100 other nations.

Before May 2022, when clusters of people with unusual rashes began appearing in clinics in the UK and Europe, the country reporting the most cases of mpox was the Democratic Republic of Congo, or DRC.

There, cases have been steadily building since the 1970s, according to a study in the CDC’s Morbidity and Mortality Weekly Report.

In the DRC, people in rural villages depend on wild animals for meat. Many mpox infections there are thought to be the result of contact with an animal to which the virus has adapted; this animal host is not known but is assumed to be a rodent.

For years, experts who studied African outbreaks observed a phenomenon known as stuttering chains of transmission: “infections that managed to transmit themselves or be transmitted from person to person to a limited degree, a certain number of links in that chain of transmission, and then suddenly just aren’t able to sustain themselves in humans,” said Stephen Morse, an epidemiologist at Columbia University’s Mailman School of Public Health.

Informally, scientists kept track, and Morse says that for years, the record for links in a mpox chain was about four.

“Traditionally, it always burned itself out,” he said.

Then the chains started getting longer.

In 2017, Nigeria – which hadn’t had a confirmed case of mpox in more than four decades – suddenly saw a resurgence of the virus, with more than 200 cases reported that year.

“People have speculated maybe it was a change in the virus that allowed it to be made better-adapted to humans,” Morse said.

From 2018 through 2021, eight cases of mpox were reported outside Africa. All were in men ages 30 to 50, and all had traveled from Nigeria. Three reported that the rashes had started in their groin area. One went on to infect a health care provider. Another infected two family members.

This Nigerian outbreak helped experts realize that mpox could efficiently spread between people.

It also hinted that the infection could be sexually transmitted, but investigators couldn’t confirm this route of spread, possibly because of the stigma involved in sharing information about sexual contact.

In early May 2022, health officials in the UK began reporting confirmed cases of mpox. One of the people had recently traveled to Nigeria, but others had not, indicating that it was spreading in the community.

Later, other countries would report cases that had started even earlier, in April.

Investigators concluded that mpox had been silently spreading before they caught up to it.

In early summer, as US case numbers began to grow, the public health response bore some uncomfortable similarities to the early days of Covid-19. People with suspicious rashes complained that it was too hard to get tested because a limited supply was being rationed. Because the virus had so rarely appeared outside certain countries in Africa, most doctors weren’t sure how to recognize mpox or how to test for it and didn’t understand all its routes of spread.

A new vaccine was available, and the government had placed orders for it, but most of those doses weren’t in the United States. Beyond that, its efficacy against mpox had been studied only in animals, so no one knew whether it would actually work in humans.

There was an experimental treatment, Tpoxx, but it too was unproven, and doctors could get it only after filling out reams of paperwork required by the government for compassionate use.

Some just gave up.

“Tpoxx was hard to get,” said Dr. Jeffrey Klausner, a clinical professor of public health at the University of Southern California’s Keck School of Medicine.

“I was scrambling to find places that could prescribe it because my own institution just became a bureaucratic nightmare. So I basically would be referring people for treatment outside my own institution to be able to get monkeypox treatment,” he said.

Finally, in August, the federal government declared a public health emergency. This allowed federal agencies to access pots of money set aside for emergencies. It also allows the government to shift funds from one purpose to another to help cover costs of the response – and it helped raise awareness among doctors that mpox was something to watch for.

The government also set up a task force led by Robert Fenton, a logistics expert from the Federal Emergency Management Agency, and Dr. Demetre Daskalakis, director of the CDC’s Division of HIV and AIDS Research.

Daskalakis is openly gay and sex-positive, right down to his Instagram account, which mixes suit-and-tie shots from White House briefings with photos revealing his many tattoos.

“Dr. Daskalakis … really walks on water in most of the gay community, and then [Fenton is] a logistics expert, and I think that combination of leadership was the right answer,” Klausner said.

Early on, after the CDC identified men who have sex with men as being at highest risk of infection, officials warned of close physical contact, the kind that often happens with sexual activity. They also noted that people could be infected through contact with contaminated surfaces like sheets or towels.

But they stopped short of calling it a sexually transmitted infection, a move that some saw as calculated.

“In this outbreak, in this time and context to Europe, United States and Australia, was definitely sexually transmitted,” said Klausner, who points out that many men got rashes on their genitals and that infectious virus was cultured in semen.

Klausner believes vague descriptions about how the virus spread were intentional, in order to garner resources needed for the response.

“People felt that if they called it an STD from the get-go, it was going to create stigma, and because of the stigma of the type of sex that was occurring – oral sex, anal sex, anal sex between same-sex male partners – there may not have been the same kind of federal response,” Klausner said. “So it was actually a political calculation to garner the resources necessary to have a substantial response to be vague about how it spread.”

This ambiguity created room for misinformation and confusion, said Tony Hoang, executive director of Equality California, a nonprofit advocacy group for LGBTQ civil rights.

“I think there was a balancing dance of not wanting to create stigma, in terms of who is actually the highest rates of transmission without being forthright,” Hoang said.

Hoang’s group launched its own public information campaign, combining information from the CDC on HIV and mpox. The messaging stressed that sex was the risky behavior and made sure to explain that light brushes or touches weren’t likely to pass the infection, he said.

Klausner thinks the CDC could have done better on messaging.

“By giving vague, nonspecific information and making comments like ‘everyone’s potentially at risk’ or ‘there’s possible spread through sharing a bed, clothing or close dancing’ … that kind of dilutes the message, and people who engage in risk behavior that does put them at risk get confused, and they say ‘well, maybe this isn’t really a route of spread,’ ” he said.

In July and August, when the US was reporting hundreds of new mpox cases each day, health officials were worried that the virus might be here to stay.

“There were concerns that there would be ongoing transmission and that ongoing transmission would become endemic in the United States like other STIs: gonorrhea, chlamydia, syphilis. We have not seen that occur,” said Dr. Jonathan Mermin, director of the CDC’s National Center for HIV, Viral Hepatitis, STD, and TB Prevention.

“We are now seeing three to four cases a day in the United States, and it continues to decline. And we see the possibility of getting to zero as real,” he said.

At the peak of the outbreak, officials scrambled to vaccinate the population at highest risk – men who have sex with men – in the hopes of limiting both severity of infections and transmission. But no one was sure whether this strategy would work.

The Jynneos vaccine was approved by the US Food and Drug Administration in 2019 to prevent monkeypox and smallpox in people at high risk of those infections.

At that time, the plan was to bank it in the Strategic National Stockpile as a countermeasure in case smallpox was weaponized. The approval for mpox, a virus closely related to smallpox, was tacked on because the US had seen a limited outbreak of these infections in 2003, tied to the importation of exotic rodents as pets.

Jynneos had passed safety tests in humans. In lab studies, it protected primates and mice from mpox infections. But researchers only learn how effective vaccines are during infectious disease outbreaks, and Jynneos has never been put through its paces during an outbreak.

“We were left, when this started, with that great unknown: Does this vaccine work? And is it safe in large numbers?” Mermin said.

Beyond those uncertainties, there wasn’t enough to go around, and infectious disease experts feared that a shortage of the vaccine might thwart any effort to stop the outbreak.

So public health officials announced a change in strategy: Instead of injecting a full dose under the skin, or subcutaneously, they would inject just one-fifth of that dose between the skin’s upper layers, or intradermally.

An early study in the trials of the vaccine had suggested that intradermal dosing could be effective, but it was a risk. Again, no one was sure this dose-sparing strategy would work.

Ultimately, all of these gambles appear to have paid off.

Early studies of vaccine effectiveness show that the Jynneos vaccine protected men from mpox infections. According to CDC data, people who were unvaccinated were almost 10 times as likely to be diagnosed with the infection as those who got the recommended two doses.

Men who had two doses were about 69% less likely, and men with a single dose were about 37% less likely, to have an mpox infection that needed medical attention compared with those who were unvaccinated, according to the CDC.

Mermin says studies have since showed that the vaccine worked well no matter if was given into the skin or under the skin – another win.

Still, the vaccine is almost certainly not the entire reason cases have plunged, simply because not enough people have gotten it. The CDC estimates that 2 million people in the United States are eligible for mpox vaccination. Mermin says that about 700,000 have had a first dose – about 36% of the eligible population.

So it’s unlikely that vaccination was the only reason for the steep decline in cases. CDC modeling suggests that behavior change may have played a substantial role, too.

In an online survey of men who have sex with men conducted in August, half of participants indicated that they had reduced their number of partners and one-time sexual encounters, behaviors that could cut the growth of new infections by 20% to 30%.

If that’s the case, some experts worry that the US could see monkeypox flare up again as the weather warms.

“The party season was during the summer, during the height of the outbreak, and we’re in the dead of winter. So there’s a possibility that behavior change may not able to be sustained,” said Gregg Gonsalves, an epidemiologist at the Yale School of Public Health.

Although we’re clearly in a much better position than we were last summer, he says, public health officials shouldn’t make this a “mission accomplished” moment.

“Now, put your foot on the accelerator. Let’s get the rest of these cases,” Gonsalves said.

Mermin says that’s exactly what the CDC intends to do. It isn’t finished with the response but intends to switch to “a ground game.”

“So much of our work in the next few months will be setting up structures so that getting vaccinated is easy,” he said.

Nearly 40% of mpox cases in the United States were diagnosed in people who also had HIV, Mermin said. So the CDC is going to make sure Jynneos vaccines are available as a routine part of care at HIV clinics and STI clinics that offer pre-exposure prophylaxis, or PrEP, for HIV.

Mermin said officials are also going to continue to go to LGBTQ festivals and events to offer on-site vaccinations.

Additionally, they’re going to study people who’ve been vaccinated and infected to see whether they remain immune – something else that’s still a big unknown.

Experts say that’s just one of many questions that need a closer look. Another is just how long the virus had been spreading outside Africa before the world noticed.

“We’re starting to see some data that suggests that asymptomatic infection and transmission is possible, and that certainly will change how we how we think about this virus and and risk,” said Anne Rimoin, an epidemiologist at the Fielding School of Public Health at UCLA.

When researchers at a sexual health clinic in Belgium rescreened more than 200 nasal and oral swabs they had taken in May 2022 to test for the STIs chlamydia and gonorrhea, they found positive mpox cases that had gone undiagnosed. Three of the people reported no symptoms, while another reported a painful rash, which was misdiagnosed as herpes. Their study was published in the journal Nature Medicine.

“Mild and asymptomatic infections may have indeed delayed the detection of the outbreak,” study author Christophe Van Dijck of the Laboratory of Medical Microbiology at the University of Antwerp in Belgium said in an email to CNN.

While researchers tackle those pursuits, advocacy groups say they aren’t ready to relax.

Hoang says Equality California is pushing the CDC to address continuing racial disparities in mpox vaccination and treatment, particularly in rural areas.

He’s not worried that gay men will drop their guard now that the emergency has expired..

“We’ve learned that we have to take health into our own hands, and I do think that we will remain vigilant as a community for this outbreak and future outbreaks,” Hoang said.



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FDA vaccine advisers vote to harmonize Covid-19 vaccines in the United States | CNN

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CNN
 — 

A panel of independent experts that advises the US Food and Drug Administration on its vaccine decisions voted unanimously Thursday to update all Covid-19 vaccines so they contain the same ingredients as the two-strain shots that are now used as booster doses.

The vote means young children and others who haven’t been vaccinated may soon be eligible to receive two-strain vaccines that more closely match the circulating viruses as their primary series.

The FDA must sign off on the committee’s recommendation, which it is likely to do, before it goes into effect.

Currently, the US offers two types of Covid-19 vaccines. The first shots people get – also called the primary series – contain a single set of instructions that teach the immune system to fight off the original version of the virus, which emerged in 2019.

This index strain is no longer circulating. It was overrun months ago by an ever-evolving parade of new variants.

Last year, in consultation with its advisers, the FDA decided that it was time to update the vaccines. These two-strain, or bivalent, shots contain two sets of instructions; one set reminds the immune system about the original version of the coronavirus, and the second set teaches the immune system to recognize and fight off Omicron’s BA.4 and BA.5 subvariants, which emerged in the US last year.

People who have had their primary series – nearly 70% of all Americans – were advised to get the new two-strain booster late last year in an effort to upgrade their protection against the latest variants.

The advisory committee heard testimony and data suggesting that the complexity of having two types of Covid-19 vaccines and schedules for different age groups may be one of the reasons for low vaccine uptake in the US.

Currently, only about two-thirds of Americans have had the full primary series of shots. Only 15% of the population has gotten an updated bivalent booster.

Data presented to the committee shows that Covid-19 hospitalizations have been rising for children under the age of 2 over the past year, as Omicron and its many subvariants have circulated. Only 5% of this age group, which is eligible for Covid-19 vaccination at 6 months of age, has been fully vaccinated. Ninety percent of children under the age of 4 are still unvaccinated.

“The most concerning data point that I saw this whole day was that extremely low vaccination coverage in 6 months to 2 years of age and also 2 years to 4 years of age,” said Dr. Amanda Cohn, director of the US Centers for Disease Control and Prevention’s Division of Birth Defects and Infant Disorders. “We have to do much, much better.”

Cohn says that having a single vaccine against Covid-19 in the US for both primary and booster doses would go a long way toward making the process less complicated and would help get more children vaccinated.

Others feel that convenience is important but also stressed that data supported the switch.

“This isn’t only a convenience thing, to increase the number of people who are vaccinated, which I agree with my colleagues is extremely important for all the evidence that was related, but I also think moving towards the strains that are circulating is very important, so I would also say the science supports this move,” said Dr. Hayley Gans, a pediatric infectious disease specialist at Stanford University.

Many others on the committee were similarly satisfied after seeing new data on the vaccine effectiveness of the bivalent boosters, which are cutting the risk of getting sick, being hospitalized or dying from a Covid-19 infection.

“I’m totally convinced that the bivalent vaccine is beneficial as a primary series and as a booster series. Furthermore, the updated vaccine safety data are really encouraging so far,” said Dr. David Kim, director of the the US Department of Health and Human Services’ National Vaccine Program, in public discussion after the vote.

Thursday’s vote is part of a larger plan by the FDA to simplify and improve the way Covid-19 vaccines are given in the US.

The agency has proposed a plan to convene its vaccine advisers – called the Vaccines and Related Biological Products Advisory Committee, or VRBPAC – each year in May or June to assess whether the instructions in the Covid-19 vaccines should be changed to more closely match circulating strains of the virus.

The time frame was chosen to give manufacturers about three months to redesign their shots and get new doses to pharmacies in time for fall.

“The object, of course – before anyone says anything – is not to chase variants. None of us think that’s realistic,” said Jerry Weir, director of the Division of Viral Products in the FDA’s Office of Vaccines Research and Review.

“But I think our experience so far, with the bivalent vaccines that we have, does indicate that we can continue to make improvements to the vaccine, and that would be the goal of these meetings,” Weir said.

In discussions after the vote, committee members were supportive of this plan but pointed out many of the things we still don’t understand about Covid-19 and vaccination that are likely to complicate the task of updating the vaccines.

For example, we now seem to have Covid-19 surges in the summer as well as the winter, noted Dr. Michael Nelson, an allergist and immunologist at the University of Virginia. Are the surges related? And if so, is fall the best time to being a vaccination campaign?

The CDC’s Dr. Jefferson Jones said that with only three years of experience with the virus, it’s really too early to understand its seasonality.

Other important questions related to the durability of the mRNA vaccines and whether other platforms might offer longer protection.

“We can’t keep doing what we’re doing,” said Dr. Bruce Gellin, chief of global public health strategy at the Rockefeller Foundation. “It’s been articulated in every one of these meetings despite how good these vaccines are. We need better vaccines.”

The committee also encouraged both government and industry scientists to provide a fuller picture of how vaccination and infection affect immunity.

One of the main ways researchers measure the effectiveness of the vaccines is by looking at how much they increase front-line defenders called neutralizing antibodies.

Neutralizing antibodies are like firefighters that rush to the scene of an infection to contain it and put it out. They’re great in a crisis, but they tend to diminish in numbers over time if they’re not needed. Other components of the immune system like B-cells and T-cells hang on to the memory of a virus and stand ready to respond if the body encounters it again.

Scientists don’t understand much about how well Covid-19 vaccination boosts these responses and how long that protection lasts.

Another puzzle will be how to pick the strains that are in the vaccines.

The process of selecting strains for influenza vaccines is a global effort that relies on surveillance data from other countries. This works because influenza strains tend to become dominant and sweep around the world. But Covid-19 strains haven’t worked in quite the same way. Some that have driven large waves in other countries have barely made it into the US variant mix.

“Going forward, it is still challenging. Variants don’t sweep across the world quite as uniform, like they seem to with influenza,” the FDA’s Weir said. “But our primary responsibility is what’s best for the US market, and that’s where our focus will be.”

Eventually, the FDA hopes that Americans would be able to get an updated Covid-19 shot once a year, the same way they do for the flu. People who are unlikely to have an adequate response to a single dose of the vaccine – such as the elderly or those with a weakened immune system – may need more doses, as would people who are getting Covid-19 vaccines for the first time.

At Thursday’s meeting, the advisory committee also heard more about a safety signal flagged by a government surveillance system called the Vaccine Safety Datalink.

The CDC and the FDA reported January 13 that this system, which relies on health records from a network of large hospital systems in the US, had detected a potential safety issue with Pfizer’s bivalent boosters.

In this database, people 65 and older who got a Pfizer bivalent booster were slightly more likely to have a stroke caused by a blood clot within three weeks of their vaccination than people who had gotten a bivalent booster but were 22 to 42 days after their shot.

After a thorough review of other vaccine safety data in the US and in other countries that use Pfizer bivalent boosters, the agencies concluded that the stroke risk was probably a statistical fluke and said no changes to vaccination schedules were recommended.

At Thursday’s meeting, Dr. Nicola Klein, a senior research scientist with Kaiser Permanente of Northern California, explained how they found the signal.

The researchers compared people who’d gotten a vaccine within the past three weeks against people who were 22 to 42 days away from their shots because this helps eliminate bias in the data.

When they looked to see how many people had strokes around the time of their vaccination, they found an imbalance in the data.

Of 550,000 people over 65 who’d received a Pfizer bivalent booster, 130 had a stroke caused by a blood clot within three weeks of vaccination, compared with 92 people in the group farther out from their shots.

The researchers spotted the signal the week of November 27, and it continued for about seven weeks. The signal has diminished over time, falling from an almost two-fold risk in November to a 47% risk in early January, Klein said. In the past few days, it hasn’t been showing up at all.

Klein said they didn’t see the signal in any of the other age groups or with the group that got Moderna boosters. They also didn’t see a difference when they compared Pfizer-boosted seniors with those who were eligible for a bivalent booster but hadn’t gotten one.

Further analyses have suggested that the signal might be happening not because people who are within three weeks of a Pfizer booster are having more strokes, but because people who are within 22 to 42 days of their Pfizer boosters are actually having fewer strokes.

Overall, Klein said, they were seeing fewer strokes than expected in this population over that period of time, suggesting a statistical fluke.

Another interesting thing that popped out of this data, however, was a possible association between strokes and high-dose flu vaccination. Seniors who got both shots on the same day and were within three weeks of those shots had twice the rate of stroke compared with those who were 22 to 42 days away from their shots.

What’s more, Klein said, the researchers didn’t see the same association between stroke and time since vaccination in people who didn’t get their flu vaccine on the same day.

The total number of strokes in the population of people who got flu shots and Covid-19 boosters on the same day is small, however, which makes the association a shaky one.

“I don’t think that the evidence are sufficient to conclude that there’s an association there,” said Dr. Tom Shimabukuro, director of the CDC’s Immunization Safety Office.

Nonetheless, Richard Forshee, deputy director of the FDA’s Office of Biostatistics and Pharmacovigilance, said the FDA is planning to look at these safety questions further using data collected by Medicare.

The FDA confirmed that the agency is taking a closer look.

“The purpose of the study is 1) to evaluate the preliminary ischemic stroke signal reported by CDC using an independent data set and more robust epidemiological methods; and 2) to evaluate whether there is an elevated risk of ischemic stroke with the COVID-19 bivalent vaccine if it is given on the same day as a high-dose or adjuvanted seasonal influenza vaccine,” a spokesperson said in a statement.

The FDA did not give a time frame for when these studies might have results.

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FDA proposes new levels for lead in baby food, but critics say more action is needed | CNN

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CNN
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The allowable levels of lead in certain baby and toddler foods should be set at 20 parts per billion or less, according to new draft guidance issued Tuesday by the US Food and Drug Administration.

“For babies and young children who eat the foods covered in today’s draft guidance, the FDA estimates that these action levels could result in as much as a 24-27% reduction in exposure to lead from these foods,” said FDA Commissioner Dr. Robert Califf in a statement.

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Baby foods covered by the new proposal – which is seeking public comment – include processed baby foods sold in boxes, jars, pouches and tubs for babies and young children younger than 2 years old, the agency said.

While any action on the part of the FDA is welcome, the suggested levels of lead are not low enough to move the needle, said Jane Houlihan, the national director of science and health for Healthy Babies Bright Futures, a coalition of advocates committed to reducing babies’ exposures to neurotoxic chemicals.

“Nearly all baby foods on the market already comply with what they have proposed,” said Houlihan, who authored a 2019 report that found dangerous levels of lead and other heavy metals in 95% of manufactured baby food.

That report triggered a 2021 congressional investigation, which found leading baby food manufacturers knowingly sold products with high levels of toxic metals.

“The FDA hasn’t done enough with these proposed lead limits to protect babies and young children from lead’s harmful effects. There is no known safe level of lead exposure, and children are particularly vulnerable,” Houlihan said.

The director of food policy for Consumers Reports, Brian Ronholm, also expressed concerns. In 2018, Consumer Reports analyzed 50 baby foods and found “concerning” levels of lead and other heavy metals. In fact, “15 of them would pose a risk to a child who ate one serving or less per day,” according to Consumer Reports.

“The FDA should be encouraging industry to work harder to reduce hazardous lead and other heavy metals in baby food given how vulnerable young children are to toxic exposure,” Ronholm said in a statement.

Exposure to toxic heavy metals can be harmful to the developing brain of infants and children. “It’s been linked with problems with learning, cognition, and behavior,” according to the American Academy of Pediatrics.

Lead, arsenic, cadmium and mercury are in the World Health Organization’s top 10 chemicals of concern for infants and children.

As natural elements, they are in the soil in which crops are grown and thus can’t be avoided. Some crop fields and regions, however, contain more toxic levels than others, partly due to the overuse of metal-containing pesticides and ongoing industrial pollution.

The new FDA guidance suggests manufactured baby food custards, fruits, food mixtures — including grain and meat-based blends — puddings, vegetables, yogurts, and single-ingredient meats and vegetables contain no more than 10 parts per billion of lead.

The exception to that limit is for single-ingredient root vegetables, such as carrots and sweet potatoes, which should contain no more than 20 parts per billion, according to the new guidance.

Dry cereals marketed to babies and toddlers should also not contain more than 20 parts per billion of lead, the new FDA guidance said.

However, the FDA didn’t propose any lead limit for cereal puffs and teething biscuits, Houlihan said, even though the products account for “7 of the 10 highest lead levels we’ve found in over 1,000 baby food tests we have assessed.”

The limit set for root vegetables will be helpful, Houlihan added. Because they grow underground, root vegetables can easily absorb heavy metals. For example, sweet potatoes often exceed the 20 parts per billion limit the FDA has proposed, she said.

Prior to this announcement, the FDA had only set limits for heavy metals in one baby food — infant rice cereal, Houlihan said. In 2021, the agency set a limit of 100 parts per billion for arsenic, which has been linked to adverse pregnancy outcomes and neurodevelopmental toxicity.

There is much more that can be done, according to Scott Faber, senior vice president of government affairs for the Environmental Working Group, a nonprofit environmental health organization.

“We can change where we farm and how we farm to reduce toxic metals absorbed by plants,” Faber said. “We also urge baby food manufacturers to conduct continuous testing of heavy metals in all their products and make all testing results publicly available.”

Companies can require suppliers and growers to test the soil and the foods they produce, and choose to purchase from those with the lowest levels of heavy metals, Houlihan added.

“Growers can use soil additives, different growing methods and crop varieties known to reduce lead in their products,” she said.

What can parents do to lessen their child’s exposure to toxic metals? Unfortunately, buying organic or making baby food at home isn’t going to solve the problem, as the produce purchased at the grocery store can also contain high levels of contaminants, experts say.

A 2022 report by Healthy Babies, Bright Futures found lead in 80% of homemade purees or store-bought family foods. Arsenic was found in 72% of family food either purchased or prepared at home.

The best way to lessen your child’s exposure to heavy metals, experts say, is to vary the foods eaten on a daily basis and choose mostly from foods which are likely to have the least contamination. Healthy Babies, Bright Futures created a chart of less to most contaminated foods based on their testing.

Fresh bananas, with heavy metal levels of 1.8 parts per billion, were the least contaminated of foods tested for the report. After bananas, the least contaminated foods were grits, manufactured baby food meats, butternut squash, lamb, apples, pork, eggs, oranges and watermelon, in that order.

Other foods with lower levels of contamination included green beans, peas, cucumbers and soft or pureed home-cooked meats, the report found.

The most heavily contaminated foods eaten by babies were all rice-based, the report said. Rice cakes, rice puffs, crisped rice cereals and brown rice with no cooking water removed were heavily contaminated with inorganic arsenic, the more toxic form of arsenic.

After rice-based foods, the analysis found the highest levels of heavy metals in raisins, non-rice teething crackers, granola bars with raisins and oat-ring cereals. But those were not the only foods of concern: Dried fruit, grape juice, arrowroot teething crackers and sunflower seed butter all contained high amounts of at least one toxic metal, according to the report.

While buying organic cannot reduce the levels of heavy metals in infant food, it can help avoid other toxins such as herbicides and pesticides, Dr. Leonardo Trasande, director of environmental pediatrics at NYU Langone Health told CNN previously.

“There are other benefits to eating organic food, including a reduction in synthetic pesticides that are known to be as bad for babies, if not even more problematic,” Trasande said.

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Flu, Covid-19 and RSV are all trending down for the first time in months | CNN

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CNN
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A rough respiratory virus season in the US appears to be easing, as three major respiratory viruses that have battered the country for the past few months are finally all trending down at the same time.

A new dataset from the US Centers for Disease Control and Prevention shows that the number of emergency department visits for the three viruses combined – flu, Covid-19 and RSV – have dropped to the lowest they’ve been in three months. The decline is apparent across all age groups.

Measuring virus transmission levels can be challenging; health officials agree that Covid-19 cases are vastly undercounted, and surveillance systems used for flu and RSV capture a substantial, but incomplete picture.

But experts say that tracking emergency department visits can be a good indicator of how widespread – and severe – the respiratory virus season is.

“There’s the chief complaint. When you show up to the emergency room, you complain about something,” said Janet Hamilton, executive director at Council of State and Territorial Epidemiologists. “Being able to look at the proportion of individuals that seek care at an emergency department for these respiratory illness concerns is a really good measure of the respiratory disease season.”

In the week following Thanksgiving, emergency department visits for respiratory viruses topped 235,000 – matching rates from last January, according to the CDC data.

While the surge in emergency department visits early in the year was due almost entirely to Omicron, the most recent spike was much more varied. In the week ending December 3, about two-thirds of visits were for flu, about a quarter were for Covid-19 and about 10% were for RSV.

Grouping the impact of all respiratory viruses together in this way offers an important perspective.

“There’s a strong interest in thinking about respiratory diseases in a more holistic way,” Hamilton said. “Transmission is the same. And there are certain types of measures that are good protection against all respiratory diseases. So that could really help people understand that when we are in high circulation for respiratory diseases, there are steps that you can take – just in general.”

Now, Covid-19 again accounts for most emergency department visits but flu and RSV are still the reason behind about a third of visits – and they’re all trending down for the first time since the respiratory virus season started picking up in September.

More new data from the CDC shows that overall respiratory virus activity continues to decline across the country. Only four states, along with New York City and Washington, DC, had “high” levels of influenza-like illness. Nearly all states were in this category less than a month ago.

Whether that pattern will hold is still up in the air, as vaccination rates for flu and Covid-19 are lagging and respiratory viruses can be quite fickle. Also, while the level of respiratory virus activity is lower than it’s been, it’s still above baseline in most places and hospitals nationwide are still about 80% full.

RSV activity started to pick up in September, reaching a peak in mid-November when 5 out of every 100,000 people – and 13 times as many children younger than five – were hospitalized in a single week.

RSV particularly affects children, and sales for over-the-counter children’s pain- and fever-reducing medication were 65% higher in November than they were a year before, according to the Consumer Healthcare Products Association. While “the worst may be over,” demand is still elevated, CHPA spokesperson Logan Ramsey Tucker told CNN in an email – sales were up 30% year-over-year in December.

But this RSV season has been significantly more severe than recent years, according to CDC data. The weekly RSV hospitalization rate has dropped to about a fifth of what it was two months ago, but it is still higher than it’s been in previous seasons.

Flu activity ramped up earlier than typical, but seems to have already reached a peak. Flu hospitalizations – about 6,000 new admissions last week – have dropped to a quarter of what they were at their peak a month and a half ago, and CDC estimates for total illnesses, hospitalizations and deaths from flu so far this season have stayed within the bounds of what can be expected. It appears the US has avoided the post-holiday spike that some experts cautioned against, but the flu is notoriously unpredictable and it’s not uncommon to see a second bump later in season.

The Covid-19 spike has not been as pronounced as flu, but hospitalizations did surpass levels from the summer. However, the rise in hospitalizations that started in November has started to tick down in recent weeks and CDC data shows that the share of the population living in a county with a “high” Covid-19 community level has dropped from 22% to about 6% over the past two weeks.

Still, the XBB.1.5 variant – which has key mutations that experts believe may be helping it to be more infectious – continues to gain ground in the US, causing about half of all infections last week. Vaccination rates continue to lag, with just 15% of the eligible population getting their updated booster and nearly one in five people remain completely unvaccinated.

Ensemble forecasts published by the CDC are hazy, predicting a “stable or uncertain trend” in Covid-19 hospitalizations and deaths over the next month.

And three years after the first Covid-19 case was confirmed in the US, the virus has not settled into a predictable pattern, according to Dr. Maria Van Kerkhove, the World Health Organization’s technical lead for the Covid-19 response.

“We didn’t need to have this level of death and devastation, but we’re dealing with it, and we are doing our best to minimize the impact going forward,” Van Kerkhove told the Conversations on Healthcare podcast this week.

Van Kerkhove says she does believe 2023 could be the year in which Covid-19 would no longer be deemed a public health emergency in the US and across the world, but more work needs to be done in order to make that happen and transitioning to longer-term respiratory disease management of the outbreak will take more time.

“We’re just not utilizing [vaccines] most effectively around the world. I mean 30% of the world still has not received a single vaccine,” she said. “In every country in the world, including in the US, we’re missing key demographics.”

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New boosters add limited protection against Covid-19 illness, first real-world study shows | CNN

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CNN
 — 

Updated Covid-19 boosters that carry instructions to arm the body against currently circulating Omicron subvariants offer some protection against infections, according to the first study to look at how the boosters are performing in the real world. However, the protection is not as high as that provided by the original vaccine against earlier coronavirus variants, the researchers say.

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, called the new data “really quite good.”

“Please, for your own safety, for that of your family, get your updated Covid-19 shot as soon as you’re eligible to protect yourself, your family and your community,” Fauci said at a White House briefing Tuesday.

Uptake of the bivalent boosters, which protect against the BA.4/5 subvariants as well as the original virus strain, has been remarkably slow. Only 11% of eligible Americans have gotten them since they became available in early September.

The new study found that the updated boosters work about like the original boosters. They protect against symptomatic infection in the range of 40% to 60%, meaning that even when vaccine protection is its most potent, about a month after getting the shot, people may still be vulnerable to breakthrough infections.

That’s in about the same range as typical efficacy for flu vaccines. Over the past 10 years, CDC data shows, the effectiveness of the seasonal flu vaccines has ranged from a low of 19% to a high of around 52% against needing to see a doctor because of the flu. The effectiveness varies depending on how similar the strains in the vaccine are to the strains that end up making people sick.

The authors of the new study say people should realize that the Covid-19 vaccines are no longer more than 90% protective against symptomatic infections, as they were when they were first introduced in 2020.

“Unfortunately, the 90% to 100% protection was what we saw during like pre-Delta time. And so with Delta, we saw it drop into the 70% range, and then for Omicron, we saw it drop even lower, to the 50% range. And so I think what we’re seeing here is that the bivalent vaccine really brings you back to that sort of effectiveness that we would have seen immediately after past boosters, which is great. That’s where we want it to get,” said Dr. Ruth Link-Gelles, an epidemiologist at the US Centers for Disease Control and Prevention.

“This protection is not 100%, but it is something,” Link-Gelles said. “Especially going into the holidays where you’re likely to be traveling, spending time with elderly relatives, with vulnerable people. I think having some protection from infection and therefore some protection from infecting your loved one is better than having no protection at all.”

Link-Gelles says it also means that people should continue to adopt a layered approach to protection, utilizing rapid tests, good-quality masks and ventilation as a comprehensive approach, rather than relying on vaccines alone.

“This should be sort of one of the things in your toolbox for protecting yourself and your family,” she said. “Personally, we’re my family is all vaccinated up to date, but I think if we go to the airport tomorrow, we’ll be wearing our N95 [masks] because we’re seeing elderly relatives this weekend. And while we of course trust the vaccines, and I’m not super worried about a mild infection in myself or my healthy husband, we certainly would not want to infect his grandmother.”

Link-Gelles added that she expects that vaccine protection against severe outcomes from Covid-19, like hospitalization and death, will be higher, but that data isn’t in yet.

The study, which was led by CDC scientists, relied on health records from more than 360,000 tests given at nearly 10,000 retail pharmacies between Sept. 14 and Nov. 11, a period when the BA.4 and BA.5 subvariants were causing most Covid-19 infections in the US. The study included people ages 18 and up who had Covid-19 symptoms and were not immunocompromised.

The study looked at how effective the boosters were in two ways: Researchers calculated a value called absolute vaccine effectiveness, which compared the odds of symptomatic infection in people who received bivalent boosters with those who reported being unvaccinated. They also calculated relative vaccine effectiveness, which looked at the odds of symptomatic infection in people who received updated bivalent boosters compared with those who had two, three or four doses of the original single-strain vaccine.

Compared with people who were unvaccinated, adults 18 to 49 who had gotten bivalent boosters were 43% less likely to get sick with a Covid-19 infection. Older adults, who tend to have weaker immune function, got less protection. Those ages 50 to 64 were 28% less likely, and those ages 65 and up were 22% less likely to get sick with Covid-19 than the unvaccinated group.

The relative vaccine effectiveness showed the added protection people might expect on top of whatever protection they had left after previous vaccine doses. If a person was two to three months past their last vaccine dose, the bivalent boosters added an average of 30% protection for those who were ages 18 to 49, 31% more protection if they were 50 to 64, and 28% more protection if they were 65 or older. At 3 months after their last booster, people ages 50 and older still had about 20% protection from Covid-19 illness, CDC data show. So overall, the updated boosters got them to around 50% effectiveness against symptomatic infection.

If a person was more than eight months away from their last vaccine dose, they got more protection from the boosters. But Link-Gelles said that by eight months, there was little protection left from previous shots against Omicron and its variants, meaning the vaccine effectiveness for this group was probably close to their overall protection against infection.

Those ages 18 to 49 who were eight months or more past their last dose of a vaccine had 56% added protection against a Covid-19 infection with symptoms; adults 50 to 64 had 48% added protection, and adults over 65 had 43% added protection, on top of whatever was left from previous vaccinations.

John Moore, an immunologist and microbiologist at Weill Cornell Medicine, said it boils down to the fact that that boosters will probably cut your risk of getting sick by about 50%, and that protection probably won’t last.

“Having a booster will give you some additional protection against infection for a short term, which is always what we see with a booster, but it won’t last long. It’ll decline, and it will decline more as the more resistant variants spread,” said Moore, who was not involved in the new research.

The immunity landscape in the United States is more complex than ever. According to CDC data, roughly two-thirds of Americans have completed at least their primary series of Covid-19 vaccines. And data from blood tests shows that almost all Americans have some immunity against the virus, thanks to infection, vaccination or both.

A new preprint study from researchers at Harvard and Yale estimates that 94% of Americans have been infected with the virus that causes Covid-19 at least once, and 97% have been infected or vaccinated, increasing protection against a new Omicron infection from an estimated 22% in December 2021 to 63% by November 10, 2022. Population protection against severe disease rose from an estimated 61% in December 2021 to around 89%, on average, this November.

All of this means the US is in a better spot, defensively at least, than it ever has been against the virus – which is not to say that the country couldn’t see another Covid-19 wave, especially if a new variant emerges that is very different from what we’ve seen, if immunity continues to wane or if behavior shifts dramatically.



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