By Deanna Neff HealthDay ReporterTHURSDAY, Feb. 12, 2026 (HealthDay News) — Your smartwatch might soon do more than just count your steps or check your heart rate: It could serve as a literal early-warning system for your mental health.
New research from McMaster University suggests that wearable trackers can detect the subtle signs of a depression relapse weeks or even months before an actual episode.
The study — published Feb. 11 in JAMA Psychiatry, — followed 93 Canadian adults for up to two years. All had a diagnosis of major depressive disorder and had previously recovered from a depression episode.
Patients wore a research-grade device similar to a Fitbit or Apple Watch around the clock and had regular in-person visits for depression assessment and data download.
By analyzing more than 32,000 days of their data, scientists found that a person’s daily rhythms tell a story.
Specifically, people with irregular sleep schedules had nearly double the risk of falling back into a depressive episode.
The most telling sign wasn’t just how long someone slept, but how different their day was from their night.
When the data showed less of a difference between daytime movement and nighttime rest, a relapse was often right around the corner.
“Imagine a future where a smartwatch can warn people with depression: ‘A new episode of depression is very likely coming within the next four weeks. How about seeing your health-care provider?’ ” said Dr. Benicio Frey, a professor of psychiatry at McMaster University in Hamilton, Ontario, Canada.
By collecting data passively, digital health wearables allow for continuous monitoring between doctor’s appointments. This “always-on” approach could revolutionize how mental health is managed, moving from reactive treatments to proactive prevention, researchers noted.
“While it has been long recognized that abnormal sleep and activity patterns are associated with greater risk of depression relapse, the ability to passively detect these abnormal patterns using smart sensors opens an exciting new window of opportunity for personalizing the care of conditions that may reoccur, like depression,” the researchers noted.
Major depressive disorder is a recurring challenge for many, with about 60% of patients experiencing a relapse within five years of recovery, researchers said in background notes. Roughly 16% of U.S. adults are faced with it in a given year.
Traditionally, doctors have had to wait for patients to report symptoms — like low mood or loss of interest — which often appear only after the depression relapse is already in full swing.
The foresight from digital health tools may give patients and clinicians a chance to adjust treatments or lifestyle changes before quality of life takes a turn.
Artificial intelligence has gotten a bad reputation lately, and often for good reason. But a team of scientists at Google’s DeepMind now claims to have found a revolutionary use case for AI: helping humanity unravel the “dark matter” of our genome more effectively than ever before.
In a study published today in Nature, DeepMind researchers debuted their deep learning model, dubbed AlphaGenome. Compared to existing models, AlphaGenome can predict the function of much longer sequences of DNA while still maintaining a similar level of accuracy, the researchers claim. The team is hopeful its model can become a valuable tool to analyze how subtle variations in human DNA can affect our health and biology, particularly in the vast majority of the genome that works silently in the background.
“We are thrilled to introduce AlphaGenome: our solution to deciphering the complex regulatory code,” said Pushmeet Kohli, vice president of research at Google DeepMind, in a press briefing held Tuesday.
A guide to our genetic dark matter
Our DNA contains the instructions for building and regulating every biological aspect of ourselves. But only a tiny portion of our genes, 2% or so, actually carry the code for the tens to hundreds of thousands of proteins that perform the functions a body needs to survive, such as insulin or collagen. The other 98% of our DNA is made of non-coding regions, more eloquently known as the dark matter of our genome. Scientists once assumed our genetic dark matter was comprised of worthless junk DNA, but we now know that it contains sequences vital to regulating our protein-making genes.
While scientists have mapped out most of the human genome, we still know very little about how many of these genes work, especially those found in non-coding regions; we’re also largely in the dark about how variations in these genes can affect their functioning. Long before AI became a cultural buzzword (and punching bag), scientists had been using deep learning models—trained on lab data—to more efficiently sift through the mountains of the human genome and to predict a gene or DNA sequence’s function. But DeepMind researchers say AlphaGenome is the most comprehensive and accurate DNA sequence model to date.
The DeepMind researchers trained the model on both human and mouse genomes. It can reportedly analyze up to 1 megabase (Mb)—about 1 million DNA letters—at a time, compared to older models capable of analyzing upwards of 500 kilobases (kb), though at some cost. From that sequence, the model is said to “predict thousands of functional genomic tracks.” These tracks don’t just include how a gene or DNA sequence is expressed but also other less visible functions. These include the interactions between coding and non-coding regions of DNA, or the structure of chromatins (the loose packages of genetic material typically found in a cell; chromosomes are the more neatly packaged version).
In the paper, the researchers also detailed how AlphaGenome matched or outperformed other existing AI models in 25 out of 26 tests measuring how well it could predict the effects of a genetic variant. More than just accuracy, however, the model can also do more at once; it can simultaneously predict nearly 6,000 human genetic signals tied to specific functions, according to the researchers.
The future of AI genomics
At least some outside scientists have praised the capabilities of AlphaGenome, while noting that it can’t solve every lingering mystery about our genetic code just yet.
“At the Wellcome Sanger Institute we have tested AlphaGenome using over half a million new experiments and it does indeed perform very well,” Ben Lehner, head of Generative and Synthetic Genomics at the University of Cambridge’s Wellcome Sanger Institute, told the Science Media Center. “However, AlphaGenome is far from perfect and there is still a lot of work to do. AI models are only as good as the data used to train them. Most existing data in biology is not very suitable for AI—the datasets are too small and not well standardized.”
All that said, the DeepMind researchers—and others in the field—believe AlphaGenome marks a true milestone in AI genomics, one that could help make the technology practical for broader use. They argue that AlphaGenome, or similar models, could now be used to better diagnose rare genetic diseases, identify mutations that drive cancer, or uncover new drug targets.
Before co-founding biotech startup Inceptive, Jakob Uszkoreit had an idea that would eventually make generative artificial intelligence possible. As a researcher at Google in 2017, Uszkoreit was trying to speed up the training of neural networks.
He suggested using a new way to interpret data called self-attention. That idea gave way to the transformer, the neural network architecture that underpins generative AI.
“There are actually applications, for example at Google and other places, where transformers have been deployed in production long before, but to much, much less fanfare,” Uszkoreit told CNBC in an interview in June. He said OpenAI’s ChatGPT, which was launched in late 2022, shined “the spotlight on these applications.”
The transformer idea was published by Uszkoreit and seven other Google researchers in the 2017 “Attention Is All You Need” paper. All eight authors have since left Google.
“Maybe Google here hasn’t been able to be as daring as, you know, a much, much smaller company such as OpenAI when it comes to applying this technology to quite different types of products,” Uszkoreit said. “This is something that we fundamentally have to accept and actually, in a certain sense, be maybe even grateful for because Google is providing something to the world that we all rely on day to day.”
Inceptive Co-Founder and CEO Jakob Uszkoreit is working on tranforming the way drugs work using generative AI
Inceptive
Uszkoreit left Google in 2021 to co-found Inceptive, which he describes as a a biological software company. In September, Inceptive raised $100 million in a funding round led by Andreessen Horowitz and Nvidia in an attempt to apply AI to drug development.
“We’re starting with a focus on RNA, whose exact composition has been designed with generative artificial intelligence, such that these molecules inside certain biological systems exhibit behaviors that ultimately are native to those systems,” Uszkoreit said. “There’s actually this promise of a flavor of medicine that is in much greater harmony with living systems than most existing medicines.”
Watch the video to hear the full conversation between CNBC’s Katie Tarasov and Inceptive CEO Jakob Uszkoreit.
The decision is another win for the White House in a bitter legal fight with several drugmakers over the price talks. The ruling also weakens the pharmaceutical industry’s strategy of seeking split decisions in lower courts scattered across the U.S., which could escalate the issue to the Supreme Court.
Medicare drug-price negotiations are a key policy under President Joe Biden’s Inflation Reduction Act that aims to make costly medications more affordable for seniors. In doing so, it could take a bite out of drugmakers’ profits. Final negotiated prices for the first round of drugs subject to the talks, which includes one each from J&J and Bristol Myers, will go into effect in 2026.
J&J and Bristol Myers Squibb did not immediately respond to requests for comment on the ruling.
In separate lawsuits, the drugmakers argued that the negotiations are an unconstitutional confiscation of their drugs by the government and a violation of their right to freedom of speech. They also argued that the talks are an unconstitutional condition to participate in the Medicaid and Medicare programs.
But Judge Zahid Quraishi of the District of New Jersey wrote in a 26-page opinion that participation in the price talks and Medicare and Medicaid markets is voluntary.
The negotiations don’t require drugmakers to “set aside, keep or otherwise reserve any of their drugs” for the use of the government or Medicare beneficiaries, he wrote. Quraishi added the talks don’t force manufacturers to physically transmit or transport drugs at a new negotiated price.
“Selling to Medicare may be less profitable than it was before the institution of the Program, but that does not make [J&J and Bristol Myers Squibb’s] decision to participate any less voluntary,” Quraishi wrote. “For the reasons provided, the Court concludes that the Program does not result in a physical taking nor direct appropriation” of medications from the two drugmakers.
J&J, Bristol Myers Squibb, Novo Nordisk and Novartis presented their oral arguments before Quraishi during the same hearing in March.
That same month, a federal judge in Delaware rejected AstraZeneca’s separate lawsuit challenging the negotiations. In Texas, a third federal judge tossed a separate lawsuit in February.
A federal judge in Ohio also issued a ruling in September denying a preliminary injunction sought by the Chamber of Commerce, one of the largest lobbying groups in the country, which aimed to block the price talks before Oct. 1.
It might be time to buy gold. The Federal Reserve is poised to cuts interest rates this year and history shows that’s pushed up precious metal prices, according to Bernstein analyst Bob Brackett. “The logic is simple,” Brackett told clients in a note Wednesday. When the expected real interest rates fall, investors buy gold because because owning dollars becomes less attractive, the analyst wrote. Spot gold prices were last trading at $2,052.89 an ounce and were mostly flat in January as traders wait for the central bank’s rate decision and, more importantly, the statement regarding the future outlook, later this afternoon. The pattern of gold rising on lower rates is supported by 50 years of history, with the precious metal rallying in seven of the nine previous rate cut cycles, according to Brackett. The two exceptions to the rule were 1974 and 1981 when the precious metal did not rally after rate cuts, largely because the 10-year Treasury yield didn’t fall, Brackett told clients. “Learning from the last 9 rate cut cycles, especially the 1974 and 1981 cycles, we conclude that rate cut cycle is positive for gold, as long as the Fed successfully brings rates down” for longer-dated Treasurys, Brackett said. “When the Fed fails to bring LT rates down, USD is likely to gain strength (and work against gold prices),” the analyst pointed out. Looking back at the 95 rate cuts since 1971, buying gold delivered weighted average returns of 2.48% in one month and up to 6.53% in a year, according to Brackett. Purchasing the precious metal ahead of a rate cut cycle is correlated with a slightly higher return of 6 basis points, or 0.06%. One major risk to Bernstein’s bullish thesis would come if the U.S. economy continues to show robust growth and low unemployment, Brackett told clients. Traders are already moderating expectations for rate cuts, though gold has held steady so far, Brackett said. Indeed, respondents to CNBC’s recent Fed survey now anticipate the central bank will cut rates fewer times this year and start the cycle later. “In general, the anticipation of more rate cuts often lead to a positive sentiment on gold and mining equities, while the expectation of fewer rate cuts tends to be negative,” Brackett said. Still, it is reasonable to expect that the U.S. economy will slow this year with real rates at the highest level since 2010, which would justify Fed cuts, according to Brackett. “Gold in the long term is generally observed to benefit from rate cuts,” the analyst said. @GC.1 3M mountain April gold futures over the past three months. — CNBC’s Michael Bloom contributed reporting
JPMorgan thinks investors should flock to biotechnology company Beam Therapeutics , which the firm says stands to benefit from increased market share and a strong gene therapy pipeline. Analyst Eric Joseph upgraded the stock to overweight from neutral and upped his price target by $2 to $40, implying shares could jump a whopping 64.7% over the next 12 months. “In our view, Beam’s proprietary genetic base-editing platform provides either first or best-in-class potential across a diverse array of programs in heme and liver-mediated disease indications with advantages in editing efficiency, specificity, and editing in larger organ systems,” Joseph wrote in a Monday note. Heme is a component of hemoglobin, a protein in red blood cells. “We see BEAM outperforming our coverage over the mid-term, with current levels being an attractive entry point,” the analyst said. Beam’s stock price jumped 7% Monday. The stock is down more than 4% so far this year, and has lost more than 42% over the past 12 months. BEAM 1Y mountain Beam stock. However, according to Joseph, the company is at the frontier of a rising theme for investors this year: therapeutics. Beam has had compelling preclinical datasets, the analyst noted, saying he finds attractive and de-risked commercial opportunities for Beam in its advancements against sickle cell disease and alpha-1-antitrypsin deficiency, or AATD, which is a genetic condition that predisposes an individual to chronic obstructive pulmonary disease and liver disease. According to the analyst, Beam’s BEAM-302 therapy is “uniquely positioned” as a one-time genetic medicine for AATD, which he expects to be a strong opportunity for investors in the coming years. “We see AATD (re)building as therapeutic theme in 2024/25…With orphan disease-like pricing, we estimate a current TAM upwards of $10-15B in the U.S. alone,” Joseph said. “In view of multiple gene modifying programs getting underway in 1H24… we see AATD returning as an investor focus over the next 12-24 months.” Beam has a roughly $12 billion commercial opportunity from BEAM-302, a liver-targeting lipid-nanoparticle therapeutic that is designed to correct the PiZ mutation, which is the most common gene variant associated with severe AATD, Joseph said. “Core to our upgrade thesis is the expectation of alpha-1 antitrypsin deficiency (AATD) being a rising therapeutic theme in 2024, and BEAM-302 being a compelling gene therapy candidate with best-in-class disease modifying potential across the full breadth of patients,” Joseph said. He added that BEAM-302 is “uniquely positioned” as a one-time genetic medicine for AATD, particularly given its success in preclinical trials. Data has proven that treatment with BEAM-302 significantly increased levels of corrected and functional alpha-1 antitrypsin, while reducing mutant PiZ in many in vivo rodent disease models, according to Beam. A phase 1 trial for BEAM-302 is set to start in the first half of this year.
SingleTimeMicroneedles to showcase STM Patch in the Food, Nutrition, and Health category
STORRS, Conn., January 24, 2024 (Newswire.com)
– SingleTimeMicroneedes, Inc., a microneedle drug development and delivery company has been selected as a finalist in the Food, Nutrition, and Health category for the 15th annual SXSW Pitch (formerly SXSW Accelerator).
SXSW Pitch, presented by KPMG, is the marquee event of South by Southwest® (SXSW®) Conference & Festivals (March 8 – 16, 2024), where leading startups from around the world showcase some of the most impressive technology innovations to a panel of hand-picked judges and a live audience. Out of the 670 companies that applied to present at SXSW Pitch 2024, STM was selected among the 45 finalists spanning nine separate categories.
SingleTimeMicroneedles has developed a drug and vaccine microneedle delivery platform that can revolutionize access to lifesaving pharma products in animals and humans. The microneedle patch temperature stabilizes drugs and vaccines to eliminate the need for cold-chain storage and transportation and are the only patches that can deliver doses immediately, over-time, or separately over weeks/months in one application. The technology supports most types of vaccines and therapeutics, including large molecules, subunit protein-based antigens, vector-based vaccines, mRNAs, and any compound that benefits from multiple/longitudinal dosing. STM patches have broad applications and are being planned for use in animals and humans.
“We believe that our technology will have a huge impact on the health of humans, animals, and whole communities by democratizing access to critical drugs and vaccines and are honored to have the opportunity afforded by SXSW to share our product and mission,” said CEO and co-founder, Jasdeep Singh.
The initial technology for SingleTimeMicroneedles came out Dr. Thanh Nguyen’s lab at the University of Connecticut. Dr. Nguyen said, “Translating a research product from the lab to the market is always my goal and I think SingleTimeMicroneedles will make a large impact in healthcare and add to the research.”
The two-day SXSW Pitch event will be held the first weekend of the SXSW Conference & Festivals, Saturday, March 9 and Sunday, March 10, on the fourth floor of the Downtown Hilton Austin, Salon D/E. The event will then culminate with the 2024 SXSW Pitch Awards Ceremony on Sunday evening, March 10, where winning startups from each category and a Best in Show winner will be announced and honored in Salon H on the sixth floor of the Hilton Hotel.
The Russell 2000 Index soared 12% in December, which might reflect investors’ exuberance about the state of the U.S. economy — it appears the Federal Reserve has won its battle against inflation.
But if you are looking to broaden your exposure to the stock market beyond the large-cap S&P 500 SPX,
buying shares of a fund that tracks the Russell 2000 Index RUT
might not be the best way to do it. This is because the Russell 2000 isn’t selective — it is made up of the smallest 2,000 companies by market capitalization in the Russell 3000 Index RUA,
which itself is designed to capture about 98% of the U.S. public equity market.
A better choice might be the S&P Small Cap 600 Index SML
because S&P Global requires companies to show four consecutive quarters of profitability to be initially included in the index, among other criteria.
Below is a screen of analysts’ favorite stocks among the S&P Small Cap 600, along with another for the Russell 2000.
Watch for a “head fake”
Much of the small-cap buying in December might have resulted from covering of short positions by hedge-fund managers. This idea is backed by the timing of trading activity immediately following the Federal Open Market Committee’s announcement on Dec. 13 that it wouldn’t change its interest-rate policy, according to MacroTourist blogger Kevin Muir. The Fed’s economic projections released the same day also indicate three cuts to the federal-funds rate in 2024.
Heading into the end of the year, a fund manager who had shorted small-caps, and then was surprised by the Fed’s interest-rate projections, might have scrambled to buy stocks it had shorted to close-out the positions and hopefully lock in gains, or limit losses.
That buying activity and resulting pop in small-cap prices could set up a typical “head fake” for investors as the new year begins, according to Muir.
The long-term case for quality
Looking at data for companies’ most recently reported fiscal quarters, 58% of the Russell 2000 reported positive earnings per share, according to data provided by FactSet. In other words, hundreds of these companies were losing money. These might include promising companies facing “binary events,” such as make-or-break drug trials in the biotechnology industry.
In comparison, 78% of companies among the S&P Small Cap 600 were profitable, and 93% of the S&P 500 were in the black.
Here are long-term performance figures for exchange-traded funds that track all three indexes:
For the first screen, we began with the S&P Small Cap 600 and narrowed the list to 385 companies covered by at least five analysts polled by FactSet. Then we cut the list to 92 companies with “buy” or equivalent ratings among at least 75% of the covering analysts.
Here are the 20 remaining stocks among the S&P Small Cap 600 with the highest 12-month upside potential indicated by analysts’ consensus price targets:
Any stock screen should only be considered a starting point. You should do your own research to form your own opinion before making any investment. one way to begin is by clicking on the tickers for more about each company.
Moving on to the Russell 2000, when we narrowed this group to stocks covered by at least five analysts polled by FactSet, we were left with 936 companies. Among these, 355 have “buy” or equivalent ratings among at least 75% of the covering analysts.
Among those 355 stocks in the Russell 2000, these 20 have the highest implied upside over the next year, based on consensus price targets:
AbbVie on Wednesday said it will acquire neuroscience drugmaker Cerevel Therapeutics for roughly $8.7 billion.
Under the terms of the deal, AbbVie will pay $45 per share for Cerevel. AbbVie said it expects to complete the acquisition in the middle of 2024.
Shares of Cerevel jumped 16% after the close Wednesday to nearly $43 per share, just below the purchase price. Shares of Abbvie were down less than 1% in extended trading.
The deal is AbbVie’s latest attempt to expand its drug pipeline as its top-selling treatments, such as Humira, face generic competition. Just last week, AbbVie agreed to buy cancer drug developer Immunogen for nearly $10 billion.
Cerevel will specifically beef up AbbVie’s portfolio for psychiatric and neurological disorders “where significant unmet needs remain,” according to a release from AbbVie.
Cerevel will bring over drugs such as Emraclidine, an experimental treatment for both schizophrenia and Alzheimer’s disease psychosis, including symptoms like hallucinations and delusion. That drug is currently in a phase one study in elderly volunteers.
“Our existing neuroscience portfolio and our combined pipeline with Cerevel represents a significant growth opportunity well into the next decade,” said Richard Gonzalez, CEO and chairman of AbbVie, in a statement. “AbbVie will leverage its deep commercial capabilities, international infrastructure, and regulatory and clinical expertise to deliver substantial shareholder value with multibillion-dollar sales potential across Cerevel’s portfolio of assets.”
AbbVie said it will hold an investor conference call about the deal on Thursday at 8:00 a.m. ET.
The free version of ChatGPT may provide inaccurate or incomplete responses — or no answer at all — to questions related to medications, which could potentially endanger patients who use OpenAI’s viral chatbot, a new study released Tuesday suggests.
Pharmacists at Long Island University who posed 39 questions to the free ChatGPT in May deemed that only 10 of the chatbot’s responses were “satisfactory” based on criteria they established. ChatGPT’s responses to the 29 other drug-related questions did not directly address the question asked, or were inaccurate, incomplete or both, the study said.
The study indicates that patients and health-care professionals should be cautious about relying on ChatGPT for drug information and verify any of the responses from the chatbot with trusted sources, according to lead author Sara Grossman, an associate professor of pharmacy practice at LIU.
For patients, that can be their doctor or a government-based medication information website such as the National Institutes of Health’s MedlinePlus, she said.
An OpenAI spokesperson said the company guides ChatGPT to inform users that they “should not rely on its responses as a substitute for professional medical advice or traditional care.”
The spokesperson also shared a section of OpenAI’s usage policy, which states that the company’s “models arenot fine-tuned to provide medical information.” People should never use ChatGPT toprovide diagnostic or treatment services for serious medical conditions, the usage policy said.
ChatGPT was widely seen as the fastest-growing consumer internet app of all time following its launch roughly a year ago, which ushered in a breakout year for artificial intelligence. But along the way, the chatbot has also raised concerns about issues including fraud, intellectual property, discrimination and misinformation.
Several studies have highlighted similar instances of erroneous responses from ChatGPT, and the Federal Trade Commission in July opened an investigation into the chatbot’s accuracy and consumer protections.
In October, ChatGPT drew around 1.7 billion visits worldwide, according to one analysis. There is no data on how many users ask medical questions of the chatbot.
Notably, the free version of ChatGPT is limited to using data sets through September 2021 — meaning it could lack significant information in the rapidly changing medical landscape. It’s unclear how accurately the paid versions of ChatGPT, which began to use real-time internet browsing earlier this year, can now answer medication-related questions.
Grossman acknowledged there’s a chance that a paid version of ChatGPT would have produced better study results. But she said that the research focused on the free version of the chatbot to replicate what more of the general population uses and can access.
She added that the study provided only “one snapshot” of the chatbot’s performance from earlier this year. It’s possible that the free version of ChatGPT has improved and may produce better results if the researchers conducted a similar study now, she added.
Grossman noted that the research, which was presented at the American Society of Health-System Pharmacists’ annual meeting on Tuesday, did not require any funding. ASHP represents pharmacists across the U.S. in a variety of health-care settings.
The study used real questions posed to Long Island University’s College of Pharmacy drug information service from January 2022 to April of this year.
In May, pharmacists researched and answered 45 questions, which were then reviewed by a second researcher and used as the standard for accuracy against ChatGPT. Researchers excluded six questions because there was no literature available to provide a data-driven response.
ChatGPT did not directly address 11 questions, according to the study. The chatbot also gave inaccurate responses to 10 questions, and wrong or incomplete answers to another 12.
For each question, researchers asked ChatGPT to provide references in its response so that the information provided could be verified. However, the chatbot provided references in only eight responses, and each included sources that don’t exist.
One question asked ChatGPT about whether a drug interaction — or when one medication interferes with the effect of another when taken together — exists between Pfizer‘s Covid antiviral pill Paxlovid and the blood-pressure-lowering medication verapamil.
ChatGPT indicated that no interactions had been reported for that combination of drugs. In reality, those medications have the potential to excessively lower blood pressure when taken together.
“Without knowledge of this interaction, a patient may suffer from an unwanted and preventable side effect,” Grossman said.
Grossman noted that U.S. regulators first authorized Paxlovid in December 2021. That’s a few months before the September 2021 data cutoff for the free version of ChatGPT, which means the chatbot has access to limited information on the drug.
Still, Grossman called that a concern. Many Paxlovid users may not know the data is out of date, which leaves them vulnerable to receiving inaccurate information from ChatGPT.
Another question asked ChatGPT how to convert doses between two different forms of the drug baclofen, which can treat muscle spasms. The first form was intrathecal, or when medication is injected directly into the spine, and the second form was oral.
Grossman said her team found that there is no established conversion between the two forms of the drug and it differed in the various published cases they examined. She said it is “not a simple question.”
But ChatGPT provided only one method for the dose conversion in response, which was not supported by evidence, along with an example of how to that conversion. Grossman said the example had a serious error: ChatGPT incorrectly displayed the intrathecal dose in milligrams instead of micrograms
Any health-care professional who follows that example to determine an appropriate dose conversion “would end up with a dose that’s 1,000 times less than it should be,” Grossman said.
She added that patients who receive a far smaller dose of the medicine than they should be getting could experience a withdrawal effect, which can involve hallucinations and seizures
The drugmaker observed high rates of adverse side effects, which were mostly mild and gastrointestinal, among patients. A significant share of patients alsostopped taking the drug.
“At this time, twice-daily danuglipron formulation will not advance into Phase 3 studies,” the company said.
But Pfizer said it still plans to release phase two trial data on a once-a-day version of the drug in the first half of 2024, which will “inform a path forward.” The pharmaceutical giant will wait to see that data before deciding whether to start a phase three study on the once-daily pill, which Wall Street views as the more competitive form of the treatment.
Shares of Pfizer fell 4% in premarket trading Friday after it announced the trial results.
Still, the data on the twice-daily drug is a blow to Pfizer’s hopes to win a $10 billion slice of the booming weight loss drug market, which CEO Albert Bourla has said could grow to $90 billion. The company is betting on a successful weight loss pill to help it rebound from plummeting demand for its Covid products and a roughly 40% share price drop this year.
But investors have been pessimistic about Pfizer’s potential in the weight loss drug space since the company scrapped a different once-daily pill in June and proceeded with the less attractive danuglipron. Now, Friday’s data puts Pfizer even further behind the dominant players in the weight loss drug market, Eli Lilly and Novo Nordisk, which are racing to develop more convenient pill versions of their blockbuster weight loss and diabetes injections.
Pfizer’s phase two trial on its twice-daily pill followed around 600 obese adults who did not have Type 2 diabetes. The trial examined the drug’s effect on weight loss after 26 or 32 weeks, at different dosage amounts ranging from 40 milligrams to 200 milligrams.
Like Novo Nordisk’s Wegovy and Ozempic, Pfizer’s pill works by mimicking a hormone produced in the gut called GLP-1, which signals to the brain when a person is full.
Pfizer said the trial on danuglipron met the primary goal of demonstrating “statistically significant” reductions in body weight.
Patients who took the pill twice a day lost 6.9% to 11.7% of their body weight on average at 32 weeks, and from 4.8% to 9.4% at 26 weeks.
Meanwhile, patients on a placebo gained 1.4% of their body weight at 32 weeks and 0.17% at 26 weeks.
When adjusting for the difference between the weight gain observed in patients who took the placebo, Pfizer’s twice-daily pill caused 8% to 13% weight loss on average at 32 weeks and 5% to 9.5% at 26 weeks.
The company said high rates of adverse events were observed among patients in the study, with up to 73% experiencing nausea, up to 47% vomiting and up to 25% experiencing diarrhea. More than 50% of patients across all dose sizes stopped taking the pill, compared to roughly 40% among those on the placebo, according to Pfizer.
No new safety issues were observed, and danuglipron was not associated with increased liver enzymes like Pfizer’s other discontinued weight loss pill.
Data from the phase two trial will be presented at a future scientific conference or published in a peer-reviewed journal.
The tolerability issues align with some analysts’ predictions ahead of the data release.
Leerink Partners analyst David Risinger wrote in a Monday note that the proportion of patients who discontinue treatment with Pfizer’s twice-daily danuglipron in the phase two trial would likely be higher than those who stopped taking a once-daily pill from Eli Lilly.
By comparison, 10% to 21% of patients who took Eli Lilly’s pill, orforglipron, in a mid-stage trial discontinued the treatment at 32 weeks due to adverse side effects, he noted.
Risinger said that’s likely because danuglipron’s total daily dose is far higher, which may cause more adverse effects. Patients on the highest dose size of Pfizer’s pill took 400 milligrams each day, while those on the highest dosage of Eli Lilly’s drug took 45 milligrams a day.
Pfizer’s phase-two trial also didn’t allow downtitration, or decreasing the dose of a drug over time once a specific response has been achieved. Eli Lilly’s mid-stage trial on its pill did.
There is hope that patients will better tolerate the once-daily version of danuglipron compared to the twice-daily form. Pfizer appears to believe a once-daily version of the drug could lessen gastrointestinal side effects, according to some analysts.
They pointed to Pfizer’s second-quarter earnings call, when the company’s chief scientific officer, Mikael Dolsten, suggested that a once-daily version may improve a patient’s tolerability of the drug, which could lessen the gastrointestinal side effects “that have been seen as limiting” danuglipron.
But the effects will be unclear until the mid-stage trial data is released next year.
Notably, the weight loss caused by twice-daily danuglipron appeared to fall short of analysts’ expectations.
Ahead of the data release, several analysts said Pfizer’s twice-daily pill has to be about as effective as Eli Lilly’s once-a-day pill to be competitive. That means at least a 14% to 15% weight loss, Cantor Fitzgerald analyst Louise Chen told CNBC earlier this month.
Risinger also wrote in October that Pfizer’s danuglipron needs to show weight reduction in the “mid-teens” percentages to be considered competitive with Eli Lilly’s pill.
Obese or overweight patients who took 45 milligrams of Eli Lilly’s pill once a day lost up to 14.7% of their body weight, or 34 pounds, after 36 weeks, according to the company’s phase-two trial results.
Eli Lilly’s results appear consistent with the weight reduction caused by a high-dose oral version of Novo Nordisk’s semaglutide – the active ingredient used in the diabetes drug Ozempic and weight loss treatment Wegovy – but came over a shorter trial period.
More than 2 in 5 adults have obesity, according to the National Institutes of Health. About 1 in 11 adults have severe obesity.
Clarification: This story was updated to reflect that some weight-loss data was adjusted to include results from the placebo group.
The Gorgon liquefied natural gas (LNG) and carbon capture and storage (CCS) facility, operated by Chevron Corp., on Barrow Island, Australia, on Monday, July 24, 2023.
Bloomberg | Bloomberg | Getty Images
The oil and gas industry needs to let go of the “illusion” that carbon capture technology is a solution to climate change and invest more in clean energy, the head of the International Energy Agency said Thursday.
“The industry needs to commit to genuinely helping the world meet its energy needs and climate goals – which means letting go of the illusion that implausibly large amounts of carbon capture are the solution,” IEA Executive Director Fatih Birol said in a statement ahead of the United Nations Climate Change Conference in Dubai next week.
The technology captures carbon dioxide from industrial operations before emissions enter the atmosphere and stores it underground.
Oil and gas companies face a moment of truth over their role in the clean energy transition, Birol wrote in a an IEA report reviewing the industry’s role in transitioning to an economy with net zero carbon emissions by 2050.
Just 1% of global investment in clean energy has come from oil and gas companies, according to Birol. The industry needs to face the “uncomfortable truth” that a successful clean energy transition will require scaling back oil and gas operations, not expanding them, the IEA chief wrote.
“So while all oil and gas producers needs to reduce emissions from their own operations, including methane leaks and flaring, our call to action is much wider,” Birol wrote.
The industry would need to invest 50% of capital expenditures in clean energy projects by 2030 to meet the goal of limiting climate change to 1.5 degrees Celsius, according to the IEA report. About 2.5% of the industry’s capital spending went toward clean energy in 2022.
One of the major pitfalls in the energy transition is excessive reliance on carbon capture, according to the report. Carbon capture is essential for achieving net zero emissions in some sectors, but it should not be used as a way to retain the status quo, according to the IEA.
An “inconceivable” 32 billion tons of carbon would need to be captured for utilization or storage by 2050 to limit climate change to 1.5 degrees Celsius under current projections for oil and gas consumption, according to the IEA.
The necessary technology would require 26,000 terawatt hours of electricity to operate in 2050, more than total global demand in 2022, according to the IEA.
It would also require $3.5 trillion in annual investment from today through mid-century, which equivalent to the entire oil and gas industry’s annual revenue in recent years, according to the report.
U.S. oil major such as Exxon Mobil and Chevron are investing billions in carbon capture technology and hydrogen, while European majors Shell and BP have focused more on renewables such as solar and wind.
Exxon and Chevron are also doubling down on fossil fuels through mega deals. Exxon is buying Pioneer Resources for nearly $60 billion, while Chevron is purchasing Hess for $53 billion.
A study published in Nature Genetics that analyzed the genomes of more than 1 million people found sequences of DNA that could be linked to a disposition to cannabis addiction. What do you think?
“So you’re saying being cool is genetic?”
Judy Robison, Sous Chef
Chiefs Fans Try To Name A Single Taylor Swift Song
“That’s it, I’m flushing all my DNA down the toilet.”
Representative Mike Johnson, a Republican from Louisiana, left, speaks with Representative Kat Cammack, a Republican from Florida, outside of a House Republican caucus meeting on Capitol Hill in Washington, DC, US, on Tuesday, Oct. 24, 2023.
Al Drago | Bloomberg | Getty Images
Republican Rep. Mike Johnson of Louisiana was elected speaker of the House of Representatives on Wednesday, ending a three-week leadership crisis that has paralyzed Congress.
Vice chairman of the House Republican conference, Johnson had maintained a low public profile until he was thrust into the spotlight this week after securing the party’s nomination for speaker.
Johnson was elected unanimously by the 220 Republicans who voted, despite being the fourth nominee tapped by the GOP conference in two weeks, as the deeply divided party repeatedly failed to put forward a candidate who had enough support.
Every Democrat who voted Wednesday cast their ballot for Minority Leader Rep. Hakeem Jeffries, D-N.Y.
Johnson managed to rally the GOP conference behind his bid after recalcitrant Republicans rejected the three previous nominees — House Majority Leader Steve Scalise of Louisiana, Rep. Jim Jordan of Ohio and Majority Whip Tom Emmer of Minnesota.
Johnson’s bid received a boost Wednesday from former President Donald Trump, who encouraged Republicans to vote for the Louisianan.
He also consolidated the backing of several moderate New York Republicans who had been reluctant to support some of the more hardline conservatives who sought the top job.
Johnson, who is serving his fourth term in Congress, will wield the gavel as America faces a looming government shutdown, Israel wages war on Hamas, and Ukraine struggles to beat back Russia’s invasion.
The House needs to pass spending legislation by Nov. 17 to keep the government running, and President Joe Biden has called on Congress to approve emergency security assistance for Israel and Ukraine.
Johnson voted against legislation in September that has kept the government running through November, and he has opposed assistance for Kyiv in the past. The Louisiana Republican said earlier this month that the House needs to take all necessary action to help Israel destroy Hamas.
Johnson is a social conservative who served on Trump’s legal team during the former president’s first impeachment. He previously did legal work for the Alliance Defense Freedom, an ultraconservative advocacy group that litigates to restrict abortion access and prohibit same-sex marriage.
Johnson also participated in Republican efforts to overturn Biden’s 2020 election victory.
He filed a legal brief in support of a lawsuit that sought to block the certification of Biden’s victories in Georgia, Pennsylvania, Michigan and Wisconsin. Johnson then supported objections in Congress to the certification Arizona’s and Pennsylvania’s 2020 presidential election results.
This is a developing story. Please check back for updates.
Two experts see major challenges facing the adoption of new obesity drugs.
Dr. Kavita Patel, a physician and NBC News medical contributor, believes fresh data from Novo Nordisk on Ozempic’s ability to delay the progression of chronic kidney disease is among the strongest supporting evidence for secondary uses of the drug.
However, she considers data supporting the use of obesity drugs for other conditions including Alzheimer’s and alcohol addiction as underdeveloped.
“Those trials … are nowhere near as robust as the data we have on [Novo Nordisk trial] FLOW, on sleep apnea, cardiovascular risks, on diabetes control — double-blind placebo, randomized controlled trials that are incredible,” she told CNBC’s “Fast Money” on Wednesday. “We have a long way to go for that. I’ve seen a lot of miracle drugs before.”
Novo Nordisk halted FLOW on Tuesday. According to the company’s press release, it happened more than a year after an interim analysis showed that Ozempic could treat chronic kidney disease in Type 2 diabetic patients.
As of Friday’s close, Novo Nordisk is up 9.82%since itsannouncement. Its obesity drug maker competitor Eli Lilly is up 5.16% in the same period.
Patel believes efficacy is just one of the major hurdles the medication needs to clear before it can be approved for uses outside of diabetes management.
“We know this drug works really well in diabetics. But there are so many barriers to getting there —including cost, adherence, prescriber rate,” said Patel, who also served as a White House Health Policy Director under President Obama.
Patients opting to use GLP-1 drugs — a group of medications initially designed to control diabetes — for weight management often must pay out-of-pocket.
“Right now, we are seeing active employers, entire states that are declining to cover on the weight loss indication,” Patel said.
If the U.S. Food and Drug Administration approves Ozempic for use in Type 2 diabetics with chronic kidney disease, which Patel believes will happen, it could force the hand of insurance companies to expand their coverage of the drug.
“We’ll see a final package of data that will just be so compelling, that it would be wrong not to cover this, because it should be superior to what we have available to us,” she noted. “That is something that I think the insurance companies will have a difficult time [with].”
Mizuho Health Care Sector Strategist Jared Holz also expects challenges related to insurance coverage as more patients begin taking GLP-1 drugs, which could limit overall adoption.
“The payers, at some point, are going to be saying, ‘We get it, but we cannot pay for these at this volume without seeing the benefit, which may be 10 years from now, 20 years from now, 30.’ We have no idea when the offset is going to be,”he also told CNBC’s “Fast Money.”
Holz also pointed out the divide emerging in the health care sector between Novo Nordisk, Eli Lilly and their pharmaceutical peers.
“We haven’t seen this kind of valuation disconnect between the peer group, maybe in the history of the sector,” he said.
The growth trend may not be sustainable for Novo Nordisk and Eli Lilly, based on current supply constraints that have left patients unable to secure dosages.
“The companies can’t make enough, I don’t think, to actually put out revenue that’s going to appease investors, given where the stocks are trading,” said Holz.
A Novo Nordisk spokesperson did not offer a comment due to the company’s quiet period ahead of earnings. Eli Lilly did not immediately respond to a request for comment.
Bristol Myers Squibb Co. said Sunday it will buy Mirati Therapeutics Inc. in a deal valued at up to $5.8 billion.
The pharmaceutical giant announced it will pay $58 a share for Mirati, for a total equity value of $4.8 billion. Mirati stockholders will also receive one non-tradeable Contingent Value Right for each share they hold, potentially worth $12 a share in cash, representing an additional $1 billion of possible value.
Mirati shares closed Friday at $60.20, with the company’s market cap at about $4.21 billion.
Mirati develops commercial-stage oncology therapies, and through the deal, Bristol Myers Squibb will add lung-cancer medicine Krazati, among others, to its portfolio.
“We are excited to add these assets to our portfolio and to accelerate their development as we seek to deliver more treatments for cancer patients,” Giovanni Caforio, Bristol Myers Squibb’s chief executive and chairman, said in a statement. “With a strong strategic fit, great science and clear value creation opportunities for our shareholders, the Mirati transaction is aligned with our business development goals.”
The deal is expected to be dilutive to Bristol Myers Squibb’s non-GAAP earnings per share by about 35 cents a share in the first 12 months after the transaction closes. The merger is expected to close by the first half of 2024.
Bristol Myers Squibb, with a market cap of about $118.4 billion, has seen its shares BMY, +0.43%
sink 21% year to date. Mirati shares MRTX, -3.49%
are up 33% this year. The S&P 500 SPX,
in comparison, has gained about 12% in 2023.
Judge Michael Newman of the Southern District of Ohio issued a ruling denying a preliminary injunction sought by the Chamber of Commerce, one of the largest lobbying groups in the country, which aimed to block the price talks before Oct. 1.
That date is the deadline for manufacturers of the first 10 drugs selected for negotiations to agree to participate in the talks.
But Newman, a nominee of former president Donald Trump, also declined to grant the Biden administration’s motion to dismiss the case entirely.
Instead, he asked the Chamber to amend its complaint by Oct. 13 to clarify certain details in the case.
Newman also gave the Biden administration until Oct. 27 to renew its motion to dismiss the case.
He said “a final determination on standing issues will be made following a short (60-day) discovery period and—assuming they are filed—renewed motions to dismiss.”
The ruling from Newman is a blow to the pharmaceutical industry, which views the process as a threat to its revenue growth, profits and drug innovation.
President Joe Biden’s Inflation Reduction Act, which passed in a party-line vote last year, gave Medicare the power to directly hash out drug prices with manufacturers for the first time in the federal program’s nearly 60-year history
The Chamber, which represents some companies in the industry, and drugmakers like Merck and Johnson & Johnson filed at least eight separate lawsuits in recent months seeking to declare the negotiations unconstitutional. But the Chamber’s suit was the only one seeking a preliminary injunction.
Michael Newman, U.S. District Court Judge Ohio
Source: U.S. District Court
The Chamber’s lawsuit argues that the program violates drugmakers’ due process rights under the Fifth Amendment by giving the government the power to effectively dictate prices for their medicines.
The Chamber said an appeals court established a precedent that when the government sets prices, it must provide procedural safeguards to ensure a company receives a reasonable rate and fair return on investment. Itstems from the 2001 case Michigan Bell Telephone Co. v. Engler, according to the Chamber.
The Medicare negotiations do not provide these safeguards and impose price caps that are well below a drug’s market value, the Chamber argued.
“There is a very, very high risk, maybe a guarantee, but certainly a very, very high risk, that this regime will result in prices that are unfair,” Jeffrey Bucholtz, an attorney for the Chamber, told judge Newman during a hearing earlier this month.
He added that drugmakers either must agree to theprice the government sets, or face an excise tax of up to 1,900% of U.S. sales of the drug.
But lawyers for the DOJ said during the hearing that the program was far from compulsory. Drugmakers can choose the alternative to those two options: Withdraw their voluntary participation in the Medicare and Medicaid programs, according to attorney Brian Netter.
“The measure of relief here is for manufacturers to decide whether they want to stay in the program under the terms that are on offer,” Netter said. “If they choose not to, that’s their prerogative.”
The other suits are scattered in federal courts around the U.S.
Legal experts say the pharmaceutical industry hopes to obtain conflicting rulings from federal appellate courts, which could fast-track the issue to the Supreme Court.
Medicare covers roughly 66 million people in the U.S., according to health policy research organization KFF. The drug price talks are expected to save the insurance program an estimated $98.5 billion over a decade, the Congressional Budget Office said.
In August, the Biden administration unveiled the 10 drugs that will be subject to the first round of price talks, officially kicking off a lengthy negotiation process that will end in August 2024. The reduced prices for those initial medications won’t go into effect until January 2026.
That includes blood thinners from Bristol-Myers Squibb and J&J, and diabetes drugs from Merck and AstraZeneca. It also includes a blood cancer drug from AbbVie, one of the companies represented by the Chamber of Commerce.
A nurse prepares doses of the Pfizer vaccine during a COVID-19 vaccination event at Josephine’s Southern Cooking in Chatham, Illinois, Dec. 30, 2021.
Brian Cassella | Tribune News Service | Getty Images
A new round of Covid vaccines is finally here in the U.S.
The Centers for Disease Control and Prevention cleared single-strain shots from Pfizer and Moderna on Tuesday, following approvals from the Food and Drug Administration on Monday. Those mRNA vaccines are designed to target a relatively new omicron subvariant called XBB.1.5.
The first doses of the new shots will be available at some pharmacies and other vaccine distribution locations within 48 hours of the CDC’s recommendation, agency staff said Tuesday during a meeting of independent advisors to the CDC. That means jabs could reach Americans as soon as Thursday.
Meanwhile, the FDA is still reviewing a third updated vaccine from Novavax for people ages 12 and up.
The debut of the new shots comes after Covid hospitalizations increased for the seventh straight week in the U.S., hitting 17,418 as of the week ending Aug. 26, according to the latest data from the CDC. That number remains below the surge the nation saw in the summer of 2022.
But the recent uptick is raising concerns about how much traction Covid will gain inthe coming fall and winter months, when respiratory viruses typically spread at higher levels and people spend more time indoors.
Public health officials and health experts hope the arrival of new vaccines will help the U.S. avoid another severe Covid wave and “tripledemic” of Covid, the flu and respiratory syncytial virus, which inundated hospitals last winter. The Biden administration said last month that it will encourage eligible Americans to receive an updated Covid vaccine alongside an annual flu shot and an RSV jab approved for older adults or mothers.
Roughly 42% of Americans surveyed by the CDC in August said they “definitely will” or “probably will” get a Covid vaccine this fall, Dr. Megan Wallace, a CDC epidemiologist, said during the advisory meeting.
Here’s everything you need to know about the updated Covid vaccines, from where to find them, whether you can get them for free and when to get them.
The CDC on Tuesday recommended that all Americans ages six months and older get the new shots. The agency’s website outlines more specific guidelines for staying up to date on Covid vaccines, which differ depending on age group and risk level.
The CDC said that everyone ages 6 and older should get at least one dose of an updated mRNA vaccine this year, regardless of whether they’ve received any of the original Covid shots.
People ages 65 years and older may get an additional dose of an new Covid vaccine four or more months after their first new shot.
Children 6 months through 5 years of age who are getting their vaccines for the first time should complete their primary series with two doses of an updated Moderna shot or three doses of a new Pfizer jab, according to the CDC. If children previously received prior vaccines, the CDC has different recommendations for how many updated doses to get.
People who are moderately or severely immunocompromised should get one or more doses of a new shot, depending on their vaccination history. Those patients are at higher risk of getting severely sick from Covid, according to the CDC.
A sign advertises COVID-19 (coronavirus) vaccine shots at a Walgreens Pharmacy in Somerville, Massachusetts, August 14, 2023.
Brian Snyder | Reuters
The updated shots will soon be available to eligible people at pharmacies, health clinics and community centers, among other vaccine distribution sites. Those locations will stop offering last year’s bivalent boosters, which are no longer authorized for use in the U.S.
Several retail pharmacy chains told CNBC that they will start offering appointments for the new shots shortly after the CDC recommendation:
Walgreens will allow people to schedule appointments for the new shots within 24 hours after the CDC recommendation, “with available appointments starting that week,” a company spokesperson said. People can schedule those appointments through the Walgreens website orapp, or by calling 1-800-WALGREENS. The company will add more appointments on a rolling basis.
CVS Pharmacy locations will start receiving supply of the updated vaccines “later this week,” a company spokesperson said. Pharmacies will receive more doses on a rolling basis and appointments will be available to schedule on the CVS website and CVS Pharmacy app.
Albertsons expects its 1,700 pharmacies to begin administering the updated shots “as early as Friday,” a spokesperson said. The company’s pharmacies span stores like Safeway, Vons, Jewel-Osco, Shaw’s, Acme, Tom Thumb, Randalls, United Supermarkets, Pavilions, Star Market, Haggen, Carrs, Amigos and Market Street. People can view and schedule appointments on the Albertsons website or app.
Kroger will allow people to walk in or schedule appointments to get the new Covid vaccine at the company’s pharmacies or clinics.
Americans will soon be able to use the federal website vaccines.gov to find other locations offering the updated Covid shots, according to a CDC spokesperson. The agency is still “unsure of the exact timing” for when the site will be updated to include a search filter for the new vaccines, the spokesperson added.
Later this week, uninsured and underinsured people will also be able to use the site to find locations offering the new vaccines for free through the Bridge Access Program. Around 85% of uninsured Americans live within five miles of a location participating in that program, according to the CDC’s Twentyman.
There are slight changes to how Covid vaccines are covered in the U.S this year. But the federal government aims to ensure all people can still receive them for free.
The U.S. Covid public health emergency ended in May, which means the federal government is shifting vaccine distribution to the private market this fall.
Manufacturers will sell their updated shots directly to health-care providers at more than $120 per dose. Previously, the government purchased vaccines directly from manufacturers at a discount to distribute to all Americans for free.
All three vaccine manufacturers shared the list prices of their new vaccines during the advisory meeting on Tuesday: Moderna’s shot is $129 per dose, Pfizer’s is $120 per dose and Novavax’s jab is $130 per dose.
Private insurers will provide the vaccines to beneficiaries at no cost. Government payers such as Medicare and Medicaid will also cover the new shots with no co-payments.
For the estimated 30 million uninsured Americans, the Biden administration aims to offer shots for free through its “Bridge Access Program” at health centers, clinics and pharmacies across the U.S.
“We’re setting up the Bridge Access Program as a temporary solution to maintain access to Covid-19 vaccines, specifically in the short term,” said Dr. Evelyn Twentyman, a CDC medical officer, during the advisory meeting on Tuesday.
The program will begin as soon as vaccines have reached participating providers, which include CVS and Walgreens, according to Twentyman. Free vaccines through the program will not be available after December 2024.
The CDC’s Vaccines For Children program will also provide free Covid shots to children whose families or caretakers can’t afford them after the shots move to the commercial market.
People should talk to their doctors about when to get an updated shot because it largely depends on individual risk levels and situations, health experts told CNBC.
Individuals at higher risk of getting severely ill from Covid, including older adults and those who are immunocompromised, should get a new vaccine as soon as they can, according to Dr. Taison Bell, an associate professor of medicine at the University of Virginia Health.
Younger, healthy adults can choose to wait so that immunity from the vaccine kicks in around the winter holidays or a specific event where they may be more exposed to Covid, Bell added.
He said Covid vaccines take around two weeks to produce an immune response against the virus, and that protection tends to last for a few months. So if a patient has upcoming travel or a large gathering to attend in mid-October, they could plan to get the new shot at the beginning of that month.
People recently vaccinated should wait two months before getting an updated vaccine, according to the CDC’s Wallace. Spacing out shots will allow people to maximize the protection they get from each shot.
Those who have been recently infected can wait three months, but they can also get it “as soon as they’re feeling better,” Wallace added.
“You have the option to wait for three months, but it is not a requirement,” she said during the advisory meeting.
The new shots from Pfizer, Moderna and Novavax are designed to target XBB.1.5, which has since been overtaken in prevalence by other, related strains. It only accounted for around 3% of all U.S. cases as of Sept. 2, according to the latest data from the CDC.
All three companies said that their updated vaccines produced robust immune responses against the now-dominant EG.5, or “Eris,” variant in trials. That omicron strain is closely related to XBB.1.5 and accounted for 21.5% of all U.S. cases as of Sept. 2, according to the CDC.
They also presented preliminary trial data in June indicating that their jabs will protect against all other XBB strains. Collectively, those variants make up more than 90% of all cases in the U.S., according to CDC microbiologist Dr. Natalie Thornburg.
“So the take-home message is that currently, almost all circulating lineages of viruses are XBB variants,” Thornburg said during the advisory meeting Tuesday.
Both Pfizer and Moderna have also released initial trial data indicating that their new shots were effective against another omicron variant called BA.2.86. Novavax on Monday said it was still testing its vaccine against that strain.
BA.2.86 has been detected in small numbers across the U.S., but health officials worldwide are watching it closely due to its high number of mutations.
Following the approvals on Monday, the FDA said the “extent” of protection provided by the updated shots from Pfizer and Moderna against currently circulating variants like EG.5 and BA.2.86 “appears to be of a similar magnitude” to the protection provided by previous Covid vaccines against prior variants of the virus.
“This suggests that the vaccines are a good match for protecting against the currently circulating Covid-19 variants,” the agency said in a release.
The FDA also said it is confident in the safety of the updated vaccines, noting that the benefits of the shots for people 6 months and older outweigh their risks.
The Centers for Disease Control and Prevention on Tuesday recommended updated COVID-19 vaccines for people 6 months of age and older.
Director Mandy Cohen late Tuesday backed the findings of CDC advisers, who voted 13-to-1 for approval earlier in the day. The updated vaccines from Moderna Inc. MRNA, -0.53%
and Pfizer Inc. PFE, +0.62%
-BioNTech BNTX, -1.97%
should become available later this week.
“We have more tools than ever to prevent the worst outcomes from COVID-19,” Cohen said in a statement. “CDC is now recommending updated COVID-19 vaccination for everyone 6 months and older to better protect you and your loved ones.”
The move comes just one day after the U.S. Food and Drug Administration approved the updated shots from Moderna and Pfizer. The FDA approved single-dose vaccines for people 12 and older and authorized emergency use of new shots for children as young as 6 months.
The CDC recommendations Tuesday include some key changes from the recommendations that previously applied to the bivalent COVID vaccines. People age 65 and older were recommended to get a second bivalent dose, for example, but the CDC is not currently recommending two doses of the new shot for older adults. The CDC said it will monitor epidemiology and vaccine effectiveness to determine if additional doses are needed.
The recommendations come as the vaccines are transitioning from federal procurement and distribution to the commercial market. The new shots are expected to have list prices of $110 to $130 per dose. But the Affordable Care Act requires insurers to cover most vaccines recommended by the CDC advisory committee at no cost to plan enrollees, and people with Medicare and Medicaid also have no-cost access to the vaccines.
The CDC meeting Tuesday addressed some concerns about the accessibility and cost of the vaccines for people without health-insurance coverage. The CDC’s new Bridge Access program will provide free shots to uninsured people within days at retail pharmacies as well as local health centers, the CDC said. The agency had previously said that the free shots might not arrive in retail pharmacies until mid-October. The federal government’s vaccines.gov website will be updated later this week to list Bridge Access program sites, the CDC said.
Roughly 25 million to 30 million U.S. adults do not have health insurance. About 85% of people without coverage live within 5 miles of a Bridge Access program site, according to CDC data.
Under the Bridge Access program, CVS Health Corp. CVS, +2.57%
will administer doses in stores and Minute Clinics, the CDC said, and Walgreens Boots Alliance Inc. WBA, +1.35%
will offer doses in stores and at off-site events that target areas of low access and uptake. Healthcare-services company eTrueNorth is also working with the program to reach lower-access areas without other coverage under the program, the CDC said.
A health-care worker prepares a dose of the Pfizer-BioNTech Covid-19 vaccine at a vaccination clinic in the Peabody Institute Library in Peabody, Massachusetts, Jan. 26, 2022.
The new vaccines, which target the omicron variant XBB.1.5, are approved for people 12 and older and are authorized under emergency use for children 6 months through 11 years old, according to an FDA release.
The updated vaccines from Pfizer and Moderna won’t be available to Americans just yet.
A CDC advisory panel is scheduled to meet Tuesday to vote on a recommendation on the use of those jabs. After the CDC director signs off on those recommendations, the shots can be administered at pharmacies, health clinics and other vaccine distribution sites.
The Biden administration said in August that it expects new single-strain vaccines from Pfizer, Moderna and Novavax targeting XBB.1.5 to be available to the public in mid-September.
The FDA did not announce a decision Monday on an updated Covid shot from Novavax, but the company said in a statement that the agency is still reviewing its vaccine. Shares of Novavax closed nearly 13% lower Monday following the approval of the other updated jabs.
Novavax’s vaccine uses protein-based technology, a decades-old method deployed in routine vaccinations against hepatitis B and shingles. Meanwhile, Pfizer’s and Moderna’s shots use messenger RNA, which teaches cells how to make proteins that trigger an immune response against Covid.
The upcoming arrival of updated vaccines offers some reassurance to Americans as the nation sees an increase in Covid cases and hospitalizations.
While the shots do not target the variants dominant now, the vaccine makers have said the shots will still offer protection against those strains as children return to school and the weather gets cooler.
“We expect this season’s vaccine to be available in the coming days, pending recommendation from public health authorities,” Pfizer CEO Albert Bourla said in a release following the approval.
Bourla and Moderna CEO Stéphane Bancel, in a separate statement, urged Americans to receive their updated Covid shot during the same appointment as their annual flu shot.
Hospitalizations have increased for seven straight weeks, and rose more than 15% for the week ending Aug. 26, to 17,418, according to the latest data from the CDC. But that number remains below the surge the nation saw in summer 2022, when hospitalizations climbed to more than 40,000.
The uptick is fueled by newer — but closely related to XBB.1.5 — strains of the virus such as EG.5, or Eris. That omicron strain accounted for 21.5% of all cases as of Sept. 2, according to the CDC.
Meanwhile, XBB.1.5 is declining in the U.S., the CDC said.
A resident receives a Covid-19 booster shots at a vaccine clinic inside Trinity Evangelic Lutheran Church in Lansdale, Pennsylvania, U.S, on Tuesday, Apr. 5, 2022.
Hannah Beier | Bloomberg | Getty Images
Pfizer, Moderna and Novavax have released early trial data indicating their new shots provide protection against Eris.
Both Pfizer and Moderna have also said their updated shots produced a strong immune response against BA.2.86, a highly mutated omicron subvariant that health officials are watching closely.
“The updated vaccines are expected to provide good protection against COVID-19 from the currently circulating variants,” the FDA said in the release Monday.
The agency noted that last year’s Covid boosters from Pfizer and Moderna are no longer authorized in the U.S.
The upcoming vaccine rollout will be the first since the end of the U.S. Covid public health emergency, which expired in May.
The end of that declaration means the federal government will shift vaccine distribution to the private market, where manufacturers will sell their updated shots directly to health-care providers at higher prices. Previously, the government purchased vaccines directly from manufacturers at a discount to distribute to all Americans for free.
Private insurers and government payers such as Medicare, which cover the vast majority of Americans, are expected to provide the vaccines to people for no fee. Federal efforts such as the Biden administration’s Bridge Access Program aim to provide free Covid shots to uninsured people.
The Biden administration will urge Americans to receive an updated Covid shot this fall, White House press secretary Karine Jean-Pierre said last week.
“Vaccinations against Covid-19 remains the safest protection for avoiding hospitalization, long-term health outcomes, and death,” Jean-Pierre said during a briefing.
But it’s unclear how many Americans will actually roll up their sleeves to get another shot in the coming months.
Only around 17% of the U.S. population — around 56 million people — have received Pfizer’s and Moderna’s latest boosters since they were approved in September 2022, according to the CDC.
