Tag Archives: PHAR

China’s COVID spike not due to lifting of restrictions, WHO director says

  • WHO says China’s control measures were not stopping COVID-19
  • Countries should ask are the right people sufficiently vaccinated
  • Open channels between China and WHO – Ryan

GENEVA, Dec 14 (Reuters) – COVID-19 infections were exploding in China well before the government’s decision to abandon its strict “zero-COVID” policy, a World Health Organization director said on Wednesday, quashing suggestions that the sudden reversal caused a spike in cases.

The comments by the WHO’s emergencies director Mike Ryan came as he warned of the need to ramp up vaccinations in the world’s No. 2 economy.

Speaking at a briefing with media, he said the virus was spreading “intensively” in the nation long before the lifting of restrictions.

“There’s a narrative at the moment that China lifted the restrictions and all of a sudden the disease is out of control,” he said.

“The disease was spreading intensively because I believe the control measures in themselves were not stopping the disease. And I believe China decided strategically that was not the best option anymore.”

Beijing started pivoting away from its signature “zero-COVID” policy this month after protests against the economically damaging curbs championed by President Xi Jinping.

The sudden loosening of restrictions has sparked long queues outside fever clinics in a worrying sign that a wave of infections is building, even though official tallies of new cases have trended lower recently as authorities eased back on testing.

In its most recent COVID report for the week to Nov. 27, the WHO said China had reported increasing hospitalisations for four consecutive weeks.

“So the challenge that China and other countries still have is: are the people that need to be vaccinated, adequately vaccinated, with the right vaccines and the right number of doses and when was the last time those people had the vaccines,” said Ryan.

WESTERN VACCINE

The elation in China that met the changes in policy allowing people to live with the virus has quickly faded amid mounting concerns about surging infections because the population lacks “herd immunity” and has low vaccination rates among the elderly.

WHO’s senior epidemiologist Maria Van Kerkhove said the UN agency was providing technical advice to China and Ryan said there were open channels.

Among the first major announced deals in which a Western drugmaker will supply China with COVID therapies, China Meheco Group Co Ltd (600056.SS) said on Wednesday it would import and distribute Pfizer’s (PFE.N) oral COVID-19 treatment Paxlovid.

Earlier in the briefing, WHO chief Tedros Adhanom Ghebreyesus said he was “hopeful” that the pandemic, which has killed more than 6.6 million people since it emerged in Wuhan, China three years ago, will no longer be considered a global emergency some time next year.

Reporting by Emma Farge in Geneva;
Writing by Josephine Mason in London; Editing by Alison Williams, Raissa Kasolowsky, Alexandra Hudson

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Wall St rises after CPI data but Fed concerns persist

  • Consumer prices rise moderately in November
  • Growth, real estate stocks climb as yields fall
  • Moderna surges on upbeat trial data
  • Dow up 0.3%, S&P 500 up 0.73%, Nasdaq up 1.01%

NEW YORK, Dec 13 (Reuters) – U.S. stocks rose on Tuesday after a unexpectedly small consumer price increase buoyed optimism that the Federal Reserve could soon dial back its inflation-taming interest rate hikes, but concerns remained the central back could stay aggressive.

The benchmark S&P 500 (.SPX) jumped as much as 2.76% to a three-month high early in the trading session on news that November U.S. consumer prices barely rose as gasoline and used cars cost less, leading to the smallest annual inflation increase in nearly a year at 7.1%.

Rising expectations for smaller and slower Fed rate hikes sent U.S. Treasury yields sharply lower and helped lift rate-sensitive gauges like the S&P 500 growth index (.IGX), up 1.18%, and the S&P 500 real estate index (.SPLRCR) up 2.04% to their highest intraday levels in nearly three months. The real estate sector notched its biggest daily percentage gain in two weeks as the best performing of the 11 major sectors.

Fed funds futures prices implied a better-than-even chance that the Fed will follow an expected half-point rate hike this week, with smaller 25-basis point hikes at its first two meetings of 2023, and stopping shy of 5% by March.

Morgan Stanley’s chief U.S. economist Ellen Zentner now sees even smaller Fed rate hikes, of 25 basis points at the central bank’s February meeting, and no further increases in March, leaving the peak fed funds rate at 4.625%.

Still, equities pared gains ahead of the Fed’s policy statement on Wednesday, in which the central bank is widely expected to announce a 50 basis point rate hike.

“There was some excitement early on that the CPI number was once again below expectations – it shows some sequential cooling – but once we saw that initial pop, stock investors kind of reassessed,” said Jason Ware, chief investment officer at Albion Financial Group in Salt Lake City, Utah.

“That probably took some of the steam out of the markets once investors realized tomorrow very well may be (Fed Chair) Jerome Powell throwing cold water on the rally today.”

The Dow Jones Industrial Average (.DJI) rose 103.6 points, or 0.3%, to 34,108.64, the S&P 500 (.SPX) gained 29.09 points, or 0.73%, to 4,019.65 and the Nasdaq Composite (.IXIC) added 113.08 points, or 1.01%, to 11,256.81.

Energy (.SPNY), up 1.77%, was among the best performing S&P sectors on the day as the softer-than-anticipated inflation data sent the dollar lower and boosted crude oil prices.

The consumer inflation numbers follow November’s producer prices report last week, which was slightly higher than expected but pointed to a moderation in the trend.

Still, some questioned whether the trend in prices could continue.

“Today’s CPI print is incrementally good, but it needs to be sustained,” said Venu Krishna, head of U.S. equity strategy at Barclays in New York.

“There is a big question mark whether we can really come to the 2% inflation (Fed target). Perhaps we live in a world in which it will be higher and that means rates will be higher and then multiples will certainly be lower.”

Moderna Inc (MRNA.O) surged 19.63% after the biotechnology firm’s experimental vaccine in combination with Merck & Co Inc’s (MRK.N) blockbuster drug Keytruda showed promising results in a skin cancer study. Merck shares advanced 1.78%.

Pinterest Inc (PINS.N) jumped 11.90% after Piper Sandler upgraded the social media platform’s stock to “overweight” from “neutral.”

Advancing issues outnumbered declining ones on the NYSE by a 2.83-to-1 ratio; on Nasdaq, a 1.49-to-1 ratio favored advancers.

The S&P 500 posted 18 new 52-week highs and 1 new lows; the Nasdaq Composite recorded 92 new highs and 212 new lows.

Reporting by Chuck Mikolajczak, additional reporting by Carolina Mandl; Editing by Richard Chang

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Positive Moderna, Merck cancer vaccine data advances mRNA promise, shares rise

CHICAGO, Dec 13 (Reuters) – An experimental cancer vaccine from Moderna Inc (MRNA.O) based on the messenger RNA (MRNA) technology used in successful COVID-19 vaccines has been shown to work against melanoma, sending Moderna shares more than 20% higher and driving up of other biotechs working on similar treatments.

A combination of Moderna’s personalized cancer vaccine and Merck & Co’s (MRK.N) blockbuster immunotherapy Keytruda cut the risk of recurrence or death of the most deadly skin cancer by 44% compared with Keytruda alone in a mid-stage trial, the companies said on Tuesday.

The result was considered a “statistically significant and clinically meaningful improvement,” the companies said.

Moderna shares were up nearly 23% at $202.80 on Tuesday, while Merck’s shares rose 1%. Shares of BioNTech SE (22UAy.DE), which also has successful mRNA vaccine technology, were up 6%, and tiny Gritstone Bio Inc (GRTS.O), which has a cancer vaccine in development, jumped 20% to $3.09.

The study is the first randomized trial to show that combining mRNA vaccine technology with a drug that revs up the immune response would offer a better result for melanoma patients and potentially for other cancers.

“It’s a tremendous step forward in immunotherapy,” Eliav Barr, Merck’s head of global clinical development and chief medical officer, said in an interview.

Paul Burton, Moderna’s chief medical officer, said in a separate interview that the combination “has the capacity to be a new paradigm in the treatment of cancer.”

The ongoing study involved 157 patients with stage III/IV melanoma whose tumors were surgically removed before being treated with either the drug/vaccine combo or Keytruda alone with the aim of delaying disease recurrence.

The combination was generally safe and demonstrated the benefit compared with Keytruda alone after a year of treatment. Serious drug-related side effects occurred in 14.4% of patients who received the combination compared with 10% with Keytruda alone.

A PROMISING FIELD

In October, Merck exercised an option to jointly develop and commercialize the treatment, known as mRNA-4157/V940, sharing costs and any profits equally. Merck and Moderna plan to discuss the results with regulatory authorities and start a large Phase III study in melanoma patients in 2023.

The Merck/Moderna collaboration is one of several combining powerful drugs that unleash the immune system to target cancers with mRNA vaccine technology. They are designed to target highly mutated tumors.

The personalized vaccine works in concert with Merck’s Keytruda, a so-called checkpoint inhibitor designed to disable a protein called programmed death 1, or PD-1, that helps tumors to evade the immune system.

To build the vaccine, researchers took samples of patients’ tumors and healthy tissue. After analyzing the samples to decode their genetic sequence and isolate mutant proteins associated only with the cancer, that information was used to design a tailor-made cancer vaccine.

When injected into a patient, the patient’s cells act as a manufacturing plant, producing perfect copies of the mutations for the immune system to recognize and destroy.

Moderna’s personalized vaccine can be made in about eight weeks, a time frame the company eventually hopes to halve, Burton said.

Barr said the companies intend to study the approach in other highly mutated cancers, such as lung cancer. Other such cancers include bladder cancers and some breast cancers.

Moderna mRNA rival BioNTech has several cancer vaccine trials in the works including one with Memorial Sloan Kettering Cancer Center in New York testing a personalized vaccine in combination with Roche’s (ROG.S) Tecentriq in patients with pancreatic cancer.

Gritstone is testing a personalized, self-amplifying mRNA vaccine in combination with Bristol Myers Squibb’s (BMY.N) immunotherapies Opdivo and Yervoy in a midstage trial in patients with advanced solid tumors.

Experts said the personalized vaccines were among several promising cancer vaccine ideas in the works after many failures in the field.

“In general, I think cancer vaccines are kind of at a tipping point, and there are going to probably be a lot of vaccines coming down the pipeline in the next five years,” said Dr. Mary Lenora Disis, director of the UW Medicine Cancer Vaccine Institute in Seattle.

Although the COVID-19 pandemic demonstrated the speed, ease and safety of mRNA vaccines, they came out of years of cancer vaccine research, Disis said.

Reporting by Julie Steenhuysen in Chicago, Michael Erman in New Jersey and Aditya Samal in Bengaluru; Editing by Caroline Humer, Edwina Gibbs and Bill Berkrot

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Some bloodstream infection bacteria grew resistant to last-resort drugs in 2020 – WHO

LONDON, Dec 9 (Reuters) – Increased drug resistance in bacteria causing bloodstream infections, including against last-resort antibiotics, was seen in the first year of the coronavirus pandemic, a World Health Organization report based on data from 87 countries in 2020 showed.

The overuse and/or misuse of antibiotics has helped microbes to become resistant to many treatments, while the pipeline of replacement therapies in development is alarmingly sparse.

High levels (above 50%) of resistance have been reported in bacteria that typically cause life-threatening bloodstream infections in hospitals such as Klebsiella pneumoniae and Acinetobacter spp, report authors highlighted on Friday.

These infections often require treatment with ‘last-resort’ antibiotics, drugs that are used when all other antibiotics fail.

About 8% of bloodstream infections caused by Klebsiella pneumoniae grew resistant to a vital last-resort group of drugs called carbapenems, the report said.

Rates of antimicrobial resistance (AMR) remain very high, but last-resort antibiotics are only just starting to lose potency, said Dr Carmem Pessoa-Silva, the lead for WHO Global Antimicrobial Resistance Surveillance System, in a media conference.

The message of hope, she said is, “we have a very narrow window of opportunity…for responding to the threat.”

While there is a concerted push to limit the unbridled use of antibiotics, the pace of new research remains grim.

The effort, cost and time it takes to get an antibiotic approved and the limited return on investment have deterred drugmakers, as treatments must be priced cheaply and are designed to be used as little as possible to limit drug resistance.

As a result, the lion’s share of antibiotic development is taking place in a handful of labs of small biopharma companies as a majority of their larger counterparts focus on more lucrative markets.

Only a few big pharmaceutical companies remain in the space — including GSK (GSK.L) and Merck (MRK.N) — down from more than 20 in the 1980s.

A landmark global analysis published earlier this year found that 1.2 million people died in 2019 due to antibiotic-resistant bacterial infections, making AMR a leading cause of death worldwide, higher than HIV/AIDS or malaria.

“Political commitment (on AMR) must now urgently move from aspiration into action,” said Thomas Cueni, director general at International Association of Pharmaceutical Manufacturers and Associations.

The authors of the WHO report said more research is needed to identify the reasons behind the jump in AMR in the period studied, and to what extent it is linked to the accelerated use of antibiotics during the pandemic.

AMR rates also remain difficult to interpret due to insufficient testing and weak laboratory capacity, particularly in low- and middle-income countries, the authors wrote.

Reporting by Natalie Grover in London; Editing by Barbara Lewis and Arun Koyyur

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S&P 500, Nasdaq snap losing streaks after jobless claims rise

  • Weekly jobless claims rise in line with estimates
  • Moderna, Pfizer up as FDA authorizes updated COVID boosters
  • Exxon climbs after boosting buyback program
  • Indexes up: Dow 0.55%, S&P 0.75%, Nasdaq 1.13%

Dec 8 (Reuters) – The S&P 500 (.SPX) ended higher on Thursday, snapping a five-session losing streak, as investors interpreted data showing a rise in weekly jobless claims as a sign the pace of interest rate hikes could soon slow.

Wall Street’s main indexes had come under pressure in recent days, with the S&P 500 shedding 3.6% since the beginning of December on expectations of a longer rate-hike cycle and downbeat economic views from some top company executives.

Such thinking had also weighed on the Nasdaq Composite (.IXIC), which had posted four straight losing sessions prior to Thursday’s advance on the tech-heavy index.

Stocks rose as investors cheered data showing the number of Americans filing claims for jobless benefits increased moderately last week, while unemployment rolls hit a 10-month high toward the end of November.

The report follows data last Friday that showed U.S. employers hired more workers than expected in November and increased wages, spurring fears that the Fed might stick to its aggressive stance to tame decades-high inflation.

Markets have been swayed by data releases in recent days, with investors lacking certainty ahead of Federal Reserve guidance next week on interest rates.

Such behavior means Friday’s producer price index and the University of Michigan’s consumer sentiment survey will likely dictate whether Wall Street can build on Thursday’s rally.

“The market has to adjust to the fact that we’re moving from a stimulus-based economy – both fiscal and monetary – into a fundamentals-based economy, and that’s what we’re grappling with right now,” said Wiley Angell, chief market strategist at Ziegler Capital Management.

The Dow Jones Industrial Average (.DJI) rose 183.56 points, or 0.55%, to close at 33,781.48; the S&P 500 (.SPX) gained 29.59 points, or 0.75%, to finish at 3,963.51; and the Nasdaq Composite (.IXIC) added 123.45 points, or 1.13%, at 11,082.00.

Traders work on the floor of the New York Stock Exchange (NYSE) in New York City, U.S., December 7, 2022. REUTERS/Brendan McDermid

Nine of the 11 major S&P 500 sectors rose, led by a 1.6% gain in technology stocks (.SPLRCT).

Most mega-cap technology and growth stocks gained. Apple Inc (AAPL.O), Nvidia Corp (NVDA.O) and Amazon.com Inc (AMZN.O) rose between 1.2% and 6.5%.

Microsoft Corp (MSFT.O) ended 1.2% higher, despite giving up some intraday gains after the Federal Trade Commission filed a complaint aimed at blocking the tech giant’s $69 billion bid to buy Activision Blizzard Inc . The “Call of Duty” games maker closed 1.5% lower.

The energy index (.SPNY) was an exception, slipping 0.5%, despite Exxon Mobil Corp (XOM.N) gaining 0.7% after announcing it would expand its $30-billion share repurchase program. The sector had been under pressure in recent sessions as commodity prices slipped: U.S. crude is now hovering near its level at the start of 2022.

Meanwhile, Moderna Inc (MRNA.O) advanced 3.2% after the U.S. Food and Drug Administration authorized COVID-19 shots from the vaccine maker that target both the original coronavirus and Omicron sub-variants for use in children as young as six months old.

The regulator also approved similar guidance for fellow COVID vaccine maker Pfizer Inc (PFE.N), which rose 3.1%, and its partner BioNTech, whose U.S.-listed shares gained 5.6%.

Rent the Runway Inc (RENT.O) posted its biggest ever one-day gain, jumping 74.3%, after the clothing rental firm raised its 2022 revenue forecast.

Volume on U.S. exchanges was 10.07 billion shares, compared with the 10.90 billion average for the full session over the last 20 trading days.

The S&P 500 posted 15 new 52-week highs and three new lows; the Nasdaq Composite recorded 82 new highs and 232 new lows.

Reporting by Shubham Batra, Ankika Biswas, Johann M Cherian in Bengaluru and David French in New York; Editing by Vinay Dwivedi, Sriraj Kalluvila, Anil D’Silva and Richard Chang

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Wall Street ends higher as investors eye U.S. midterms

  • Take-Two, Lyft slump on downbeat forecasts
  • Amgen climbs on cholesterol drug data
  • Indexes: S&P 500 +0.56%, Nasdaq +0.49%, Dow +1.02%

Nov 8 (Reuters) – Wall Street ended higher on Tuesday during voting in midterm elections that will determine control of the U.S. Congress, with investors betting on a political stalemate that could prevent major policy changes.

It was the third straight day of gains on the U.S. stock market, leaving the Dow Jones Industrial Average (.DJI) down less than 10% year-to-date.

Helping the blue-chip Dow, shares of drugmaker Amgen Inc (AMGN.O) rallied almost 6% to a record high after the company reported positive data related to its cholesterol drug and obesity treatment.

All 435 House of Representative seats and some 35 seats in the Senate are on the ballot, with experts saying there may be days of waiting before it is clear who won certain races. Nonpartisan forecasts and opinion polls suggested a strong chance of Republicans winning a House majority and a tight race for Senate control.

“On balance, financial markets like gridlock. To the extent that change will be slow and evolving, a divided government of course provides that backdrop,” said Terry Sandven, chief equity strategist at U.S. Bank Wealth Management in Minneapolis.

A surprise victory for Democrats, however, could raise concerns about tech-sector regulation as well as budget spending that could add to already-high inflation, according to market strategists.

Investors are also awaiting a key inflation reading due on Thursday, which is expected to show easing in consumer prices and provide further clues on whether the U.S. Federal Reserve could soften its campaign of aggressive interest rate hikes.

Traders are divided about whether the Fed will raise rates by 50 basis points or 75 basis points at the central bank’s meeting in December, according to CME Fedwatch tool.

Cryptocurrency-related stocks including Coinbase Global (COIN.O) and Microstrategy (MSTR.O) tumbled after Crypto giant Binance signed a nonbinding agreement to buy rival FTX’s non-U.S. unit to help cover a “liquidity crunch” at the cryptocurrency exchange.

Traders work on the floor of the New York Stock Exchange (NYSE) in New York City, U.S., November 7, 2022. REUTERS/Brendan McDermid

“Some investors will shoot first and ask questions later, but the good thing is crypto is kind of isolated. They are on their own, they really are not part of the equity market,” said Joe Saluzzi, co-manager of trading at Themis Trading in Chatham, New Jersey.

Every S&P 500 stock’s performance in 2022

The S&P 500 (.SPX) is up about 7% from its October closing low, but it remains down about 20% in 2022 due to worries that the Fed’s aggressive rate hikes could cripple the U.S. economy.

The S&P 500 climbed 0.56% to end the session at 3,828.13 points.

The Nasdaq gained 0.49% to 10,616.20 points, while the Dow Jones Industrial Average rose 1.02% to 33,160.83 points.

Of the 11 S&P 500 sector indexes, 10 rose, led by materials (.SPLRCM), up 1.72%, followed by a 0.92% gain in information technology (.SPLRCT).

Take-Two Interactive Software Inc (TTWO.O) slumped almost 14% after the videogame publisher lowered its annual sales outlook, while ride-hailing firm Lyft Inc (LYFT.O) tumbled 23% after forecasting current-quarter revenue below Wall Street estimates.

Advancing issues outnumbered falling ones within the S&P 500 (.AD.SPX) by a 2.5-to-one ratio.

The S&P 500 posted 21 new highs and 9 new lows; the Nasdaq recorded 97 new highs and 258 new lows.

Volume on U.S. exchanges was relatively light, with 11.7 billion shares traded, compared with an average of 11.8 billion shares over the previous 20 sessions.

Reporting by Noel Randewich in Oakland, Calif., and David Carnevali in New York
Additional reporting by Amruta Khandekar, Sruthi Shankar, Devik Jain and Shubham Batra in Bengaluru
Editing by Maju Samuel and Matthew Lewis

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Explainer: COVID, flu and RSV this U.S. winter: Why experts are worried

Oct 26 (Reuters) – U.S. doctors are warning that a surge in cases of respiratory syncytial virus (RSV) is coinciding with an increase in COVID transmission and an earlier-than-normal flu season, raising the specter of a “tripledemic” of respiratory illness this winter.

In particular, RSV infections among young children are reportedly filling some U.S. hospitals to capacity.

“We are already seeing patients testing positive for more than one virus,” said pediatrician Dr. Ira Wardono of Providence Cedars-Sinai Tarzana Medical Center in Tarzana, California, in a statement.

WHO IS AT RISK?

Infants are most at risk from RSV because they often cannot cough up the secretions caused by the virus and may need airway suctioning or intravenous fluids. Some may need extra oxygen. Older children and most adults typically experience mild, cold-like symptoms.

On average, RSV leads to 58,000 hospitalizations among children under age 5 and 177,000 hospitalizations among adults age 65 and older each year, according to the U.S. Centers for Disease Control and Prevention.

RSV deaths are rare in U.S. children, but 14,000 adults die annually from the virus, with older or immunocompromised individuals at greatest risk, the CDC said.

WHAT CAN PREVENT RSV?

Infection with RSV can be prevented in the same way one would ward off any virus: staying away from people who are sick, ensuring the best possible ventilation when you are indoors, wearing a high quality mask, and keeping your hands as clean as possible, said Dr. Jay Varma, Chief Medical Adviser at Kroll.com and Director of the Weill Cornell Center for Pandemic Prevention and Response.

High-risk infants can receive preventive treatment with monthly doses of Synagis (palivizumab) from Swedish drugmaker Orphan Biovitrum. AstraZeneca Plc and Sanofi SA are hoping for U.S. and European approval of Beyfortus (nirsevimab) for preventing RSV infections in newborns and infants.

There is no vaccine against RSV, although Pfizer Inc is developing RSVpreF for adults. In the meantime, it is important “for everyone to get up to date on their COVID and flu vaccines,” Varma said.

WHAT IS CAUSING THIS SURGE?

Part of the increase in RSV cases is due to the relaxation of COVID-precautions, such as masking and social distancing, which reduced rates of both RSV and flu during the pandemic, Varma said.

RSV rates were unusually low in the fall/winter of 2020-2021 but increased dramatically starting in Spring 2021 and have spiked since late August.

The CDC says it cannot yet predict when the previous seasonal patterns will return.

Reporting by Nancy Lapid; Editing by Michele Gershberg and Richard Pullin

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Pfizer expects to hike U.S. COVID vaccine price to $110-$130 per dose

NEW YORK, Oct 20 (Reuters) – Pfizer Inc expects to roughly quadruple the price of its COVID-19 vaccine to about $110 to $130 per dose after the United States government’s current purchase program expires, Pfizer executive Angela Lukin said on Thursday.

Lukin said she expects the vaccine – currently provided for free to all by the government – will be made available at no cost to people who have private insurance or government paid insurance.

Reuters earlier on Thursday reported that Wall Street was expecting such price hikes due to weak demand for COVID vaccines, which meant vaccine makers would need to hike prices to meet revenue forecasts for 2023 and beyond.

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The U.S. government currently pays around $30 per dose to Pfizer and German partner BioNTech SE (22UAy.DE). In 2023, the market is expected to move to private insurance after the U.S. public health emergency expires.

“We are confident that the U.S. price point of the COVID-19 vaccine reflects its overall cost effectiveness and ensures the price will not be a barrier for access for patients,” Lukin said.

It is not yet clear what kind of access people without health insurance will have to the vaccine.

Pfizer said it expects the COVID-19 market to be about the size of the flu shot market on an annual basis for adults, but that the pediatric market would take longer to build based on shots given so far.

So far the U.S. rollout of updated COVID-19 booster shots which target both the original coronavirus strain and the Omicron strain has lagged last year’s rate despite more people being eligible for the shots.

Around 14.8 million people in the U.S. received a booster shot over the first six weeks of the rollout of the new shots. In the first six weeks of the 2021 revaccination campaign, over 22 million people received their third shot even though only older and immunocompromised people were eligible at that point.

Lukin said she does not expect purchasing of the vaccines to transfer to the private sector until the first quarter of 2023 “at the earliest.” The move is dependent on the government contracted supply being depleted.

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Reporting by Michael Erman; Writing by Caroline Humer; Editing by Bill Berkrot and Richard Pullin

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Addiction drug shows promise lifting long COVID brain fog, fatigue

CHICAGO, Oct 18 (Reuters) – Lauren Nichols, a 34-year-old logistics expert for the U.S. Department of Transportation in Boston, has been suffering from impaired thinking and focus, fatigue, seizures, headache and pain since her COVID-19 infection in the spring of 2020.

Last June, her doctor suggested low doses of naltrexone, a generic drug typically used to treat alcohol and opioid addiction.

After more than two years of living in “a thick, foggy cloud,” she said, “I can actually think clearly.”

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Researchers chasing long COVID cures are eager to learn whether the drug can offer similar benefits to millions suffering from pain, fatigue and brain fog months after a coronavirus infection.

The drug has been used with some success to treat a similar complex, post-infectious syndrome marked by cognitive deficits and overwhelming fatigue called myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).

Drawing on its use in ME/CFS and a handful of long COVID pilot studies, there are now at least four clinical trials planned to test naltrexone in hundreds of patients with long COVID, according to a Reuters review of Clinicaltrials.gov and interviews with 12 ME/CFS and long COVID researchers.

It is also on the short list of treatments to be tested in the U.S. National Institutes of Health’s $1 billion RECOVER Initiative, which aims to uncover underlying causes and find treatments for long COVID, advisers to the trial told Reuters.

Unlike treatments aimed at addressing specific symptoms caused by COVID damage to organs, such as the lungs, low-dose naltrexone (LDN) may reverse some of the underlying pathology driving symptoms, they said.

Naltrexone has anti-inflammatory properties and has been used at low doses for years to treat conditions such as fibromyalgia, Crohn’s disease and multiple sclerosis, said Dr. Jarred Younger, director of the Neuro-inflammation, Pain and Fatigue Laboratory at the University of Alabama at Birmingham.

At 50 milligrams – 10 times the low dose – naltrexone is approved to treat opioid and alcohol addiction. Several generic manufacturers sell 50mg pills, but low-dose naltrexone must be purchased through a compounding pharmacy.

Younger, author of a scientific review of the drug as a novel anti-inflammatory, in September submitted a grant application to study LDN for long COVID. “It should be at the top of everyone’s list for clinical trials,” he said.

Still, the drug is unlikely to help all patients with long COVID, a collection of some 200 symptoms ranging from pain and heart palpitations to insomnia and cognitive impairment. One 218-patient ME/CFS study found 74% had improvements in sleep, reduced pain and neurological disturbances.

“It’s not a panacea,” said Jaime Seltzer, a Stanford researcher and head of scientific outreach for the advocacy group MEAction. “These people weren’t cured, but they were helped.”

‘HUMAN AGAIN’ Dr. Jack Lambert, an infectious disease expert at University College Dublin School of Medicine, had used LDN to treat pain and fatigue associated with chronic Lyme disease.

During the pandemic, Lambert recommended LDN to colleagues treating patients with lingering symptoms after bouts of COVID.

It worked so well that he ran a pilot study among 38 long COVID patients. They reported improvements in energy, pain, concentration, insomnia and overall recovery from COVID-19 after two months, according to findings published in July.

Lambert, who is planning a larger trial to confirm those results, said he believes LDN may repair damage of the disease rather than mask its symptoms.

Other planned LDN trials include one by the University of British Columbia in Vancouver and a pilot study by Ann Arbor, Michigan-based startup AgelessRx. That study of 36 volunteers should have results by year-end, said company co-founder Sajad Zalzala.

Scientists are still working on explaining the mechanism for how LDN might work.

Experiments by Dr. Sonya Marshall-Gradisnik of the National Centre for Neuroimmunology and Emerging Diseases in Australia suggest ME/CFS and long COVID symptoms arise from a significant reduction in function of natural killer cells in the immune system. In laboratory experiments, LDN may have helped restore their normal function, a theory that must still be confirmed.

Others believe infections trigger immune cells in the central nervous system called microglia to produce cytokines, inflammatory molecules that cause fatigue and other symptoms associated with ME/CFS and long COVID. Younger believes naltrexone calms these hypersensitized immune cells.

Dr. Zach Porterfield, a virologist at the University of Kentucky who co-chairs a RECOVER task force looking at commonalities with other post-infectious syndromes, said it has recommended LDN be included in RECOVER’s treatment trials.

Other therapies under consideration, sources said, were antivirals, such as Pfizer Inc’s (PFE.N) Paxlovid, anti-clotting agents, steroids and nutritional supplements. RECOVER officials said they have received dozens of proposals and could not comment on which drugs will be tested until trials are finalized.

Dr. Hector Bonilla, co-director of the Stanford Post-Acute COVID-19 Clinic and a RECOVER adviser, has used LDN in 500 ME/CFS patients, with about half reporting benefits.

He studied LDN in 18 long COVID patients, with 11 showing improvements, and said he believes larger, formal trials could determine whether LDN offers a true benefit.

Nichols, a patient adviser to RECOVER, was “ecstatic” when she learned LDN was being considered for the government-funded trials.

While LDN has not fixed all her COVID-related problems, Nichols can now work all day without breaks and have a social life at home.

“It has made me feel like a human again.”

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Reporting by Julie Steenhuysen in Chicago; Editing by Caroline Humer and Bill Berkrot

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Wall Street rallies after BofA results, UK reversal

  • Bank of America, BNY benefit from rising interest rates
  • Growth stocks jump as Treasury yields fall
  • Goldman Sachs up on report of major business overhaul
  • Dow up 1.86%, S&P 500 up 2.65%, Nasdaq up 3.43%

NEW YORK, Oct 17 (Reuters) – U.S. stocks kicked off the trading week on Monday with a rally after Britain reversed course on an economic plan, while Bank of America was the latest financial company to post solid quarterly results, which lifted optimism about the corporate earnings season.

Britain named Jeremy Hunt finance minister, and he immediately dispelled many of Prime Minister Liz Truss’ fiscal measures, which had unnerved markets in recent weeks.

Bank of America Corp (BAC.N) shares surged 6.06% as the lender’s net interest income was buoyed by rising interest rates in the quarter, even though it added $378 million to its loan-loss reserves to buttress against a softening economy.

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Fellow financial Bank of NY Mellon Corp (BK.N) also benefited from higher interest rates, and its shares climbed 5.08%.

Overall, higher rates boosted interest incomes for lenders in the third quarter, giving investors hope the current earnings season will be able to hurdle a lowered bar of expectations. The earnings growth estimate for the quarter is 3%, according to Refinitiv data, down from 4.5% at the start of the month and 11.1% on July 1.

“In a fragile market like this, any type of good news in the margin can go a long way,” said Emily Roland, co-chief investment strategist at John Hancock Investment Management in Boston.

“There is better sentiment around what is happening in the UK, financials earnings are being supported by a number of factors, better net interest margins are one key element, higher rates are going to be good for the banks so Q3 earnings maybe are looking a little less bad than feared, I would put it, maybe not necessarily better than feared.”

The S&P 500 banks index (.SPXBK) was up 3.48%, while each of the 11 major S&P 500 sector were higher.

The Dow Jones Industrial Average (.DJI) rose 550.99 points, or 1.86%, to 30,185.82, the S&P 500 (.SPX) gained 94.88 points, or 2.65%, to 3,677.95 and the Nasdaq Composite (.IXIC) added 354.41 points, or 3.43%, to 10,675.80.

U.S. equities remain mired in a bear market, after struggling through September, historically a tough month. Analysts said to better stock valuations entering what is traditionally a stronger period for stocks were also supporting Monday’s rally. Aggressive Federal Reserve interest rate hikes could be a stumbling block though.

Valuations have come down sharply but still above the 20-year average

“Right now the Fed owns the market, Fed policy is the key driver, they are implementing the most aggressive tightening in the shortest amount of time that we have seen in our generation and it is important to remember that Fed policy, it works with a lag,” said Roland.

Data on manufacturing in the New York region was weaker than expected, adding fuel to expectations a pivot by the Fed may be on the horizon.

Shares of Goldman Sachs (GS.N), which will post results on Tuesday, advanced 2.24% following reports of a plan to combine its investment banking and trading businesses.

Major megacap growth stocks like Apple Inc (AAPL.O), Meta Platforms Inc (META.O), Amazon.com (AMZN.O) and Tesla Inc (TSLA.O) all rallied, helping to lift the S&P 500 growth index (.IGX) by 3.42%, its biggest daily percentage jump since July 27.

Tesla Inc (TSLA.O), Netflix (NFLX.O) and Johnson & Johnson (JNJ.N) are among companies expected to report results later in the week.

Volume on U.S. exchanges was 10.65 billion shares, compared with the 11.52 billion average for the full session over the last 20 trading days.

Advancing issues outnumbered declining ones on the NYSE by a 4.79-to-1 ratio; on Nasdaq, a 2.98-to-1 ratio favored advancers.

The S&P 500 posted no new 52-week highs and 2 new lows; the Nasdaq Composite recorded 83 new highs and 146 new lows.

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Reporting by Chuck Mikolajczak; Editing by David Gregorio

Our Standards: The Thomson Reuters Trust Principles.

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