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☆ Biden administration to provide free Covid vaccines to uninsured Americans this fall through end of 2024
▼ + stars: | 2023-07-13 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

The Biden administration on Thursday announced a program to provide free Covid vaccines to uninsured Americans through December 2024 after the federal government's supply of shots runs out this fall. Those free shots, which the government is purchasing at a discount, will be available to the uninsured at pharmacies and 64 state and local health departments. There are between 25 to 30 million uninsured adults in the United States and other Americans whose insurance will not cover free Covid products this fall, according to the federal Centers for Disease Control and Prevention. In the fall, the companies will begin selling shots directly to health providers, and the government's supply is expected to run out. Earlier this year, the World Health Organization declared an end to the global Covid public health emergency earlier this year.

Persons: Biden Organizations: Pfizer, BioNTech, Peabody Institute Library, The, Human Services Department, for Disease Control, Moderna, World Health Organization, HHS Locations: Peabody , Massachusetts, United States, Novavax

☆ Sanofi says it's back to the drawing board on mRNA flu vaccines
▼ + stars: | 2023-06-29 | by ( Ludwig Burger | ) www.reuters.com time to read: +2 min

Both A and B viruses are responsible for seasonal flu epidemics each year and currently available flu shots work against both strains. "To succeed in mRNA flu, you need the next generation of mRNA technology, which is exactly what we are working on," Thomas Triomphe, head of vaccines at Sanofi, told Reuters. Pfizer (PFE.N) last year started a large late-stage trial testing an mRNA-based flu vaccine candidate. Sanofi, which is among the top four global vaccines makers by sales, trailing GSK (GSK.L), Merck & Co (MRK.N) and Pfizer (PFE.N), has a broad vaccines offering, including flu, childhood shots and travel vaccines. The French company's vaccine sales accounted for 7.2 billion euros ($7.85 billion) of 43 billion euros in group sales last year.

Persons: Thomas Triomphe, BioNTech, Ludwig Burger, Elaine Hardcastle Organizations: Sanofi, Reuters, Pfizer, COVID, GSK, Merck & Co, Thomson

☆ Moderna seeks US FDA authorization for updated COVID vaccine
▼ + stars: | 2023-06-22 | by ( ) www.reuters.com time to read: +1 min

June 22 (Reuters) - Moderna (MRNA.O) said on Thursday it has completed a submission to the U.S. Food and Drug Administration seeking authorization for its updated COVID-19 vaccine to target the XBB.1.5 subvariant. The submission from the company follows the FDA's advice last week to manufacturers that are updating their COVID-19 vaccines to develop monovalent shots to target XBB.1.5. Moderna said preliminary clinical data demonstrated a robust immune response by its XBB.1.5 monovalent vaccine against XBB descendent lineage viruses. Pending authorization, the updated shot would be available in time for the fall vaccination, Moderna said. Other COVID vaccine makers Pfizer (PFE.N)/BioNTech (22UAy.DE) and Novavax (NVAX.O) are already developing versions of their respective vaccines targeting XBB.1.5 and other currently circulating subvariants.

Persons: Moderna, Raghav Mahobe, Krishna Chandra Eluri Organizations: U.S . Food, Drug Administration, Pfizer, Thomson Locations: U.S, Bengaluru

☆ Morning Bid: Markets drift ahead of central bank extravaganza
▼ + stars: | 2023-06-12 | by ( ) www.reuters.com time to read: +2 min

A look at the day ahead in European and global markets from Ankur BanerjeeAfter surprise interest rate hikes from the Reserve Bank of Australia and Bank of Canada, investors are a bit nervy heading into a week that brings us three major central banks meetings. Last week's moves have inflamed uncertainty in investor minds about whether the U.S. Federal Reserve will skip or surprise on Wednesday. CME Fedwatch tool showed the probability of the Fed standing still is over 70%, but with inflation data due on Tuesday there may just be a late sting in the tail. No such surprises are expected from the European Central Bank or Bank of Japan, with markets widely expecting the ECB to hike and stay hawkish, and the BOJ to stick to its ultra-loose monetary policy. Reuters GraphicsReuters GraphicsWith not a lot on the data calendar, stocks in Asia are muted, while the U.S. dollar is steady.

Persons: Ankur Banerjee, BioNTech, Crispin Odey, Nicola Sturgeon, Christopher Cushing Organizations: Ankur, Reserve Bank of Australia, Bank of Canada, Fed, ECB, U.S . Federal Reserve, CME, European Central Bank, Bank of Japan, Reuters Graphics Reuters, U.S ., Nikkei, Odey, Management, Scottish First, Scottish National Party ., Thomson Locations: Asia, Germany, Britain, Denmark, Czech Republic, Turkey, Singapore

HAMBURG, June 11 (Reuters) - BioNTech (22UAy.DE) will go to court on Monday to defend itself against a lawsuit from a German woman who is seeking damages for alleged side effects of its COVID-19 vaccine, the first of potentially hundreds of cases in the country. The plaintiff claims she suffered upper-body pain, swollen extremities, fatigue and sleeping disorder due to the vaccine. Tobias Ulbrich, a lawyer at Rogert & Ulbrich, told Reuters he aimed to challenge in court the assessment made by European Union regulators and German vaccine assessment bodies that the BioNTech shot has a positive risk-benefit profile. Almost 768 million vaccine doses have been administered in the European Economic Area (EEA), which includes the 27 EU member states plus Iceland, Liechtenstein and Norway. Rogert & Ulbrich says it has filed about 250 cases for clients seeking damages for alleged side-effects of COVID-19 vaccines.

Persons: Tobias Ulbrich, Caesar, Preller, Ludwig Burger, Patricia Weiss, Emilio Parodi, Natalie Grover, Sam Tobin, Josephine Mason, Mark Potter Organizations: Reuters, European Union, Pfizer, European Medicines Agency, EMA, Economic, BioNTech, United, Thomson Locations: HAMBURG, Hamburg, Germany, Iceland, Liechtenstein, Norway, United States, Italy, Milan, London

☆ Fact Check-EMA recommends COVID vaccine during pregnancy
▼ + stars: | 2023-06-07 | by ( Reuters Fact Check | ) www.reuters.com time to read: +2 min

The EMA said it found evidence showing heavy menstrual bleeding can occur after COVID vaccination, concluding there was a “reasonable possibility” the vaccines may cause it (here). The EMA in fact encourages pregnant women to get vaccinated (here). Reuters previously addressed false claims that COVID-19 vaccines impact fertility and cause miscarriage, including (here), (here), (here) and (here). The European Medicines Agency (EMA) did not say COVID-19 vaccines cause infertility, nor advise pregnant women not to get vaccinated. The EMA, in fact, advises vaccination during pregnancy.

Persons: “, Read Organizations: European Medicines Agency, COVID, EMA, Moderna, Pfizer, Victoria, Imperial College London, Reuters

☆ Cancer vaccines poised to unlock 'new treatment paradigm' with Merck/Moderna data
▼ + stars: | 2023-06-05 | by ( Julie Steenhuysen | ) www.reuters.com time to read: +5 min

The hope is for "a completely new treatment paradigm in cancer that will be better tolerated and unique to individual patients' tumors," said Dr. Jane Healy, an executive overseeing in early cancer treatment development at Merck. The Merck/Moderna collaboration is one of several combining powerful drugs that unleash the immune system to target cancers with mRNA vaccine technology. Aiming at these unique proteins allows the immune system to kill cancer cells while leaving healthy tissue unscathed. With standard treatment, 90% of pancreatic cancer patients die within five years of diagnosis. The approach first primes the immune system with an older technology called a chimpanzee adenovirus vaccine that targets patients' tumors.

Persons: Andrew Kelly, Keytruda, Jane Healy, Germany's BioNTech, Vinod Balachandran, we've, we're, Andrew Allen, Healy, Julie Steenhuysen, Caroline Humer, Bill Berkrot Organizations: Merck & Co, REUTERS, CHICAGO, Moderna Inc, American Society of Clinical Oncology, Merck, Moderna, Memorial Sloan Kettering Cancer Center, Thomson Locations: Kenilworth , New Jersey, U.S, Chicago, New York, Nature

☆ Here’s what Pfizer and Moderna say is next for their Covid vaccines
▼ + stars: | 2023-05-22 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +9 min

Scott Olson | Getty ImagesThree years and billions of Covid vaccinations into the pandemic, Pfizer and Moderna say their work is far from over. Here's what Moderna and Pfizer say is next for their Covid shots. Annual Covid shotsPfizer and Moderna aim to keep up with a shift in the U.S. toward annual Covid shots rather than frequent booster doses. Miller, who helped lead the development of Moderna's Covid shot in 2020, said the advantages of using mRNA became evident earlier on in the pandemic. 'Next-generation' Covid shotsPfizer's and Moderna's Covid vaccines both deliver robust protection against the virus, but that immunity can start to fade after four to six months.

[1/3] A vial labelled "CureVac COVID-19 Vaccine" is seen in this illustration taken January 16, 2022. REUTERS/Dado Ruvic/IllustrationMay 19 (Reuters) - CureVac NV said on Friday it had filed an expanded patent infringement claim against Pfizer Inc (PFE.N) and BioNTech over the use of mRNA technology and that a U.S. court had granted its request to transfer the trial. In July 2022, CureVac had filed a patent lawsuit against BioNTech over the use of mRNA technology in the companies' COVID-19 vaccine. Pfizer and BioNTech in response had filed a complaint with the U.S. District Court in Massachusetts, seeking a judgment that they did not infringe U.S. patents held by CureVac. The companies have previously told the court that their COVID vaccine Comirnaty does not work in the same way as CureVac's patented technology.

☆ WHO recommends new COVID shots should target only XBB variants
▼ + stars: | 2023-05-18 | by ( ) www.reuters.com time to read: +2 min

May 18 (Reuters) - A World Health Organization (WHO) advisory group on Thursday recommended that this year's COVID-19 booster shots be updated to target one of the currently dominant XBB variants. New formulations should aim to produce antibody responses to the XBB.1.5 or XBB.1.16 variants, the advisory group said, adding that other formulations or platforms that achieve neutralizing antibody responses against XBB lineages could also be considered. The U.S. Food and Drug Administration is also set to hold a meeting of outside experts in June to discuss the strain compositions of COVID-19 shots for later this year; vaccine manufacturers will be expected to update their shots once the strains are selected. The bivalent booster shots developed and distributed last year targeted two different strains - the Omicron variant as well as the original virus. WHO's advisory group, which recommends if changes are needed to the composition of future COVID-19 shots, said currently approved vaccines should continue to be used in accordance with the agency's recommendations.

☆ Here are Wednesday's biggest analyst calls: Tesla, Wynn, Walmart, Alphabet, Western Alliance & more
▼ + stars: | 2023-05-17 | by ( Michael Bloom | ) www.cnbc.com time to read: +6 min

Here are Wednesday's biggest calls on Wall Street: Bernstein reiterates Tesla as underperform Bernstein said after the automaker's shareholder meeting that it sees trouble ahead. Bank of America upgrades AppLovin to buy from neutral Bank of America said it sees accelerating revenue growth for the mobile tech company. Stephens reiterates Walmart as overweight Stephens said it's standing by its overweight rating heading into Walmart earnings Thursday. Bank of America reiterates ServiceNow as buy Bank of America said the software company is well positioned for AI. " Stephens reiterates Western Alliance as overweight Stephens said it's standing by its overweight rating on the regional bank.

☆ Here's why Covid vaccines will still be free for uninsured Americans as public health emergency ends
▼ + stars: | 2023-05-12 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +4 min

Vanessa Leroy | Bloomberg | Getty ImagesBut the vast majority of Americans will not have to pay out of pocket for Covid vaccines even after the federal government's stockpile runs out. Insured Americans will be able to access Covid shots as part of their coverage, without having to pay out of pocket. Under the arrangement, the CDC will continue to purchase Covid vaccines at a discount and distribute them through 64 state and local health departments. That HHS effort will leverage the "public commitments" by drug manufacturers to provide free Covid vaccines and treatments to uninsured people. Pfizer and Moderna have not said whether they would supply free shots to pharmacies.

☆ Pfizer CEO says Medicare will likely face legal action over drug price negotiations
▼ + stars: | 2023-05-11 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

Pfizer CEO Albert Bourla on Thursday said pharmaceutical companies will likely take legal action against Medicare drug price negotiations, which aim to cut costs for older Americans, but will likely reduce company profits. Bourla referred to a provision in the Biden administration's Inflation Reduction Act that will allow the Medicare program to negotiate prices on the costliest prescription drugs each year. The first negotiations start in September and new prices will go into effect in 2026. Some drugmakers are already preparing to fight Medicare drug negotiations, industry sources told Reuters. Another provision of the Inflation Reduction Act requires Pfizer and other prescription drug companies to refund Medicare through rebates if the prices of their drugs rise faster than the rate of inflation.

☆ Fact Check-UK COVID vaccine offer for vulnerable young children not mandatory
▼ + stars: | 2023-05-10 | by ( Reuters Fact Check | ) www.reuters.com time to read: +4 min

The offer of COVID vaccination for very young children is voluntary and specifically targeted to children who are most at risk from COVID, according to the government’s April announcement of the new policy. After Britain’s Joint Committee on Vaccination and Immunisation (JCVI) recommended that young children in clinical risk groups should be offered COVID vaccination, some social media users responded with outrage. JCVI ADVICEThe UK advice does not include all young children. In fact, the prioritisation of COVID-19 vaccination for clinically vulnerable children explains higher mortality rates seen during the pandemic among vaccinated children as compared with unvaccinated children (here and here). There is no evidence the vaccine is unsafe for infants and young children, according to experts and health regulators.

☆ BioNTech, Roche's experimental pancreatic cancer treatment wins Nature plaudit
▼ + stars: | 2023-05-10 | by ( ) www.reuters.com time to read: +2 min

FRANKFURT, May 10 (Reuters) - Scientific journal Nature on Wednesday said a personalised treatment based on messenger RNA by BioNTech (22UAy.DE) potentially bodes well for the future of fighting an extremely aggressive form of cancer after the regimen was shown to trigger a promising immune reaction in some pancreatic cancer patients. Pancreatic cancer is among the most deadly forms of cancer because it typically grows undetected until an effective treatment is too late. The trial focused on pancreatic ductal adenocarcinoma (PDAC), which accounts for more than 90% of pancreatic cancer cases. Nature covers a wide range of topics in science and technology beyond medicine. Among the eight trial participants with a detectable immune response, there was no evidence of cancer recurrence 18 months after surgery, while the median time to recurrence was 13.4 months among the non-responders.

Novavax, whose COVID vaccine is its lone marketed product after 35 years in business, is relying on launching an updated COVID shot this fall to match circulating strains and cost cuts to improve its prospects. Novavax said $800 million of that was from "locked-in" overseas purchase contracts for the COVID shot that it has committed to ship this year. Novavax is working to produce an update version of its protein-based vaccine in time for the fall COVID-19 booster season. Novavax expects the cost cuts to reduce its annual research and commercial expenses by 20% to 25% from last year. Data from a mid-stage trial in adults aged 50 to 80 years showed that the combination shot produced an immune response comparable to its protein-based COVID vaccine and already approved influenza shots, Novavax said.

BioNTech reaffirmed its outlook for revenues from the shot to reach about 5 billion euros in 2023, down from 17.2 billion euros last year. It also repeated that its research and development (R&D) budget would be between 2.4 and 2.6 billion euros this year, up from 1.54 billion euros last year, as it hires scientists and initiates more expensive late-stage trials. And it reiterated that it remained in talks with the European Union about deferred or reduced COVID-19 vaccine deliveries as it re-negotiates a bulk purchase contract. The company declined comment on the state of discussions on the price to be paid per shot. ($1 = 0.9052 euros)Reporting by Ludwig Burger and Patricia Weiss, Editing by Rachel MoreOur Standards: The Thomson Reuters Trust Principles.

☆ Warren Buffett's Berkshire Hathaway just hosted its legendary annual investor weekend. Here's what to know.
▼ + stars: | 2023-05-08 | by ( Phil Rosen | ) www.businessinsider.com time to read: +4 min

Before we get to the news, we've got a dispatch from Theron — our in-house Warren Buffett expert — on the legendary conference. That's how Todd Finkle, the author of a new biography on Buffett, described the investor's yearly bash. There were also investment panels, cocktail parties, steak dinners, fun runs, and shopping events during the weekend. The stock market could become "untouchable" if the bank crisis keeps spiraling. Four of the world's top investors agree on the biggest risks that will cause the next recession.

☆ As earnings season winds down, investors turn to Tuesday's debt ceiling meeting
▼ + stars: | 2023-05-06 | by ( Zev Fima | ) www.cnbc.com time to read: +12 min

With only a small fraction of the S & P 500 left to report quarterly earnings, investors are now turning their focus to another major hurdle for the markets and economy: the debt ceiling crisis. Earlier this week, we looked back to debt limit crisis of 2011 for potential lessons. The protracted fight ultimately ended in an agreement in early August of that year, but it was a choppy summertime ride for investors. Within the portfolio, Wynn Resorts will report Tuesday, after the closing bell, and Disney will report on Wednesday, after the closing bell. Estee Lauder (EL) and Emerson Electric (EMR) reported earnings before the opening bell.

☆ Fact Check-COVID ‘monovalent’ vaccines not banned, FDA approval not withdrawn
▼ + stars: | 2023-04-25 | by ( Reuters Fact Check | ) www.reuters.com time to read: +6 min

But the original vaccines remain licensed in the United States and are not “banned” as suggested by some social media users. An FDA spokesperson also commented on the agency’s official Twitter account: “It's probably worth clarifying that the monovalent vaccines are still approved (licensed). EUA information for the Moderna and Pfizer vaccines can be seen on the FDA website (here) , (here). The FDA withdrew authorizations for emergency use of Pfizer-BioNTech and Moderna monovalent COVID vaccines while authorizing use of the updated, bivalent versions in all age groups. The agency did not withdraw its approval or license of the original vaccines, nor “ban” their use.

☆ US CDC signs off on second Omicron-updated COVID booster for older adults
▼ + stars: | 2023-04-19 | by ( ) www.reuters.com time to read: +1 min

April 19 (Reuters) - Older people and those with weakened immune systems may get a second dose of Omicron-targeting COVID-19 vaccines, the U.S. Centers for Disease Control and Prevention (CDC) said on Wednesday. The agency's decision after its advisory committee's meeting aligns it with the U.S. Food and Drug Administration's authorization on Tuesday for a second dose of Omicron-updated booster for the specified high-risk population. Adults aged 65 years and older can take a second dose of the updated vaccine, the CDC said, while people who are immunocompromised can get additional doses. It also said the original COVID-19 vaccine will no longer be recommended for use in the United States. Monovalent COVID-19 vaccines from Novavax (NVAX.O) or Johnson & Johnson's (JNJ.N) Janssen were not affected by the changes made today, the agency said.

The Merck/Moderna collaboration is one of several combining powerful drugs that unleash the immune system to target cancers with mRNA vaccine technology. BioNTech SE (22UAy.DE) and Gritstone Bio Inc (GRTS.O) are working on competing cancer vaccines based on mRNA technology. Barr said it took about eight weeks to design a personalized mRNA vaccine for each patient. In the past, similar experimental cancer vaccines were developed targeting a single tumor mutation, or neoantigen. With mRNA technology in combination with Keytruda, "we can create this shotgun approach ... that can create a more potent immune response," Barr said.

The Merck/Moderna collaboration is one of several combining powerful drugs that unleash the immune system to target cancers with mRNA vaccine technology. BioNTech SE (22UAy.DE) and Gritstone Bio Inc (GRTS.O) are working on competing cancer vaccines based on mRNA technology. Barr said it took Moderna about eight weeks to design a personalized mRNA vaccine for each patient. In the past, similar experimental cancer vaccines were developed targeting a single tumor mutation, or neoantigen. With mRNA technology in combination with Keytruda, "we can create this shotgun approach ... that can create a more potent immune response," Barr said.

April 11 (Reuters) - A U.S. appeals court handed Moderna Inc (MRNA.O) a win on Tuesday, affirming a decision to cancel an Arbutus Biopharma Corp (ABUS.O) patent related to the companies' legal fight over Moderna's blockbuster COVID-19 vaccines. The U.S. Court of Appeals for the Federal Circuit upheld a U.S. Patent and Trademark Office tribunal's ruling that the patent for Arbutus' lipid nanoparticle (LNP) technology was invalid based on an earlier Arbutus patent that disclosed the same invention. Moderna challenged the patent at the PTO's Patent Trial and Appeal Board in 2018, and the board invalidated it in 2019. Arbutus separately sued Pfizer and BioNTech for patent infringement last week over their COVID-19 shots, in a lawsuit that also does not include the canceled patent. The Federal Circuit case is Arbutus Biopharma Corp v. ModernaTX Inc, U.S. Court of Appeals for the Federal Circuit, No.

☆ Fact Check-Document mentioning cryogenic-electron microscopy does not prove Pfizer COVID-19 vaccine contains graphene oxide
▼ + stars: | 2023-04-04 | by ( Reuters Fact Check | ) www.reuters.com time to read: +4 min

Graphene oxide is not an ingredient in the vaccine,” she said. When contacted by Reuters, a Pfizer spokesperson sent a link with the full list of ingredients of the Pfizer-BioNTech COVID-19 vaccine (here, see page six). No graphene oxide is listed. “We confirm that graphene oxide is not used in the manufacture of the Pfizer-BioNTech COVID-19 vaccine,” the spokesperson said. The Pfizer COVID-19 vaccine does not contain graphene oxide.

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