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WASHINGTON (AP) — The U.S. approved updated COVID-19 vaccines Monday, hoping to rev up protection against the latest coronavirus strains and blunt any surge this fall and winter. It’s part of a shift to treat fall updates of the COVID-19 vaccine much like getting a yearly flu shot. A CDC advisory panel is set to issue recommendations Tuesday on who most needs the updated shots. The FDA pointedly isn’t calling this latest round a “booster” but instead a vaccine updated to better match the currently circulating virus. But while the FDA's decision allows for wide use of the updated shots, the CDC will decide how strongly different groups are urged to get them.
Persons: BioNTech, they’ve, There’s, Novavax, It’s, Peter Marks Organizations: WASHINGTON, Drug Administration, Moderna, Pfizer, Disease Control, CDC, FDA, Associated Press Health, Science Department, Howard Hughes Medical Institute’s Science, Educational Media Group, AP
The Food and Drug Administration on Monday approved updated Covid vaccines from Pfizer and Moderna , putting the shots on track to reach Americans within days as U.S. hospitalizations from the virus rise. The updated vaccines from Pfizer and Moderna won't be available to Americans just yet. 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 upcoming arrival of updated vaccines offers some reassurance to Americans as the nation sees an increase in Covid cases and hospitalizations. 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.
Persons: Biden, Pfizer's, Albert Bourla, Stéphane Bancel, hospitalizations Organizations: Pfizer, BioNTech, Peabody Institute Library, Drug Administration, Moderna, FDA, CDC, Covid, EG Locations: Peabody , Massachusetts, U.S
What to Know About the New Covid Booster Shots
  + stars: | 2023-09-11 | by ( Knvul Sheikh | ) www.nytimes.com   time to read: +2 min
How are the new Covid shots different from the last ones? Unlike the bivalent shots from last fall, the latest mRNA vaccines developed by Pfizer and Moderna are monovalent, meaning they are designed to protect against just one variant: XBB.1.5, a recent descendant of Omicron that emerged earlier this year. Vaccine makers Pfizer and Moderna have also announced that, according to their initial research, the new Covid vaccines provide good protection against both EG.5 and BA.2.86. The new shots do not include protection against the original virus, which may actually help broaden protection against new variants. “Our immune system, when we have seen something, is biased to seeing that again,” Dr. Ho said.
Persons: David Ho, , , ” Dr, Ho Organizations: Pfizer, Moderna, Columbia University, Vaccine, EG, Regulators, XBB
The latest Covid boosters are expected to be approved by the Food and Drug Administration as early as Monday, arriving alongside the seasonal flu vaccine and shots to protect infants and older adults from R.S.V., a potentially lethal respiratory virus. After a final decision by the C.D.C.’s director, millions of doses will be shipped to pharmacies, clinics and health systems nationwide within days. As Covid cases creep up, the prevention measures could portend the first winter of the decade without a crush of patients pushing hospitals beyond capacity. But a healthy winter is far from a lock: Last year, the updated Covid vaccine made it into the arms of only 20 percent of adults in the United States. Others see this year as an opportunity to protect more vulnerable people from severe illness or death.
Persons: Organizations: Food and Drug Administration, Disease Control, Pfizer, BioNTech Locations: R.S.V, Moderna, United States
Syringes with needles are seen in front of a displayed Moderna logo in this illustration taken, November 27, 2021. Moderna said the companies would use Immatics' drug discovery platform to develop mRNA-based cancer vaccines, and also study its own cancer vaccine for use in combination with Immatics' cancer therapy IMA203. Moderna is already developing a cancer vaccine with Merck (MRK.N), which was shown to cut the risk of recurrence or death by 44% in patients with deadly skin cancer melanoma, in a mid-stage trial. Under the terms of collaboration, Moderna will lead the development and commercialization of the cancer vaccines resulting from the collaboration, while Immatics will be responsible for pre-clinical and potential early-stage studies. Immatics will also receive research funding and is eligible for development, regulatory, and commercial milestone payments that could exceed $1.7 billion, Moderna said.
Persons: Dado Ruvic, Moderna, Immatics, Christy Santhosh, Anil D'Silva, Shounak Organizations: REUTERS, Moderna, Merck, Thomson Locations: COVID, Bengaluru
Tesla — Shares of the electric vehicle maker jumped 6% after Morgan Stanley upgraded the stock to overweight from equal weight. Kenvue — Shares of the Band-Aid maker gained 3% after being upgraded by Deutsche Bank to buy from hold on Sunday. The Wall Street firm called Kenvue a high-quality company and believes the stock's slide has created an attractive entry point. Nubank – The U.S.-traded shares of the Brazilian financial firm rose nearly 6% after JPMorgan upgraded Nubank to overweight from neutral. Discovery and Paramount also traded higher on the news, rising 2.2% and 1.9%, respectively,AstraZeneca — The pharmaceutical company's shares lost nearly 3% midday Monday.
Persons: Morgan Stanley, Adam Jones, — Smucker, Alibaba, Daniel Zhang, Zhang, Nubank, Warner, Pascal Soriot, Immatics, — CNBC's Alexander Harring, Samantha Subin, Yun Li, Jesse Pound, Michelle Fox, Tanaya Macheel Organizations: Artificial Intelligence, Hostess Brands, Tenable Holdings, JPMorgan, Deutsche Bank, Alibaba Group, Wall Street, Meta, Qualcomm, Apple, Media, Disney, Charter Communications, Warner Bros . Discovery, Paramount, AstraZeneca, Reuters, Mail, Moderna —, Moderna Locations: Shanghai, U.S, Brazil
“Perhaps we should start passing this message across and be a little more protective, in terms of vocabulary and language,” he added. We don’t know what to do with a woman in government who penalizes women,” the Democratic Women caucus said in a statement to CNN. Instead, Meloni has focused on her own family, which is increasingly prominent in party politics. Giorgia Meloni and Francesco Lollobrigida talk during the election of the new President of the Chamber of Deputies, on October 14, 2022 in Rome, Italy. Meloni’s party won the September 22 elections last year with nearly 26% of the vote.
Persons: Rome, Giorgia Meloni, ” Meloni, Andrea Giambruno, , you’d, Giorgia, Ivan Romano, Giambruno, don’t, ’ ”, Ginevra, Joe Biden, Meloni, Pope Francis, , “ Donna Moderna ”, assertively, ” Giorgia Meloni, Gian Mattia D'Alberto, Rosa, , Elly Shlein, Donna, Francesco Lollobridgida, Arianna, Meloni’s, Massimo Milani, Francesco Lollobrigida, Alessandra Benedetti, Corbis, Giovanni Montuori, Giovanni, Silvio Berlusconi Organizations: Rome CNN, Italy’s, Democratic, Democratic Women, CNN, Brothers Locations: Caivano, “ Italy, Italian, Sicilian, Palermo, United States, Italy, Rome, Rome’s Garbatella
WASHINGTON (AP) — Updated COVID-19 vaccines are coming soon, just in time to pair them with flu shots. Approval of updated COVID-19 shots is expected within days. Political Cartoons View All 1148 ImagesHere is what you need to know about fall vaccinations:WHY MORE COVID-19 SHOTS? Earlier this month, European regulators authorized Pfizer’s updated vaccine for this fall, for adults and children as young as 6 months. CAN I GET A FLU SHOT AND COVID-19 SHOT AT THE SAME TIME?
Persons: Mandy Cohen, haven’t, , , David Montefiori, it's, Carla K, Johnson Organizations: WASHINGTON, Centers for Disease Control, CDC, Food and Drug Administration, Pfizer, Moderna, FDA, Duke, WHO, GSK, AstraZeneca, AP, Associated Press Health, Science Department, Howard Hughes Medical Institute’s Science, Educational Media Group Locations: Novavax, Sanofi
NEXU Science Communication/via Acquire Licensing Rights Read moreSept 8 (Reuters) - UK Health Security Agency (UKSHA) said on Friday that 34 COVID-19 cases linked to the highly mutated variant BA.2.86 had been identified in England. Of the 34 confirmed cases identified as of Sept. 4, five patients were hospitalised and no deaths had been linked to the new emerging variant. The agency said 28 of the confirmed cases were identified from a single outbreak at a care home in Norfolk. Moderna (MRNA.O) and rival Pfizer (PFE.N) said on Wednesday their updated COVID-19 vaccines generated strong responses in testing against the BA.2.86 subvariant. Reporting by Khushi Mandowara in Bengaluru; Editing by Saumyadeb ChakrabartyOur Standards: The Thomson Reuters Trust Principles.
Persons: Renu Bindra, Khushi, Saumyadeb Organizations: Science, Trinity College, Reuters, Health Security Agency, Omicron, Moderna, Pfizer, Thomson Locations: Dublin, Wuhan, England, Norfolk, Denmark, Switzerland, South Africa, Israel, U.S, Bengaluru
Nicknamed "Pirola" on social media, the BA.2.86 Omicron subvariant is being tracked by both the World Health Organization (WHO) and the U.S. Centers for Disease Control and Prevention (CDC). As of Aug. 30, CDC said the BA.2.86 variant was detected in at least four U.S. states in people or wastewater. Delaware on Tuesday said it had detected a BA.2.86 infection at a hospital. Moderna on Wednesday said clinical data showed that its retooled COVID vaccine generated a nearly 9-fold increase in human antibodies that can neutralize BA.2.86. Pfizer said on Wednesday that its updated COVID shot showed neutralizing activity against BA.2.86 and EG.5 in studies conducted on mice.
Persons: Emily Elconin, David Dowdy, Dowdy, Dan Barouch, David Ho, Deena Beasley, Julie Steenhuysen, Bill Berkrot Organizations: REUTERS, Moderna, Pfizer, World Health Organization, WHO, U.S . Centers for Disease Control, Prevention, CDC, EG, Omicron, East, Johns Hopkins Bloomberg School of Public Health, Center, Virology, Vaccine, Beth Israel Deaconess Medical, Columbia University, U.S . Food, Drug Administration, Thomson Locations: Waterford , Michigan, U.S, Europe, Asia, Delaware, East Coast, Boston, Sweden, China
FLORHAM PARK, N.J. (AP) — Aaron Rodgers crossed an item off his sports bucket list — and then made a statement with a more visible crossout. To mark the occasion, Rodgers posted a picture on a since-expired Instagram story of No. Political Cartoons View All 1148 Images“Well, I’m a big fan of Novak and I got to see him in person,” Rodgers said. Djokovic plays unseeded Ben Shelton in one men's semifinal Friday, while No. Rodgers and the Jets open their season on Monday night at home against the Buffalo Bills.
Persons: — Aaron Rodgers, Rodgers, Novak Djokovic, , Djokovic, Novak, ” Rodgers, COVID, Ben Shelton, Carlos Alcaraz, Daniil Medvedev, ___ Organizations: New York Jets, U.S, Green Bay Packers, COVID, NFL, FDA, Jets, Buffalo Bills Locations: FLORHAM, N.J, New York, New Jersey
How Covid Affects the Heart
  + stars: | 2023-09-07 | by ( Dana G. Smith | More About Dana G. Smith | ) www.nytimes.com   time to read: +2 min
Others may develop because Covid is also associated with the onset of risk factors for heart disease, most notably hypertension. How vaccines reduce the riskResearch has shown that people who are vaccinated are roughly 40 to 60 percent less likely to have a heart attack or stroke following a Covid infection than those who are unvaccinated. This may be because vaccinated people are less likely to develop severe Covid, which in turn lowers the risk of many of these heart-related issues. There is a small risk of developing myocarditis (inflammation of the heart muscle) in the weeks after getting an mRNA Covid vaccine made by Pfizer-BioNTech or Moderna. For males 30 and older, the risk of myocarditis was 28 times higher from Covid than from the vaccine.
Persons: , Helene Glassberg, who’ve, Laffin, myocarditis Organizations: University of Pennsylvania Perelman School of Medicine, Pfizer, Centers for Disease Control, Prevention
Data is trickling in on a new COVID-19 strain nicknamed “pirola,” giving researchers a wider picture of what the variant could mean for the U.S. and the world. Van Kerkhove said that the global COVID-19 variant picture is complex, and that while BA.2.86 is spreading, it is not currently outcompeting other strains. “It is quite a complex picture globally in terms of how these variants behave because different variants circulate in different countries at different times.”Will Vaccines Work on Pirola? Moderna and Pfizer have announced that early data indicates that their updated vaccines do produce an immune response against BA.2.86. "These results demonstrate that our updated COVID-19 vaccine generates a strong human immune response against the highly mutated BA.2.86 variant.
Persons: “ pirola, ” Mandy Cohen, Maria Van Kerkhove, ” Benjamin Murrell, Ashish Jha, pirola, Van Kerkhove, it’s, , , Stephen Hoge Organizations: U.S, CDC, Centers for Disease Control, World Health Organization, WHO, White, Moderna, Pfizer, EG Locations: United States, Denmark, Sweden, Portugal, Israel, Canada, South Africa
FDA Approval of New COVID Boosters Could Come by Friday
  + stars: | 2023-09-07 | by ( Sept. | At A.M. | ) www.usnews.com   time to read: +2 min
Sources familiar with U.S. Food and Drug Administration plans say boosters could be approved as soon as Friday, NBC News reported. This time, the FDA may grant full approval for the boosters rather than emergency use authorization, according to NBC News sources. If the FDA doesn’t approve the boosters on Friday, it could do so early next week. While protection wanes over time, about 97% of adults have some level of protective immunity from past COVID infections and vaccinations. The Biden administration has announced a “bridge” program to offer uninsured people access to free boosters through 2024.
Persons: Cara Murez HealthDay, Mandy Cohen, Jennifer Kates, Biden, Kates Organizations: U.S . Food, Drug Administration, NBC News, U.S . Centers for Disease Control, Prevention, Pfizer, Moderna, NBC, Global Health, HIV
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Persons: Dow Jones, 86549e1b
The late summer Covid spike comes after a quiet year in which hospitalizations and deaths declined week after week since January. "We're living in a bit of a fantasy world where we're pretending Covid is not relevant," Birx told ABC in a podcast interview last week. Birx said those vaccines should have been released weeks ago to combat the predictable summer wave, adding the U.S. should already be developing new shots for January to target the emerging BA.2.86 variant. The updated shots should be effective at reducing severe disease and hospitalization from the variant, according to the agency. The first lady last caught Covid in August 2022 and the president tested positive in July of last year.
Persons: Shannon Stapleton, Reuters Covid, Deborah Birx, Trump, Covid, Birx, we're, Novavax, Moderna, Karine Jean, Pierre, Biden, Anthony Fauci, Fauci, It's, Still, Jill Biden, Joe Biden Organizations: Intensive Care Unit, Western Reserve Hospital, Reuters, hospitalizations, Centers for Disease Control, White, ABC, Pfizer, Moderna, CDC, U.S, BBC, National Institute of Allergy, White House Locations: Cuyahoga Falls , Ohio, U.S, ., Arkansas , Colorado , Indiana , Kansas , Minnesota , Oklahoma , Tennessee , Utah, Wyoming, China, Kentucky, Texas, India
Moderna 's new Covid vaccine produced a strong immune response against BA.2.86, a highly mutated omicron variant that health officials are watching closely, according to clinical trial data the biotech company released Wednesday. The updated shot produced an 8.7-fold increase in protective antibodies against BA.2.86, which has been detected in small numbers nationwide. Moderna is the first out of the companies producing updated Covid jabs to release data on how its shot fares against BA.2.86. Last month, Moderna also released clinical trial data suggesting that its new shot provides protection against the now-dominant EG.5, or "Eris," variant and another rapidly spreading strain called FL.1.5.1. New vaccines are set to arrive as Eris and other Covid variants fuel a rise in cases and hospitalizations across the country.
Persons: Stephen Hoge, Covid hospitalizations Organizations: Disease Control, Moderna, Pfizer, Novavax, U.S . Food, Drug Administration, EG, CDC Locations: U.S
"These results demonstrate that our updated COVID-19 vaccine generates a strong human immune response against the highly mutated BA.2.86 variant. "Moderna will continue to rapidly assess global public health threats and is committed to leveraging our mRNA platform against COVID-19." The company’s announcement comes as the Biden administration prepares to authorize the updated shots from Moderna, Pfizer and Novavax as soon as next week. While the shots target XBB.1.5, which was responsible for about 3% of new infections in recent weeks, researchers are optimistic that it will hold up against other circulating variants. “With governments accelerating the timing of COVID-19 vaccination campaigns due to the potential risk of BA.2.86, Moderna has shared this data with regulators and is ready to supply its updated COVID-19 vaccine pending regulatory approval,” the company wrote in a press release.
Persons: “ pirola, Stephen Hoge, Ashish Jha, ” Pirola, Biden Organizations: Moderna, Wednesday, EG, COVID, White, Centers for Disease Control, Pfizer, Novavax Locations: U.S, Moderna
In this videoShare Share Article via Facebook Share Article via Twitter Share Article via LinkedIn Share Article via EmailModerna: Updated Covid vaccine is effective against newer variantCNBC's Angelica Peebles reports on the latest news from Moderna.
Persons: Angelica Peebles Organizations: Moderna
Moderna said its shot generated an 8.7-fold increase in neutralizing antibodies against BA.2.86 compared with an untreated natural antibody response in clinical trials in humans. Pfizer said its updated vaccine with partner BioNTech (22UAy.DE) elicited a strong antibody response against BA.2.86 in a preclinical study in mice. Moderna, Pfizer/BioNTech and relative newcomer to the COVID vaccine market Novavax (NVAX.O) have created versions of their shots aimed at the XBB.1.5 subvariant, the dominant variant through most of 2023. Moderna shares were down 1.6% and Pfizer shares were off nearly 3% in afternoon trading. The Omicron offshoot carries more than 35 mutations in key portions of the virus compared with XBB.1.5, the target of the updated shots.
Persons: Moderna, Jacqueline Miller, BioNTech, Cowen, Tyler Van Buren, Dado Ruvic, Patrick Wingrove, Michael Erman, Bill Berkrot Organizations: Pfizer, World Health Organization, WHO, U.S . Centers for Disease Control, Prevention, ” Moderna, Moderna, REUTERS, CDC, Omicron, U.S . Food, Drug Administration, Britain's Medicines, Healthcare, Agency, Reuters, Thomson Locations: Switzerland, South Africa, Israel, Denmark, U.S, Britain, New York, New Jersey
[1/2] A vial and sryinge are seen in front of a displayed Moderna logo in this illustration taken January 11, 2021. REUTERS/Dado Ruvic/Illustration/File Photo Acquire Licensing RightsSept 6 (Reuters) - Moderna (MRNA.O) on Wednesday said clinical trial data showed its updated COVID-19 vaccine will likely be effective against the highly-mutated BA.2.86 subvariant of the coronavirus that has raised fears of a resurgence of infections. The Omicron offshoot carries more than 35 mutations in key portions of the virus compared with XBB.1.5, the dominant variant through most of 2023 and the target of the updated shots. Moderna said it had shared the new finding on its vaccine with regulators and submitted it for peer review publication. European regulators have since backed the Pfizer/BioNTech shot, with Britain's Medicines and Healthcare products Regulatory Agency approving the vaccine on Tuesday, but have yet to make any announcements on Moderna’s updated vaccine.
Persons: Dado Ruvic, Jacqueline Miller, Moderna, COVID, BioNTech, Patrick Wingrove, Bill Berkrot Organizations: REUTERS, World Health Organization, WHO, U.S . Centers for Disease Control, Prevention, ” Moderna, CDC, Omicron, U.S . Food, Drug Administration, Pfizer, Moderna, Britain's Medicines, Healthcare, Agency, Reuters, Thomson Locations: The Massachusetts, Switzerland, South Africa, Israel, Denmark, U.S, Britain, New York
Ohio Governor Mike DeWine, right, shakes hands with Judge Thomas Rose of the U.S. District Court Southern District of Ohio after taking his oath of office, Monday, Jan. 14, 2019, in Cedarville, Ohio. A federal judge on Friday withdrew from a case that could block Medicare from negotiating over drug prices, just hours after a watchdog group revealed his ownership of stock in two pharmaceutical companies that would be directly impacted by the new program. He also owns Moderna stock worth between $15,000 and $50,000, the filing shows. The suit asked the court to rule that for Medicare to negotiate drug prices would be unconstitutional. Merck, Bristol Myers Squibb, Johnson & Johnson, Boehringer Ingelheim, AstraZeneca and the drugmaker lobby PhRMA have all filed complaints in different districts courts.
Persons: Mike DeWine, Judge Thomas Rose, Judge Thomas M, Rose, Biden, George W, Bush, Johnson, Boehringer Ingelheim, Robert Davis, Davis Organizations: U.S, District Court Southern District of Ohio, Southern, Southern District of Ohio, Johnson, AstraZeneca, Republican, Moderna, U.S . Chamber of Commerce, Department of Health, Human Services, Centers, Medicare, Merck, Bristol Myers Squibb, Court, Circuit Court Locations: Cedarville , Ohio, Southern District
An uptick in Covid cases and hospitalizations in the U.S., and the emergence of new variants of the virus, are prompting questions about whether Americans should start masking up again. One thing's for sure: People infected with Covid should wear masks around others to prevent the spread of the virus. That includes your personal risk level, Covid rates in your region and who you might make contact with, public health experts said. Newer Covid variants like the now-dominant EG.5, or "Eris," and a handful of XBB strains have fueled the rise. New Covid shots from Pfizer , Moderna and Novavax are slated to roll out in mid-September, and will likely provide robust protection against those variants.
Persons: Michael Nason, Donna Nason, Andrew Pekosz, Francesca Torriani, Pavitra, Axios Organizations: Centers for Disease Control, Johns Hopkins Bloomberg School of Public Health, CNBC, CDC, U.S, Pfizer, Moderna, University of California, University of Washington School of Medicine Locations: Bakersfield, Los Angeles , CA, California, U.S, Covid, San Diego
Coronavirus is on the rise in the U.S., prompting questions about when Americans can roll up their sleeves for the next COVID-19 vaccine. The updated shots target XBB.1.5, which was responsible for less than 5% of new coronavirus infections in recent weeks. But all the strains circulating are still descendants of omicron, so experts believe the shots will still protect against severe COVID-19 from the variants. Historically, vaccine uptake decreases each time a new coronavirus shot is offered. Just 17% of Americans as of May rolled up their sleeves for the latest round of shots offered.
Persons: it’s, Biden, ” Mandy Cohen, Novavax, – Cohen, ” Cohen, Cohen, Organizations: Centers for Disease Control, CDC, Food and Drug Administration, Pfizer, FDA, EG Locations: U.S, COVID, Moderna
A general view of the drug product manufacturing laboratory in biologics and sterile injectables, Catalent, in Brussels, Belgium June 27, 2023. The sources declined to be identified because the information is confidential and cautioned a deal could still collapse at the last minute. Spokespeople for Catalent and Elliott declined to comment. In the past when Elliott has pushed for sales of pieces or the entire target company, including at eBay and Switch Inc., and then won board representation, significant ownership changes have followed. Novo Nordisk's weight-loss drug Wegovy is filled by Catalent’s Brussels factory and last week Reuters reported that Catalent’s plant in Bloomington, Indiana will begin filling Wegovy injection pens for Novo.
Persons: Yves Herman Acquire, Elliott, Catalent, Elliott isn't, Keith Meister's, Scott Ferguson's, Mauricio Gutierrez, Svea Herbst, Bayliss, Maggie Fick, Shri Navaratnam Organizations: REUTERS, Catalent, Elliott Investment Management, AstraZeneca, Johnson, Moderna, eBay, Inc, Deutsche Bank, Management, Capital Management, Reuters, NRG, Svea, Thomson Locations: Brussels, Belgium, U.S, Bloomington , Indiana, Novo, Boston, London
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