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☆ Pfizer's RSV vaccine shows potential to protect high-risk adults ages 18-59, widening possible use
▼ + stars: | 2024-04-09 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

A vaccine from Pfizer showed the potential to protect adults ages 18 to 59 who are at increased risk of getting severely sick from respiratory syncytial virus in a late stage clinical trial, the company said Tuesday. The initial data suggests that Pfizer's shot, known as Abrysvo, could help protect a far wider population from RSV. The jab is currently approved in the U.S., Europe, Japan and other countries for adults ages 60 and older and expectant mothers who can pass on protection to their fetuses. Nearly 10% of U.S. adults ages 18 to 49 have a chronic condition that puts them at risk of severe RSV disease, according to Pfizer. GSK's RSV vaccine for adults ages 60 and above booked around £1.2 billion ($1.5 billion) in sales last year.

Persons: Dr, Iona Munjal, Pfizer's Organizations: Pfizer, CNBC, GlaxoSmithKline Locations: U.S, Europe, Japan

☆ Pfizer RSV vaccine maintains protection in older adults over two seasons in trial
▼ + stars: | 2024-02-29 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +2 min

Pfizer 's vaccine against respiratory syncytial virus maintained protection for older adults across two full seasons of the disease in an ongoing late-stage clinical trial, the company announced Thursday. The shot's efficacy declined slightly compared with the levels of protection after one RSV season, but the new data suggests that the jab generally offers durable protection for adults ages 60 and above, who are more vulnerable to severe illness from RSV. The jab showed 66.7% efficacy against that condition after one RSV season. Pfizer noted that the vaccine showed consistent efficacy against RSV A and RSV B, which are the two major subtypes of the virus, after the second RSV season. Analysts don't expect the committee to make a final recommendation until June – a decision that may have huge implications for Moderna , which is hoping to launch its own RSV jab this year.

Persons: – Organizations: Pfizer, GlaxoSmithKline, Centers for Disease Control, Moderna Locations: Northern, Southern

☆ Here are Friday's biggest analyst calls: Rivian, DraftKings, Nio, Fox, Carvana, Pfizer and more
▼ + stars: | 2024-02-23 | by ( Alex Harring | ) www.cnbc.com time to read: +9 min

Here are Friday's biggest calls on Wall Street: UBS double-downgrades Rivian The firm said to sell the electric vehicle maker's stock, joining a growing group of concerned analysts following the company's earnings report. Raymond James upgrades Carvana The investment bank moved Carvana to market perform from underperform following the fourth-quarter earnings results. Guggenheim initiates Pfizer The firm opened coverage of the biopharmaceutical stock with a buy rating and $36 price target. " Rosenblatt initiates Adeia The firm began coverage with a buy rating and $15 price target. Roth MKM initiates CPI Card Group Roth MKM started coverage of the financial technology stock with a buy rating and $40 price target.

Persons: Ross, ROST, Raymond James, EBITDA, 4Q23, Guggenheim, ATNI, Morgan Stanley, Brighthouse, Rosenblatt, Roth MKM, Fred Imbert Organizations: UBS, Barclays, CNBC, Citi, Fox, JV, Ross, Price, Pfizer, DRG, Equitable, JPMorgan, Traction, JPMorgan downgrades Locations: 1Q24, Xperi, 4Q22

☆ GSK posts blowout RSV vaccine sales, raises outlook as shots give big pharma a boost
▼ + stars: | 2024-01-31 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

GlaxoSmithKline on Wednesday lifted its long-term outlook following the smash-hit launch of its new RSV vaccine. GSK in November had forecast 2023 sales for the shot Arexvy between £900 million, or $1.1 billion, and £1 billion, or $1.26 billion, following its strong launch in the U.S. The company's RSV shot in part drove the higher forecast. The vaccine has about 70% market share for RSV, Walmsley added on Wednesday. Meanwhile, biotech company Moderna hopes to launch its own RSV vaccine this year.

Persons: Emma Walmsley, Walmsley, Arexvy, That's, Pfizer's, Albert Bourla, Bourla Organizations: GlaxoSmithKline, Stevenage, GSK, U.S, Pfizer, U.S . Food, Drug Administration, Moderna Locations: Britain, British, U.S, Canada, Japan

☆ GSK CEO says RSV vaccine revenue to top 1 bln pounds in first year
▼ + stars: | 2023-11-30 | by ( Michele Gershberg | ) www.reuters.com time to read: +4 min

GSK had previously forecast 2023 sales for Arexvy between 900 million pounds and 1 billion pounds ($1.26 billion) following a strong U.S. launch. "We’re delighted with the start of our RSV vaccine," Walmsley said in a Reuters Newsmaker interview. The U.S. Food and Drug Administration (FDA) approved Arexvy for adults aged 60 years or older in May and GSK launched the vaccine in the U.S. later in the year. GSK made close to two-thirds of RSV doses given in the United States since early September, according to IQVIA data earlier this month. On Tuesday, rival Pfizer (PFE.N) said it was disappointed in the performance of its RSV shot Abrysvo compared with GSK.

Persons: Walmsley, GSK's, Emma Walmsley, We’re, David Denton, AstraZeneca's, commercialise Johnson, Ludwig Burger, Michael Erman, Josephine Mason, Kirsten Donovan, Elaine Hardcastle Organizations: GSK, Reuters, U.S . Food, Drug Administration, Pfizer, U.S, Thomson Locations: British, U.S, Europe, Japan, United States

[1/4] Employees work in the manufacturing of Pfizer’s new respiratory syncytial virus (RSV) vaccine Abrysvo, in this undated handout picture. Pfizer/Handout via REUTERS Acquire Licensing RightsWASHINGTON, Nov 28 (Reuters) - Senior Biden administration officials met with RSV vaccine makers this week to underscore the need for manufacturers such as Sanofi (SASY.PA) and AstraZeneca (AZN.L) to urgently meet demand as winter approaches, the White House said on Tuesday. At a meeting at the White House on Monday, officials and manufacturers also agreed to plan now to meet next year's demand for the vaccines targeting respiratory syncytial virus, which generally causes mild, cold-like symptoms but can develop into severe illness in infants and older adults. "Monday's meeting follows numerous in-person and virtual meetings to seek ways manufacturers can make more RSV immunizations available for infants," the White House said in a statement. Reporting by Susan Heavey and Ahmed Aboulenein; Additional reporting by Mike Erman; Editing by Katharine Jackson and Nick ZieminskiOur Standards: The Thomson Reuters Trust Principles.

Persons: Susan Heavey, Ahmed Aboulenein, Mike Erman, Katharine Jackson, Nick Zieminski Organizations: Pfizer, Handout, REUTERS Acquire, Rights, Biden, Sanofi, AstraZeneca, White, U.S . Centers for Disease Control, Prevention, CDC, Thomson Locations: U.S

☆ GSK lifts annual forecasts on strong launch of RSV vaccine
▼ + stars: | 2023-11-01 | by ( Eva Mathews | ) www.reuters.com time to read: +3 min

Arexvy, launched in the United States recently, recorded third quarter sales of 709 million pounds ($862 million), trouncing analysts' expectations of 358 million pounds, according to a company-compiled consensus. GSK accounts for close to two-thirds of RSV shots given in the United States since early September, according to IQVIA data. Full-year sales are seen between 900 million pounds and 1 billion pounds for the shot, GSK said. The company faces about 79,000 cases related to Zantac in the United States, with 73,000 of them in Delaware and scheduled for trial starting January 2024. For the third quarter, Shingrix, the company's top-selling drug for shingles, generated 825 million pounds in sales.

Persons: Dado Ruvic, Abrysvo, Dani Saurymper, Emma Walmsley, Eva Mathews, Maggie Fick, Tomasz Janowski, Mark Potter Organizations: GSK, GlaxoSmithKline, REUTERS, stg, CVS, Pfizer, Pacific Asset Management, GSK's, Thomson Locations: London, United States, U.S, Europe, Japan, Delaware, Bengaluru

Paxlovid, Pfizer's anti-viral medication to treat the coronavirus disease (COVID-19), is displayed in this picture illustration taken October 7, 2022. Sales of Paxlovid and the vaccine Pfizer makes with German partner BioNTech (22UAy.DE) had boosted revenue to record levels the last two years. Reuters GraphicsPfizer continues to expect 2023 revenue growth of 6%-8% from non-COVID products, with a majority occurring in the second half. Paxlovid sales slumped 97% in the third quarter to $202 million, while vaccine revenue of $1.31 billion was down from $4.4 billion a year earlier. Analysts had expected $1.44 billion for the vaccine and $618.20 million from Paxlovid, according to LSEG data.

Persons: Wolfgang Rattay, Evan Seigerman, BioNTech, Albert Bourla, Angela Hwang, Paxlovid, Bhanvi Satija, Michael Erman, Sriraj Kalluvila, Bill Berkrot Organizations: REUTERS, Pfizer, BMO Capital, Reuters Graphics Pfizer, GSK, CVS, Analysts, U.S ., Thomson Locations: Europe, Paxlovid, Bengaluru, New York

☆ Pfizer swings to quarterly loss as COVID product demand slump sparks charges
▼ + stars: | 2023-10-31 | by ( ) www.reuters.com time to read: +3 min

The company recorded a $5.6 billion charge in the third quarter related to Paxlovid and vaccine Comirnaty, most of which was disclosed earlier this month. Paxlovid sales slumped 97% in the third quarter to $202 million, while vaccine revenue came in at $1.31 billion, down from $4.4 billion a year earlier. Analysts had expected sales of $1.44 billion for the vaccine and $618.20 million for Paxlovid, according to LSEG data. Sales of its recently launched respiratory syncytial virus (RSV) vaccine, Abrysvo, came in at $375 million for the quarter. Overall revenue was $13.23 billion, compared to $22.64 billion a year earlier.

Persons: Wolfgang Rattay, Evan Seigerman, Bhanvi Satija, Michael Erman, Sriraj Organizations: REUTERS, Pfizer, U.S, BioNTech, Analysts, BMO Capital, U.S ., Thomson Locations: Bengaluru, New York

☆ Pfizer RSV vaccine lags GSK’s as head-to-head competition underway
▼ + stars: | 2023-10-30 | by ( Michael Erman | ) www.reuters.com time to read: +4 min

[1/3] View of Pfizer's new respiratory syncytial virus (RSV) vaccine Abrysvo during its manufacture in this undated handout picture. "800 POUND GORILLAS"CVS, which has more than 9,000 U.S. locations, declined to comment on why it was only carrying GSK's vaccine. It was not immediately clear how many RSV shots were being administered in pharmacies versus doctors' offices. GSK declined to discuss its RSV vaccine contracts, but said customer relationships gives it a competitive advantage. Two independent pharmacists said they are being charged a lower price by wholesalers for the GSK vaccine, which comes in boxes of 10.

Persons: Price, Ben Link, Link, Pfizer's, Dovato, Morningstar, Damien Conover, We’ve, Alison Hunt, Michelle Vargas, Michael Erman, Caroline Humer, Bill Berkrot Organizations: Pfizer, Handout, REUTERS, GSK, Reuters, CVS Health, CVS, Walgreens, Walmart, Aid, Thomson Locations: United States, British, U.S, South Carolina

☆ New RSV protections for infants hit cost, insurance hurdles in U.S. rollout
▼ + stars: | 2023-10-13 | by ( Angelica Peebles | In Angelicapeebles | ) www.cnbc.com time to read: +2 min

Two new immunizations promise to protect babies from respiratory syncytial virus – if people can find them. Providers are scrambling to offer Pfizer's vaccine, Abrysvo, to pregnant patients and Sanofi's monoclonal antibody, Beyfortus, to babies. Until now, the only preventative treatment was another monoclonal antibody called Synagis that's given once a month during RSV season, which generally runs from fall through spring. Sanofi's Beyfortus is a monoclonal antibody that's given directly to babies and provides them with immediate protection. "I know that [RSV]'s a threat to little babies, and so to have an opportunity to prevent illness in the first place is really exciting."

Persons: Michael Chamberlin, hasn't, we're, Chamberlin, that's, Erin Bakke, Graham Organizations: Pediatric Associates Locations: Carmel, Cincinnati , Ohio

☆ RSV vaccine: There’s one for older adults, pregnant people and infants
▼ + stars: | 2023-10-05 | by ( Katia Hetter | ) edition.cnn.com time to read: +7 min

CNN —For the first time, adults 60 and older are eligible to receive a vaccine against the respiratory syncytial virus, or RSV. Since this is the first time an RSV vaccine has been made widely available, some older people may be wondering why it might be needed. Is RSV a major problem in adults, especially older adults? Tragically, around 10,000 to 13,000 older adults annually die from this infection. I also do not recommend that people who have decided to get the RSV vaccine to wait.

Persons: Abrysvo, Leana Wen, —, Wen Organizations: CNN, Food and Drug Administration, GlaxoSmithKline, Pfizer, US Centers for Disease Control, CNN Wellness, George Washington University Milken Institute School of Public Health, CDC, FDA Locations: United States, It’s

☆ CDC advisors recommend Pfizer maternal RSV vaccine to protect infants
▼ + stars: | 2023-09-22 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

Pfizer's vaccine, called Abrysvo, is already approved and available in the U.S. for adults ages 60 and up. The panel's recommendation puts Pfizer's maternal shot on track to reach the public as RSV begins to spread at higher levels. But younger children and older adults are particularly vulnerable to more severe RSV infections. Each year, the virus kills a few hundred children younger than 5, and 6,000 to 10,000 seniors, according to the CDC. RSV also causes around 58,000 to 80,000 hospitalizations among children younger than 5 years old each year, the CDC said.

Persons: Pfizer, Mandy Cohen, Luis Jodar, Pfizer's Abrysvo, Jefferson Jones, Jones Organizations: Disease Control, U.S, Public, CDC, Pfizer, Northern, Drug Administration, FDA, AstraZeneca Locations: U.S, Sanofi

NEW YORK (AP) — U.S. health officials on Friday recommended RSV vaccinations for moms-to-be, a second new option to protect newborns from serious lung infections. The shots should be given late in pregnancy but only during RSV season, the Centers for Disease Control and Prevention said. The RSV vaccine, made by Pfizer, should only be given between 32 weeks and 36 weeks of pregnancy. Some CDC panel members who ultimately supported the recommendation expressed reservations. Several also balked at the $295-a-dose price Pfizer has been charging for the same RSV vaccine for seniors, called Abrysvo.

Persons: ”, Mandy Cohen, Cohen, Grace Lee Organizations: —, Centers for Disease Control, Prevention, Pfizer, CDC, Associated Press Health, Science Department, Howard Hughes Medical Institute’s Science, Educational Media Group, AP Locations: — U.S, U.S

Aug 21 (Reuters) - The U.S. Food and Drug Administration on Monday approved Pfizer's (PFE.N) respiratory syncytial virus (RSV) vaccine for use in women during the middle of the third trimester of pregnancy to protect their babies. An FDA panel of outside experts backed the safety and effectiveness of Pfizer's RSV vaccine for women in their second and third trimesters earlier in May. RSV is a common respiratory virus that usually causes mild, cold-like symptoms but can also lead to serious illness and hospitalization. Infants are at greatest risk for severe illness from RSV. An estimated 58,000 to 80,000 children below the age of five years are hospitalized every year due to RSV infection in the U.S., according to government data.

Persons: Pfizer, Mariam Sunny, Bhanvi, Patrick Wingrove, Caroline Humer, Bill Berkrot Organizations: U.S . Food, Drug Administration, FDA, Pfizer, U.S . Centers for Disease Control, Sanofi, AstraZeneca, GSK, Thomson Locations: U.S, United States, Bengaluru, New York

☆ GSK sues Pfizer in U.S. court for patent infringement over RSV vaccine
▼ + stars: | 2023-08-02 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +1 min

GlaxoSmithKline on Wednesday sued Pfizer in U.S. court, alleging patent infringement over Britain-based GSK's respiratory syncytial virus vaccine. GSK claims Pfizer's RSV vaccine, Abrysvo, infringes on four of its patents related to the antigen used in its own shot. "Upon information and belief, Pfizer knowingly uses GSK's claimed inventions in Abrysvo without permission," GSK wrote in a scathing complaint filed in federal court in Delaware. They are the first shots approved to prevent RSV, a common respiratory infection that usually causes mild, cold-like symptoms, but more severe cases in older adults and children. Each year, RSV kills 6,000 to 10,000 seniors and a few hundred children younger than 5, according to CDC data.

Persons: infringes Organizations: GlaxoSmithKline, Wednesday, Pfizer, GSK, U.S . Food, Drug Administration, Walgreens Locations: Britain, Delaware

June 7 (Reuters) - European regulators have approved the region's first vaccine for respiratory syncytial virus (RSV), which causes thousands of hospitalisations and deaths annually. The shot, called Arexvy, is made by British drugmaker GSK (GSK.L) and is designed to protect people aged 60 and over. The complex molecular structure of the virus and safety concerns with previous vaccine attempts had stymied efforts to successfully develop a shot since the virus was first discovered in 1956. Given the different definitions of the trial endpoints across the GSK and Pfizer trials, a direct comparison of efficacy is difficult. In Europe, RSV leads to over 270,000 hospitalisations and about 20,000 in-hospital deaths in adults over 60 each year.

Persons: Luke Miels, Peter Welford, TD Cowen, Steve Scala, Natalie Grover, Eva Mathews, Maggie Fick, Savio D'Souza, Mark Potter Organizations: GSK, European Commission, European Medicines Agency, Reuters, U.S . Food, Drug Administration, Pfizer, Jefferies, Thomson Locations: British, Europe, U.S, London, Bengaluru

☆ F.D.A. Approves Pfizer’s R.S.V. Vaccine for Older Adults
▼ + stars: | 2023-05-31 | by ( Christina Jewett | ) www.nytimes.com time to read: +3 min

Each year, about 60,000 adults 65 and older are hospitalized with R.S.V. The Centers for Disease Control and Prevention estimated that in one year, more than 21,000 people in that age group would need to take the GSK vaccine to prevent one R.S.V. Several treatments, including a maternal vaccine and a monoclonal antibody for infants against R.S.V., are under agency review. The GSK vaccine, called Arexvy, was nearly 83 percent effective against severe R.S.V. The final vote of the F.D.A.’s advisory panel in favor of the Pfizer vaccine’s safety and efficacy was 7 to 4.

Persons: Miller Fisher, Jerica Pitts Organizations: Disease Control, GSK, Pfizer, Infants, R.S.V

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