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☆ It's Time to Start Preparing Against Flu, RSV & COVID-19
▼ + stars: | 2023-09-15 | by ( Sept. | At A.M. | ) www.usnews.com time to read: +5 min

The flu vaccine is now available in some locations. And new respiratory syncytial virus (RSV) vaccines are recommended for some. "We should do what we can to protect ourselves — and others — with the best tool we have: the flu vaccine." Not only that, but COVID-19 and RSV could again spike at the same time as the flu, triggering a "tripledemic," Gandhi said. Women who are between 32 and 36 weeks pregnant can also protect their infants at birth by getting a new Pfizer RSV vaccine.

Persons: Cara Murez HealthDay, Soniya Gandhi, Gandhi, There's, Priya Soni, Sinai Guerin Children’s, Soni, Sonja Rosen, Rosen Organizations: Southern Hemisphere, U.S . Food, Drug Administration, Pfizer, GSK, U.S . Centers for Disease Control Locations: United States, Cedars, Sinai, Los Angeles, U.S, Guillain, Barre

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

☆ US CDC panel recommends Sanofi-AstraZeneca's preventive RSV therapy for babies
▼ + stars: | 2023-08-03 | by ( ) www.reuters.com time to read: +1 min

[1/2] Sanofi logo at the company's headquarters during the annual results news conference in Paris, France, February 4, 2022. REUTERS/Benoit Tessier/File PhotoCompanies AstraZeneca PLC FollowSanofi SA FollowAug 3 (Reuters) - The U.S. Centers for Disease Control and Prevention (CDC) said its advisory panel on Thursday recommended use of Sanofi (SASY.PA) and partner AstraZeneca's (AZN.L) antibody therapy to prevent respiratory syncytial virus (RSV) in infants and toddlers. The Advisory Committee on Immunization Practices unanimously recommended nirsevimab for preventing lower respiratory tract disease in newborns and infants below eight months of age born during or entering their first RSV season. It also recommended its use in children aged 8-19 months who remain vulnerable to severe RSV disease through their second such season. The therapy, branded as Beyfortus, will be available in the U.S. ahead of the upcoming 2023-24 RSV season, Sanofi said.

Persons: Benoit Tessier, AstraZeneca's, Sanofi, Mrinmay Dey, Mariam Sunny Organizations: Sanofi, REUTERS, Companies AstraZeneca, U.S . Centers for Disease Control, Prevention, U.S . Food, Drug Administration, Thomson Locations: Paris, France, U.S, Bengaluru

☆ Infant RSV shot faces final hurdle at CDC, could be available by fall
▼ + stars: | 2023-08-03 | by ( Spencer Kimball | ) www.cnbc.com time to read: +1 min

CDC Director Mandy Cohen is not obligated to endorse the vote of the advisors, though the head of the agency usually follows the panel's advice. Beyfortus, also called nirsevimab, is set to become the first shot in the U.S. that protects all infants from RSV. Sanofi has said the companies are prepared to roll the shot out before RSV season this fall and do not foresee any challenges meeting demand. Although Beyfortus works like a vaccine, the shot is considered a drug, not a vaccine, because it is an antibody injection. Advisors are also voting Thursday on whether Beyfortus should be included in the Vaccines for Children program, making the votes a crucial step for the drug.

Persons: Mandy Cohen Organizations: Centers for Disease Control, Sanofi, Children, Advisors, Vaccines Locations: U.S

☆ FDA approves AstraZeneca, Sanofi shot that protects infants and toddlers against RSV
▼ + stars: | 2023-07-17 | by ( Spencer Kimball | ) www.cnbc.com time to read: +3 min

The FDA approval of nirsevimab, sold under the brand name Beyfortus, comes ahead of RSV season this fall. This is a major advantage over palivizumab, which is administered monthly throughout RSV season. Nirsevimab is administered either before or during an infant's first RSV season. Toddlers up to two years old who remain vulnerable can also receive the shot during their second RSV season. Pfizer has developed a vaccine that protects infants by administering the shot to the mother while she is pregnant.

Persons: Biden, Nirsevimab Organizations: Drug Administration, AstraZeneca, Sanofi, FDA, Disease Control, Children, CDC, Pfizer Locations: U.S, Nirsevimab

☆ FDA advisors recommend AstraZeneca, Sanofi antibody to protect babies from RSV
▼ + stars: | 2023-06-08 | by ( Spencer Kimball | ) www.cnbc.com time to read: +2 min

If the FDA approves nirsevimab, the antibody would become the first medical intervention available in the U.S. that can protect all infants from RSV. Nirsevimab is a monoclonal antibody made by AstraZeneca. Infants hospitalized with RSV often require oxygen support, intravenous fluids and are sometimes placed on a ventilator to support their breathing. There is another monoclonal antibody used against RSV called palivizumab. Nirsevimab is not considered a vaccine because it is a monoclonal antibody.

Persons: Infants, Biden, Palivizumab, Nirsevimab Organizations: Food and Drug Administration, FDA, AstraZeneca, Sanofi, Children Locations: U.S, Nirsevimab, United States, Canada, Europe, United Kingdom

☆ Sanofi forecasts moderate profit growth on Dupixent demand
▼ + stars: | 2023-02-03 | by ( Ludwig Burger | ) www.reuters.com time to read: +3 min

Feb 3 (Reuters) - Sanofi (SASY.PA) on Friday forecast moderate earnings growth this year, saying higher demand for bestselling asthma and eczema drug Dupixent would be partly offset by competition for its multiple sclerosis pill Aubagio and product launch costs. Aubagio, with 2 billion euros in sales last year, will face competition from cheaper products over the next few months after losing patent protection, Sanofi said. The company reaffirmed its target to achieve sales of Dupixent, jointly developed with Regeneron (REGN.O), of 10 billion euros this year, up more than 20% from 8.29 billion euros in 2022. Sanofi reported a 20.7% rise in fourth-quarter business operating income, or adjusted earnings before interest and tax, to 2.72 billion euros ($2.96 billion), edging past an average analyst estimate of 2.69 billion euros posted on the company's website. Revenue from Dupixent surged 42% to 2.4 billion euros during the quarter ended Dec. 31, slightly above a consensus of 2.37 billion euros.

☆ Nearly 2% of healthy infants hospitalized with RSV before first birthday, study finds
▼ + stars: | 2022-11-10 | by ( Spencer Kimball | ) www.cnbc.com time to read: +3 min

Even healthy infants face a considerable risk of hospitalization from respiratory syncytial virus, according to a large European study published Thursday. Dutch and British scientists, in a study published in Lancet Respiratory Medicine, found that 1.8% of healthy infants are hospitalized with RSV before their first birthday. This means about 1 in 56 healthy infants are hospitalized with the virus annually. The scientists found that a majority of the infants hospitalized with RSV were younger than 3 months. About 1 in 18 infants hospitalized with RSV required treatment in the intensive care unit.

☆ New RSV vaccines may soon put an end to rough seasons
▼ + stars: | 2022-10-31 | by ( Brenda Goodman | ) edition.cnn.com time to read: +15 min

The monoclonal antibody, Synagis, is given monthly during RSV season to protect preemies and other high-risk babies. In the failed RSV vaccine trial, the chemical the researchers used to deactivate the virus denatured its proteins – essentially flattening them. Four companies have RSV vaccines for adults in the final phases of human trials: Pfizer and GSK are testing vaccines for pregnant women as well as seniors. Janssen, Pfizer and GSK each appear effective at preventing infections in adults for the first RSV season after the vaccine. The vaccines for pregnant women are meant to get newborns through their first RSV season.

☆ Explainer: COVID, flu and RSV this U.S. winter: Why experts are worried
▼ + stars: | 2022-10-26 | by ( Nancy Lapid | ) www.reuters.com time to read: +3 min

REUTERS/Carlo Allegri/File PhotoOct 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. Older children and most adults typically experience mild, cold-like symptoms. In the meantime, it is important "for everyone to get up to date on their COVID and flu vaccines," Varma said. 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.

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