• Home
  • Politics
  • Health
  • World
  • Business
  • Finance
  • Tech
  • More
    • Sports
    • Entertainment
    • Lifestyle
What's Hot

Trump Announces First Post-Tariff Trade Deal

May 8, 2025

100 Funny Father’s Day Quotes for Hilariously Relatable Humor (and Plenty of Love Too)

May 8, 2025

Top 10 Benefits Of Acupuncture

May 8, 2025
Facebook Twitter Instagram
  • Contact
  • Privacy Policy
  • Terms & Conditions
Friday, May 9
Patriot Now NewsPatriot Now News
  • Home
  • Politics

    Security video shows brazen sexual assault of California woman by homeless man

    October 24, 2023

    Woman makes disturbing discovery after her boyfriend chases away home intruder who stabbed him

    October 24, 2023

    Poll finds Americans overwhelmingly support Israel’s war on Hamas, but younger Americans defend Hamas

    October 24, 2023

    Off-duty pilot charged with 83 counts of attempted murder after allegedly trying to shut off engines midflight on Alaska Airlines

    October 23, 2023

    Leaked audio of Shelia Jackson Lee abusively cursing staffer

    October 22, 2023
  • Health

    Disparities In Cataract Care Are A Sorry Sight

    October 16, 2023

    Vaccine Stocks—Including Pfizer, Moderna, BioNTech And Novavax—Slide Amid Plummeting Demand

    October 16, 2023

    Long-term steroid use should be a last resort

    October 16, 2023

    Rite Aid Files For Bankruptcy With More ‘Underperforming Stores’ To Close

    October 16, 2023

    Who’s Still Dying From Complications Related To Covid-19?

    October 16, 2023
  • World

    New York Democrat Dan Goldman Accuses ‘Conservatives in the South’ of Holding Rallies with ‘Swastikas’

    October 13, 2023

    IDF Ret. Major General Describes Rushing to Save Son, Granddaughter During Hamas Invasion

    October 13, 2023

    Black Lives Matter Group Deletes Tweet Showing Support for Hamas 

    October 13, 2023

    AOC Denounces NYC Rally Cheering Hamas Terrorism: ‘Unacceptable’

    October 13, 2023

    L.A. Prosecutors Call Out Soros-Backed Gascón for Silence on Israel

    October 13, 2023
  • Business

    Trump Announces First Post-Tariff Trade Deal

    May 8, 2025

    Electric Vehicle Sales Nosedive As GOP Takes Buzzsaw To Biden’s Mandate

    May 7, 2025

    Tyson Foods Announces It Will Bend The Knee To Trump Admin’s New Rules

    May 7, 2025

    Federal Reserve Holds Interest Rates Steady Despite Pressure From Trump

    May 7, 2025

    ‘Wait Them Out’: John Kennedy Tells Larry Kudlow One Lie He Suspects China’s Telling US

    May 7, 2025
  • Finance

    Ending China’s De Minimis Exception Brings 3 Benefits for Americans

    April 17, 2025

    The Trump Tariff Shock Should Push Indonesia to Reform Its Economy

    April 17, 2025

    Tariff Talks an Opportunity to Reinvigorate the Japan-US Alliance

    April 17, 2025

    How China’s Companies Are Responding to the US Trade War

    April 16, 2025

    The US Flip-flop Over H20 Chip Restrictions 

    April 16, 2025
  • Tech

    Cruz Confronts Zuckerberg on Pointless Warning for Child Porn Searches

    February 2, 2024

    FTX Abandons Plans to Relaunch Crypto Exchange, Commits to Full Repayment of Customers and Creditors

    February 2, 2024

    Elon Musk Proposes Tesla Reincorporates in Texas After Delaware Judge Voids Pay Package

    February 2, 2024

    Tesla’s Elon Musk Tops Disney’s Bob Iger as Most Overrated Chief Executive

    February 2, 2024

    Mark Zuckerberg’s Wealth Grew $84 Billion in 2023 as Pedophiles Target Children on Facebook, Instagram

    February 2, 2024
  • More
    • Sports
    • Entertainment
    • Lifestyle
Patriot Now NewsPatriot Now News
Home»Health»FDA advisers recommend approval of RSV monoclonal antibody
Health

FDA advisers recommend approval of RSV monoclonal antibody

June 9, 2023No Comments5 Mins Read
Facebook Twitter Pinterest LinkedIn Tumblr Email
Drug in early trial appears to reduce harmful protein buildup in heart
Share
Facebook Twitter LinkedIn Pinterest Email

A Food and Drug Administration advisory committee voted overwhelmingly on Thursday to recommend approval of a monoclonal antibody product to protect newborns and young children from RSV.

The Antimicrobial Drugs Advisory Committee voted unanimously to recommend use of nirsevimab — which will be marketed as Beyfortus — in children in the first year of life. In a second vote, the committee voted 19 to 2 to recommend approval of the product for use in high-risk children in the second year of life.

The drug was developed by AstraZeneca. It will be marketed in the United States by Sanofi, which welcomed the committee’s recommendations.

“Most babies hospitalized with RSV are born at term and healthy, which is why interventions specifically designed to protect all infants are likely to result in the greatest impact,” Thomas Triomphe, Sanofi’s executive vice president for vaccines, said after the results of the initial vote were announced.

“We are encouraged by the advisory committee’s positive vote based on the compelling clinical development program supporting nirsevimab and its breakthrough potential to reduce the magnitude of annual RSV burden.”

RSV is a major cause of illness among young children. It is estimated that in any given year, about 400,000 children in this country go to a doctor’s office or a medical clinic for care for lower respiratory tract infections caused by RSV, about 150,00o seek emergency room care, and between 58,000 and 80,000 end up being hospitalized with the illness. It’s estimated that between 100 and 300 children in this country die every year from RSV infection.

See also  HIV rates decline in U.S., data show, but disparities persist

The infection is often most severe in very young children, whose lungs are still developing. Designing a vaccine to use in this age group would be challenging as it might take several doses, given over a period of weeks or months, to generate protection — a time during which infants would still be vulnerable to RSV.

Pfizer has come up with a rival approach, developing a vaccine — if approved — that will be given in pregnancy. The antibodies that the pregnant person develops will be shared in utero with the fetus, meaning babies born to vaccinated people will have some protection in the early months of life. That vaccine is also wending its way through the regulatory process.

The AstraZeneca-Sanofi approach would see babies given a single injection of antibodies against RSV either at birth, if they are born during RSV season, or in the autumn, if they are born at a different point in the year. In normal years, RSV season lasts about five months, typically starting around November and peaking in January or February.

Data that AstraZeneca presented to the committee suggested there is a strong protection for at least five months after administration. In a randomized controlled trial, babies who received nirsevimab saw their risk of having RSV infection that required medical care reduced by 70%, and their risk of being hospitalized for RSV infection reduced by 78.4%.

The members of the committee — many of whom are pediatricians — were enthusiastic about the potential of the treatment, noting that the annual crush of RSV cases overwhelms children’s hospitals, compromising the care not just of kids with RSV, but any child needing hospital care.

See also  FDA approves RSV monoclonal antibody for infants, toddlers

And they praised AstraZeneca for conducting good, thorough studies in the challenging context of the Covid-19 pandemic.

But they did note that there are questions that remain to be answered, and pressed both the companies and the FDA on the importance of further study.

There are no data, several pointed out, about whether giving nirsevimab to a baby whose mother was vaccinated against RSV during pregnancy would give the infant more protection or would be a waste of the product. And several members of the committee worried that the dose given in the first year of life might be too small to benefit a baby who was 8 months or older when receiving the injection, depending on the size of the baby.

Igovwhera Ofotokun, an infectious diseases professor at Emory University School of Medicine, raised concerns about how nirsevimab will be used in warmer parts of the country, where RSV is not a winter disease. Tonya Villafana, AstraZeneca’s vice president and global franchise head for vaccines and immune therapies, said the company would work with the FDA and other experts to figure out how to best use nirsevimab in such settings.

Committee chair Lindsey Baden, director of clinical research in the division of infectious diseases at Brigham and Women’s Hospital, also stressed the need for ongoing safety monitoring. Though there were no safety signals in the clinical trials, he said, “safety in 3,000 [children] is not safety in 3 million.”

The FDA is not obligated to follow the advice of the committee, but it would seem unlikely that it would ignore these recommendations, given the high degree of need for tools with which to protect children from respiratory syncytial virus, the No. 1 cause of hospitalizations in infants in this country.

See also  Global experts call for ten urgent actions to address declining male fertility

But if the FDA approves Beyfortus, the final word on how it will be used and in whom will rest with the Centers for Disease Control and Prevention, and its expert panel, the Advisory Committee on Immunization Practices. The ACIP can only vote on whether to recommend use of the monoclonal after the FDA approves the product.

advisers antibody Approval FDA monoclonal Recommend RSV
Share. Facebook Twitter Pinterest LinkedIn Tumblr Email

Related Posts

Improving Your Chances For SSDI Approval

January 30, 2025

Can Changes in FDA Regulation Affect Your Beauty Products?

January 28, 2025

Bitcoin Volatility Spikes Following False SEC ETF Approval Claim

January 11, 2024

Judges Given Cautious Approval to Use A.I. in Writing Legal Opinions

January 8, 2024
Add A Comment

Leave A Reply Cancel Reply

Top Posts

U.S. Cycling Champion Ethan Boyes Struck and Killed by Car in San Francisco

April 13, 2023

70 Years Since Brutally Repressed Uprising Against German Communism

June 18, 2023

Google Search Buried Links to Rumble’s Exclusive Republican Presidential Debate Stream

September 21, 2023

OPEC+ may spur U.S. crude oil exports, tick production higher

April 4, 2023
Don't Miss

Trump Announces First Post-Tariff Trade Deal

Business May 8, 2025

President Donald Trump announced Thursday the U.S. has reached a trade agreement with the U.K.,…

100 Funny Father’s Day Quotes for Hilariously Relatable Humor (and Plenty of Love Too)

May 8, 2025

Top 10 Benefits Of Acupuncture

May 8, 2025

Electric Vehicle Sales Nosedive As GOP Takes Buzzsaw To Biden’s Mandate

May 7, 2025
About
About

This is your World, Tech, Health, Entertainment and Sports website. We provide the latest breaking news straight from the News industry.

We're social. Connect with us:

Facebook Twitter Instagram Pinterest
Categories
  • Business (4,110)
  • Entertainment (4,220)
  • Finance (3,202)
  • Health (1,938)
  • Lifestyle (1,626)
  • Politics (3,084)
  • Sports (4,036)
  • Tech (2,006)
  • Uncategorized (4)
  • World (3,944)
Our Picks

Florida man arrested for allegedly firing his gun after finding drunk roommate naked in his teen​​ daughter’s bed

March 16, 2023

INSTC: Pipeline Dream or a Counterweight to Western Sanctions and China’s BRI? 

June 21, 2023

This Is Your Clinique Set of Essentials That Stand the Test of Time

March 7, 2024
Popular Posts

Trump Announces First Post-Tariff Trade Deal

May 8, 2025

100 Funny Father’s Day Quotes for Hilariously Relatable Humor (and Plenty of Love Too)

May 8, 2025

Top 10 Benefits Of Acupuncture

May 8, 2025
© 2025 Patriotnownews.com - All rights reserved.
  • Contact
  • Privacy Policy
  • Terms & Conditions

Type above and press Enter to search. Press Esc to cancel.