Internewscast Journal
  • Home
  • US News
  • Local News
  • Health
  • People
  • Guest Post
  • Support Our Cause
Internewscast Journal
  • Home
  • US News
  • Local News
  • Health
  • People
  • Guest Post
  • Support Our Cause
Home Local news FDA Approves Novavax COVID-19 Vaccine with Unique Restrictions
  • Local news

FDA Approves Novavax COVID-19 Vaccine with Unique Restrictions

    FDA approves Novavax COVID-19 shot but with unusual restrictions
    Up next
    What The Cast Of Baywatch Looks Like Today
    Current Looks of the Baywatch Cast
    Published on 18 May 2025
    Author
    Internewscast
    Tags
    • approves,
    • Business,
    • but,
    • COVID19,
    • fda,
    • health,
    • John C. Jacobs,
    • Novavax,
    • restrictions,
    • Robert F. Kennedy Jr,
    • shot,
    • Unusual,
    • Washington news,
    • with
    Share this @internewscast.com
    FacebookXRedditPinterest

    WASHINGTON – The Food and Drug Administration has issued a long-awaited approval of Novavax’s COVID-19 vaccine but with unusual restrictions.

    Novavax produces the country’s sole traditional protein-based COVID-19 vaccine, which, until now, held an emergency authorization from the FDA for individuals aged 12 and above.

    However, the FDA granted the vaccine full approval late Friday, but specifically for adults aged 65 and older, or those aged 12 to 64 with at least one underlying health condition that heightens their risk from COVID-19.

    Vaccines from competitors Pfizer and Moderna have already received full licensure for use in those aged 12 and up, and they are also authorized for children as young as 6 months old.

    Next month, influential advisers to the Centers for Disease Control and Prevention were set to debate if yearly COVID vaccines still should be recommended for everyone or only certain people at higher risk. The Novavax decision suggests the Trump administration may already have decided how to proceed in advance of that meeting.

    Novavax chief executive John C. Jacobs welcomed the licensure.

    “Market research and U.S. CDC statistics indicate that older individuals and those with underlying conditions are the populations most likely to seek out COVID-19 vaccination seasonally. This significant milestone demonstrates our commitment to these populations and is a significant step towards availability of our protein-based vaccine option,” he said.

    In its Friday approval letter, the FDA didn’t explain the restrictions although they reflect skepticism about vaccines from Health Secretary Robert F. Kennedy Jr. and other Trump officials.

    Novavax originally showed its vaccine was safe and effective in a 30,000-person clinical trial. The FDA had been on track to grant Novavax full approval – without restrictions — by its April 1 target date, according to two people with direct knowledge of the situation who spoke on condition of anonymity to discuss confidential agency matters.

    Novavax later announced the FDA instead was asking it to run an additional trial after approval, which is highly unusual. FDA did order several additional trials to be completed in the next few years, some examining whether the vaccine might be associated with some heart conditions. Another required study must assess the benefits of continuing vaccination in 50- to 64-year-olds who don’t have health problems that increase their risk from COVID-19.

    —-

    The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.

    Copyright 2025 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed without permission.

    Share this @internewscast.com
    FacebookXRedditPinterest
    You May Also Like
    Judge temporarily blocks Trump from deploying Guard in Portland
    • Local news

    Court Halts Trump’s Plan to Send National Guard to Portland Indefinitely

    A federal judge has halted President Donald Trump’s plan to deploy 200…
    • Internewscast
    • October 5, 2025
    Several people canoe in flooded Utah streets
    • Local news

    Residents Paddle Through Flooded Streets in Utah

    Internet Explorer 11 is not compatible. For the best experience, please visit…
    • Internewscast
    • October 5, 2025
    Man denies accusations of decapitating California sea lion
    • Local news

    Man Refutes Claims of Beheading California Sea Lion

    Graphic Warning: This story contains graphic images or video that may be…
    • Internewscast
    • October 5, 2025
    Sarasota non-profit holds event pushing back against statewide street art removals
    • Local news

    Sarasota Charity Hosts Event Opposing Statewide Removal of Street Art

    SARASOTA, Fla. (WFLA) — On Saturday evening, members of Sarasota’s LGBTQ+ community,…
    • Internewscast
    • October 5, 2025
    Watching 2 areas highlighted by the National Hurricane Center
    • Local news

    Monitoring Two Regions Identified by the National Hurricane Center

    ORLANDO, Fla. – As of 8 p.m. Saturday, the National Hurricane Center…
    • Internewscast
    • October 5, 2025
    Hamas Agrees to Release All Israeli Hostages, Alive and Dead
    • Local news

    Hamas Plans to Return All Israeli Captives and Remains

    IE 11 is not supported. For an optimal experience visit our site…
    • Internewscast
    • October 4, 2025
    Japan elects first female prime minister
    • Local news

    Japan Makes History with First Female Prime Minister

    Internet Explorer 11 isn’t supported. For the best experience, please use a…
    • Internewscast
    • October 4, 2025
    Most Americans believe the shutdown will last two weeks or less: Survey
    • Local news

    Survey: Majority of Americans Think Shutdown Will Be Over in Two Weeks or Less

    According to a recent poll, a majority of Americans anticipate the government…
    • Internewscast
    • October 5, 2025
    Ukrainian train station hit by Russian drone strike
    • Local news

    Russian Drone Attack Strikes Ukrainian Train Station

    Internet Explorer 11 is not compatible. For the best experience, please access…
    • Internewscast
    • October 5, 2025
    Fatal crash slowing traffic on I-4 in Volusia County
    • Local news

    Tragic Accident Causes Traffic Delays on I-4 in Volusia County

    Crash reported at mile marker 108 A fatal crash is slowing traffic…
    • Internewscast
    • October 5, 2025
    Illinois Gov. JB Pritzker says Trump is set to federalize the state's National Guard
    • Local news

    Illinois Governor JB Pritzker Claims Trump Plans to Federalize State National Guard

    On Saturday, Illinois Governor JB Pritzker announced that he learned from the…
    • Internewscast
    • October 4, 2025
    The first supermoon of the year is approaching. Here's what to know
    • Local news

    The Year’s First Supermoon is Nearing: Everything You Need to Know

    NEW YORK – The moon will appear slightly larger and brighter Monday…
    • Internewscast
    • October 4, 2025
    The country that inspired Keir Starmer digital ID card fiasco
    • News

    The Nation Behind Keir Starmer’s Digital ID Card Blunder

    Estonia’s digital identity system, once hailed as a model of efficiency, has…
    • Internewscast
    • October 5, 2025
    Travis Kelce's ex Kayla Nicole FIRES BACK at Taylor Swift after diss
    • News

    Kayla Nicole, Travis Kelce’s ex, Responds Strongly to Taylor Swift’s Insult

    Kayla Nicole, the former partner of Travis Kelce, seems to have responded…
    • Internewscast
    • October 5, 2025
    Storm Team 3: Much needed rain continues today
    • Local news

    Storm Team 3: Continued Rainfall Brings Welcomed Relief Today

    We’re anticipating more rain today, especially along the coast, as a weak…
    • Internewscast
    • October 5, 2025
    Jony Ive, Sam Altman and an OpenAI logo
    • Business

    OpenAI and Jony Ive Face Technical Challenges with Confidential AI Gadget

    Stay informed with free updates OpenAI, in collaboration with renowned designer Jony…
    • Internewscast
    • October 5, 2025
    Internewscast Journal
    • Home
    • Privacy Policy
    • DMCA Notice
    • Terms and Conditions
    • Guest Post
    • Support Our Cause
    Copyright 2023. All Right Reserverd.