financetom
Business
financetom
/
Business
/
GSK and Pfizer's RSV vaccines to carry warnings of neurological disorder risk
News World Market Environment Technology Personal Finance Politics Retail Business Economy Cryptocurrency Forex Stocks Market Commodities
GSK and Pfizer's RSV vaccines to carry warnings of neurological disorder risk
Jan 7, 2025 3:37 PM

Jan 7 (Reuters) - GSK and Pfizer's ( PFE )

respiratory syncytial virus (RSV) vaccines will carry warnings

that they can increase the risk of developing a rare

neurological disorder, the U.S. Food Drug Administration said on

Tuesday.

The regulator conducted a postmarketing trial which

suggested increased risk of Guillain-Barré syndrome (GBS) 42

days following vaccination.

However, the available evidence was insufficient to

establish a causal relationship, the FDA said.

The risks flagged in the prescribing information of GSK's

Arexvy and Pfizer's ( PFE ) Abrysvo were not the regulator's strictest

"boxed" warnings.

GBS is a rare disorder in which the body's immune system

damages nerve cells, causing muscle weakness and sometimes

paralysis. RSV, which typically causes cold-like symptoms, is a

leading cause of pneumonia in toddlers and older adults.

In Arexvy's clinical trial, a participant had developed GBS

after receiving the vaccine, while in Abrysvo's trial, one

participant developed the disease and another got a variant of

it.

Last year, advisers to the U.S. Centers for Disease Control

and Prevention had postponed endorsing Arexvy's use in the 50-59

age group. They had also flagged the risk of GBS.

Comments
Welcome to financetom comments! Please keep conversations courteous and on-topic. To fosterproductive and respectful conversations, you may see comments from our Community Managers.
Sign up to post
Sort by
Show More Comments
Related Articles >
Hutchmed Begins Registration Stage for Phase 2/3 Trial of Investigational Autoimmune Disorder Drug
Hutchmed Begins Registration Stage for Phase 2/3 Trial of Investigational Autoimmune Disorder Drug
Mar 22, 2024
05:04 AM EDT, 03/22/2024 (MT Newswires) -- Hutchmed ( HCM ) said late Thursday it has started the registration stage for a phase 2/3 clinical trial of investigational drug sovleplenib for adult patients with warm antibody autoimmune hemolytic anemia in China. The move follows positive data from the proof-of-concept phase 2 stage of the trial and a consultation with the...
Japan's union group Rengo announces biggest wage hikes on record
Japan's union group Rengo announces biggest wage hikes on record
Mar 22, 2024
TOKYO (Reuters) -Japanese firms have agreed to raise pay by 5.25% this year, the biggest rise under comparable data since 2013, the country's largest union group Rengo confirmed on Friday. The results of the closely-watched wage negotiations are announced in several stages, in which the blue-chip firms are first to wrap up their talks in mid-March. The second announcement on...
Cathie Wood's ARK Invest scoops up nearly 10,000 Reddit shares in debut
Cathie Wood's ARK Invest scoops up nearly 10,000 Reddit shares in debut
Mar 22, 2024
(Reuters) - Popular investor Cathie Wood's ARK Invest bought nearly 10,000 shares of Reddit ( RDDT ) in the social media platform's strong market debut on Thursday, an email from the asset manager showed. A total of 9,982 shares of the loss-making company was added to ARK Next Generation Internet ETF ( ARKW ) and ARK Fintech Innovation ETF (...
Once a beacon of stability, Vietnam to name third president in a year
Once a beacon of stability, Vietnam to name third president in a year
Mar 22, 2024
HANOI, March 22 (Reuters) - Communist-ruled Vietnam is seeking its third president in little more than a year after the resignation of Vo Van Thuong, who was only elected last year after the sudden dismissal of his predecessor. With accumulated foreign direct investment higher than its gross domestic product, Vietnam's stability is crucial to multinationals with large operations in the...
Copyright 2023-2026 - www.financetom.com All Rights Reserved