May 26, 2024

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The World First RSV Vaccine Gets FDA Approval

The World First RSV Vaccine Gets FDA Approval



 

The World First RSV Vaccine Gets FDA Approval

On May 3, GlaxoSmithKline (GSK) announced that its respiratory syncytial virus (RSV) vaccine Arexvy ( RSVPreF3 OA/ GSK3844766A) was approved by the FDA . Prevention of lower respiratory tract diseases caused by RSV infection in the above patients.

 

The World First RSV Vaccine Gets FDA Approval

 


RSV is a common contagious virus that primarily affects the lungs and airways.

Older adults are at high risk of severe disease when infected with RSV, in part due to age-related declines in immunity, with older adults with underlying medical conditions (such as respiratory and heart disease, and diabetes) at risk for severe disease bigger.

RSV can also exacerbate other diseases, including chronic obstructive pulmonary disease, asthma, and chronic heart failure, and can lead to serious complications (such as pneumonia, hospitalization, and death).


Arexvy is GSK’s RSV vaccine for the elderly, which is composed of RSV prefusion (prefusion) F glycoprotein (RSVPreF3) combined with GSK’s proprietary AS01 adjuvant.

This pre-fusion F glycoprotein is required for RSV virus to enter human cells. The marketing application of this vaccine was previously granted priority review qualification by the US FDA.

 

In the study, approximately 12,500 participants received the Arexvy vaccine and 12,500 participants received a placebo.

Vaccination with Arexvy reduced the risk of developing RSV-associated LRTD by 82.6% and reduced the risk of developing severe RSV-associated LRTD by 94.1%.

 

The World First RSV Vaccine Gets FDA Approval The World First RSV Vaccine Gets FDA Approval

Efficacy data from the AReSVi 006 study (Source: NEJM )


The most commonly reported side effects of the Arexvy vaccine include pain at the injection site, fatigue, muscle pain, headache, and joint stiffness/pain.

Among all clinical trial participants, 10 participants who received Arexvy and 4 participants who received placebo developed atrial fibrillation within 30 days of vaccination.


After 60 years of research and development, the RSV vaccine has finally ushered in a breakthrough.

This is a large market worth tens of billions of dollars. GlaxoSmithKline, Pfizer, and Moderna have successively achieved phase III clinical success. It will be approved for listing this month.

In addition, Pfizer’s phase III clinical trial for pregnant women has also been successful and is expected to be approved for marketing by the end of the year.

Under fierce competition, Johnson & Johnson recently announced the abandonment of the adenovirus vector RSV vaccine in the third phase of clinical trials.

 

 

 

 

 

The World First RSV Vaccine Gets FDA Approval

(source:internet, reference only)


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