September 25, 2023

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Pfizer and GlaxoSmithKline RSV Vaccine Receives Limited Support from US CDC Experts

Pfizer and GlaxoSmithKline RSV Vaccine Receives Limited Support from US CDC Experts



 

Pfizer and GlaxoSmithKline RSV Vaccine Receives Limited Support from US CDC Experts.

A group of independent advisors from the Centers for Disease Control and Prevention (CDC) in the United States recently recommended the limited introduction of new vaccines from Pfizer (PFE.US) and GlaxoSmithKline (GSK.US) to prevent severe respiratory syncytial virus (RSV) infections in older adults.

 

Pfizer and GlaxoSmithKline RSV Vaccine Receives Limited Support from US CDC Experts.

Pfizer and GlaxoSmithKline RSV Vaccine Receives Limited Support from US CDC Experts.

 

The experts in attendance did not agree that all older adults should receive the vaccines from GlaxoSmithKline and Pfizer, which are branded as Arexvy and Abrysvo, respectively. Last month, the US Food and Drug Administration (FDA) approved the market launch of these two vaccines.

 

The Advisory Committee on Immunization Practices (ACIP) of the CDC recommended, by a vote of 9 to 5, that Americans aged 65 and above “may” receive the RSV vaccine after discussing it with healthcare providers.

 

The committee supported the same policy for individuals aged 60 to 64 by a vote of 13 to 0, with one member abstaining. CDC Director Rochelle Walensky will consider their recommendations before issuing a final decision later this week or early next week.

 

ACIP’s decision presents a narrower recommendation that could result in lower vaccination rates than what the vaccine manufacturers may have hoped for if ACIP had adopted a stronger “should” recommendation.

 

During the meeting, GlaxoSmithKline pledged to price its vaccine at $200 to $295 per dose, while Pfizer stated that its vaccine would be priced between $180 and $270 per dose, noting that the final price will depend on ongoing pricing negotiations.

 

Both pharmaceutical companies hope to introduce the new vaccines before the RSV season later this year.

 

RSV vaccine market has seen continuous developments this year.

 

First, GlaxoSmithKline (GSK) announced the FDA approval for its RSV vaccine Arexvy (RSVPreF3 OA/GSK3844766A), which is used to prevent lower respiratory tract disease (RSV-LRTD) caused by RSV infections in the elderly.

It became the first globally approved RSV vaccine on the market. Following that, products from multinational giants such as Sanofi/AstraZeneca and Pfizer also made breakthroughs.

 

Recently, the National Medical Products Administration (NMPA) Drug Evaluation Center (CDE) officially granted priority review qualification for nirsevimab, indicating that the first respiratory syncytial virus prevention measure applicable to all infants has entered the “fast lane” of evaluation.

Nirsevimab is a long-acting fully human recombinant monoclonal antibody for RSV prevention jointly developed by Sanofi and AstraZeneca.

 

In addition, the FDA approved Pfizer’s ABRYSVO (respiratory syncytial virus vaccine) for the prevention of lower respiratory tract disease caused by RSV in individuals aged 60 and above. ABRYSVO, which does not contain an adjuvant, consists of two preF proteins and has been confirmed to be safe and effective in providing maximum protection against RSV subtypes A and B.

 

RSV is an infectious virus and a common cause of respiratory diseases worldwide. The virus can affect the lungs and respiratory tract of infected individuals, potentially leading to severe illness or death.

Infants and older adults are both key and high-risk populations for RSV infection. This also means that the RSV virus has significant market potential within these two population groups.

 

 

 

Pfizer and GlaxoSmithKline RSV Vaccine Receives Limited Support from US CDC Experts

(source:internet, reference only)


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