Commercialization of global RSV vaccines in progress in KOR

latecomers also in pace to develop their respective RSV vaccines

MFDS approves Phase III IND for Pfizer's RSV vaccine

Moderna’s vaccine receives approval in the U.S... SK Bioscience and EuBiologics are working to develop a domestic version

A global respiratory syncytial virus (RSV) vaccine has entered late-stage clinical trials for the first time in Korea, testing its potential for commercialization.

 

Pfizer recently received approval to initiate a Phase III clinical trial in Korea to evaluate the immunogenicity of its RSV vaccine.

 

Moderna is applying for Japanese approval of its RSV vaccine, which was approved in the U.S.

 

in May, and making its way into Asian countries.

 

Among domestic biotech companies, EuBiologics has entered Phase I clinical trials in Korea.

 

RSV is a virus that causes pneumonia and bronchitis.

 

The virus can affect a person of any age, but the infection rate is particularly high in infants and young children.

 

It is the leading cause of hospitalization in infants and young children, and 90% of infants worldwide are infected with RSV before the age of 2.

 

When infected, RSV causes symptoms similar to the common cold, but some infants and children may experience a more severe course, leading to lower respiratory tract illnesses such as pneumonia and bronchiolitis.

 

According to industry sources on the 30th, the Ministry of Food and Drug Safety approved the Phase III IND for the RSV vaccine 'PF-06928316' submitted by Pfizer on the 26th.

 

The trial will be conducted at 16 institutions, including Samsung Medical Center, Severance Hospital, and Seoul St.

 

Mary's Hospital, from October this year to December next year.

 

In the trial, Pfizer will evaluate the safety, tolerability, and immunogenicity of the RSV vaccine in 360 older adults.

 

The primary endpoints will be local reactions (redness, swelling, and pain at the injection site) and systemic events (fever, fatigue, headache, vomiting, nausea, diarrhea, muscle pain, and joint pain), based on which the company will evaluate the adverse events and tolerability of PF-06928316.

 

Participants will be randomized in a 2:1 ratio to PF-06928316 or placebo.

 

Pfizer

Pfizer’s RSV vaccine was approved in the U.S.

 

last year and launched under the brand name Abrysvo.

 

Abrysvo is indicated for adults 60 years of age and older, infants 6 months of age and younger, and pregnant women at less than 37 weeks gestation.

 

Recently, Pfizer confirmed the immunogenicity of Abrysvo in adults aged 18 to 59 years, raising the possibility of its indication expansion.

 

Abrysvo demonstrated non-inferior neutralization responses in 681 adults aged 18 to 59 years with certain chronic diseases and 200 immunocompromised adults compared to that identified in the original clinical trial that evaluated the vaccine in older adults.

 

Participants also achieved at least a four-fold increase in serum neutralizing titers following receipt of Abrysvo compared to pre-vaccination.

 

These results support the potential for Abrysvo’s expanded indication.

 

It also opened the door for Pfizer to enter clinical trials in Korea to evaluate the immunogenicity of the RSV vaccine in all ages.

 

Moderna receives approval in the U.S.

 

and seeks to enter the Asian market…EuBiologics starts clinical trial in Korea

The RSV vaccine market is currently in a three-way battle between Abrysvo, GSK’s ‘Arexvy,’ and Moderna’s mRNA-1345, with Moderna conducting a clinical trial to develop a follow-on drug.

 

Among the companies, Moderna has applied for mRNA-1345’s approval in Japan and is seeking to enter the Asian market.

 

Moderna submitted an application for mRNA-1345 to Japan's Ministry of Health, Labour and Welfare in May.

 

mRNA-1345 was approved in the U.S.

 

in May and was developed to prevent RSV in adults aged 60 and older.

 

The application is based on the interim analysis results of the Phase III ConquerRSV that demonstrated immunogenicity and tolerability of mRNA-1345.

 

The trial was conducted in 22 countries, including Japan.

 

The ConquerRSV trial was a randomized, double-blind, placebo-controlled study that enrolled approximately 37,000 adults aged 60 years and older in 22 countries, including the United States.

 

The interim analysis was based on two definitions of RSV lower respiratory tract disease (RSV-LRTD), defined as two or more symptoms or three or more disease symptoms.

 

Results showed that in RSV-LRTD defined as two or more symptoms, mRNA-1345 met all primary endpoints, including demonstrating 83.7% vaccine efficacy.

 

Adverse events with mRNA-1345 were mild to moderate, with the most commonly reported adverse events in the mRNA-1345 arm being injection site pain, fatigue, headache, myalgia, and arthralgia.

 

In addition to the U.S.

 

and Japan, Moderna plans to file for approval of mRNA-1345 in the European Union (EU) and other countries.

 

In Korea, EuBiologics has entered clinical trials.

 

The euRSV vaccine being developed by EuBiologics has recently been administered to 3 RSV patients at Korea University Guro Hospital.

 

Patients were randomized to placebo, low-dose EuRSV, and high-dose EuRSV to evaluate the vaccine’s tolerability and safety.

 

EuRSV is a recombinant protein subunit vaccine that combines the virus’s F-protein antigen with an immune booster.

 

In 2017, Eubiologics in-licensed the immune booster EuIMT from the Korea Institute of Science and Technology.

 

EuBiologics aims to enter global Phase 2/3 trials through its U.S.

 

subsidiary, Eupop Life Sciences, which holds the marketing rights for EuRSV in the North American and European markets.

 

In addition, SK Bioscience is also developing an mRNA-based RSV vaccine candidate like that being developed by Moderna.

 

SK Bioscience began RSV vaccine development in 2018 with the aim to commercialize it by 2029 but is still in the basic research stage.