Global RSV vaccines emerge…K-pharma enters clinical trials

for the first time

Beyfortus receives approval in KOR…young children less than 24 months can be vaccinated

Moderna waits for FDA approval…EuBiologics enters clinical trials in KOR

The RSV vaccine Beyfortus, developed by Sanofi and AstraZeneca, GSK’s Arexvy, and Pfizer’s Abrysvo.

Competition is expected to intensify as new drugs emerge in the respiratory syncytial virus (RSV) market.

 

Sanofi received approval for its RSV vaccine and is the third company to acquire the approval, following GSK and Pfizer.

 

Furthermore, Moderna’s messenger RNA (mRNA) vaccine awaits the FDA approval.

 

In South Korea, EuBiologics has entered the Phase 1 trial.

 

According to industry sources on the 20th, the RSV vaccine Beyfortus, developed by Sanofi and AstraZeneca, received approval in South Korea on April 30th.

 

Consequently, Beyfortus has become the first preventative RSV vaccine targeting young children to obtain domestic approval from the regulatory institution.

 

Last year, GSK’s Arexvy and Pfizer’s Abrysvo were launched overseas, but they have yet to start acquiring domestic approval.

 

RSV is a virus that causes pneumonia and bronchiolitis.

 

Although RSV can be infected at any age, young children are particularly prone to infection.

 

It is the common cause of hospitalization for young children, with a high disease incidence, and 90% of young children worldwide are infected before 2 years.

 

When infected, the symptoms are similar to the common cold.

 

Certain young children experience worsening symptoms, having lower respiratory symptoms such as pneumonia and bronchiolitis.

 

In South Korea, RSV Synagis Inj, an antibody directed to RSV, is available.

 

However, it has the disadvantage of multiple injections due to short-lasting in the body.

 

Moreover, Synagis can only be administered to patients with certain diseases.

 

With the long-lasting Beyfortus, healthy children less than 24 months can be vaccinated.

 

The efficacy and safety of Beyfortus were confirmed in MELODY clinical trials against medically attended Lower Respiratory Tract Infection (LRTI) caused by RSV through 150 days after the treatment.

 

In clinical trials, Beyfortus reduced the RSV LRTI infection rate to 74.5% in full-term infants and late preterm infants.

 

The Beyfortus effect was 70.1% in preterm infants.

 

Furthermore, the NIRSE-Gal interim analysis result, which was the basis for the European real-world evidence (RWE), has shown that the Beyfortus administration reduced the hospitalization rate by 82% in infants less than 6 months compared to non-vaccinated infants.

 

RSV circulates between October and March every year.

 

Sanofi and AstraZeneca are producing Beyfortus before the RSV season and plan to distribute most vaccine stocks before October.

 

Moderna completes clinical trials and waits for FDA approval...EuBiologics enters clinical trials in South Korea as the first and only

Moderna’s RSV vaccine will receive the decision for the FDA approval within this month.

 

Moderna’s mRNA-1345 vaccine is developed to prevent RSV in adults over 60.

 

When approved, it will be the third RSV vaccine that targets adults, following Arexvy and Abrysvo.

 

The ConquerRSV trials, which evaluated the safety and efficacy of Moderna’s RSV vaccine, involved about 37,000 adults 60 years or older in 22 countries, including the United States.

 

They were conducted as randomized, double-blind, and placebo-controlled studies.

 

The interim analysis was based on two definitions of RSV-LRTD defined as either two or more symptoms, or three or more symptoms of disease.

 

According to the clinical results, mRNA-1345 demonstrated vaccine efficacy of 83.7% in RSV-LRTD defined as two or more symptoms, and all primary endpoints were met.

 

Adverse reactions of mRNA-1345 were mild or moderate, and the most common adverse reactions reported in the mRNA-1345 group were injection site pain, fatigue, headache, myalgia, and arthralgia.

 

Moderna expects approval this month and plans to launch its first RSV vaccine to the market by the second half of the year.

 

Additionally, EuBiologics has entered full-scale clinical trials in South Korea.

 

EuBiologics’ euRSV vaccine under development has recently started administration in three RSV patients in Korea University Guro Hospital.

 

The clinical trials involve patients randomly assigned to a placebo group, EuRSV low-dose group, or high-dose group, and tolerability and the safety will be evaluated.

 

EuRSV is a recombinant protein subunit vaccine that combines an RSV F protein antigen with immunostimulants.

 

In 2017, EuBiologics acquired immune modulation technology (EuIMT) from KIST.

 

EuBiologics emphasizes that the manufacturing process of EuIMT is simple compared to GSK’s immunostimulant technology, MPL(monophosphoryl lipid).

 

Consequently, the company expects that vaccine mass manufacturing will be possible at a low cost.

 

After starting a phase 1 trial in South Korea, EuBiologics aims to enter global phase 2/3 trials through its U.S.

 

subsidiary EUPOP Life sciences, which has North America and Europe licenses.