The modern pharmaceuticals reported that it has sought global regulatory approvals for its respiratory syncytial virus vaccine (RNAm-1345).
Applications have been sent to the European Medicines Agency, Swissmedica (Switzerland) and the Australian Medicines Agency. Its development is based on the same technology as Moderna’s covid-19 vaccine, demonstrating the potential of its mRNA platform.
In addition, the company has initiated a phased-in biologics license application to the US Food and Drug Administration for mRNA-1345.
Respiratory syncytial virus (RSV) is a very common pathogen lower respiratory tract infection (bronchi, bronchioles, and alveoli) that can affect people of any age, but can be serious, especially in infants and the elderly.
According to the Pan American Health Organization (PAHO), an increasing trend in RSV cases has been reported in several Latin American countries, including Guatemala, Brazil and Chile.
“RNAm-1345 met the targets primary efficiency, with an efficiency of 83.7% against the disease respiratory tract infection caused by RSV in the elderly in the pivotal phase 3 efficacy trial, ConquerRSV,” the company reported.
The regulatory applications are based on positive data from a prespecified interim analysis of the ConquerRSV study, a randomized, double-blind, placebo-controlled trial that enrolled approximately 37,000 adults aged 60 years and older in 22 countries.
The primary efficacy endpoints were based on two definitions of RSV-LRTD, defined as two or more symptoms or three or more symptoms of the disease.
The vaccine was well tolerated and showed a favorable safety profile. Most of the requested side effects were mild or moderate, and the most common in the mRNA-1345 group were injection site pain, fatigue, headache, myalgia, and arthralgia.
The ConquerRSV study is ongoing and additional efficacy analyzes are planned as more cases accumulate, including those with severe RSV. In addition to older adults, mRNA-1345 is being investigated in a full phase 1 trial in the pediatric population.
In Panama, the peak of this disease comes from May, especially in children.
Source: Panama America
I am Amelia James, a passionate journalist with a deep-rooted interest in current affairs. I have more than five years of experience in the media industry, working both as an author and editor for 24 Instant News. My main focus lies in international news, particularly regional conflicts and political issues around the world.
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