Hear
The United States Food and Drug Administration (FDA) approved the mRESVIA vaccine from the Moderna laboratory against respiratory syncytial virus (VSR), better known as bronchiolitis. It is the first mRNA vaccine to be approved for a disease other than Covid-19. It was designed to protect adults over 60 years of age and represents a crucial step in protecting against this serious respiratory disease. With the help of the research group Equipo Ciencia, Argentina was one of the 22 countries where trials were carried out on volunteers.
For its part, last week, in the country the National Administration of Medicines, Food and Medical Technology (Anmat) approved the GlaxoSmithKline (GSK) laboratory vaccine against RSV. AREXVY doses are now available in vaccination centers in Argentina. The FDA had approved this serum in early May.
RSV is a virus that causes respiratory infections in people of all ages. Its transmission occurs through droplets expelled when coughing and breathing. In most cases it manifests mild symptoms, such as a prolonged cold, but occasionally it can seriously affect babies, young children and older adults.
It is the main cause of bronchiolitis in children. For those over 60 years of age, the virus can lead to complications due to the deterioration of the body’s defenses as a result of aging, also called immunosenescence. In older adults or people with risk factors, it can cause severe complications (pneumonia, need for oxygen, prolonged hospitalizations). It represents the second cause of respiratory infections of viral origin and hospitalization (behind the flu) and the first in those vaccinated against the flu.
The FDA approval of Moderna’s mRESVIA is based on positive data from the Phase 3 ConquerRSV clinical trial that included approximately 37,000 adults over the age of 60 from 22 countries, including Argentina. According to the data, the vaccine demonstrated an efficacy against RSV lower respiratory tract disease of 83.7% in the primary analysis and 78.7% in the long-term follow-up. The safety and effectiveness demonstrated by the results determined its approval under the designation of innovative therapy.
Following approval, mRESVIA is expected to be available in the United States for the 2024/2025 respiratory virus season. In addition, Moderna has requested approval in several countries.
In Argentina, the Equipo Ciencia research group played a fundamental role in the development of the mRESVIA vaccine. With more than 1,600 participants, he led the global recruitment of volunteers for the Phase 3 ConquerRSV clinical trial.
“For us it is a huge source of pride. Another milestone in the race we are doing to find solutions for the most serious diseases caused by respiratory viruses,” said Gonzalo Pérez Marc, doctor specializing in clinical pharmacological research, principal investigator at the Central Military Hospital and general director of Equipo Ciencia. And he added: “This is the first approved RSV vaccine that has a messenger RNA platform. The previous ones were recombinant protein.”
The Moderna vaccine is added as another strategy to vaccinate older adults against RSV. “Today there are three vaccines available: GSK’s, monovalent recombinant protein only (approved for older adults); Pfizer’s, which is a bivalent recombinant protein (for adults and pregnant women); and it is made of messenger RNA,” said the director of Team Science.
Regarding approval in Argentina, Gonzalo Pérez Marc pointed out that it should not delay. “Although Anmat has its own decision, it usually takes the FDA definitions into account.”
In March, the Ministry of Health added a free dose of the vaccine developed by Pfizer to the national vaccination schedule for pregnant women between 32 and 36 weeks. The objective of this was to function as a reinforcement of children’s defenses at birth and during their first months of life. The virus is the main cause of acute lower respiratory infections (SARI) in childhood and particularly in infants under one year of age.
For its part, the GSK laboratory announced on May 29 Anmat’s approval of its RSV vaccine and its commercialization. “The doses were distributed through national drugstores and vaccination centers,” the British pharmaceutical company indicated. And they added: “GSK has sufficient stock to respond to the estimated demand in adult patients with comorbidities throughout the country.”
The vaccine developed by GSK had been approved by the FDA in early May. It was the first authorized by the North American organization for those over 60 years of age. As far as he could know THE NATIONGSK’s AREXVY vaccine can be purchased at vaccination centers at a price of $265,000.
