It is Moderna's messenger RNA; a few days ago, Anmat authorized the commercialization in the country of the drug manufactured by GlaxoSmithKline; meanwhile, Pfizer's drug is included in the calendar for pregnant women between 32 and 36 weeks.
The trials in the country were carried out at the Central Military Hospital, in Palermo.
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The U.S. Food and Drug Administration (FDA) has approved Moderna's mRESVIA vaccine against respiratory syncytial virus (RSV), better known as bronchiolitis, for the first mRNA vaccine to be approved for a disease other than Covid-19 . 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 the protection against this serious respiratory disease. Argentina was one of the 22 countries where the vaccine was tested on volunteers by the research group Equipo Ciencia.
Last week, the National Administration of Medicines, Food and Medical Technology (Anmat) approved GlaxoSmithKline's (GSK) vaccine against RSV. AREXVY doses are already available in Argentina's vaccination centers. The FDA had approved this serum in early May.
RSV is a virus that causes respiratory infections in people of all ages. It is transmitted 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 infants, young children and older adults.
It is the main cause of bronchiolitis in children. In 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 generate severe complications (pneumonia, need for oxygen, prolonged hospitalization). It represents the second cause of respiratory infections of viral origin and hospitalization (after influenza) and the first in those who are vaccinated against influenza.
The FDA's approval of Moderna's mRESVIA is based on positive data from the ConquerRSV Phase 3 clinical trial involving approximately 37,000 adults over 60 years of age from 22 countries, including Argentina. According to the data, the vaccine demonstrated efficacy against RSV lower respiratory tract disease of 83.7% in the primary analysis and 78.7% in long-term follow-up. The safety and effectiveness demonstrated by the results determined its approval under the innovative therapy designation.
Following approval, mRESVIA is expected to be available in the United States for the 2024/2025 respiratory virus season. In addition, Moderna has filed for approval in several countries.
The study in the country
Gonzalo Pérez Marc, principal investigator of the study that includes a team of 800 people.
Courtesy of Hospital Militar Central
Moderna's vaccine is added as another strategy to vaccinate older adults against RSV. "Today there are three vaccines available: GSK's monovalent recombinant protein vaccine alone (approved for older adults); Pfizer's bivalent recombinant protein vaccine (for adults and pregnant women); and the messenger RNA vaccine," said the director of Equipo Ciencia.
Regarding approval in Argentina, Gonzalo Pérez Marc pointed out that it should not take long. "Although Anmat has its own decision, it usually takes the FDA's definitions into account".
Groups
In March, the Ministry of Health incorporated a free dose of the vaccine developed by Pfizer into the national vaccination schedule for pregnant women between 32 and 36 weeks. The purpose of this vaccine was to reinforce children's defenses at birth and during their first months of life. The virus is the main cause of acute lower respiratory infections (ALRI) in childhood and particularly in infants under one year of age.
For its part, GSK laboratory announced on May 29 the approval by Anmat of its vaccine against RSV and its commercialization. "The doses were distributed through nationwide drugstores and vaccination centers", the British pharmaceutical company stated. And they added: "GSK has enough stock to meet 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 one authorized by the US agency for people over 60 years of age. According to LA NACIÓN, GSK's AREXVY vaccine can be acquired in vaccination centers at a price of $265,000.
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