The FDA authorized the first messenger RNA for a pathology other than Covid.
Prevents respiratory syncytial, a virus that especially affects infants and older adults.
MMR is the vaccine that protects against measles, rubella and mumps and is one of the vaccines included in the national immunization schedule. But perhaps in a few years, there will be another MMR. The FDA, the equivalent body of our ANMAT, has just taken an important step in that direction: it authorized a new messenger RNA vaccine that was tested in Argentina.
To understand what we are talking about and why it is important, we need to put it in context and go back in time to the pandemic era, when the "panvaccine" or triple vaccine was first being discussed. At the dawn of Covid vaccination, the novel messenger RNA platform was opening up a world of immunology.
At that time, the focus was already on what would happen in the future: this technology would make it possible to develop, in a single jab, protection against the new Covid and against the old known influenza, and also against a well-known but underestimated virus: respiratory syncytial virus (RSV).
This 2024 seems to be the year of the syncytial. Back to context, in 2023 this respiratory virus collapsed the pediatric ward due to cases of bronchiolitis, as it usually happens, but in recent times it has worsened due to the lack of pediatricians.
This year, for the first time, a vaccine against RSV was started to be applied to pregnant women and it is able to protect infants. The impact of this vaccine - developed by the U.S. pharmaceutical company Pfizer - will not be assessed until the winter is over, but the authorities of the Ministry of Health had indicated a few weeks ago that the vaccination campaign is going very well.
This vaccine is included in the national vaccination schedule, so it is mandatory and free of charge. But the syncytial is a virus that is characterized by hitting more severely in the two extremes of life: young children and older adults. ANMAT authorized this year this Pfizer vaccine and another one developed by the British company GSK for people over 60 years of age, but in this case in the private sector. Both are already available in vaccination centers and use a virus prefusion protein.
The RSV vaccine was one of the "holy grails" of immunology. It has been investigated for decades and only now, with the prefusion protein, an effective vaccine has been achieved. And also with messenger RNA.
The new vaccine tested here
Earlier this month, the highest U.S. health authority authorized the first RSV vaccine with messenger RNA, developed by the U.S. laboratory Moderna. In Argentina, it is estimated that the application for approval will be made soon. Here, Moderna's Covid vaccine is marketed by the Raffo laboratory, which could expand its portfolio to other vaccines. Moderna is also studying a messenger RNA vaccine for influenza.
Gonzalo Pérez Marc is principal investigator of Equipo Ciencia, which conducted trials in Argentina of Pfizer's Covid vaccine, the two US RSV vaccines and Moderna's influenza vaccine. For this new RSV vaccine, he led the global recruitment of volunteers for the Phase 3 clinical trial, with more than 1,600 participants.
This first approval of a messenger RNA vaccine for a pathology other than Covid "represents an important milestone in the fight against RSV and we are proud to have contributed to its development," the scientist remarked.
"We are achieving new vaccines for old viruses that had no vaccines," remarks Pérez Marc.
Respiratory syncytial, he says, "is as or more harmful than the flu," mainly because of "the impact on patients with cardiovascular pathology. It destabilizes heart failure," he explains about the impact on older adults hospitalized for RSV.
However, he concedes, it is a virus that is somehow underestimated because it is little tested. He believes that with the vaccines, we will begin to have a better understanding of its seriousness and it will be investigated more because now it can also be prevented. And he is convinced that the new RSV vaccines will change the paradigm.
In the short term, there will be a combination of options to cover the entire spectrum of prevention and care. On the one hand, the authorized vaccines for older adults and for pregnant women to protect the youngest (who are often the ones who infect their grandparents who take care of them). On the other hand, the already existing monoclonal antibodies used in infants.
In addition, an inhaled pediatric vaccine from the French laboratory Sanofi will be tested, which not only has the advantage of application but would generate antibodies in the upper airways, thus reducing transmissibility.
But there is more: an antiviral, also developed by Pfizer, for pediatrics and older adults, to lower the burden of disease, because as we learned with Covid, vaccines significantly prevent disease but do not prevent transmission.
