In a press release, Pfizer announced that its vaccine against Respiratory Syncytial Virus (RSV)the virus responsible for bronchiolitisachieved an efficacy of 85,7%. This figure is the result of a preliminary analysis of the Phase III study. Phase IIIstudy, aimed at over 60 years of agewhich has more than 8,000 volunteers in Argentina. Infobae talked to Gonzalo Pérez Marca pediatrician (MN 110.813) and principal investigator of the study that is being developed at the Military Hospitalto know how the research that is being developed on national soil continues.
"These results are historic because it is the first time that a vaccine against RSV not only proves to be effective, which would be a value above 40%, but it also proves it at a very high level, almost 86%", said Pérez Marc in an interview with Infobae. In this sense, he recalled that this immunization has been under study since the end of the 60s and that, with these figures, it is "really a milestone in the field of immunization, It is "really a milestone in the research of respiratory virus vaccines".
The study, called RENOIRanalyzes the performance of the bivalent vaccine which targets pre-fusion proteins of the virus with cells, whose vaccine platform is made of recombinant proteins, and is "administered to adults 60 years of age or older".. "A vaccine efficacy of 85.7% was observed in participants with the primary endpoint of most severe lower respiratory tract illness (LRTI-RSV), defined by analysis of three or more RSV-associated symptoms," Pfizer said.
"Today, we have this efficacy for people over 60 years of age, which is very important because they are the people most at risk of presenting serious complications secondary to low lung disease or respiratory syncytial virus pneumonia. They are the ones who have a higher incidence of heart attacks, worsening of previous conditions, heart failure, lung damage and death," said Pérez.
According to Pfizer, this vaccine seeks to attack RSV disease, which is characterized by various respiratory symptoms that vary from a mild to a more severe illness.. "A pre-planned interim analysis of the efficacy of Pfizer's RSVpreF, conducted by an external, independent Data Monitoring Committee (DMC) to assess protection against RSV-associated lower respiratory tract disease (LRTI-RSV) defined by two or more symptoms, demonstrated the vaccine's efficacy: 66.7%," they said in the statement.
This result, Pfizer said, also allowed them to analyze the primary endpoint of the most severe RSV illness, which is defined by three or more symptoms. It was at this stage that "a vaccine efficacy of 85.7% was observed", while the Committee also noted that "a vaccine efficacy of 85.7% was observed".The Committee also noted that "the investigational vaccine was well tolerated, with no safety problems".
"We are delighted that this first bivalent RSV candidate vaccine has been observed, RSVpreFis effective in our clinical trial against this disease, which is associated with high levels of morbidity and mortality in older adults", said Annaliesa Andersonsenior vice president and chief scientific officer of vaccine research and development at Pfizer.
"A vaccine efficacy of 85.7% was observed in participants with the primary endpoint of more severe lower respiratory tract disease," Pfizer said.
In this regard, the executive said: "Scientists and researchers have been working to develop RSV vaccines with little success for more than half a century. These findings are an important step in our effort to help protect against RSV disease, and we look forward to working with the FDA and other regulatory agencies to ensure that this candidate vaccine will be a successful vaccine candidate.and we look forward to working with the FDA and other regulatory agencies to make this vaccine candidate available to help address the substantial burden of RSV disease in older adults." "Each year an estimated 336,000 older adults are hospitalized globally due to RSV," he added.
According to the advance, the documents for approval by the Food and Drug Administration (FDA) are expected to be submitted this year, during the fall of this year.. In addition, the U.S. laboratory assured that it will seek to "present the results of this provisional analysis at a future medical congress", while "sending the results for peer review in a scientific journal".
"Obviously the efficacy is already there, but the safety of the volunteers is followed for a year, as is always the case with these trials," Perez Marc said.
The Phase III trial is a global, randomized, double-blind, placebo-controlled (1:1 ratio) study; which is "designed to evaluate the efficacy, immunogenicity and safety of a single dose of RSVpreF in adults aged 60 years and older." So far, RENOIR has about 37,000 volunteers worldwide, of whom worldwide, of which more than 8,000 more than 8,000 are Argentines.
"The study in Argentina started in November last year, in two stages. One was done in November, December and January; and the other in June, July and August. So far, more than 8,000 people have enrolled; that is to say, almost one fifth of the almost one fifth of the world study is being carried out on national soil," said Pérez Marc."said Perez Marc. According to the scientist, this study is not only carried out at the Central Military Hospital, but there are other centers all over the country where the analysis is carried out.
The scientist also warned that this study on the bronchiolitis vaccine "continues to work". "Obviously, the efficacy is already there, but the safety of the volunteers is being monitored for one year, as always happens with these trials," he pointed out and added: "The laboratory is going to present the documents to the FDA for the approval of this vaccine, and thus be able to market it. In this way, all the countries that consider it convenient will be able to include it in their vaccination schedules".
On the other hand, with respect to the test he is analyzing, with this same formula, he same formulathe protection provided by pregnant women to their newborns, Pérez Marc said: "We are close to the end of the enrollment process.We are close to the end of enrollment, which will be in October.which will be in October. Once we finish vaccinating them, we will continue with the children until after they are one year old to see the same efficacy. Some of the children are finishing their birth now and they will be followed until they are one year old.".
In any case, Pérez Marc was hopeful about this immunization aimed at newborns, after the results in people over 60 years of age, and stressed: "That it is the same vaccine that is inoculated to pregnant women, and that it is the same vaccine that is inoculated to pregnant women. pregnant women allows us to think that it can also have a very high efficacy can also have a very high efficacy in children born to vaccinated mothers.. The efficacy is not yet known, but it augurs a good result, although we have to finish it and evaluate the results. With the same efficacy, we would be talking about the first vaccine against RSV that protects newborn children, who are at higher risk of severe bronchiolitis, the main cause of morbidity and mortality due to respiratory infection in infancy and early childhood worldwide".
It is worth noting that, as reported by Pfizer, this vaccine "builds on fundamental basic science discoveries, including those made at the National Institutes of Health (NIH), which detailed the crystal structure of the F-prefusion, a key form of the viral fusion (F) protein that RSV uses to enter human cells."
By Romina Cansler-Infobae
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