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How is the new Phase III clinical trial of mRNA vaccine against influenza in Argentina?

After the formulations against COVID and Respiratory Syncytial Virus proved to be effective against infections, a new study advances at national level against influenza. Details to Infobae from one of the leaders of the work.

Ever since the COVID-19 pandemic was classified as such, science intensified its efforts to find a vaccine that could put a stop to this new virus. The way was to accelerate what had already been systematically carried out for more than 200 years in the face of different immunizations and drugs: clinical trials.

Today, with SARS-CoV-2, this process has already been recognized by the entire population. That is why in the face of influenza, a disease that causes thousands of infections and deaths worldwide, the response was to develop a new formulation and initiate these processes that guarantee its safety, but also its efficacy and effectiveness.

In this sense, Argentina has once again positioned itself as a world center for this type of trial. Infobae talked to Gonzalo Pérez Marc, pediatrician (MN 110,813), principal investigator of the Hospital Militar Central and General Director of Equipo Ciencia, who will lead a new Phase III study. In this case, it is an immunization against influenza with messenger RNA platform, which was developed by the Pfizer laboratory.

According to the latest Epidemiological Bulletin issued by the National Ministry of Health, between January and the second week of last June, 402,061 Argentines were infected, which translates into 861.8 cases of influenza reported per 100,000 inhabitants. Likewise, 11 deaths due to influenza were reported this year, whereas in 2022, the year in which more cases were recorded since 2014, a total of 143 deaths were reported.
"It is the stepping stone to an immunization with a triple vaccine against coronavirus, influenza and bronchiolitis (RSV). mRNA vaccines have revolutionized the way we fight infectious diseases. Unlike current vaccines, which are modified every year and can take months to produce, this new mRNA vaccine could be quickly adapted to the most frequent flu strains, improving its efficacy and protection," said Pérez Marc in a conversation with Infobae.
In this sense, the expert pointed out that this study is "multicenter, randomized and double-blind", and that it "evaluates the non-inferiority, or superiority, of the vaccine against other existing vaccines, which in this case is the tetravalent vaccine against influenza". "We are evaluating a new messenger RNA platform vaccine against influenza from Pfizer, which is going to be analyzed in the population considered most vulnerable, that is, in those over 65 years of age", said the expert, while clarifying that, in addition, "the safety of the vaccine is always evaluated".
"Unlike other trials, in this case it is not against placebo, but against the vaccine already on the market. The aim is to define whether the efficacy of the flu vaccine with the mRNA platform is superior to the vaccines available today. The rest of the objectives have to do with evaluating whether the level of antibodies is superior and whether the vaccine is equally safe. It has a duration of 6 months from the moment the volunteer enters the study and volunteers over 65 years of age can participate. adult volunteers over 65 years of age can participate"he added.
Regarding the details of this research, Pérez Marc indicated: "It is a short study because, firstly, it is a very large sample and also because this is a vaccine that is already being investigated and for which we have safety data. It is already being investigated in young adults, which is being done here in Argentina, and we are doing research together with the respiratory syncytial vaccine, in other words, as a combo. In the United States, it is already being done together with the COVID vaccine. Therefore, we already have a lot of data on long-term safety, that is to say, for approximately one year, and we have data from other similar studies. And here what is going to be evaluated is the safety in these first six months".

Towards the trivalent vaccine
Vaccines that conjugate more than one formulation and target more than one disease are not new. However, the road towards this goal is longer than when dealing with a single pathology. That is why, for each condition, all the steps of clinical trials are carried out and then must be repeated when these "combos" are consolidated.

"This revolution that has taken place in the field of clinical vaccine research is moving towards a trivalent vaccine. In fact, let us remember that there are already mRNA and recombinant protein vaccines against COVID. These are now being tested against influenza, as well as against RSV, both Pfizer's recombinant protein and Moderna's mRNA. And we are already doing in Argentina, which is the only country in the world and the Military Hospital is the only center in the world, the first combo between RSV and influenzais being investigated", said Pérez Marc.

Likewise, the expert highlighted that "the arrival of messenger RNA platforms and the efficacies that have been seen, both in COVID for the Pfizer and Moderna vaccines and against respiratory syncytial virus in people over 60 years of age, are very high. That is why the new mRNA platform is also being evaluated to have much higher efficacies than those already on the market."

"The next step is to join the three: influenza, COVID and RSV. In the case of Pfizer, it is recombinant protein against RSV and two mRNAs (COVID and Influenza), in the case of Moderna it would be the three messenger RNAs. These studies are already in phase 1. In addition, before reaching this stage, progress is being made in other combinations, human metapneumovirus with RSV, for example. So, the future augurs that there will be triple viral or quadruple viral vaccines in winter, which will allow a person to apply, perhaps annually, only one vaccine for these diseases. Especially in the most vulnerable populations against all respiratory viruses".

Also, when asked about the time when the vaccine against these viruses will finally reach the population, Pérez Marc said: "This messenger RNA vaccine against influenza, which we will be starting the enrollment this Wednesday in Argentina, has already started in the world a short time ago".

"I believe that in a couple of months, although it depends on the global enrollment and the number of positive cases of influenza in the population studied, in addition to the safety events that occur, we may have the result of demonstrating that this vaccine is not inferior to those already on the market, or that it may even be better. Therefore, based on the data for the next six months, one would think that this immunization could be on the market next year".

And he added: "For the trivalent vaccine, I imagine that the Phase 3 studies will be carried out between the first and second half of next year. Thus, if efficacy and safety are demonstrated, as we all hope they will be in clinical studies, it would not be strange to think that by 2025 this vaccine could be reaching people's arms". Finally, he reemphasized the importance of volunteers and assured that those interested can sign up at: www.equipociencia.com

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