The Food and Drug Administration's (FDA) independent advisory committee voted unanimously in favor of Moderna's mFlusiva vaccine, saying its benefits outweigh the risks for the 50 to 64 and 65 and older age groups, marking an important step toward final approval expected in August.

Studies have shown that Moderna's vaccine reduced flu cases by 27% in a study of 40,000 participants over 50 years of age, also generating a strong immune response in people 65 years of age and older, compared to existing vaccines.

mRNA technology allows for faster adaptation to mutated strains of the flu virus, a technology that was key to ending the COVID-19 pandemic. This position of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) is in open opposition to measures by the Trump administration, which last August canceled $500 million in funds that would be allocated to 22 research projects to create new mRNA vaccines against respiratory diseases that could trigger another health emergency.

Vaccines with this type of technology have the advantage of being manufactured more quickly than other types, something that experts say could be useful if the flu virus, with its ability to change shape, mutates in a way that requires the sudden production of new doses.

“Having this technology puts us in a better position to be prepared for the emergence of new strains in the future,” said Dr. Flor Muñoz-Rivas of Texas Children’s Hospital, one of the FDA advisors.

“We believe mRNA-1010 has the potential to offer an important new option for the prevention of seasonal influenza and further demonstrate the versatility of our mRNA platform,” Stephane Bancel, MBA, MSc, CEO of Moderna, stated in a press release. “We look forward to continuing to collaborate with the FDA as it completes its review,” he stressed.

Preparing for flu season

It is anticipated that, if approved, the mFlusiva vaccine will ensure greater availability of up-to-date doses in years where strain predictions are uncertain.

Moderna plans a follow-up study that will include 400,000 people over the age of 65 to continue evaluating the safety and effectiveness of the vaccine.

Moderna's application has faced regulatory challenges in the past, including criticism over its vaccine comparison methods. Despite this, it is expected that the FDA will move forward with a more positive evaluation, considering the importance of the development of this vaccine in the context of public health.

Understanding mRNA technology

Messenger RNA (mRNA) technology is one of the most important biomedical innovations of recent decades. Its basic principle is simple and elegant: instead of directly administering a therapeutic protein or an attenuated virus to teach the immune system, the genetic instruction necessary for the patient's own cells to build the desired protein is delivered.

mRNA acts as a transient instruction manual that cells read to synthesize a specific protein; This protein can serve as a vaccine, as a temporary gene therapy or as a tool to modulate biological processes.

One of the key advantages of mRNA is its speed and flexibility. The mRNA sequences are designed and synthesized rapidly in the laboratory, allowing agile responses against new pathogens or to personalize treatments.

In vaccines, for example, an mRNA sequence encodes a protein in the pathogen (such as the surface protein of a virus). When administered, the cells produce that protein, the immune system recognizes it as foreign and generates defensive responses—antibodies and T cells—that confer immunity without exposing the body to the entire pathogen.

For mRNA to be useful in the body, it has to overcome several challenges: it is an unstable molecule and easily degraded by enzymes; Furthermore, it must efficiently enter the cells.

Beyond vaccines, the potential applications of mRNA are broad. In cancer therapy, for example, mRNA encoding specific tumor antigens is designed to stimulate an immune response directed against tumor cells. In genetic diseases, mRNA can be used to provide a temporary functional version of a missing or defective protein, avoiding some complications of permanent gene therapies. There is also research that explores the use of mRNA to produce drugs directly in the body, or for tissue regeneration through the temporary expression of growth factors.

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