Moderna reported on August 5 that the United States Food and Drug Administration (FDA) has granted approval for its new messenger RNA vaccine (mFLUSIVA®) aimed at adults aged 50 and over. This is the first influenza vaccine to use the innovative mRNA platform, already successfully used in immunizations against Covid-19.
The pharmaceutical company’s expectation is that the vaccine will begin to be applied in the next season of respiratory diseases in the United States. Moderna also announced that mFLUSIVA® has already started the registration processes in several other parts of the world, with regulatory procedures expected to be completed by 2026.
First mRNA vaccine against influenza hits the market
The objective of mFLUSIVA® is to protect against the most prevalent variants of Influenza viruses, A and B. Although general approval is for individuals over 50 years of age, application in patients aged 65 years and over received authorization under an accelerated FDA regimen, based on relative efficacy studies. However, the clinical benefits for this specific age group still require confirmation through additional clinical trials.
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Who should not receive the mFLUSIVA® vaccine
The vaccine is contraindicated for patients who:
- They had a history of a severe allergic reaction to previous doses of any immunization agent;
- Developed Guillain-Barré Syndrome after vaccination;
- Have a compromised immune system or are undergoing treatment that affects their immune response;
- Are breastfeeding, pregnant or planning to become pregnant;
- They have had injection-related fainting.
Details of the clinical study that supported the approval of the vaccine
The FDA’s decision was based on a Phase 3 clinical study, randomized, with blinded observers and controlled by an active comparator. The research involved 40,703 adults aged 50 and over, distributed across 11 nations. The objective of the study was to analyze the safety and reactogenicity of mFLUSIVA®, in addition to its relative vaccine efficacy (rVE) compared to a standard dose of vaccine, evaluating protection against influenza-like illnesses (ILI) — diagnosed by protocol and confirmed by RT-PCR — caused by any strain of influenza A or B.