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Rachel V Thomas

US FDA Panel Recommends First-Ever mRNA Flu Shot For Older Adults: All About The Moderna Vaccine

The US Food and Drug Administration's independent advisory panel has recommended approval of <span>Moderna</span>'s mRNA-based influenza vaccine for older adults.

The panel backed the vaccine, known as <span>mFLUSIVA</span>, for adults aged 50 years and older, concluding that its benefits outweigh its risks.

If ultimately approved by the <span>FDA</span>, mFLUSIVA would become the world's first messenger RNA (mRNA) vaccine for seasonal influenza. The development could provide a new tool against a disease that causes an estimated 15 million to 60 million illnesses, 180,000 to 700,000 hospitalizations, and 17,000 to 75,000 deaths annually in the United States, according to data from the US Centers for Disease Control and Prevention (CDC).

<h2>What Did The <span rel="noindex">FDA Advisory Panel</span> Decide?</h2>

The recommendation came from the Vaccines and Related Biological Products Advisory Committee (VRBPAC), which reviews vaccine applications and advises the FDA.

The meeting marked the committee's first review of a new vaccine application since 2023 and could lead to the first vaccine approval under the second Trump administration.

In a unanimous vote, all nine panel members supported the use of Moderna's mFLUSIVA vaccine for adults aged 50 to 64 years, as well as for those aged 65 years and older—the age group that had previously raised regulatory concerns.

<strong>Also read: </strong><a href="https://www.healthandme.com/health-news/no-women-aged-20-24-died-of-cervical-cancer-in-england-over-five-years-thanks-to-hpv-vaccine-article-154681867" data-type="tilCustomLink">No Women Aged 20-24 Died of Cervical Cancer in England Over Five Years, Thanks to HPV Vaccine</a>

However, before the vaccine can be made available for the upcoming flu season, it must receive formal FDA approval and be recommended by the CDC's Advisory Committee on Immunization Practices (ACIP). The CDC advisory panel has not recently convened due to ongoing legal and administrative challenges. An FDA decision on the vaccine is expected by August 5.

<h2>How Effective Is Moderna's mRNA Flu Vaccine?</h2>

According to Moderna, the vaccine outperformed standard-dose flu vaccines in adults aged 50 to 64 years.

In a large clinical trial involving approximately 40,000 adults aged 50 years and older, Moderna's mRNA vaccine reduced influenza cases by about 27% compared with another routinely used flu vaccine.

The company also conducted a smaller study among adults aged 65 years and older. The results showed that mFLUSIVA generated a strong immune response compared with a high-dose influenza vaccine already recommended for seniors.

FDA adviser Dr. Anna Durbin of Johns Hopkins University described the immune-response data as "very compelling," adding that "the vaccine looks very promising," AP News reported.

<strong>Read More: </strong><a href="https://www.healthandme.com/health-wellness/sickle-cell-disease-why-india-must-add-curative-treatment-to-meet-its-2047-elimination-goal-article-154672434" data-type="tilCustomLink">Sickle Cell Disease: Why India Must Add Curative Treatment to Meet Its 2047 Elimination Goal</a>

Like Moderna's COVID-19 vaccines, mFLUSIVA uses messenger RNA technology. Rather than introducing a weakened or inactivated virus, mRNA vaccines deliver genetic instructions that help the body's cells produce proteins that trigger an immune response. This approach allows vaccines to be updated more quickly and may improve protection against evolving viruses.

Moderna's data showed no major safety concerns.

The most commonly reported side effects included:

<ul><li>Injection-site pain</li><li>Fever</li><li>Headache</li><li>Fatigue</li><li>Muscle aches</li></ul>

These reactions were generally temporary and are commonly seen with many vaccines. However, they occurred somewhat more frequently than with currently available flu vaccines. FDA reviewers noted that this is typical of mRNA-based vaccines.

If approved, Moderna plans to conduct a large post-approval study involving approximately 400,000 adults aged 65 years and older.

Half of the participants will receive the mRNA vaccine, while the other half will receive one of the currently recommended flu vaccines for seniors. The study is expected to continue across two influenza seasons.

A Moderna executive said the company hopes to make the vaccine available to patients in time for the upcoming flu season, Reuters reported.

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The US Food and Drug Administration's independent advisory panel has recommended approval of Moderna's mRNA-based influenza vaccine for older adults.The panel backed the vaccine, known as mFLUSIVA, for adults aged 50 years and older, concluding that its benefits outweigh its risks.If ultimately approved by the FDA, mFLUSIVA would become the world's first messenger RNA (mRNA) vaccine for seasonal influenza. The development could provide a new tool against a disease that causes an estimated 15 million to 60 million illnesses, 180,000 to 700,000 hospitalizations, and 17,000 to 75,000 deaths annually in the United States, according to data from the US Centers for Disease Control and Prevention (CDC).What Did The FDA Advisory Panel Decide?The recommendation came from the Vaccines and Related Biological Products Advisory Committee (VRBPAC), which reviews vaccine applications and advises the FDA.The meeting marked the committee's first review of a new vaccine application since 2023 and could lead to the first vaccine approval under the second Trump administration.In a unanimous vote, all nine panel members supported the use of Moderna's mFLUSIVA vaccine for adults aged 50 to 64 years, as well as for those aged 65 years and older—the age group that had previously raised regulatory concerns.Also read: No Women Aged 20-24 Died of Cervical Cancer in England Over Five Years, Thanks to HPV VaccineHowever, before the vaccine can be made available for the upcoming flu season, it must receive formal FDA approval and be recommended by the CDC's Advisory Committee on Immunization Practices (ACIP). The CDC advisory panel has not recently convened due to ongoing legal and administrative challenges. An FDA decision on the vaccine is expected by August 5.How Effective Is Moderna's mRNA Flu Vaccine?According to Moderna, the vaccine outperformed standard-dose flu vaccines in adults aged 50 to 64 years.In a large clinical trial involving approximately 40,000 adults aged 50 years and older, Moderna's mRNA vaccine reduced influenza cases by about 27% compared with another routinely used flu vaccine.The company also conducted a smaller study among adults aged 65 years and older. The results showed that mFLUSIVA generated a strong immune response compared with a high-dose influenza vaccine already recommended for seniors.FDA adviser Dr. Anna Durbin of Johns Hopkins University described the immune-response data as "very compelling," adding that "the vaccine looks very promising," AP News reported.How Does The Vaccine Work?Read More: Sickle Cell Disease: Why India Must Add Curative Treatment to Meet Its 2047 Elimination GoalLike Moderna's COVID-19 vaccines, mFLUSIVA uses messenger RNA technology. Rather than introducing a weakened or inactivated virus, mRNA vaccines deliver genetic instructions that help the body's cells produce proteins that trigger an immune response. This approach allows vaccines to be updated more quickly and may improve protection against evolving viruses.Is The Vaccine Safe?Moderna's data showed no major safety concerns.The most commonly reported side effects included:Injection-site painFeverHeadacheFatigueMuscle achesThese reactions were generally temporary and are commonly seen with many vaccines. However, they occurred somewhat more frequently than with currently available flu vaccines. FDA reviewers noted that this is typical of mRNA-based vaccines.What's Next?If approved, Moderna plans to conduct a large post-approval study involving approximately 400,000 adults aged 65 years and older.Half of the participants will receive the mRNA vaccine, while the other half will receive one of the currently recommended flu vaccines for seniors. The study is expected to continue across two influenza seasons.A Moderna executive said the company hopes to make the vaccine available to patients in time for the upcoming flu season, Reuters reported.

us fda panel recommends first-ever mrna flu shot for older adults: all about the moderna vaccine

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