FDA Evaluates Groundbreaking Mrna Flu Vaccine Proposal

WHO:

ABC News - Dr. Vinay Prasad was a top FDA official involved in a public dispute over Moderna's application earlier this year.

AP News - Dr. Rituparna Das from Moderna stated that the company's ability to quickly manufacture mRNA vaccines could prevent thousands of hospitalizations in older Americans.

NY Post - Moderna is the company seeking FDA approval for the new flu vaccine.

ABC News - U.S. health advisers are involved in the debate regarding the new flu vaccine.

AP News - Dr. Vinay Prasad was a top FDA official involved in a public dispute over Moderna's application.

WHAT:

ScienceAlert - The FDA's independent advisory committee voted unanimously that the benefits of Moderna's mRNA flu vaccine, mFlusiva, appear to outweigh any risks for both the 50- to 64-year-old population and those 65 and older.

ScienceAlert - The FDA will consider the advisory committee's recommendation in making a final decision by early August.

AP News - In a smaller study of people 65 and older, Moderna's shot generated a strong protective immune response compared with a high-dose flu vaccine already recommended for that age group.

NPR - Dr. Lisa Grohskopf from the CDC reported that there have been at least 32 million flu cases, 390,000 hospitalizations, and 24,000 deaths in the U.S. in the past flu season.

NPR - Moderna is planning its required next-step study to include 400,000 people 65 and older, half given the mRNA vaccine and the rest given one of today's special-for-seniors shots, to be repeated for two flu seasons.

NPR - The FDA's top vaccine advisory committee voted unanimously to recommend Moderna's mRNA influenza vaccine, mFlusiva, for adults 50 and over.

NPR - The vote by the Vaccines and Related Biological Products Advisory Committee (VRBPAC) is the first time the committee has reviewed a new vaccine application since 2023.

NPR - If approved, the mRNA flu vaccine could potentially shorten the time to develop a vaccine targeting a specific flu strain from about 6 months to 2-3 months.

NPR - Dr. Lisa Grohskopf from the CDC reported that there have been at least 32 million flu cases, 390,000 hospitalizations, and 24,000 deaths in the U.S. in the past flu season.

ABC News - The FDA's initial review noted that the new vaccine lacks data on very frail older adults and those with weak immune systems.

Ars Technica - In February, a Trump official refused to review the vaccine.

AP News - If the vaccine is cleared for use, Moderna plans a follow-up study of 400,000 people aged 65 and older, with half receiving the mRNA version and the other half receiving current senior-targeted flu vaccines.

NY Post - The new flu vaccine is called mFlusiva and is aimed at people 50 and older.

ABC News - The FDA advisory committee meeting is a step toward a final decision on the vaccine.

AP News - Moderna's mRNA vaccine reduced flu cases by about 27% in a study of 40,000 people aged 50 and older.

AP News - Moderna is seeking full approval for the vaccine's use in the 50- to 64-year-old population and authorization for those 65 and older.

WHERE:

ABC News - The FDA advisory committee meeting is taking place in Washington.

WHEN:

ABC News - The FDA advisory committee meeting is occurring ahead of the winter flu season.

AP News - If the vaccine is cleared for use, Moderna plans a follow-up study of 400,000 people 65 and older.

WHY:

NPR - The mRNA vaccine may offer greater efficacy than standard dose comparators in preventing severe influenza-associated illnesses.

ABC News - The public dispute over Moderna's application was a sign of FDA’s heightened vaccine scrutiny under Health Secretary Robert F. Kennedy Jr.

ABC News - Tens of thousands of Americans die from influenza every year, with older adults being among the most vulnerable.

AP News - Vaccines made with mRNA technology are faster to manufacture, which could help if the flu virus mutates.

HOW:

NPR - Moderna's mRNA flu vaccine includes microscopic doses of mRNA for three to four strains of the flu, totaling about the same weight that a fingerprint leaves on a mirror.

AP News - Severe flu cases in the U.S. generally rise in years when the flu shot doesn’t closely match the circulating virus, and Moderna officials noted that flu strains for fall vaccines are chosen in February.

ABC News - The FDA published a favorable review of Moderna's data and reported no safety concerns ahead of the advisory meeting.

AP News - Moderna's ability to quickly manufacture mRNA vaccines that closely match the latest flu strains could prevent thousands of hospitalizations in older Americans.

(UPDATED June 19, 2026 14:13 UTC)

In a significant development, the FDA's independent advisory committee has unanimously determined that the benefits of Moderna's mRNA flu vaccine, mFlusiva, outweigh any risks for individuals aged 50 to 64 and those 65 and older. The FDA is expected to make a final decision on this recommendation by early August, following a smaller study that showed Moderna's vaccine elicited a strong immune response in seniors compared to a high-dose flu vaccine currently recommended for that age group. Additionally, Moderna is planning a large-scale study involving 400,000 people aged 65 and older, with half receiving the mRNA vaccine and the other half receiving a special flu shot for seniors, to be conducted over two flu seasons.

(UPDATED June 19, 2026 06:41 UTC)

In a significant development, the FDA's top vaccine advisory committee has unanimously recommended Moderna's mRNA influenza vaccine, known as mFlusiva, for adults aged 50 and over. This marks the first time the Vaccines and Related Biological Products Advisory Committee has reviewed a new vaccine application since 2023, and if approved, the mRNA flu vaccine could reduce the time needed to develop a vaccine for a specific flu strain from about six months to just two to three months. Dr. Lisa Grohskopf from the CDC highlighted the urgency of this recommendation, noting that there were at least 32 million flu cases, 390,000 hospitalizations, and 24,000 deaths in the U.S. during the past flu season.

(UPDATED June 19, 2026 01:54 UTC)

Dr. Vinay Prasad, a top FDA official, was involved in a public dispute over Moderna's vaccine application earlier this year, highlighting the agency's increased scrutiny under Health Secretary Robert F. Kennedy Jr. The FDA's initial review of the vaccine raised concerns about the lack of data on very frail older adults and those with weak immune systems. Additionally, in February, a Trump official declined to review the vaccine, further complicating the approval process.

(UPDATED June 18, 2026 21:41 UTC)

Dr. Rituparna Das from Moderna announced that the company's ability to quickly manufacture mRNA vaccines could potentially prevent thousands of hospitalizations among older Americans. If the vaccine receives clearance for use, Moderna plans to conduct a follow-up study involving 400,000 participants aged 65 and older, with half receiving the mRNA vaccine and the other half getting the current senior-targeted flu vaccines. Severe flu cases in the U.S. tend to increase in years when the flu shot does not closely match the circulating virus, and Moderna officials pointed out that flu strains for fall vaccines are selected in February.

(UPDATED June 18, 2026 18:01 UTC)

Moderna is seeking FDA approval for its new flu vaccine, mFlusiva, which targets individuals aged 50 and older, and the FDA advisory committee is currently meeting in Washington to discuss this important step toward a final decision. In a study involving 40,000 participants in the same age group, the vaccine demonstrated a reduction in flu cases by about 27%, and if approved, Moderna plans to conduct a follow-up study of 400,000 people aged 65 and older. With tens of thousands of Americans dying from influenza each year, particularly among older adults, the FDA's favorable review of Moderna's data and the absence of safety concerns could pave the way for a significant advancement in flu prevention.