Moderna Announces Positive Phase 3 Results for Seasonal Influenza Vaccine
Moderna (NASDAQ:MRNA) has announced positive Phase 3 results for its seasonal influenza vaccine candidate mRNA-1010. The vaccine demonstrated 26.6% superior relative vaccine efficacy (95% CI; 16.7%, 35.4%) compared to a licensed standard-dose seasonal influenza vaccine in adults aged 50 years and older.
The study showed strong relative vaccine efficacy across all influenza strains: 29.6% for A/H1N1, 22.2% for A/H3N2, and 29.1% for B/Victoria lineages. In participants aged 65 and older, mRNA-1010 achieved a 27.4% relative vaccine efficacy. The Phase 3 trial (P304) enrolled 40,805 adults across 11 countries, with a median follow-up of six months.
Safety and tolerability profiles were consistent with previous studies, with most solicited adverse reactions being mild. The most common local reaction was injection site pain, while fatigue, headache, and myalgia were the most common systemic reactions. Moderna plans to present the data at an upcoming medical conference and engage with regulators for submissions.
Moderna (NASDAQ:MRNA) ha annunciato risultati positivi di Fase 3 per il suo candidato vaccino stagionale contro l'influenza, mRNA-1010. Il vaccino ha mostrato una efficacia relativa superiore del 26,6% (IC 95%; 16,7%, 35,4%) rispetto a un vaccino stagionale standard a dose autorizzata in adulti di età pari o superiore a 50 anni.
Lo studio ha evidenziato una forte efficacia relativa contro tutti i ceppi influenzali: 29,6% per A/H1N1, 22,2% per A/H3N2 e 29,1% per le linee B/Victoria. Nei partecipanti di età pari o superiore a 65 anni, mRNA-1010 ha raggiunto un'efficacia relativa del 27,4%. La sperimentazione di Fase 3 (P304) ha coinvolto 40.805 adulti in 11 paesi, con un follow-up mediano di sei mesi.
I profili di sicurezza e tollerabilità sono risultati coerenti con studi precedenti, con la maggior parte delle reazioni avverse sollecitate di lieve entità. La reazione locale più comune è stata il dolore nel sito di iniezione, mentre le reazioni sistemiche più frequenti sono state affaticamento, mal di testa e mialgia. Moderna prevede di presentare i dati in una prossima conferenza medica e di interagire con le autorità regolatorie per le sottomissioni.
Moderna (NASDAQ:MRNA) ha anunciado resultados positivos de la Fase 3 para su candidato a vacuna estacional contra la influenza, mRNA-1010. La vacuna demostró una eficacia relativa superior del 26,6% (IC 95%; 16,7%, 35,4%) en comparación con una vacuna estacional estándar con dosis autorizada en adultos de 50 años o más.
El estudio mostró una fuerte eficacia relativa frente a todas las cepas de influenza: 29,6% para A/H1N1, 22,2% para A/H3N2 y 29,1% para las líneas B/Victoria. En participantes de 65 años o más, mRNA-1010 alcanzó una eficacia relativa del 27,4%. El ensayo de Fase 3 (P304) inscribió a 40.805 adultos en 11 países, con un seguimiento medio de seis meses.
Los perfiles de seguridad y tolerabilidad fueron consistentes con estudios previos, siendo la mayoría de las reacciones adversas solicitadas leves. La reacción local más común fue dolor en el sitio de inyección, mientras que la fatiga, el dolor de cabeza y la mialgia fueron las reacciones sistémicas más frecuentes. Moderna planea presentar los datos en una próxima conferencia médica y trabajar con los reguladores para las presentaciones.
모더나(NASDAQ:MRNA)는 계절성 인플루엔자 백신 후보 mRNA-1010의 3상 임상 결과가 긍정적이라고 발표했습니다. 이 백신은 50세 이상 성인을 대상으로 승인된 표준 용량 계절성 인플루엔자 백신에 비해 상대 백신 효능이 26.6% 우수함(95% 신뢰구간; 16.7%, 35.4%)을 입증했습니다.
연구에서는 모든 인플루엔자 바이러스 균주에 대해 강한 상대 백신 효능을 보였으며, A/H1N1 29.6%, A/H3N2 22.2%, B/Victoria 계통 29.1%의 효능을 기록했습니다. 65세 이상 참가자에서는 mRNA-1010이 27.4%의 상대 백신 효능을 달성했습니다. 3상 시험(P304)은 11개국에서 40,805명 성인을 등록했으며, 중앙 추적 관찰 기간은 6개월이었습니다.
안전성 및 내약성 프로파일은 이전 연구와 일치했으며, 대부분의 유발된 이상 반응은 경미했습니다. 가장 흔한 국소 반응은 주사 부위 통증이었고, 피로, 두통, 근육통이 가장 흔한 전신 반응이었습니다. 모더나는 향후 의학 학회에서 데이터를 발표하고 규제 기관과 제출 절차를 진행할 계획입니다.
Moderna (NASDAQ:MRNA) a annoncé des résultats positifs de phase 3 pour son candidat vaccin saisonnier contre la grippe, mRNA-1010. Le vaccin a démontré une efficacité vaccinale relative supérieure de 26,6% (IC à 95 % ; 16,7 %, 35,4 %) par rapport à un vaccin saisonnier standard à dose autorisée chez les adultes âgés de 50 ans et plus.
L'étude a montré une forte efficacité vaccinale relative contre toutes les souches de la grippe : 29,6 % pour A/H1N1, 22,2 % pour A/H3N2 et 29,1 % pour les lignées B/Victoria. Chez les participants âgés de 65 ans et plus, mRNA-1010 a obtenu une efficacité vaccinale relative de 27,4 %. L'essai de phase 3 (P304) a recruté 40 805 adultes dans 11 pays, avec un suivi médian de six mois.
Les profils de sécurité et de tolérance étaient conformes aux études précédentes, la plupart des réactions indésirables sollicitées étant bénignes. La réaction locale la plus fréquente était la douleur au site d'injection, tandis que la fatigue, les maux de tête et la myalgie étaient les réactions systémiques les plus courantes. Moderna prévoit de présenter ces données lors d'une prochaine conférence médicale et d'engager des discussions avec les autorités réglementaires pour les soumissions.
Moderna (NASDAQ:MRNA) hat positive Ergebnisse der Phase-3-Studie für seinen saisonalen Grippeimpfstoffkandidaten mRNA-1010 bekanntgegeben. Der Impfstoff zeigte eine 26,6% höhere relative Wirksamkeit (95%-KI; 16,7%, 35,4%) im Vergleich zu einem zugelassenen Standard-Dosis-Grippeimpfstoff bei Erwachsenen ab 50 Jahren.
Die Studie zeigte eine starke relative Wirksamkeit gegen alle Influenzastämme: 29,6% für A/H1N1, 22,2% für A/H3N2 und 29,1% für B/Victoria-Linien. Bei Teilnehmern ab 65 Jahren erreichte mRNA-1010 eine relative Wirksamkeit von 27,4%. Die Phase-3-Studie (P304) umfasste 40.805 Erwachsene in 11 Ländern mit einer medianen Nachbeobachtungszeit von sechs Monaten.
Die Sicherheits- und Verträglichkeitsprofile entsprachen früheren Studien, wobei die meisten gemeldeten Nebenwirkungen mild waren. Die häufigste lokale Reaktion war Schmerzen an der Injektionsstelle, während Müdigkeit, Kopfschmerzen und Myalgie die häufigsten systemischen Reaktionen waren. Moderna plant, die Daten auf einer bevorstehenden medizinischen Konferenz vorzustellen und mit den Zulassungsbehörden für die Einreichungen zusammenzuarbeiten.
- Superior relative vaccine efficacy of 26.6% compared to standard-dose seasonal influenza vaccine
- Strong efficacy demonstrated across all influenza strains (A/H1N1: 29.6%, A/H3N2: 22.2%, B/Victoria: 29.1%)
- Consistent efficacy across age groups, risk factors, and previous vaccination status
- Large-scale Phase 3 trial with 40,805 participants validates results
- Favorable safety profile with mostly mild adverse reactions
- Injection site pain and systemic adverse reactions (fatigue, headache, myalgia) reported as common side effects
Insights
Moderna's flu vaccine shows 26.6% higher efficacy than standard vaccines, positioning it for potential market disruption in the $7B+ influenza market.
Moderna's mRNA-1010 flu vaccine has achieved a significant clinical milestone by demonstrating 26.6% superior relative vaccine efficacy compared to standard-dose vaccines in older adults. This represents a breakthrough in influenza prevention, as current vaccines typically offer only 40-60% effectiveness. The consistent efficacy across all targeted strains (A/H1N1 at
Particularly noteworthy is the 27.4% higher efficacy in adults 65+ - a population especially vulnerable to influenza complications yet typically showing reduced response to conventional vaccines. The successful Phase 3 trial involving 40,805 participants across 11 countries provides robust evidence for regulatory submissions.
The timing is opportune, following a severe 2024-2025 flu season with 600,000+ hospitalizations. The mRNA platform's ability to precisely match circulating strains addresses a fundamental limitation of egg-based vaccine production, which requires months of lead time and risks mutation during production. This technology could potentially enable more responsive updates to match emerging strains and create combination vaccines with COVID-19 protection.
The safety profile remains consistent with previous findings, showing predominantly mild adverse reactions similar to other mRNA vaccines. With these strong results, Moderna appears well-positioned to disrupt the
mRNA-1010 demonstrated superior relative vaccine efficacy that was
CAMBRIDGE, MA / ACCESS Newswire / June 30, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced positive results from a Phase 3 efficacy study (P304) evaluating the relative vaccine efficacy (rVE) against influenza illness of mRNA-1010, the Company's seasonal influenza (flu) vaccine candidate, compared to a licensed standard-dose seasonal influenza vaccine in adults aged 50 years and older. mRNA-1010 achieved the most stringent superiority criterion prespecified in the protocol, with an rVE of
"Today's strong Phase 3 efficacy results are a significant milestone in our effort to reduce the burden of influenza in older adults. The severity of this past flu season underscores the need for more effective vaccines," said Stéphane Bancel, Chief Executive Officer of Moderna. "An mRNA-based flu vaccine has the potential advantage to more precisely match circulating strains, support rapid response in a future influenza pandemic, and pave the way for COVID-19 combination vaccines."
In a previous Phase 3 study, mRNA-1010 had already demonstrated superior seroconversion rates and geometric mean titer ratios (GMR) against all strains included in the vaccine compared to both high-dose and standard-dose licensed seasonal influenza vaccine. [1]
According to the CDC, seasonal flu-related hospitalizations and outpatient visits reached a 15-year high during the 2024-2025 season. [2] More than 600,000 Americans were hospitalized due to flu-related illness last year, leading to substantial direct and indirect costs, as well as widespread disruption to daily life and work. [3]
P304 ( NCT06602024 ) is a Phase 3, randomized, observer-blind, active-controlled, case-driven, pivotal efficacy, immunogenicity and safety study. The trial enrolled 40,805 adults aged 50 years and older across 11 countries. Participants were randomly assigned to receive either a single dose of mRNA-1010 or a standard-dose licensed comparator, with a median follow-up of six months.
Safety and tolerability of mRNA-1010 were consistent with reported results from a previous Phase 3 study. [4] The majority of solicited adverse reactions (SARs) were mild. Injection site pain was the most common local SAR, and fatigue, headache and myalgia were the most common systemic SARs reported. There were no significant differences between the groups in the rates of unsolicited adverse events, serious adverse events, or adverse events of special interest.
Moderna plans to present these data at an upcoming medical conference and submit for peer-reviewed publication. The Company will engage with regulators on filing submissions for mRNA-1010.
About Moderna
Moderna is a leader in the creation of the field of mRNA medicine. Through the advancement of mRNA technology, Moderna is reimagining how medicines are made and transforming how we treat and prevent disease for everyone. By working at the intersection of science, technology and health for more than a decade, the company has developed medicines at unprecedented speed and efficiency, including one of the earliest and most effective COVID-19 vaccines.
Moderna's mRNA platform has enabled the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and autoimmune diseases. With a unique culture and a global team driven by the Moderna values and mindsets to responsibly change the future of human health, Moderna strives to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit modernatx.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: Moderna's engagement with regulators on filing submissions for its standalone flu vaccine candidate; and the efficacy, safety and tolerability of mRNA-1010. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others, those risks and uncertainties described under the heading "Risk Factors" in Moderna's Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and in subsequent filings made by Moderna with the U.S. Securities and Exchange Commission, which are available on the SEC's website at www.sec.gov . Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date of this press release.
Moderna Contacts
Media:
Chris Ridley
Head of Global Media Relations
+1 617-800-3651
Chris.Ridley@modernatx.com
Investors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
+1 617-209-5834
Lavina.Talukdar@modernatx.com
SOURCE: Moderna, Inc.
View the original press release on ACCESS Newswire
FAQ
What were the Phase 3 results for Moderna's flu vaccine mRNA-1010?
How effective is Moderna's mRNA-1010 flu vaccine in elderly adults?
What are the side effects of Moderna's new flu vaccine mRNA-1010?
How many participants were in Moderna's mRNA-1010 Phase 3 trial?
What is the efficacy of mRNA-1010 against different flu strains?
