FLUBLOK® (Influenza Vaccine) US label updated with one of Sanofi's largest flu vaccine safety studies in pregnant individuals
Sanofi announced that the FDA has updated the label for FLUBLOK (Influenza Vaccine) to include data from a new safety study involving pregnant individuals 18 years and older. The study, involving over 48,000 pregnant individuals across multiple flu seasons, demonstrated that FLUBLOK safety is consistent with a standard-dose flu vaccine and pregnancy-related outcomes in the general population.
Key findings include:
- No increased risk of pregnancy, birth or neonatal/infant outcomes compared to standard-dose flu vaccine
- Similar rates of pregnancy outcomes between FLUBLOK and standard-dose vaccine groups
- Comparable birth and neonatal/infant outcomes between the two groups
The CDC, ACIP, and ACOG recommend flu vaccination for pregnant individuals due to their higher risk for severe illness and complications from flu.
Sanofi ha annunciato che la FDA ha aggiornato l'etichetta per FLUBLOK (Vaccino Antinfluenzale) per includere i dati di un nuovo studio sulla sicurezza che coinvolge individui in gravidanza di 18 anni e oltre. Lo studio, che ha coinvolto oltre 48.000 individui in gravidanza in più stagioni influenzali, ha dimostrato che la sicurezza di FLUBLOK è coerente con quella di un vaccino antinfluenzale a dose standard e con gli esiti legati alla gravidanza nella popolazione generale.
I risultati chiave includono:
- Nessun aumento del rischio di gravidanza, parto o esiti neonatali/infantili rispetto al vaccino antinfluenzale a dose standard
- Frequenze simili di esiti di gravidanza tra i gruppi FLUBLOK e del vaccino a dose standard
- Esiti di nascita e neonatali/infantili comparabili tra i due gruppi
Il CDC, l'ACIP e l'ACOG raccomandano la vaccinazione antinfluenzale per gli individui in gravidanza a causa del loro maggiore rischio di malattie severe e complicazioni dovute all'influenza.
Sanofi anunció que la FDA ha actualizado la etiqueta de FLUBLOK (Vacuna contra la Influenza) para incluir datos de un nuevo estudio de seguridad que involucra a individuos embarazados de 18 años o más. El estudio, que involucró a más de 48,000 individuos embarazados a lo largo de varias temporadas de influenza, demostró que la seguridad de FLUBLOK es consistente con la de una vacuna contra la influenza de dosis estándar y los resultados relacionados con el embarazo en la población general.
Los hallazgos clave incluyen:
- No hubo un aumento del riesgo de embarazo, parto o resultados neonatales/infantiles en comparación con la vacuna contra la influenza de dosis estándar
- Tasas similares de resultados de embarazo entre los grupos de FLUBLOK y de vacuna de dosis estándar
- Resultados de nacimiento y neonatales/infantiles comparables entre los dos grupos
El CDC, ACIP y ACOG recomiendan la vacunación antigripal para individuos embarazados debido a su mayor riesgo de enfermedades graves y complicaciones por la gripe.
사노피는 FDA가 FLUBLOK(독감 백신)의 라벨을 업데이트하여 18세 이상의 임산부를 포함하는 새로운 안전성 연구의 데이터를 포함했다고 발표했습니다. 이 연구는 여러 독감 시즌에 걸쳐 48,000명 이상의 임산부를 대상으로 하였으며, FLUBLOK의 안전성이 표준 용량 독감 백신과 일치하고 일반 인구의 임신 관련 결과와도 일관됨을 보여주었습니다.
주요 발견 사항은 다음과 같습니다:
- 표준 용량 독감 백신과 비교했을 때 임신, 출산 또는 신생아/유아 결과에 대한 위험 증가 없음
- FLUBLOK과 표준 용량 백신 그룹 간의 임신 결과 유사성
- 두 그룹 간의 출생 및 신생아/유아 결과 비교 가능
CDC, ACIP 및 ACOG는 임산부가 독감으로 인한 심각한 질병 및 합병증의 위험이 더 높기 때문에 독감 예방 접종을 권장합니다.
Sanofi a annoncé que la FDA a mis à jour l'étiquette de FLUBLOK (Vaccin contre la Grippe) pour inclure les données d'une nouvelle étude de sécurité impliquant des personnes enceintes de 18 ans et plus. L'étude, impliquant plus de 48 000 personnes enceintes au cours de plusieurs saisons de la grippe, a démontré que la sécurité de FLUBLOK est cohérente avec celle d'un vaccin anti-grippal à dose standard et les résultats liés à la grossesse dans la population générale.
Les principales conclusions comprennent :
- Aucun risque accru de grossesse, d'accouchement ou de résultats néonatals/infantils par rapport au vaccin antigrippal à dose standard
- Taux similaires de résultats de grossesse entre les groupes FLUBLOK et vaccin à dose standard
- Résultats de naissance et néonatals/infantils comparables entre les deux groupes
Le CDC, l'ACIP et l'ACOG recommandent la vaccination contre la grippe pour les personnes enceintes en raison de leur risque plus élevé de maladies graves et de complications liées à la grippe.
Sanofi gab bekannt, dass die FDA das Label für FLUBLOK (Grippeschutzimpfung) aktualisiert hat, um Daten aus einer neuen Sicherheitsstudie, die schwangere Personen ab 18 Jahren umfasst, aufzunehmen. Die Studie, an der über 48.000 schwangere Personen in mehreren Grippesaisons teilnahmen, zeigte, dass die Sicherheit von FLUBLOK mit der einer Standarddosis-Grippeimpfung übereinstimmt und die schwangerschaftsbedingten Ergebnisse in der Allgemeinbevölkerung.
Wichtige Ergebnisse sind:
- Kein erhöhtes Risiko für Schwangerschaft, Geburt oder neonatalen/infantilen Ergebnisse im Vergleich zur Standarddosis-Grippeimpfung
- Ähnliche Raten von Schwangerschaftsergebnissen zwischen Gruppen von FLUBLOK und Standarddosis-Impfstoffen
- Vergleichbare Geburts- und neonatalen/infantilen Ergebnisse zwischen den beiden Gruppen
Das CDC, ACIP und ACOG empfehlen die Grippeschutzimpfung für schwangere Personen aufgrund ihres höheren Risikos für schwere Erkrankungen und Komplikationen durch die Grippe.
- FDA updated FLUBLOK label with new safety data for pregnant individuals
- Large-scale study involving 48,781 pregnant individuals supports FLUBLOK's safety profile
- FLUBLOK demonstrated no increased risk of adverse pregnancy, birth, or neonatal outcomes compared to standard-dose flu vaccine
- Study results align with CDC, ACIP, and ACOG recommendations for flu vaccination during pregnancy
- None.
Insights
This study on FLUBLOK's safety in pregnant individuals is significant for Sanofi's vaccine portfolio. The large sample size of over 48,000 participants adds robustness to the findings. Key points:
- No increased risk of adverse pregnancy, birth, or neonatal outcomes compared to standard flu vaccines
- Consistent safety profile with general population outcomes
- Data now included in FDA-approved label, enhancing credibility
This strengthens FLUBLOK's position in the $4 billion U.S. flu vaccine market. It addresses a important gap in vaccine safety data for pregnant women, a high-risk group for flu complications. The timing aligns well with CDC recommendations for vaccination before flu season peaks.
While positive, the impact on Sanofi's
This label update for FLUBLOK is a modest positive for Sanofi's vaccine business. Key financial implications:
- Potential for increased market share in the pregnant women segment
- Enhanced competitive positioning against other flu vaccine manufacturers
- Possible boost to FLUBLOK sales, though likely incremental rather than transformative
Sanofi's vaccine division accounted for about
Investors should view this as a quality improvement rather than a major catalyst. It aligns with Sanofi's strategy of leveraging its extensive vaccine expertise, but is unlikely to significantly move the needle on the stock in the short term.
- US FLUBLOK label1 updated to incorporate new safety study in pregnant individuals
- New safety data involving more than 48,000 pregnant individuals published in American Journal of Obstetrics and Gynecology (AJOG) Global Reports
- Recombinant or inactivated flu vaccines are recommended by the
U.S. Centers for Disease Control and Protection (CDC), Advisory Committee on Immunization Practices (ACIP) and American College of Obstetricians and Gynecologists (ACOG) for individuals who are or will become pregnant during flu season2,3,4 - Sanofi is committed to the ongoing rigorous scientific study of flu vaccines in at-risk populations, including older patients, patients with comorbidities and pregnant individuals
Thomas Grenier
Head of Vaccines,
"Today, we're proud to announce an important update to our label for FLUBLOK, from one of Sanofi's largest flu vaccine safety studies ever done in pregnant individuals, an important at-risk population group for influenza. Here at Sanofi, we strive to bring immunizations to populations at various stages of life. This update is an example of our ambition to continue expanding the body of real-world evidence for our flu vaccines portfolio, grounded in robust efficacy data. We do this so that patients and healthcare providers can have the confidence to use our vaccines as an important preventative tool ahead of the influenza season."
This study was a post-licensure, observational, retrospective safety surveillance study of 48,781 pregnant individuals, including those with chronic conditions.1 In the study, patients were immunized with either FLUBLOK Quadrivalent (
Results showed:
- FLUBLOK demonstrated no increased risk of pregnancy, birth or neonatal/infant outcomes when compared to a standard-dose flu vaccine and estimated pregnancy outcomes for the general population.1
- The most frequently reported pregnancy outcomes in the FLUBLOK Quadrivalent and SD-IIV4 groups respectively were eclampsia/preeclampsia (
8.4% in both cohorts), preterm labor (3.6% and3.5% ), spontaneous abortion (3.1% and3.0% ), congenital/fetal anomalies detected during pregnancy (2.4% in both cohorts), placental abruption (0.8% and0.7% ) and stillbirth/fetal death (0.4% and0.5% ).1 - The most frequently reported birth and neonatal/infant outcomes in the FLUBLOK Quadrivalent and SD-IIV4 groups were small for gestational age (SGA) (
8.8% and8.7% ), major congenital anomalies (7.7% in both cohorts), preterm birth (7.3% and7.5% ), low birth weight (LBW) (5.9% and5.8% ) and failure to thrive (1.0% and1.1% ), respectively.1
Per the CDC, pregnant and postpartum (up to two weeks after the end of pregnancy) individuals are at higher risk for severe illness and complications from flu, particularly during the second and third trimesters.4 The American College of Obstetricians and Gynecologists (ACOG) recommends full vaccination during pregnancy, as this is when the risk of severe illness is highest.3,4 The CDC, Advisory Committee on Immunization Practices (ACIP) and ACOG recommend that individuals who are or will become pregnant during flu season receive an inactivated or recombinant vaccine as soon as it is available, as pregnant persons with influenza may be at increased risk for adverse pregnancy outcomes, including preterm labor and delivery.2,3,4
With over 125 years of heritage in helping protect global public health, Sanofi is one of the world leaders in vaccines, helping to vaccinate more than 500 million people annually. As one of the largest providers of influenza vaccines to
Indication and Important Safety Information for FLUBLOK (Influenza Vaccine)
What is FLUBLOK (Influenza Vaccine)?
FLUBLOK is a vaccine indicated for immunization for the prevention of disease caused by influenza A and B strains represented by antigens contained in the vaccine. FLUBLOK is given to people 18 years of age and older.
IMPORTANT SAFETY INFORMATION FOR FLUBLOK® (INFLUENZA VACCINE)
FLUBLOK should not be given to anyone who has had a severe allergic reaction to any component of the vaccine.
Tell your health care provider if you have ever had Guillain-Barré syndrome (severe muscle weakness) after a previous influenza vaccination.
If FLUBLOK is given to people with a compromised immune system, including those receiving therapies that suppress the immune system, the immune response may be lower than expected.
Vaccination with FLUBLOK may not protect all people who receive the vaccine.
Fainting has occurred following vaccination with FLUBLOK. Procedures should be in place to avoid injury from fainting.
In adults 18 through 64 years of age, the most common side effects were pain where you got the shot, headache, tiredness, and muscle pain. In adults 65 years of age and older, the most common side effects were pain where you got the shot, tiredness and headache. Other side effects may occur.
For more information, talk to your health care professional and refer to the full Prescribing Information for Flublok.
About Sanofi
We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people's lives. Our team, across the world, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.
Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY.
Contacts
Sandrine Guendoul | + 33 6 25 09 14 25 | sandrine.guendoul@sanofi.com
Evan Berland | +1 215 432 0234 | evan.berland@sanofi.com
Timothy Gilbert | + 1 516 521 2929 | timothy.gilbert@sanofi.com
Investor Relations
Thomas Kudsk Larsen | +44 7545 513 693 | thomas.larsen@sanofi.com
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Keita Browne | + 1 781 249 1766 | keita.browne@sanofi.com
Nathalie Pham | + 33 7 85 93 30 17 | nathalie.pham@sanofi.com
Tarik Elgoutni| + 1 617 710 3587 | tarik.elgoutni@sanofi.com
Thibaud Châtelet | + 33 6 80 80 89 90 | thibaud.chatelet@sanofi.com
Sanofi Forward-Looking Statements
This media update contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that pandemics or other global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2023. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
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1 HSIAO, A., YEE, A., IZIKSON, R., FIREMAN, B., HANSEN, J., LEWIS, N., … KLEIN, N. P. (2024). Safety of quadrivalent recombinant influenza vaccine in pregnant persons and their infants. AJOG Global Reports, 100395. https://doi.org/10.1016/j.xagr.2024.100395.
2 Centers for Disease Control and Prevention. Flu Vaccine Safety and Pregnancy. Available at: https://www.cdc.gov/flu/vaccine-safety/vaccine-pregnant.html. Accessed October 2024.
3 The American College of Obstetricians and Gynecologists. Influenza in Pregnancy: Prevention and Treatment. Available at: https://www.acog.org/clinical/clinical-guidance/committee-statement/articles/2024/02/influenza-in-pregnancy-prevention-and-treatment#. Accessed October 2024.
4 Centers for Disease Control and Prevention. Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices –
5 Flublok [Prescribing Information].
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SOURCE Sanofi
FAQ
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