US FLUBLOK label 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 season. 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.
BRIDGEWATER, N.J. , Oct. 16, 2024
The U.S. Food and Drug Administration (FDA) has updated the label for FLUBLOK (Influenza Vaccine) to include data from a new safety study involving pregnant individuals 18 years and older, in time to inform those hoping to comply with U.S. Centers for Disease Control and Prevention (CDC) recommendations to receive their annual flu vaccine ideally before the end of October. The results from the study of more than 48,000 pregnant individuals across multiple flu seasons were recently published in American Journal of Obstetricians and Gynecologists (AJOG) Global Reports and demonstrate FLUBLOK safety is consistent with a standard-dose flu vaccine and pregnancy-related outcomes in the general population.
Thomas Grenier Head of Vaccines, North America, Sanofi
“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.”
Effects on Individuals
The updated label for FLUBLOK incorporating new safety data in pregnant individuals is beneficial for pregnant individuals who are at risk of contracting the flu. This new study provides reassurance that FLUBLOK is safe for use in pregnant individuals and can help protect both the mother and the developing fetus from influenza.
Effects on the World
The incorporation of new safety data in pregnant individuals in the FLUBLOK label has global implications. It sets a precedent for the rigorous scientific study of flu vaccines in at-risk populations, which can lead to improved vaccination recommendations and practices worldwide. By ensuring the safety and efficacy of flu vaccines in pregnant individuals, we can help prevent the spread of influenza and protect vulnerable populations.
Conclusion
The update to the FLUBLOK label incorporating new safety data in pregnant individuals is a significant step in ensuring the safety and efficacy of flu vaccines in at-risk populations. This study contributes to the body of evidence supporting the use of flu vaccines in pregnant individuals and highlights the importance of ongoing research in this area. By prioritizing the health and well-being of pregnant individuals, we can work towards a safer and healthier future for all.
