FluBlok® Vaccine Clinical Trials, Dosage, Indication, Side Effects
Sanofi Flublok® is a recombinant influenza vaccine produced without using eggs. It, therefore, is not subject to the mutations that are sometimes introduced into the vaccine during the process of egg adaptation that can cause the traditional vaccines to be ineffective. Flublok was initially licensed (STN: 125285) for use in the USA by the Food and Drug Administration (FDA) in 2013 and the European Medicines Agency (EMA, EMEA/H/C/005159). It has been used since 2016 and distributed to over 9 million people. The FDA considers the vaccine safe and acceptable for use. Unlike other flu vaccines, Flublok is highly purified and does not contain influenza virus, antibiotics, formaldehyde, preservatives, egg protein, latex, gluten, or gelatin. Flublok Quadrivalent is given to people 18 years of age and older.
On December 14, 2023, an Original Article published by the NEJM reported that the high-dose recombinant vaccine FluBlok conferred more protection against PCR-confirmed influenza than an egg-based standard-dose vaccine among adults between the ages of 50 and 64.
FluBlok quadrivalent is marketed in the E.U. as Supemtek. The European Commission authorized it on November 18, 2020. Visit SanofiFluShots.com to learn about potential flu complications, including heart attack, stroke, and pneumonia, and more about Sanofi's Flublok Quadrivalent (Influenza Vaccine).
Sanofi is located at 14 Espace Henry Vallée, 69007 Lyon, France.
FluBlok Vaccine Price
Sanofi provides a guide for coding and reimbursement for vaccines. According to CMS.gov, the payment allowance for FluBlok in 2022-2023 is $69.94.
FluBlok Vaccine Indication
Flublok vaccine is given to people 18 years and older. Flublok should not be given to anyone with a severe allergic reaction (anaphylaxis) to any vaccine component (including eggs or egg products for Fluzone High-Dose Quadrivalent).
On October 16, 2024, the U.S. FDA updated the label for FLUBLOK to include data from a new safety study involving pregnant women 18 years and older. In this study, FLUBLOK demonstrated no increased risk of pregnancy, birth, or neonatal/infant outcomes compared to a standard-dose flu vaccine and estimated pregnancy outcomes for the general population. Recombinant or inactivated flu vaccines are recommended by the U.S. CDC, Advisory Committee on Immunization Practices, and American College of Obstetricians and Gynecologists for individuals who are or will become pregnant during flu season.
FluBlok and COVID-19 Vaccines
The US Centers for Disease Control and Prevention (CDC) issued interim clinical considerations stating that 'COVID-19 vaccines and other vaccines, including influenza vaccines, can be administered without regard to timing.
FluBlok Vaccine Dosage
Administer Flublok Quadrivalent as a single 0.5 mL dose intramuscular injection only.
FluBlok Vaccine News
October 16, 2024 - Thomas Grenier, Head of Vaccines, North America, Sanofi, stated, "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 women, an important at-risk population group for influenza."
September 13, 2023 - "The flu can be a serious public health threat, leading to complications such as heart attack, stroke, and pneumonia. These can be especially dangerous for older adults, ethnic and racial minority groups who are at an increased risk for being hospitalized from the flu, and those living with chronic conditions, like asthma, diabetes, and heart disease," commented Michael Greenberg, MD, MPH, North America Medical Head of Vaccines at Sanofi.
August 26, 2022 - Sanofi's Flublok® Quadrivalent Vaccine was among the flu vaccines preferentially recommended by the U.S. CDC's ACIP for adults 65+.
October 22, 2020 - Flublok has been given authorization for temporary supply by the U.K. Department of Health and Social Care and the Medicines and Healthcare products Regulatory Agency (MHRA) for immunization against flu in this year's seasonal flu program to meet public health needs. Their assessment was partly based on evidence from another closely related Sanofi flu vaccine, Supemtek. This was recommended for approval by the European Medicines Agency in September 2020. The MHRA assessment showed that the two products are fundamentally similar based on a review of the manufacturing, control, quality, non-clinical, and clinical evaluations.
FluBlok Vaccine Clinical Trials
As of October 2024, the Flublok vaccine has been studied in various clinical trials.
The results from the study of more than 48,000 pregnant individuals across multiple flu seasons were recently published in the American Journal of Obstetricians and Gynecologists (AJOG) Global Reports. They demonstrate that FLUBLOK safety is consistent with a standard-dose flu vaccine and pregnancy-related outcomes in the general population.
A phase 3 efficacy trial demonstrated improved protection against influenza compared to a standard-dose influenza vaccine and reduced the risk of flu by an additional 30% in adults aged 50 years and older.