Vaccine Info

Flublok Quadrivalent Influenza Vaccine

Flublok Vaccine Description

Sanofi's Flublok Quadrivalent is a recombinant influenza vaccine. Flublok Quadrivalent consists of the 4 influenza strains that have been identified to be the most likely strains for the flu season. An earlier trivalent version was licensed in 2013, but has been replaced by the quadrivalent version, says the CDC.

Flublok is the only flu vaccine made without the use of eggs and 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 contains three times more active ingredients than traditional vaccines and produced significantly higher immune responses to the A strains of influenza (especially H3N2) in the Flublok Quadrivalent study.

Furthermore, Flublok Quadrivalent is the first and only high antigen-content quadrivalent flu vaccine that with its high efficacy makes it ideal for older adults and those with a compromised immune system. 

Flublok is highly purified and does not contain influenza viruses, antibiotics, formaldehyde, preservatives, egg protein, latex, gluten, or gelatin, unlike other flu vaccines.

Sanofi Pasteur recently acquired Protein Sciences that developed the Flublok Quadrivalent vaccine, using a recombinant DNA technology.

Flublok Vaccine Indication

Flublok Quadrivalent is indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B virus(es) contained in each vaccine. Flublok Quadrivalent vaccine is approved for use in persons 18 years of age and older.

Flublok Vaccine Dosage

Flublok Quadrivalent is administered as an intramuscular (IM) injection.

Flublok Vaccine Adverse Events

Flublok Quadrivalent vaccine should not be given to anyone who has had a severe allergic reaction (eg, anaphylaxis) to any component of the vaccine (including egg or egg products for Fluzone Quadrivalent and Fluzone High-Dose vaccines) or after a previous dose of the corresponding vaccine. 

Tell your health care professional if you/your child have ever experienced Guillain-Barré syndrome (severe muscle weakness) after a previous dose of influenza vaccine. If you notice any other problems or symptoms following vaccination, please contact your health care professional immediately.

In adults, the most common side effects to Flublok Quadrivalent vaccine include pain where the shot was given; headache and muscle aches. 

In children, the most common side effects to Flublok Quadrivalent vaccine include pain, redness, and swelling where the shot was given; muscle aches, fatigue, and headache (irritability, abnormal crying, drowsiness, appetite loss, vomiting, and fever in young children). Other adverse reactions to these vaccines may occur. Vaccination with Flublok Quadrivalent may not protect all individuals.

Flublok Vaccine News

December 23, 2019 - The “higher dose” vaccine Flublok® Quadrivalent Influenza Vaccine is currently available for immediate delivery. Sanofi Pasteur is on track to deliver approximately 70 million doses of influenza vaccine to all of our US customers in line with the delivery schedule that was communicated to our customers in June once we assessed the impact of the delayed strain selection on our production timeline.

August 8, 2019 - NIH-funded study will test seasonal flu vaccines with two experimental adjuvants.

August 28, 2017 - Sanofi announced today that it has completed the acquisition of Protein Sciences, a vaccine biotechnology company based in Meriden, Connecticut in the United States. 

June 22, 2017 - Protein Sciences Corporation announced the publication of clinical trial results comparing Flublok® Quadrivalent – the quadrivalent version of Flublok® influenza vaccine – to a traditional egg-based quadrivalent inactivated vaccine. The data published in the June 22nd issue of the New England Journal of Medicine showed that Flublok Quadrivalent provided significantly improved protection against laboratory-confirmed influenza illness in older adults.

Flublok Vaccine Clinical Trial

May 23, 2020 - This Phase 4 observational, postmarketing safety study included persons ≥18 years vaccinated with RIV3 or IIV3 in during the 2015-2016 influenza season. This study evaluated the safety of RIV3 compared with the trivalent standard-dose, inactivated influenza vaccine (IIV3) in Kaiser Permanente Northern California (KPNC).

We compared the rates of pre-specified diagnoses of interest (Guillain-Barré Syndrome, pericarditis, pleural effusion, narcolepsy/cataplexy, asthma, acute hypersensitivity reactions, and fever) during various post-vaccination risk intervals, as well as all-cause hospitalization and mortality 0-180 days following vaccination.

Comparing the 21,976 persons who received RIV3 with the 283,683 who received IIV3, there were statistically significant differences in the pre-specified diagnoses of interest between the 2 groups. Specifically, RIV3 vaccination was associated with fewer fever diagnoses during the 0-41 days post-vaccination (OR 0.38, 95% CI 0.14–0.86). RIV3 was also associated with fewer all-cause hospitalizations during the 0-180 day post-vaccination (OR 0.66, 95% CI 0.61–0.73), which was mostly related to pregnancy-related hospitalizations in IIV3 recipients. There were no serious adverse events or deaths related to RIV3.

Updated
06/15/2020 - 01:56