Flublok [Influenza Vaccine] is a sterile, clear, colorless solution of recombinant hemagglutinin (HA) proteins from three influenza viruses for intramuscular injection. It contains purified HA proteins produced in a continuous insect cell line that is derived from cells of the fall army worm, Spodoptera frugiperda, and grown in serum-free medium composed of chemically-defined lipids, vitamins, amino acids, and mineral salts. Each of the three HAs is expressed in this cell line using a baculovirus vector (Autographa californica nuclear polyhedrosis virus), extracted from the cells with Triton X-100 and further purified by column chromatography. The purified HAs are then blended and filled into single-dose vials”
Flublok Quadrivalent Product Information and Supporting Documents
Package Insert – Flublok Quadrivalent
Found 386 cases where Vaccine is FLUR4 and Manufacturer is PROTEIN SCIENCES CORPORATION
July 26. 2018 – Repeat vaccination reduces antibody affinity maturation across different influenza vaccine platforms in humans “This study identifies an important impact of repeat vaccination on antibody-affinity maturation following vaccination, which may contribute to lower vaccine effectiveness of seasonal influenza vaccines in humans”
October 19, 2017 – Influenza vaccine response: future perspectives “Possible explanations for reduced LAIV VE has been a decreased immune response against A/H1N1pdm09 (thought to be the result of a more highly vaccinated population during seasons 2013–2014 and 2015–2016), antigenically drifted A/H3N2 viruses during the 2014–2015 season, potential interference of viruses included in the LAIV, heat susceptibility, and also methodological issues in studies (biases in the design and statistical limits) … The decision of the ACIP to no longer support its use in the United States was not supported by several other health authorities where LAIV VE was considered adequate. Given the lack of clarity behind these differences, there is an urgent need for its clarification since LAIV can significantly improve vaccination rates in all ages, especially in children. … Factors like age, sex, and immunity inherited factors are complex phenomena that cause several changes to different components of the immune system.”
April 2013 – Egg-independent influenza vaccine: making great strides forward (pdf) “FluBlok, is a trivalent influenza vaccine composed of highly purified recombinant influenza hemagglutin (rHA0) proteins (45 µg for each virus strains) that are manufactured by using Protein Sciences’ proprietary baculovirus expression vector system (BEVS) technology and expresSF+® cell line.”
March 1, 2013 – Approval History, Letters, Review, and Related Documents – Flublok
January 16, 2013 – FDA approves new seasonal influenza vaccine made using novel technology “Unlike current flu vaccines, Flublok does not use the influenza virus or eggs in its production. Flublok’s novel manufacturing technology allows for production of large quantities of the influenza virus protein, hemagglutinin (HA) – the active ingredient in all inactivated influenza vaccines that is essential for entry of the virus into cells in the body. The majority of antibodies that prevent influenza virus infection are directed against HA. While the technology is new to flu vaccine production, it is used to make vaccines that have been approved by the FDA to prevent other infectious diseases. “This approval represents a technological advance in the manufacturing of an influenza vaccine,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research. “The new technology offers the potential for faster start-up of the vaccine manufacturing process in the event of a pandemic, because it is not dependent on an egg supply or on availability of the influenza virus.”
January 16, 2013 – Flublok Summary Basis for Regulatory Action (pdf) “flublok Final Product Composition Ingredients Quantity per 0.5 mL dose Active Ingredients Recombinant hemagglutinin (HA) proteins from the influenza virus strains 45 mcg recombinant HA per influenza strain Excipients Sodium chloride Monobasic sodium phosphate Dibasic sodium phosphate Polysorbate 20 4.4 mg 0.195 mcg 1.3 mg 27.5 mcg
October 2012 – Innovations in vaccine development: can regulatory authorities keep up? (full text) “Manon Cox (Protein Sciences Corporation, CT, USA) illustrated regulatory challenges associated with novel cell substrates. Protein Sciences’ biologics license application for approval of FluBlok®, a new recombinant influenza vaccine for the prevention of the influenza in healthy adults 18 years and older, was filed in April 2008 and is still under scrutiny due to reviewers questions relating to the potential presence of unknown retroviruses in this new insect cell substrate, despite previous approval of Cervarix® and Provenge® by this agency; two other vaccines made using insect cell substrates.
September 2011 – New technologies to meet the challenge of pandemic (pdf) “As for other prophylactic vaccines, regulatory scrutiny of these processes will be particularly high, with a strong focus on safety. Because no recombinant or cell-culture based influenza vaccine has yet been approved for sale in the United States, regulatory uncertainty for approval of these new approaches remains high.”
March 9, 2011 – Evaluation of the safety, reactogenicity and immunogenicity of FluBlok® trivalent recombinant baculovirus-expressed hemagglutinin influenza vaccine administered intramuscularly to healthy adults 50-64 years of age. “Alternative methods for influenza vaccine production are needed to ensure adequate supplies.”
November 5, 2009 – Evaluation of the safety, reactogenicity and immunogenicity of FluBlok® trivalent recombinant baculovirus-expressed hemagglutinin influenza vaccine administered intramuscularly to healthy children aged 6–59 months “These data suggests that FluBlok is as safe but less immunogenic than similar volumes of TIV, particularly in the youngest children. The immunogenicity data is the converse of what has been observed in adults. Further studies examining the immunogenicity of FluBlok in older children are warranted.”
June 2009 – FluBlok, a next generation influenza vaccine manufactured in insect cells “In addition, this review includes an update on the clinical development of FluBlok. The highly purified protein vaccine, administered at three times higher antigen content than TIV, is well tolerated and results in stronger immunogenicity, a long lasting immune response and provides cross-protection against drift influenza viruses.”
December 8, 2008 – FluBlok, a recombinant hemagglutinin influenza vaccine “FluBlok, a recombinant trivalent hemagglutinin (HA) vaccine produced in insect cell culture using the baculovirus expression system, provides an attractive alternative to the current egg-based trivalent inactivated influenza vaccine (TIV) manufacturing process. “