Flulaval Vaccine Package Insert
NDC 19515-897 FLULAVAL QUADRIVALENT 2019/2020
URGENT: VACCINE RECALL 2014-2015 Season FLULAVAL® QUADRIVALENT Package Size: 10 Prefilled Syringes (PFS) each containing one 0.5 mL dose Carton NDC 19515-894-52 Syringe NDC 19515-894-41
June 7, 2018 – Do health care providers trust product monograph information regarding use of vaccines in pregnancy? A qualitative study “The first statement emphasized uncertainty: “safety and effectiveness in pregnancy is not established [and it should be used] only if clearly needed” (Fluvirin®, Novartis Vaccines and Diagnostics, Ltd, Liverpool, United Kingdom; Fluzone®, Sanofi Pasteur Inc, Swiftwater, Pennsylvania, US). The second statement described conditions for vaccine use: “use only following the advice of a health care professional, based on consideration of the benefits and risks to the mother and the foetus” (FluLaval®, GlaxoSmithKline, Sainte-Foy, Québec, Canada). The third statement most closely aligned with public health recommendations: “use only from the 2nd pregnancy trimester onwards [limiting use throughout pregnancy to women] at risk of complications of infection” (Vaxigrip®, Sanofi Pasteur Ltd, Lyon, France). … Rather than enabling the evidence-based use of vaccines, ambiguously worded and outdated product monograph statements may be a barrier to vaccine uptake during pregnancy in Canada. Health Canada, NACI and vaccine manufacturers should consider adopting best practices for developing product monograph content that clearly conveys the risks and benefits of vaccination during pregnancy in language that health care providers can understand.”
May 11, 2016 – Post-licensure surveillance of quadrivalent inactivated influenza (IIV4) vaccine in the United States, Vaccine Adverse Event Reporting System (VAERS), July 1, 2013−May 31, 2015 “Febrile seizures. We identified 19 reports of febrile seizures; 12 were verified. Age ranged from 4 to 35 months; 11 reports were in males and seven in females. Median onset interval from vaccination to febrile seizure onset was 12 h (range 0–12 days). Four febrile seizures were classified as serious. In 14 (78%) reports, IIV4 was given concurrently with other vaccines. All 18 children reportedly recovered. Vaccination in pregnancy. We identified 36 reports of pregnant women who received IIV4 with a median age of 32 years (range 15–42 years); 34 received IIV4 alone. Twenty-three reports specified the trimester of pregnancy: nine in first trimester, nine in second trimester, and five in the third trimester. Three reports described an AE related to pregnancy: spontaneous abortion, uterine bleeding, and trisomy (one report each).”
April 12, 2016 – PEDIATRIC ADVISORY COMMITTEE MEETING “After the full review, the vaccines met 4/12/16 PEDIATRIC ADVISORY COMMITTEE MEETING Page: 86 Anderson Court Reporting — 703-519-7180 — www.andersonreporting.net the criteria for an abbreviated presentation format, because there were no new safety signals recognized. There were no reports specifically of pediatric deaths that would be attributed to the vaccine. The FDA would see that the product could go back to continued routine monitoring. The first vaccine is the FluLaval Quadrivalent vaccine. … The initiation of this pediatric post marketing safety review, was August 15, 2013, approval of FluLaval Quadrivalent vaccine in persons 3 years and older. Based on the background material you receive the plan would be that FDA will continue its ongoing standard safety monitoring. … Questions? All right, hearing none, we can vote on the question, does the Committee concur with continuing standard ongoing safety monitoring for the FluLaval Quadrivalent influenza virus vaccine? … (Committee concurs with FDA’s view, passed unanimously. No nays.)
June 2011 – Ovalbumin content of 2010-2011 influenza vaccines “In summary, although these data suggest that the 2010-2011 FDA-approved influenza vaccines measured in this study have lower ovalbumin content than last season and are well below 1.2 μg/mL, there is still uncertainty with lot-to-lot variability and variability from year to year and manufacturer to manufacturer. Measurement and reporting of the actual ovalbumin content of each manufacturer’s vaccine would provide additional assurance that specific influenza vaccines do contain very low levels of ovalbumin. This could be done annually by the manufacturers, by academic centers, or by the Centers for Disease Control and Prevention with laboratory capabilities and resources available to provide this information.”
Summer 2013 – Letter to Hospital Authorities on Mandatory Influenza Vaccination “From 5% to 11% of children became febrile after vaccination. Importantly, the studies of 10,000 people on which approval was based only looked at a 21‐day window after the vaccination. Other problems self‐reported via the vaccine registry include Stevens‐Johnsons syndrome, encephalomyelitis, neuritis, facial palsy, meningitis, myelitis, Guillain‐Barré syndrome, and other neurologic sequelae. There is general agreement that neurologic problems can occur after immunizations of various sorts, and that these neurologic changes are of an acute and unpredictable nature. Guillain‐Barré is perhaps the best known of the risks. The incidence is unknown because of the sometimes delayed onset and the need for self‐reporting, but is common enough that during my career I have seen a handful of cases that occurred after vaccination. This ascending paralysis can be fatal or leave permanent movement and sensory deficits. A study of 10,000 people may not be large enough to capture the incidence in controlled studies, and cases will be missed in studies looking at only a 21‐day postvaccination window.”