Vaccine Choice Canada received this urgent missive from Meryl Nass MD who stated that:
“ I think this is pretty important for legislators to see–using a novel adjuvant only in those over 65 and babies under 24 months–this adjuvant is not used in children in the US.”
The National Advisory Committee on Immunization (NACI) provides details of their approval here: https://www.canada.ca/content/dam/phac-aspc/migration/phac-aspc/naci-ccni/assets/pdf/pediatric-pediatrique-fluad-eng.pdf
Dr. Nass writes, “What I would really like to do is use Fluad as an example of how Canada has already used a novel adjuvant (MF59/Fluad) on 6-24 month old babies with very limited info on safety or efficacy, according to Canada’s own vaccine advisory group. This is basically an experiment on babies without informed consent. Such vaccines have not been approved for children in the US.
Canada licensed Fluad for those over 65 around 2011. And then a few years later started giving it to babies.”
Quoting from page 4 of the NACI Report;
“Until recently, seasonal influenza vaccines approved for use in Canada did not include adjuvants. In 2011, Fluad®, an inactivated subunit adjuvanted trivalent influenza vaccine (ATIV), containing MF59™ as the adjuvant, was approved for use in older (≥ 65 years) adults for active immunization against influenza. Adjuvanted vaccines were used extensively during the 2009 H1N1 pandemic; a monovalent AS03 adjuvanted vaccine was used in Canada. However, the discussion of adjuvanted pandemic vaccines is beyond the scope of this review and has been excluded.”
“Based on this review, information on comparative efficacy is available only from a single trial suggesting a higher efficacy for ATIV (86% vs. 40% for comparator UTIV). The bulk of the data was obtained during one mild season that was dominated by influenza A/H3N2. The comparator vaccine induced a poorer immune response compared to equivalent UTIVs. There were also concerns raised by a European Medicine Agency inspection about the quality of diagnostic laboratory testing and validity of ascertainment of influenza cases.”
Quoting from page 5 of the NACI Report;
“Taken together, the limited body of evidence identified in this review suggests that ATIV (adjuvanted trivalent influenza vaccine) is likely both more immunogenic and more reactogenic than UTIV among children 6-72 months of age. There are insufficient data to assess whether ATIV is more effective than UTIV or LAIV in practice or to make an informed risk-benefit analysis. “
Quoting from page 11 of the NACI Report:
“Excluding the pandemic year, the number of deaths attributed to influenza in Canadian children was small, ranging from 2-6 per season,”
Quoting from page 12 of the NACI Report:
“The European Medicines Agency (EMA) raised concerns regarding trial V70P5 during the regulatory approval process in 2011. Critical and major flaws in good clinical practice (GCP) were identified following an inspection of the sites of the main study. Some of these flaws included: • insufficient quality assurance system at the laboratory site in Germany, • reliability of patient data collection (including recording of adverse events and tracking of suspected influenza cases) and data handling, and • issues with sample storage and transport, including lack of temperature monitoring (some samples may have reached temperatures that resulted in sample degradation). As evidenced in the product monograph, data from the efficacy trial was also not considered in granting product authorization in Canada. NACI considers the findings from the report of the EMA should be taken into account when assessing the results from the study.”
Quoting from page 16 of the NACI Report:
“All the identified primary clinical trials were sponsored and conducted by the manufacturer with the aim of obtaining licensure for pediatric use. No data provided by independent researchers were available for review.”
Despite this exceedingly lukewarm review, the same group (NACI) recommended Fluad for babies in 2016: https://www.canada.ca/en/public-health/services/reports-publications/canada-communicable-disease-report-ccdr/monthly-issue/2016-42/ccdr-volume-42-9-september-1-2016/ccdr-volume-42-9-september-1-2016-scientific-writing-5.html
Fluad Pediatric Vaccine Monograph is here: https://www.novartis.ca/sites/www.novartis.ca/files/fluad_scrip_e%202016.pdf
The Northwest Territories is the only province/territory to use Fluad Pediatric at this time (2019/2020) to our knowledge.
NWT vaccine schedule: https://vaccinechoicecanada.com/wp-content/uploads/vcc-northwest-territories-vaccine-schedule-1983-vs-2020.pdf