fact-checker/fact_checked_claims.json at main · wish2023/fact-checker · GitHub

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{
    "claims": [
        {
            "claim": "Flublok ensures identical antigenic match with WHO- and FDA-selected flu strains.",
            "match_source": [
                {
                    "document_name": "Clinical Files/FlublokPI.pdf",
                    "matching_text": "Flublok contains recombinant HA proteins of the three strains of in\ufb02uenza virus speci\ufb01ed by health authorities for inclusion in the annual seasonal vaccine."
                }
            ]
        },
        {
            "claim": "Flublok contains 3x the hemagglutinin (HA) antigen content of standard-dose flu vaccines, which has been linked to greater immunogenicity vs standard-dose flu vaccines.",
            "match_source": [
                {
                    "document_name": "Clinical Files/FlublokPI.pdf",
                    "matching_text": "Flublok is standardized according to United States Public Health Service (USPHS) requirements. For the 2024-2025 in\ufb02uenza season it is formulated to contain 135 mcg HA per 0.5 mL dose, with 45 mcg HA of each of the following 3 in\ufb02uenza virus strains: A/West Virginia/30/2022 (A/Wisconsin/67/2022 pdm09-like virus) (H1N1), A/Massachusetts/18/2022 (H3N2) and B/Austria/1359417/2021."
                }
            ]
        },
        {
            "claim": "Cell- and egg-based flu vaccines have the potential to develop mutations during production, which may reduce their effectiveness.",
            "match_source": [
                {
                    "document_name": "Clinical Files/Arunachalam et al. (2021).pdf",
                    "matching_text": "A known risk of traditional split or subunit vaccines is the potential for the candidate vaccine virus or working virus seeds to acquire adaptive mutations as they grow in embryonated chicken egg or mammalian host cells during vaccine manufacture. Such adaptive mutations in HA peptides may reduce the effectiveness of the resultant vaccine"
                },
                {
                    "document_name": "Clinical Files/Hsiao et al. (2023).pdf",
                    "matching_text": "Mutations in the hemagglutinin protein during egg-based manufacturing can result in mismatch between the selected strain and the vaccine strain."
                }
            ]
        },
        {
            "claim": "Recombinant technology leads to a broader immune response that may provide cross-protection, even in a mismatch season.",
            "match_source": [
                {
                    "document_name": "Clinical Files/Arunachalam et al. (2021).pdf",
                    "matching_text": "The higher quantity and greater accessibility of the genetically conserved stem region of rHA produced in insect cells (resulting in smaller N-linked glycans) may contribute to cross-protection against mismatched in\ufb02uenza strains12,75."
                },
                {
                    "document_name": "Clinical Files/Arunachalam et al. (2021).pdf",
                    "matching_text": "in smaller N-linked glycans) may contribute to cross-protection against mismatched in\ufb02uenza strains12,75. The study by Nachba- gaeur et al. 78 supports the hypothesis that a recombinant vaccine results in increased titre of broadly neutralising HA stem- reactive antibodies and that these immune responses increase with age78."
                },
                {
                    "document_name": "Clinical Files/Arunachalam et al. (2021).pdf",
                    "matching_text": "result in differences, both qualitative and quantitative, in the immune response to vaccines in humans and animals. Portnoff et al.64 demonstrated that recombinant HA antigens (speci\ufb01cally for the H3 strain) produced using BEVS (as used for RIV4), induced signi\ufb01cantly higher levels of broadly cross-reactive antibodies against highly conserved regions of the HA head and stem domains than egg-derived split vaccines 64."
                },
                {
                    "document_name": "Clinical Files/Arunachalam et al. (2021).pdf",
                    "matching_text": "In\ufb02uenza vaccines can afford signi\ufb01cant protection against in\ufb02uenza illness, even when there is an antigenic mismatch against the predominant circulating virus strains16,17. Such cross- protection can occur through the priming of the immune system by vaccination or natural infection and is primarily due to antibodies speci\ufb01c to conserved regions on the HA head and stem18."
                }
            ]
        },
        {
            "claim": "Vaccination with a higher-dose recombinant flu vaccine may induce a more robust antibody response than egg-based standard-dose vaccines.",
            "match_source": [
                {
                    "document_name": "Clinical Files/Hsiao et al. (2023).pdf",
                    "matching_text": "Quadrivalent recombinant influenza vaccines contain three times the amount of hemagglutinin protein as standard-dose egg-based vaccines, and the recombinant formulation is not susceptible to antigenic drift during manufacturing."
                }
            ]
        },
        {
            "claim": "Flublok (quadrivalent) was evaluated in the pivotal trial against Fluarix (quadrivalent standard-dose vaccine).",
            "match_source": [
                {
                    "document_name": "Clinical Files/FlublokPI.pdf",
                    "matching_text": "Study 6 (NCT02285998) enrolled subjects 50 years of age and older, randomized to receive Flublok Quadrivalent or Comparator (Fluarix Quadrivalent, manufactured by GlaxoSmithKline) as an active control"
                }
            ]
        },
        {
            "claim": "Flublok is produced using a novel production platform in which recombinant HA is expressed in insect cells using a baculovirus expression vector system (BEVS).",
            "match_source": [
                {
                    "document_name": "Clinical Files/Arunachalam et al. (2021).pdf",
                    "matching_text": "The production of RIV4 is based on a novel production platform in which recombinant HA (rHA) is expressed in insect cells using a baculovirus expression vector system"
                }
            ]
        },
        {
            "claim": "Recombinant HA antigens produced using BEVS have been shown to induce significantly higher levels of broadly cross-reactive antibodies against highly conserved regions of HA compared with egg-derived vaccines.",
            "match_source": [
                {
                    "document_name": "Clinical Files/Arunachalam et al. (2021).pdf",
                    "matching_text": "Portnoff et al.64 demonstrated that recombinant HA antigens (speci\ufb01cally for the H3 strain) produced using BEVS (as used for RIV4), induced signi\ufb01cantly higher levels of broadly cross-reactive antibodies against highly conserved regions of the HA head and stem domains than egg-derived split vaccines 64."
                }
            ]
        },
        {
            "claim": "Flublok contains 45 micrograms (mcg) of HA per strain vs 15 mcg of HA per strain in a standard-dose influenza vaccine.",
            "match_source": [
                {
                    "document_name": "Clinical Files/FlublokPI.pdf",
                    "matching_text": "Flublok is standardized according to United States Public Health Service (USPHS) requirements. For the 2024-2025 in\ufb02uenza season it is formulated to contain 135 mcg HA per 0.5 mL dose, with 45 mcg HA of each of the following 3 in\ufb02uenza virus strains: A/West Virginia/30/2022 (A/Wisconsin/67/2022 pdm09-like virus) (H1N1), A/Massachusetts/18/2022 (H3N2) and B/Austria/1359417/2021."
                },
                {
                    "document_name": "Clinical Files/Grohskopf et al. (2023).pdf",
                    "matching_text": "Fluarix Quadrivalent (GlaxoSmithKline) 0.5 mL (15 \u00b5g) Flucelvax Quadrivalent (Seqirus) 0.5 mL (15 \u00b5g) FluLaval Quadrivalent (GlaxoSmithKline) 0.5 mL (15 \u00b5g) Fluzone Quadrivalent (Sanofi Pasteur) 0.5 mL (15 \u00b5g) \u00a7"
                }
            ]
        }
    ]
}