Background Concomitant seasonal influenza vaccination with a COVID-19 vaccine booster could help to minimise potential disruption to the seasonal influenza vaccination campaign and maximise protection against both diseases among individuals at risk of severe disease and hospitalisation. This study aimed to assess the safety and immunogenicity of concomitant administration of high-dose quadrivalent influenza vaccine (QIV-HD) and a mRNA-1273 vaccine booster dose in older adults. Methods This study is an ongoing, phase 2, multicentre, open-label, descriptive trial at six clinical research sites in the USA. We describe the interim results up to 21 days after vaccination (July–August, 2021). Community-dwelling adults aged 65 years and older, who were previously vaccinated with a two-dose primary schedule of the mRNA-1273 SARS-CoV-2 vaccine, were eligible for inclusion. The second dose of the primary mRNA-1273 vaccination series was required to have been received at least 5 months before enrolment in the study. Participants were randomly assigned (1:1:1) using a permuted block method stratified by site and by age group (<75 years vs ≥75 years), to receive concomitant administration of QIV-HD and mRNA-1273 vaccine, QIV-HD alone, or mRNA-1273 vaccine alone. Randomisation lists, generated by Sanofi Pasteur biostatistics platform, were provided to study investigators for study group allocation. Unsolicited adverse events occurring immediately, solicited local and systemic reactions up to day 8, and unsolicited adverse events, serious adverse events, adverse events of special interest, and medically attended adverse events up to day 22 were reported. Haemagglutination inhibition antibody responses to influenza A/H1N1, A/H3N2, B/Yamagata, and B/Victoria strains and SARS CoV-2 binding antibody responses (SARS-CoV-2 pre-spike IgG ELISA) were assessed at day 1 and day 22. All analyses were descriptive. The study is registered with ClinicalTrials.gov , NCT04969276 . Findings Between July 16 and Aug 31, 2021, 306 participants were enrolled and randomly assigned, of whom 296 received at least one vaccine dose (100 in the coadministration group, 92 in the QIV-HD, and 104 in the mRNA-1273 group). Reactogenicity profiles were similar between the coadministration and mRNA-1273 groups, with lower reactogenicity rates in the QIV-HD group (frequency of solicited injection site reactions 86·0% [95% CI 77·6–92·1], 91·3% [84·2–96·0], and 61·8% [50·9–71·9]; frequency of solicited systemic reactions 80·0%, [70·8–87·3], 83·7% [75·1–90·2], and 49·4% [38·7–60·2], respectively). Up to day 22, unsolicited adverse events were reported for 17·0% (95% CI 10·2–25·8) of participants in the coadministration group and 14·4% (8·3–22·7) of participants in the mRNA-1273 group, and tended to be reported at a slightly lower rate (10·9% [5·3–19·1]) in participants in the QIV-HD group. Seven participants e...

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SummaryBackgroundConcomitant seasonal influenza vaccination with a COVID-19 vaccine booster could help to minimise potential disruption to the seasonal influenza vaccination campaign and maximise protection against both diseases among individuals at risk of severe disease and hospitalisation. This study assesses the safety and immunogenicity of concomitant administration of high-dose quadrivalent influenza vaccine (QIV-HD) and a mRNA-1273 vaccine booster dose in older adults.MethodsThis is an ongoing Phase II, multi-centre, open-label study (NCT04969276). We describe interim results up to 21 days after vaccination (July 2021–August 2021). Adults aged ≥ 65 years living in the community, who were to have received a second mRNA-1273 dose at least five months previously, were randomised (1:1:1) to concomitant QIV-HD and mRNA-1273 vaccination (Coad), QIV-HD alone, or mRNA-1273 vaccine alone. Unsolicited adverse events (AEs) occurring immediately, solicited local and systemic reactions up to day (D)8, and unsolicited AEs, serious AEs (SAEs), AEs of special interest (AESIs) and medically attended AEs (MAAEs) up to D22 were reported. Haemagglutination inhibition (HAI) antibody responses to influenza A/H1N1, A/H3N2, B/Yamagata and B/Victoria strains and SARS CoV-2 binding antibody responses (SARS-CoV-2 Pre-Spike IgG ELISA) were assessed at D1 and D22.FindingsOf 306 participants randomised, 296 were included for analysis (Coad, n=100; QIV-HD, n=92; mRNA-1273, n=104). Reactogenicity profiles were similar between the Coad and mRNA-1273 groups, with lower reactogenicity rates in the QIV-HD group (frequency [95% CIs] of solicited injection site reactions: 86·0% [77·6–92·1], 91·3% [84·2–96·0] and 61·8% [50·9–71·9]; solicited systemic reactions: 80·0% [70·8–87·3], 83·7% [75·1–90·2] and 49·4% [38·7–60·2], respectively). Up to D22, unsolicited AEs were reported for 17·0% and 14·4% participants in the Coad and mRNA-1273 groups, respectively, with a lower rate (10·9%) in the QIV-HD group. Seven MAAEs were reported (Coad, n=3; QIV-HD, n=1; mRNA-1273, n=3). There were no SAEs, AESIs or deaths. HAI antibody geometric mean titres (GMTs) increased from D1 to D22 to similar levels for each influenza strain in the Coad and QIV-HD groups (GMTs [95% confidence interval], range across strains: Coad, 286 [233–352] to 429 [350–525]; QIV-HD, 315 [257–386] to 471 [378–588]). SARS-CoV-2 binding antibody geometric mean concentrations (GMCs) also increased to similar levels in the Coad and mRNA-1273 groups (D22 GMCs [95% confidence interval]: 7634 [6445–9042] and 7904 [6883– 9077], respectively).InterpretationNo safety concerns or immune interference were observed for concomitant administration of QIV-HD with mRNA-1273 booster in adults aged ≥ 65 years, supporting co-administration recommendations.FundingSanofi Pasteur

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Dans le contexte général des travaux sur les processus de constitution des théories scientifiques, nous proposons une approche épistémologique permettant d’étudier le développement théorique dans ses aspects conceptuels et formels. Le cadre méthodologique que nous introduisons s’appuie sur deux hypothèses disjointes, mais complémentaires : 1° les théories scientifiques peuvent être décomposées en sous-unités autonomes, les patterns de raisonnement ; et 2° une fois découvert, un pattern de raisonnement est « projeté » dans l’ensemble des patterns accessibles à la communauté scientifique et, réciproquement, une fois qu’ils appartiennent à cet ensemble, les patterns peuvent être empruntés par les membres in « incorporés » dans une nouvelle construction théorique. Pour illustrer cette approche originale, nous utilisons, comme cas d’étude, la théorie de la descendance commune et de l’évolution par la sélection naturelle proposée par Darwin. Nous nous intéressons plus spécifiquement à la question de l’influence exercée par le principe de population de Malthus dans la constitution de cette théorie. Notre approche permet d’éclairer ce que les deux théories ont en partage, aussi bien sur le plan conceptuel que sur le plan formel. En conséquence, elle confère la possibilité d’explorer la question de la dette de Darwin à l’égard de Malthus sous un jour encore inédit. Si l’étude que nous entreprenons ne permet pas de clore définitivement le débat entourant cette question, elle introduit néanmoins un outil efficace pour aborder des cas d’étude similaires.

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À travers cet essai, je m’efforce de répondre à deux questions inextricablement liées dans la pratique des sciences biologiques en milieu francophone. Dans un premier temps, je soulève la question de la légitimité et de l’utilité de la traduction en français de certains termes scientifiques ou techniques. En d’autres mots, est-ce qu’il est possible de justifier, autrement qu’avec des motifs éthiques ou politiques, la décision de traduire un terme scientifique, quel qu’il soit ? En utilisant une perspective épistémologique, je montre qu’une justification de nature scientifique –fondée sur la notion d’efficacité– est envisageable, mais demeure hypothétique dans l’attente de certaines vérifications empiriques. De plus, si la traduction d’un terme contribue à une meilleure efficacité de la science, c’est dans le seul domaine de l’enseignement que cela peut éventuellement être apprécié. Dans un deuxième temps, et considérant qu’il existe effectivement un motif pédagogique de traduire fitness , je m’intéresse au choix d’une traduction française appropriée. Quel terme ou quelle expression devrait être privilégié ? Ici, je défends la thèse que fitness devrait être traduit non pas par une expression, mais par deux. Afin de montrer l’intérêt et la pertinence de cette suggestion, j’utilise deux arguments convergents. Dans l’argument épistémologique, je montre que depuis R. A. Fisher, les naturalistes et les biologistes utilisent deux concepts de fitness. Dans l’argument philosophique, je montre que fitness entre dans la construction et la validation de deux classes distinctes de faits empiriques.