Hyper inflammatory syndrome following COVID-19 mRNA vaccine in children: A national post-authorization pharmacovigilance study

Ouldali, Naïm; Bagheri, Haleh; Salvo, Francesco; Antona, Denise; Pariente, Antoine; LeBlanc, Claire; Tebacher, Martine; Micallef, Joëlle; Lévy, Corinne; Cohen, Robert; Javouhey, Étienne; Bader‐Meunier, Brigitte; Ovaert, Caroline; Guen, Christelle Gras-Le; Angoulvant, François; Belot, Alexandre; Donzeau, Aurélie; Aridi, Layal El; Lety, Sophie; Leboucher, B.; Baur, Agnes; Jeusset, Lucas; Fedorczuk, Cristian; Lajus, Marion; Bensaïd, Philippe; Laoudi, Yacine; Pons, Charlotte; Robert, Anne-Cécile; Beaucourt, Camille; Pontual, Loïc de; Richard, Muriel; Goisque, Etienne; Iriart, Xavier; Brissaud, Olivier; Segretin, Pierre; Molimard, Julie; Orecel, Marie-Clothilde; Benoit, Gregoire; Bongiovanni, Lucille; Guerder, Margaux; Pouyau, Robin; Resnes, Jean-Marie De Guillebon De; Mezgueldi, Ellia; Cour-Andlauer, Fleur; Horvat, Côme; Poinsot, Pierre; Frachette, Cécile; Ouziel, Antoine; Gillet, Yves; Barrey, Catherine; Brouard, J.; Villedieu, F.; Ro, Vathanaksambath; Elanga, Narcisse; Gajdos, Vincent; Basmaci, Romain; Mutar, Hadile; Rouget, Sébastien; Nattes, Elodie; Hau, Isabelle; Biscardi, Sandra; Jurdi, Houmam El; Jung, Camille; Semama, Denis S.; Huet, Frédéric; Zoccarato, Anne-Marie; Sarakbi, Mayssa; Mortamet, Guillaume; Bost-Bru, C.; Bassil, Joachim; Vinit, Caroline; Hentgen, Véronique; Leroux, Pascal; Bertrand, Valérie; Parrod, Caroline; Craiu, Irina; Koné‐Paut, Isabelle; Durand, Philippe; Tissiere, Pierre; Claude, Caroline; Morelle, Guillaume; Guiddir, Tamazoust; Borocco, Charlotte; Delion, Fréderique; Guillot, Camille; Leteurtre, Stéphane; Dubos, François; Jouancastay, Mylene; Martinot, A.; Voeusler, Valentine; Languepin, Jeanne; Garrec, Nathalie; Demersay, A. Chalvon; Morand, Aurélie; Bosdure, E.; Vanel, Noémie; Ughetto, Fabrice; Michel, Fabrice; Caujolle, Marie; Blondé, Renaud; Nguyen, Jacqueline; Vignaud, Olivier; Masserot-Lureau, Caroline; Gouraud, François; Araujo, Carine; Ingrao, Tara; Naji, Sanaa; Sehaba, Mohammed; Roche, Christine; Carbasse, Aurélia; Milési, Christophe; Mazeghrane, Mustapha; Haupt, Sandrine; Schweitzer, Cyril; Romefort, Bénédicte; Launay, Élise; Guen, Christèle Gras‐Le; Ahmed, Aziza; Blot, Nathalie; Tran, Antoine; Rancurel, Anne; Afanetti, Mickael; Odorico, Sophie; Talmud, Déborah; Chosidow, Anais; Romain, Anne-Sophie; Grimprel, E.; Pouletty, Marie; Corseri, Olivier; Faye, Albert; Gaschignard, Jean; Melki, Isabelle; Ducrocq, Charles; Benzoïd, Cherine; Lokmer, Johanna; Dauger, Stéphane; Chomton, Maryline; Dehò, Anna; Lebourgeois, Fleur; Renolleau, Sylvain; Lesage, Fabrice; Moulin, F.; Dupic, Laurent; Pinhas, Yael; Debray, Agathe; Chalumeau, Martin; Abadie, Véronique; Frange, Pierre; Cohen, Jérémie F.; Allali, Slimane; Curtis, William M.; Belhadjer, Zahra; Auriau, Johanne; Méot, Mathilde; Houyel, Lucile; Bonnet, Damien; Delacourt, Christophe; Meunier, Brigitte Bader; Quartier, Pierre; Shaim, Youssef; Baril, Laurence; Samuel, Crommelynck; Jacquot, Baptiste; Blanc, P; Maledon, Natacha; Robert, Blandine; Loeile, Camille; Cazau, Clémence; Loron, Gauthier; Gaga, Simona; Vittot, Cécile; Nabhani, Loubna El; Buisson, F.; Prudent, Muriel; Flodrops, Hugues; Mokraoui, Fadhila; Escoda, Simon; Deschamps, Nina; Bonnemains, Laurent; Mahi, Sarah-Louisa; Mertes, Clara; Terzic, J.; Helms, Julie; Idier, Charlotte; Chenichene, Soraya; Ursulescu, Nicoleta; Beaujour, Gladys; Hakim, Abdelhak; Miquel, Alice; Rey, Agnès; Wiedermann, Arnaud; Charbonneau, Anne; Veauvy-Juven, Agnès; Ferry, Alexandrine; Mandelcwajg, Alexis; Rousseau, Alix; Prenant, Amandine; Bourneuf, Anne-Laure; Filleron, Anne; Robine, Audrey; Félix, Arthur; Parizel, Aude; Labarre, Aurélie; Cantais, Aymeric; Ros, Bárbara Zas; Coulon, Basile; Biot, Blandine; Dalichoux, Bérengère; Fournier, Benjamin; Cagnard, B.; Vanel, Blandine; Brossier, David; Ménager, Bruno; Ozanne, Bruno; Marie-Jeanne, Carole; Bergerot, Camille; Chavy, Camille; Guidon, Camille; Fabre, Candice; Galeotti, Caroline; Baker, Catherine; Ballot-Schmit, Claire; Belleau, Céline; Charasse, Céline; Favel, Caroline; Toumi, Chadia; Ferrandiz, Charlène; Couturier, Charlotte; Pouchoux, Charlotte; Chomton-Cailliez, Maryline; Kevorkian-Verguet, Charlotte; Brunet, Clément; Manteau, Céline; Mougey, Clémence; Santy, Coline; Fitament, Coralie; Petriat, Charlotte; Rebelle, Charlotte; Charron, Cyril; Dartus, Maxime; Toulorge, David; Guillou-Debuisson, Cécile; Bartebin, Dorann; Klein, Valérie; Broustal, E; Desselas, E; Marteau, Elodie; Bouvrot, Emmanuelle; Delacroix, Elise; Coinde, Edeline; Elnabhani, Loubna; Amouyal, Elsa; Chaillou, E.; Gabilly-Bernard, Emeline; Ruiz, Émilie; Thibault, Emilie; Robin, Emilie; Darrieux, Etienne; Blondel, Eva; Socchi, Floriane; Cazassus, François; Bajolle, Fanny; Lacin, Fatma; Madhi, Fouad; Zekre, Franck; Guérin, François; Boussicault, Gérald; Ginies, Henri; Magloire, Gnansounou; Arnold, Guilhem; Coulognon, Ines; Sicard-Cras, Iona; Kahn, Jean‐Emmanuel; Bordet, Jeanne; Fausser, Jeanne-Lise; Baleine, Jean-François; Brice, Joséphine; Gendras, Julie; Pekin, Kaan; Norbert, Karine; Karsenty, Clément; Savary, Léa; Martinat, Laurence; Lesniewski, Léa; Charbonnier, Lorelei; Alexandre, Louise; Percheron, Lucas; Vincenti, Marie; Sélégny, Maëlle; Lanzini, Manon; Grisval, Margot; Mercy, Marianne; Lampin, Marie-Emilie; Desgranges, Marie; Duperril, Marie; Orcel, Marie-Clothilde; Audier, Marion; Favier, Marion; Carpentier, Mathieu; Balcean, Mathilde; Bonnet, Mathilde; Jouret, Maurine; Delattre, Marie; Levy, Michaël; Valensi, Michael; Shum, Mickael; Dumortier, Morgane; Gelin, Morgane; Nemmouchi, Morgane; Williaume, Morgane; Sebaha, M; Genetay-Stanescu, Nicoleta; Giroux, Nathan; Crassard, Nicolas; Derridj, Neil; Lachaume, Noémie; Werner, Oscar; Guilluy, Olivier; Richer, Olivier; Tirel, O.; Pauvert, Aurianne; Casha, Paul; Perez, Noémie; Gras, Pauline; Léger, Pierre-Louis; Pinchou, Marion; Mornand, Pierre; Largo, Prisca; Ibanez, Ramona-Christina; Roulland, Charlotte; Albarazi, Salam Hadah; Bichali, Saïd; Faton, Sarah; Schott, Amandine; Walser, Sébastien; Guillaume, Séverine; Vincent, Solene; Galène-Gromez, Sophie; Kozisek, Stanislas; Maugard, Thierry; Blanc, Thierry; Navarro, Thierry; Lauvray, Thomas; Kovács, Tamás; Launay, Valérie; Despert, Véronique; Lhostis, Victoria; Gall, Virginie; Micaelli, Xavier; Benadjaoud, Yasmine; Matoussi, Zied; Géniaux, Hélène; Facile, Anthony; Pietri, Tessa; Palassin, Pascale; Pinel, Sylvine; Chouchana, Laurent; Callot, Delphine; Boulay, Charlène

doi:10.1016/j.lanepe.2022.100393

Cited by 49 publications

(32 citation statements)

References 36 publications

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“… 37 In contrast, 113 cases of MIS‐C were observed among one million SARS‐CoV‐2 infections in the same age group. 37 Evidence is starting to emerge that vaccination can reduce the risk of MIS‐C. 38 Prevention of MIS‐C is important because affected infants and adolescents may face long‐term health sequalae that are not yet known.…”

Section: Severe Disease From Covid Does Not Occur ...mentioning

confidence: 99%

Routine SARS‐CoV‐2 vaccination for all children*

Paris

Permar

2022

Immunological Reviews

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The SARS-CoV-2 pandemic has resulted in unprecedented health and economic losses. Children generally present with less severe disease from this virus compared with adults, yet neonates and children with COVID-19 can require hospitalization, and older children can develop severe complications, such as the multisystem inflammatory syndrome, resulting in >1500 deaths in children from COVID-19 since the onset of the pandemic. The introduction of effective SARS-CoV-2 vaccines in school-age children and adult populations combined with the emergence of new, more highly transmissible SARS-CoV-2 variants has resulted in a proportional increase of infections in young children. Here, we discuss (1) the current knowledge on pediatric SARS-CoV-2 infection and pathogenesis in comparison with adults, (2) the data on vaccine immunogenicity and efficacy in children, and (3) the benefits of early life SARS-CoV-2 vaccination. K E Y W O R D S children, infant immunity, MIS-C, SARS-CoV-2, vaccines *This article is part of a series of reviews covering SARS-CoV-2 Immunity appearing in Volume 309 of Immunological Reviews.

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Section: Severe Disease From Covid Does Not Occur ...mentioning

confidence: 99%

Routine SARS‐CoV‐2 vaccination for all children*

Paris

Permar

2022

Immunological Reviews

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“…One child had diabetes mellitus as an underlying disease that may decrease vaccine effectiveness [9]. Similarly, MIS-C cases with vaccination history before diagnosis are rarely reported [10][11][12][13][14][15], leading to physician concerns regarding vaccine effectiveness or potential COVID-19 vaccine-associated MIS-C.…”

Section: Department Of Pediatric Infectious Diseases University Of He...mentioning

confidence: 99%

Frequency and safety of COVID-19 vaccination in children with multisystem inflammatory syndrome: a telephonic interview-based analysis

Aykaç

Öztürk²,

Demir

et al. 2022

World J Pediatr

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“…Covid-19 vaccination could reduce incidence of severe disease among under 5s considered at highest risk15 and may protect them against the rarer multisystem inflammatory syndrome, as observed in children aged over 12 years 18. This complication has also been reported after covid-19 vaccination in older children, but at lower rates than occur following natural infection 19. Vaccination helps protect adults against prolonged symptoms such as fatigue and loss of smell, but rates of these longer term symptoms are low in children 20.…”

mentioning

confidence: 98%

“…18 This complication has also been reported after covid-19 vaccination in older children, but at lower rates than occur following natural infection. 19 Vaccination helps protect adults against prolonged symptoms such as fatigue and loss of smell, but rates of these longer term symptoms are low in children. 20 It will be some time before the long term effects of covid-19 (both direct and indirect) on under 5s are fully understood.…”

mentioning

confidence: 99%