Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine

Early High-Titer Plasma Therapy to Prevent Severe Covid-19 in Older Adults

Polack FP, Auwaerter PG, Lee SH, Nousari HC, Valsamakis A, Leiferman KIVI, Diwan AD, Adams RJ, Griffin DE. Atypical measles: evidence for disease mediated by immune complex formation and eosinophils in the presence of fusion inhibiting antibodies. Nature Med 1999; 5: 629-634. PMID: 10371500

Polack FP, Lee SH, Permar S, Manyara E, Nousari HC, Mustafa F, Valsamakis A, Adams RJ, Robinson HL, Griffin DE. Successful DNA immunization against measles: neutralizing antibody against either the hemagglutinin or fusion glycoprotein protects rhesus macaques without evidence of atypical measles. Nature Med 2000; 6: 776-781. PMID: 10888926

Polack FP, Teng MN, Collins PL, Prince GA, Exner M, Regele H, Lirman DD, Rabold R, Hoffman SJ, Karp CL, Kleeberger SR, Wills-Karp M, Karron RA. A role for immune complexes in enhanced respiratory  syncytial virus disease. J Exp Med 2002; 196: 859-65. *Editor’s Choice in Science. PMID: 12235218

Polack FP, Hoffman SJ, Crujeiras G, Griffin DE. A role for nonprotective complement fixing antibodies with low avidity for measles virus in atypical measles. Nature Med 2003, 9:1209-1213. *Selection in Faculty 1000. PMID: 12925847

Laham FR, Israele V, Casellas JM, Garcia AM, Lac Prugent CM, Hoffman SJ, Hauer D, Thumar B, Name MI, Pascual A, Taratutto A, Ishida MT, Balduzzi M, Maccarone M, Gaivironsky RA, Karron RA; Polack NR, Polack FP. Differential production of inflammatory cytokines between primary infection with human metapneumovirus and other common respiratory viruses of infancy. J Infect Dis. 2004; 189:2047-56. PMID: 15143472

Polack FP, Irusta PM, Hoffman SJ, Schiatti MP, Melendi GA, Delgado MF, Laham FR, Thumar B, Hendry RM, Melero JA, Karron RA, Collins PL, Kleeberger SR. The cysteine-rich region of respiratory syncytial virus attachment protein inhibits innate immunity elicited by the virus and endotoxin. Proc Natl Acad Sci 2005, 102: 8996-9001. PMID: PMC1157014.

Klein MI, Bergel E, Gibbons L, Coviello S, Bauer G, Benitez A, Serra ME, Delgado MF, Melendi GA, Rodríguez S, Kleeberger SR, Polack FP. Differential gender response to respiratory infections and to the protective effect of breast milk in preterm infants. Pediatrics. 2008;121:e1510-6. PMID: PMC2631928.

Delgado MF, Coviello S, Monsalvo AC, Melendi GA, Hernandez JZ,  Batalle JP, Diaz L, Trento A,  Chang HY, Mitzner W, Ravetch J, Melero JA, Irusta PM, Polack FP. Lack of antibody affinity maturation  due to  poor Toll-like receptor stimulation leads to enhanced RSV disease. Nat Med.  2009;15:34-41. *Editor’s Choice in Science, Nat Biotecnology. PMID: PMC2987729

Libster RP, Bugna J, Coviello S, Hijano DR, Dunaiewsky M, Reynoso N, Cavalieri ML, Guglielmo MC, Areso MS, Gilligan T, Santucho F, Cabral G, Gregorio GL, Moreno R, Lutz MI, Panigasi AL, Saligari L, Caballero MT, Egües Almeida RM, Gutierrez Meyer ME, Neder MD, Davenport MC, Del Valle MP, Santidrian VS, Mosca G, Garcia Domínguez M, Alvarez L, Landa P, Pota A, Boloñati N, Dalamon R, Sanchez Mercol VI, Espinoza M, Peuchot JC, Karolinski A, Bruno M, Borsa A, Ferrero F, Bonina A, Ramonet M, Albano LC, Luedicke N, Alterman E, Savy V, Baumeister E, Chappell JD, Edwards KM, Melendi GA, Polack FP. Pediatric hospitalizations associated with 2009 pandemic influenza A (H1N1) in Argentina. N Engl J Med. 2010;362: 45-55. PMID: 20032320.

Monsalvo AC, Batalle JP, Lopez MF, Krause JC, Klemenc J, Zea Hernandez J, Maskin B, Bugna J, Rubinstein C, Aguilar L, Dalurzo L, Libster R, Savy V, Baumeister E, Aguilar L, Cabral G, Font J, Solari L, Weller KP, Johnson J, Echavarria M, Edwards KM, Chappel JD, Crowe JE Jr, Williams JV,  Melendi GA, Polack FP. Severe pandemic 2009H1N1 influenza disease due to pathogenic immune complexes. Nature Med 2011; 17:195-915. PMID: PMC3034774.

Libster R, Coviello S, Cavalieri ML, Morosi A, Alabart N, Alvarez L, Ferrero F, Edwards KM, Polack FP. Pediatric hospitalizations due to influenza in 2010 in Argentina. N Engl J Med. 2010;363:2472-3. PMID: 21158677.

Miller EK, Hernandez JZ, Wimmenauer V, Shepherd BE, Hijano D, Libster R, Serra ME, Bhat N, Batalle JP, Mohamed Y, Reynaldi A, Rodriguez A, Otello M, Pisapia N, Bugna J, Bellabarba M, Kraft D, Coviello S, Ferolla FM, Chen A, London SJ, Siberry GK, Williams JV, Polack FP. A mechanistic role for type III interferon-λ1 in asthma exacerbations mediated by human rhinoviruses. Am J Respir Crit Care Med. 2012; 185(5): 508–516. PMID: PMC3361761.

Ferolla FM, Hijano DR, Acosta PL, Rodríguez A, Dueñas K, Sancilio A, Barboza E, Caría A, Gago GF, Almeida RE, Castro L, Pozzolo C, Martínez MV, Grimaldi LA, Rebec B, Calvo M, Henrichsen J, Nocito C, González M, Barbero G, Losada JV, Caballero MT, Zurankovas V, Raggio M, Schavlovsky G, Kobylarz A, Wimmenauer V, Bugna J, Williams JV, Sastre G, Flamenco E, Pérez AR, Ferrero F, Libster R, Grijalva CG, Polack FP. Macronutrients during pregnancy and life-threatening respiratory syncytial virus infections in children. Am J Respir Crit Care Med. 2013 May 1;187(9):983-90. PMID: 23449690.

Caballero MT, Serra ME, Acosta PL, Marzec J, Gibbons L, Salim M, Rodriguez A, Reynaldi A, Garcia A, Bado D, Buchholz UJ, Hijano DR, Coviello S, Newcomb D, Bellabarba M, Ferolla FM, Libster R, Berenstein A, Siniawaski S, Blumetti V, Echavarria M, Pinto L, Lawrence A, Ossorio MF, Grosman A, Mateu CG, Bayle C, Dericco A, Pellegrini M, Igarza I, Repetto HA, Grimaldi LA, Gudapati P, Polack NR, Althabe F, Shi M, Ferrero F, Bergel E, Stein RT, Peebles RS, Boothby M, Kleeberger SR, Polack FP. TLR4 genotype and environmental LPS mediate RSV bronchiolitis through Th2 polarization. J Clin Invest 2015; 125(2): 571-82. PMID: 25555213. 

Shi T, McAllister DA, O’Brien KL, Simoes EAF, Madhi SA, Gessner BD, Polack FP, et al.  Global, regional, and national disease burden estimates of acute lower respiratory infections due to respiratory syncytial virus in young children in 2015: a systematic review and modelling study. Lancet 2017 Sep 2;390(10098):946-958.

Caballero MT, Polack FP, Stein RT.Viral bronchiolitis in young infants: new perspectives for management and treatment. J Pediatr (Rio J). 2017, Aug 30 

Byrne AB, Gutierrez GF, Bruno A, Córdoba MT, Bono MM, Polack FP, Talarico LB, Quipildor MO. Age-associated differences in clinical manifestations and laboratory parameters during a dengue virus type 4 outbreak in Argentina. J Med Virol. 2017 Sep 23. 

Scheltema NM, Gentile A, Lucion F, Nokes DJ, Munywoki PK, Madhi SA, Groome MJ, Cohen C, Moyes J, Thorburn K, Thamthitiwat S, Oshitani H, Lupisan SP, Gordon A, Sánchez JF, O’Brien KL; PERCH Study Group, Gessner BD, Sutanto A, Mejias A, Ramilo O, Khuri-Bulos N, Halasa N, de-Paris F, Pires MR, Spaeder MC, Paes BA, Simões EAF, Leung TF, da Costa Oliveira MT, de Freitas Lázaro Emediato CC, Bassat Q, Butt W, Chi H, Aamir UB, Ali A, Lucero MG, Fasce RA, Lopez O, Rath BA, Polack FP, Papenburg J, Roglić S, Ito H, Goka EA, Grobbee DE, Nair H, Bont LJ. Global respiratory syncytial virus-associated mortality in young children (RSV GOLD): a retrospective case series. Lancet Glob Health. 2017; 5: e984-e991. 

Talarico LB, Byrne AB, Amarilla S, Lovera D, Vázquez C, Chamorro G, Acosta PL, Ferretti A, Caballero MT, Arbo A, Polack FP. Characterization of type I interferon responses in dengue and severe dengue in children in Paraguay. J Clin Virol. 2017; 97:10-17. 

Soto AS,  Fenoy IM, Sanchez VR,  March F, Perrone Sibilia MD, Aldirico MLA, Picchio MS, Arcon N, Acosta PL, Polack FP, Martin V, Goldman A. Toxoplasma gondii serine-protease inhibitor-1: A new adjuvant candidate for asthma therapy. PLoS One. 2017 Oct 26 12:e0187002

Polack FP. Respiratory syncytial virus during pregnancy. Clin Infect Dis. 2017 Dec 15. 66:1666-166

Caballero MT, Polack FP. Respiratory syncytial virus is an “opportunistic” killer. Pediatr Pulmonol. 2018 Feb 20. 53: 664-667

Polack FP. Crafting Live-Attenuated Vaccines Against Respiratory Syncytial Virus. J Infect Dis. 2018 Mar 217:1335-133

Caballero MT, Hijano DR, Acosta PL, Mateu CG, Marcone DN, Linder JE, Talarico LB, Elder JM, Echavarria M, Miller EK, Polack FP; INFANT Respiratory Network.  Interleukin-13 associates with life-threatening rhinovirus infections in infants and young children. Pediatr Pulmonol. 2018 Jun 53:787-795

Mazur NI, Higgins D, Nunes MC, Melero JA, Langedijk AC, Horsley N, Buchholz UJ, Openshaw PJ, McLellan JS, Englund JA, Mejias A, Karron RA, Simões EA, Knezevic I, Ramilo O, Piedra PA, Chu HY, Falsey AR, Nair H, Kragten-Tabatabaie L, Greenough A, Baraldi E, Papadopoulos NG, Vekemans J, Polack FP, Powell M, Satav A, Walsh EE, Stein RT, Graham BS, Bont LJ; Respiratory Syncytial Virus Network (ReSViNET) Foundation. The respiratory syncytial virus vaccine landscape: lessons from the graveyard and promising candidates. Lancet Infect Dis. 2018 Oct 18:e295-e311

Rajan D, O’Keefe EL, Travers C, McCracken C, Geoghegan S, Caballero MT, Acosta PL, Polack F, Anderson LJ. MUC5AC Levels Associated With Respiratory Syncytial Virus Disease Severity. Clin Infect Dis. 2018 67:1441-1444

Caballero MT, Bianchi AM, Nuño A, Ferretti AJP, Polack LM, Remondino I, Rodriguez MG, Orizzonte L, Vallone F, Bergel E, Polack FP. Mortality Associated With Acute Respiratory Infections Among Children at Home. J Infect Dis. 2019 219:358-364

Paggi DA, Polack FP Toward Personalized Medicine in Bronchiolitis. Am J Respir Crit Care Med. 2019 199:1456-1458. 

Polack FP, Stein RT, Custovic A. The Syndrome We Agreed to Call Bronchiolitis. J Infect Dis. 2019 220:184-186.

Comerlato Scotta M, Greff Machado D, Goecks Oliveira S, de Moura A, Rhoden Estorgato G, de Souza APD, Nery Porto B, de Araújo PD, Sarria EE, Pitrez PM, Jones MH, Araújo Pinto L, Tetelbom Stein R, Polack FP, Mattiello R. Evaluation of nasal levels of interferon and clinical severity of influenza in children.  J Clin Virol. 2019 114:37-42.

Hijano DR, Vu LD, Kauvar LM, Tripp RA, Polack FP, Cormier SA. Role of Type I Interferon (IFN) in the Respiratory Syncytial Virus (RSV) Immune Response and Disease Severity. Front Immunol. 2019 10:566

Jares Baglivo S, Polack FP. The long road to protect infants against severe RSV lower respiratory tract illness. F1000Res. 2019 8. pii: F1000 Faculty Rev-610. 

Aranda SS, Polack FP. Prevention of Pediatric Respiratory Syncytial Virus Lower Respiratory Tract Illness: Perspectives for the Next Decade. Front Immunol. 2019 10:1006.

Ofman G, Caballero MT, Alvarez Paggi D, Marzec J, Nowogrodzki F, Cho HY, Sorgetti M, Colantonio G, Bianchi A, Prudent LM, Vain N, Mariani G, Digregorio J, Turconi EL, Osio C, Galletti F, Quiros M, Brum A, Lopez Garcia S, Garcia S, Bell D, Jones MH, Tipple TE, Kleeberger SR, Polack FP. The discovery BPD (D-BPD) program: study protocol of a prospective translational multicenter collaborative study to investigate determinants of chronic lung disease in very low birth weight infants. BMC Pediatr. 2019 19:227

Antunes KH, Fachi JL, de Paula R, da Silva EF, Pral LP, Dos Santos AÁ, Dias GBM, Vargas JE, Puga R, Mayer FQ, Maito F, Zárate-Bladés CR, Ajami NJ, Sant’Ana MR, Candreva T, Rodrigues HG, Schmiele M, Silva Clerici MTP, Proença-Modena JL, Vieira AT, Mackay CR, Mansur D, Caballero MT, Marzec J, Li J, Wang X, Bell D, Polack FP, Kleeberger SR, Stein RT, Vinolo MAR, de Souza APD. Microbiota-derived acetate protects against respiratory syncytial virus infection through a GPR43-type 1 interferon response. Nat Commun. 2019 10:3273.

Menendez D, Snipe J, Marzec J, Innes CL, Polack FP, Caballero M, Schurman SH, Kleeberger SR, Resncik MA, p53-responsive TLR8 SNP enhances human innate immune response to respiratory syncytial virus. J Clin Invest 2019  129:4875-4884.

Jacqui Marzec, Hye-Youn Cho, Monica High, Zachary R McCaw , Fernando Polack , Steven R Kleeberger. Toll-like Receptor 4-mediated Respiratory Syncytial Virus Disease and Lung Transcriptomics in Differentially Susceptible Inbred Mouse Strains. Physiol Genomics. 2019 51:630-643.

Wang X, Li Y, O’Brien KL, Madhi SA, Widdowson MA, Byass P, Omer SB, Abbas Q, Ali A, Amu A, Azziz-Baumgartner E, Bassat Q, Abdullah Brooks W, Chaves SS, Chung A, Cohen C, Echavarria M, Fasce RA, Gentile A, Gordon A, Groome M, Heikkinen T, Hirve S, Jara JH, Katz MA, Khuri-Bulos N, Krishnan A, de Leon O, Lucero MG, McCracken JP, Mira-Iglesias A, Moïsi JC, Munywoki PK, Ourohiré M, Polack FP, Rahi M, Rasmussen ZA, Rath BA, Saha SK, Simões EA, Sotomayor V, Thamthitiwat S, Treurnicht FK, Wamukoya M, Yoshida LM, Zar HJ, Campbell H, Nair H; Respiratory Virus Global Epidemiology Network. Global burden of respiratory infections associated with seasonal influenza in children under 5 years in 2018: a systematic review and modelling study. Lancet Glob Health. 2020 8:e497-e510.

Gaston Ofman, Brad Pradarelli, Mauricio T Caballero, Alejandra Bianchi, Luciano Alva Grimaldi, Andrea Sancilio, Karina Duenas, Andrea Rodriguez, Fernando Ferrero, Adrian Ferretti, Silvina Coviello, Fausto M Ferolla, Patricio L Acosta, Eduardo Bergel, Romina Libster, Fernando P Polack. Respiratory Failure and Death in Vulnerable Premature Children With Lower Respiratory Tract Illness. J Infect Dis 2020 PMID: 32006428 DOI: 10.1093/infdis/jiaa046

Romina Libster, Ignacio Esteban, Alejandra Bianchi, Luciano Alva Grimaldi, Karina Dueñas, Andrea Sancillo, Andrea Rodriguez, Fernando Ferrero, Katherine Stein, Patricio L Acosta, Fausto M Ferolla, Eduardo Bergel, Mauricio T Caballero, Fernando P Polack, INFANT Respiratory Network. Role for Maternal Asthma in Severe Human Metapneumovirus Lung Disease Susceptibility in Children.  J Infect Dis. 2020 PMID: 31965186 PMCID: PMC7107446 DOI: 10.1093/infdis/jiaa019

Ignacio Esteban, Renato T Stein, Fernando P Polack. A Durable Relationship: Respiratory Syncytial Virus Bronchiolitis and Asthma Past Their Golden Anniversary. Vaccines (Basel). 2020 8(2):E201. doi: 10.3390/vaccines8020201.

Goldin CJ, Vázquez R, Polack FP, Alvarez-Paggi D. Identifying pathophysiological bases of disease in COVID-19.Transl Med Commun. 2020;5(1):15. doi: 10.1186/s41231-020-00067-w.

Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, Perez JL, Pérez Marc G, Moreira ED, Zerbini C, Bailey R, Swanson KA, Roychoudhury S, Koury K, Li P, Kalina WV, Cooper D, Frenck RW Jr, Hammitt LL, Türeci Ö, Nell H, Schaefer A, Ünal S, Tresnan DB, Mather S, Dormitzer PR, Şahin U, Jansen KU, Gruber WC; C4591001 Clinical Trial Group. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med. 2020 Dec 31;383(27):2603-2615. doi: 10.1056/NEJMoa2034577. 

Libster R, Pérez Marc G, Wappner D, Coviello S, Bianchi A, Braem V, Esteban I, Caballero MT, Wood C, Berrueta M, Rondan A, Lescano G, Cruz P, Ritou Y, Fernández Viña V, Álvarez Paggi D, Esperante S, Ferreti A, Ofman G, Ciganda Á, Rodriguez R, Lantos J, Valentini R, Itcovici N, Hintze A, Oyarvide ML, Etchegaray C, Neira A, Name I, Alfonso J, López Castelo R, Caruso G, Rapelius S, Alvez F, Etchenique F, Dimase F, Alvarez D, Aranda SS, Sánchez Yanotti C, De Luca J, Jares Baglivo S, Laudanno S, Nowogrodzki F, Larrea R, Silveyra M, Leberzstein G, Debonis A, Molinos J, González M, Perez E, Kreplak N, Pastor Argüello S, Gibbons L, Althabe F, Bergel E, Polack FP; Fundación INFANT–COVID-19 Group. Early High-Titer Plasma Therapy to Prevent Severe Covid-19 in Older Adults. N Engl J Med. 2021 Jan 6. doi: 10.1056/NEJMoa2033700. PMID: 33406353