Publications

A Brighton Collaboration standardized template with key considerations for a benefit-risk assessment for the Comirnaty COVID-19 mRNA vaccine

AUTHORS: Shanti Pather, Nicola Charpentier, Frank van den Ouweland, Ruben Rizzi, Andrew Finlayson, Nadine Salisch, Alexander Muik, Claudia Lindemann, Ruzwana Khanim, Sultan Abduljawad, Emily R. Smith, Marc Gurwith, Robert T. Chen, Benefit-Risk Assessment of VAccines by TechnolOgy (BRAVATO) Working Group

PUBLICATION DATE: 17-Sep-24

Comment on “Serially Combining Epidemiological Designs Does Not Improve Overall Signal Detection in Vaccine Safety Surveillance”

AUTHORS: Chen R T, Huang WT, Cassard C

PUBLICATION DATE: 05-Mar-24

A Brighton Collaboration standardized template with key considerations for a benefit/risk assessment for the Novavax COVID-19 Vaccine (NVX-CoV2373), a recombinant spike protein vaccine with Matrix-M adjuvant to prevent disease caused by SARS-CoV-2 viruses

AUTHORS: Wilkinson B, Patel K S, Smith K, Walker R, Wang C, Greene A M, Smith G, Smith E R, Gurwith M, Chen R T, Benefit-Risk Assessment of VAccines by TechnolOgy (BRAVATO) Working Group

PUBLICATION: Vaccine

PUBLICATION DATE: 26-Oct-23

Considerations for unblinding individual study participants during vaccine trials

AUTHORS: Halsey N, Evans S, Santosham M, Hacker A, Edwards KM, Chandler R, Dudley M, Dekker C, and other members of the SPEAC meta-DSMB

PUBLICATION: Vaccine

PUBLICATION DATE: 22-May-23

ANAPHYLAXIS: Revision of the Brighton collaboration case definition.

AUTHORS: Gold MS, Amarasinghe A, Greenhawt M, Kelso JM, Kochhar S, Yu-Hor Thong B, Top KA, Turner PJ, Worm M, Law B.

PUBLICATION: Vaccine

PUBLICATION DATE: 6-Apr-23

ANOSMIA: Brighton Collaboration case definition and guidelines for data collection, analysis, and presentation of immunization safety data.

AUTHORS: Yi-Chun CL, Munoz FM, Izurieta HS, Tamborska AA, Solomon T, Law B, & Chhabra N.

PUBLICATION: Vaccine

PUBLICATION DATE: 10-Mar-23

Maternal Immunization Working Group Meeting Report (November, 2022).

AUTHORS: Maternal Immunzation Working Group Members

PUBLICATION DATE: 7-Mar-23

THROMBOSIS AND THROMBOEMBOLISM: Brighton collaboration case definition and guidelines for data collection, analysis, and presentation of immunization safety data.

AUTHORS: Gollamudi J, Sartain SE, Navaei AH, Aneja S, Kaur Dhawan P, Tran D, Joshi J, Gidudu J, Gollamudi J, Chiappini E, Varricchio F, Law B, Munoz FM.

PUBLICATION: Vaccine

PUBLICATION DATE: 19-Oct-22

Assessing the Brighton Collaboration Case Definition of Sensorineural Hearing Loss in Ghana.

AUTHORS: Bukari I, Huang W, Issahalq DM.

PUBLICATION: The American Journal of Tropical Medicine and Hygiene

PUBLICATION DATE: 17-Oct-22

Vaccines based on the replication-deficient simian adenoviral vector ChAdOx1: Standardized template with key considerations for a risk/benefit assessment.

AUTHORS: Folegatti P, Jenkin D, Morris S, Gilbert S, Kim D, Robertson JS, Smith ER, Martin E, Gurwith M, Chen RT.

PUBLICATION: Vaccine

PUBLICATION DATE: 19-Aug-22

A Brighton Collaboration standardized template with key considerations for a benefit/risk assessment for the Moderna COVID-19 Vaccine (mRNA-1273).

AUTHORS: Leav B, Straus W, White P, Leav A, Gaines T, Maggiacomo G, Kim D, Smith ER, Gurwith M, Chen RT.

PUBLICATION: Vaccine

PUBLICATION DATE: 19-Aug-22

A Brighton Collaboration standardized template with key considerations for a benefit/risk assessment for an inactivated viral vaccine against Chikungunya virus.

AUTHORS: Hernandez LM, Sumathy K, Sahastrabuddhe S, Excler JL, Kochhar S, Smith ER, Gurwith M, Chen RT.

PUBLICATION: Vaccine

PUBLICATION DATE: 19-Aug-22

MYOCARDITIS AND PERICARDITIS: case definition and guidelines for data collection, analysis, and presentation 2 of immunization safety data.

AUTHORS: Sexson Tejtel K, Munoz FM, Al-Ammouri I, Savorgnan F, Guggilla R, Khuri-Bulos N, Phillips L, Engler RJM

PUBLICATION: Vaccine

PUBLICATION DATE: 1-Mar-22

Brighton Collaboration Case Finding Definition of Thrombosis with Thrombocytopenia Syndrome (TTS).

PUBLICATION DATE: 11-Nov-21

Benefit-Risk Assessment of VAccines by TechnolOgy Working Group BRAVATO, ex-V3SWG). A Brighton Collaboration standardized template with key considerations for a benefit/risk assessment for a soluble glycoprotein vaccine to prevent disease caused by Nipah or Hendra viruses.

AUTHORS: Eldridge JH, Egan MA, Matassov D, Hamm S, Hermida L, Chen T, Tremblay M, Sciotto-Brown S, Xu R, Dimitrov A, Smith ER, Gurwith M, Chen RT.

PUBLICATION: Vaccine

PUBLICATION DATE: 7-Sept-21

Background rates of Adverse Events of Special Interest for monitoring COVID-19 vaccines | August 2021.

AUTHORS: Willame C, Dodd C, Gini R, Durán CE, Thomsen RM, Wang L, Gedebjerg A, Kahlert J, Ehrenstein V, Bartolini C, Droz C, Moore N, Haug U, Schink T, Diez-Domingo J, Mira-Iglesias A, Vergara-Hernández C, Carreras JJ, Villalobos F, Pallejà M, Aragón M, Perez-Gutthann S, Arana A, Giaquinto C, Barbieri E, Stona L, Huerta C, Pallejà M, Aragón M, García Poza P, de Burgos A, Martínez-González M, Souverein P, Gardarsdottir H, Siiskonen SJ, Weibel D, Mahy P, Klungel O, Sturkenboom MCJM.

PUBLICATION DATE: 25-Aug-21

Acute respiratory distress syndrome (ARDS) as an adverse event following immunization: Case definition & guidelines for data collection, analysis, and presentation of immunization safety data.

AUTHORS: Serazin NA, Edem B, Williams SR, Ortiz JR, Kawade A, Das MK, Šubelj M, Edwards KM, Parida SK, Wartel TA, Munoz FM, Bastero P.

PUBLICATION: Vaccine

PUBLICATION DATE: 21-May-21

Multisystem inflammatory syndrome in children and adults (MIS-C/A): Case definition & guidelines for data collection, analysis, and presentation of immunization safety data.

AUTHORS: Vogel TP, Top KA, Karatzios C, Hilmers DC, Tapia LI, Moceri P, Giovannini-Chami L, Wood N, Chandler RE, Klein NP, Schlaudecker EP, Poli MC, Muscal E, Munoz FM.

PUBLICATION: Vaccine

PUBLICATION DATE: 21-May-21

Vaccine-associated enhanced disease: Case definition and guidelines for data collection, analysis, and presentation of immunization safety data.

AUTHORS: Munoz FM, Cramer JP, Dekker CL, Dudley MZ, Graham BS, Gurwith M, Law B, Perlman S, Polack FP, Spergel JM, Van Braeckel E, Ward BJ, Didierlaurent AM, Lambert PH.

PUBLICATION: Vaccine

PUBLICATION DATE: 21-May-21

The critical role of background rates of possible adverse events in the assessment of COVID-19 vaccine safety.

AUTHORS: Black SB, Law B, Chen RT, Dekker CL, Sturkenboom M, Huang WT, Gurwith M, Poland G.

PUBLICATION: Vaccine

PUBLICATION DATE: 6-May-21

How to ensure we can track and trace global use of COVID-19 vaccines?

AUTHORS: Vander Stichele RH, Hay C, Fladvad M, Sturkenboom MCJM, Chen RT.

PUBLICATION: Vaccine

PUBLICATION DATE: 8-Jan-21

Consensus summary report for CEPI/BC March 12-13, 2020 meeting: Assessment of risk of disease enhancement with COVID-19 vaccines.

AUTHORS: Lambert PH, Ambrosino DM, Andersen SR, Baric RS, Black SB, Chen RT, Dekker CL, Didierlaurent AM, Graham BS, Martin SD, Molrine DC, Perlman S, Picard-Fraser PA, Pollard AJ, Qin C, Subbarao K, Cramer JP.

PUBLICATION: Vaccine

PUBLICATION DATE: 26-Jun-20

Sensorineural hearing loss (SNHL) as an adverse event following immunization (AEFI): Case definition & guidelines for data collection, analysis, and presentation of immunization safety data.

AUTHORS: Carol Liu YC, Ibekwe T, Kelso JM, Klein NP, Shehu N, Steuerwald W, Aneja S, Dudley MZ, Garry R, Munoz FM; Brighton Collaboration SNHL Working Group.

PUBLICATION: Vaccine

PUBLICATION DATE: 19-Jun-20

AUTHORS: Wilkinson B, Patel K S, Smith K, Walker R, Wang C, Greene A M, Smith G, Smith E R, Gurwith M, Chen R T, Benefit-Risk Assessment of VAccines by TechnolOgy (BRAVATO) Working Group

PUBLICATION: Vaccine

PUBLICATION DATE: 26-Oct-23