Publications

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