Author
Affilliation
Abstract
Importance: The COVID-19 pandemic has caused millions of infections and deaths and resulted in unprecedented international public health social and economic crises. As SARS-CoV-2 spread across the globe and its impact became evident, the development of safe and effective vaccines became a priority. Outlining the processes used to establish and support the conduct of the phase 3 randomized clinical trials that led to the rapid emergency use authorization and approval of several COVID-19 vaccines is of major significance for current and future pandemic response efforts. Observations: To support the rapid development of vaccines for the US population and the rest of the world, the National Institute of Allergy and Infectious Diseases established the COVID-19 Prevention Network (CoVPN) to assist in the coordination and implementation of phase 3 efficacy trials for COVID-19 vaccine candidates and monoclonal antibodies. By bringing together multiple networks, CoVPN was able to draw on existing clinical and laboratory infrastructure, community partnerships, and research expertise to quickly pivot clinical trial sites to conduct COVID-19 vaccine trials as soon as the investigational products were ready for phase 3 testing. The mission of CoVPN was to operationalize phase 3 vaccine trials using harmonized protocols, laboratory assays, and a single data and safety monitoring board to oversee the various studies. These trials, while staggered in time of initiation, overlapped in time and course of conduct and ultimately led to the successful completion of multiple studies and US Food and Drug Administration-licensed or -authorized vaccines, the first of which was available to the public less than 1 year from the discovery of the virus. Conclusions and relevance: This Special Communication describes the design, geographic distribution, and underlying principles of conduct of these efficacy trials and summarizes data from 136 382 prospectively followed-up participants, including more than 2500 with documented COVID-19. These successful efforts can be replicated for other important research initiatives and point to the importance of investments in clinical trial infrastructure integral to pandemic preparedness.
Publisher
American Medical Association
Citation
LORA, Alfredo J. Mena et al. Rapid Development of an Integrated Network Infrastructure to Conduct Phase 3 COVID-19 Vaccine Trials. JAMA Network Open, v. 6, n. 1, p. 1-15, Jan. 2023.
DOI
10.1001/jamanetworkopen.2022.51974
ISSN
0098-7484
Notes
COVID-19 Prevention Network: Daniel Reirden, Lilly Immergluck, Colleen Kelley, Anna Durbin, Milagritos Tapia, Megan Deming, Karen Kotloff, Jorge Pinto, Paul Goepfert, Zaheer Hoosain, Johan Lombaard, Kathryn Stephenson, Lindsey Baden, Stephen Walsh, Ken Mayer, Pedro Cahn, Marcelo Losso, Isabel Cassetti, Steven Innes, Linda-Gail Bekker, Sheetal Kassim, Catherine Orrel, Graeme Meintjes, Amy Ward, Andreas Diacon, David Wohl, Cindy Gray, Chrinstine Turley, Temitope Oyedele, Babafemi O Taiwo, Karen Krueger, Rick Novak, Beverly E Sha, Laura Hammit, Carl Fichtenbaum, David Bernstein, Jeffrey Jacobson, Dima Dandachi, Hasan Naqvi, Susan Koletar, Nadine Rouphael, Sri Edupuganti, Thomas Campbell, Elizabeth Secord, Samantha Siva, Nitesha Jeenarain, Logashvari Naidoo, Nigel Garrett, Nivashnee Naicker, Vimla Naicker, Jayganthie Naidoo, Anamikah Premrajh, Emmanuel Walter, Jeff Henderson, Hugo Tempelman, Abraham Siika, Evan Anderson, Brenda Okech, Richard Rupp, Hana El Sahly, Catherine M Healy, Robert Arduino, Patricia Winokur, Martin Casapia, Gailen Marshall, Bhagyashri D Navalkele, Sharla Badel-Faeson, Ian Sanne, Lee Fairlie, Adeodata Kekitiinwa, Patricia Ntege, Peter J Elyanu, Cissy K Mutuluuza, Sandra Rwambuya, Philippa Musoke, Deo Wabwire, Barbara Pahud, Mario Castro, Fredrick Sawe, Samuel G Ouma, Taraz Samandari, Grace Mboya, Craig Innes, Philip Kotze, Javier Lama, Jorge Sanchez, Jorge Gallardo, Pedro Gonzales, Robinson Cabello, Raphael Landovitz, Michael P Dube, Tamela Gould-Porter, Steve Shoptaw, Jesse Clark, Sheena Kotze, Olivia Kasselman, Katherine Gill, Maphoshane Nchabeleng, Aditya Gaur, Carlos Cabrera, Susanne Doblecki-Lewis, Susan Kline, Scott McClelland, Mandaliya Kishorchandra, Pamela Mda, Thozama Dubula, Walter Jaoko, Spyros Kalams, David Haas, Vladimir Berthaud, Clarence Creech, Sue Ellen Abdalian, Jessica Justman, Delafontaine, Kristen Marks, Sharon Mannheimer, Hong Van Tieu, Magda Sobieszczyk, Mark Mulligan, Vanessa Raabe, Mary Olson, Juanita Erb, Shobha Swaminathan, Jose Pilotto, Christopher Hall, Diana Florescu, Edwin de Jesus, Ian Frank, Katie Barr, Deborah McMahon, Sharon Riddler, Judith M Martin, Elizabeth Barranco, Breno Santos, Karen Tashima, Beatriz Grinsztejn, Esau J Filho, Mike Keefer, Ann Falsey, William Brumskine, Stuart Cohen, Jason Okulicz, Barbara Taylor, Thomas Patterson, Ryan Maves, Susan Little, Susan Buchbinder, Annie Luetkemeyer, Carmen Zorrilla, Esper Kallas, Vivian A Silva, Tamara Newman, Jose Valdez Madruga, Julie McElrath, Lisa Jackson, Anna Wald, Mookho Malahleha, Fatima Laher, Erica Lazarus, Anusha Nana, Daniel Hoft, Sharon Frey, Rachel Presti, Sharon Nachman, Benjamin Luft, Carina Rodriguez, Kathy Mngadi, Eric Daar, Shaun Barnabas, Mark Cotton, Stephen Spector, Karen Servilla, Kathleen A Linder, Abeer Moana, Carol Kauffman, Mary Bessesen, Rohit Talwani, Louis Dell'Italia, Augusto Alonto, Daniel Liebman, Roger Bedimo, Christopher Woods, Peruvemba Sriram, Kalpana Padala, Gregory Holt, Edwin Swialto, Melanie Jay, Sabrina Felson, Nora Henderson, Sheldon Brown, Saumuel Aguayo, Mark Riddle, Phyllis Tien, John Toney, Halima Dawood, Disebo Makhaza, Hugh Mighty, Siham Mahgoub, Wes Campbell, David Diemert, Tiffany Schwasinger-Schmidt, Caryn G Morse, John W Sanders, John Williamson, Angelique Luabeya, Elizabeth Bukusi, Nelly Mugo, Hannah Kibuuka, Betty Mwesigwe, Andrew Kambugu, Apolo P Balyegisawa, Kathleen Mullane, Ben Andagalu, Lucas Tina, Nathaniel Copeland, Jack Hutter, Claudio L de Las Casas, Guillermo Ruiz-Palacios, Joseph J Eron, Judith S Currier, Myron S Cohen, Kami Kim, Richard N Greenberg, Margaret Kasaro, Sinead Delaney-Moretlwe, Rodney Dawson, Carmen Paez, Nicole Grunenberg, William O Hahn, Huub C Gelderbloom, Michele P Andrasik, Stephaun E Wallace.
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