A strategic approach to COVID-19 vaccine R&D

• Published in: Science Vol. 368; no. 6494; pp. 948 - 950
• Main Authors: Corey, Lawrence, Mascola, John R, Fauci, Anthony S, Collins, Francis S
• Format: Journal Article Web Resource
• Language: English
• Published: United States 29.05.2020
• Subjects: Adjuvants, Immunologic; Animals; Betacoronavirus - immunology; Clinical Trial Protocols as Topic; Clinical Trials as Topic; Coronavirus Infections - immunology; Coronavirus Infections - prevention & control; COVID-19; COVID-19 Vaccines; Disease Models, Animal; Humans; Immunogenicity, Vaccine; International Cooperation; National Institutes of Health (U.S.); Pandemics - prevention & control; Pneumonia, Viral - immunology; Pneumonia, Viral - prevention & control; Public-Private Sector Partnerships; RNA, Messenger; SARS-CoV-2; Spike Glycoprotein, Coronavirus - immunology; T-Lymphocytes - immunology; United States; Vaccines, DNA; Vaccines, Synthetic - immunology; Viral Vaccines - adverse effects; Viral Vaccines - immunology; United States
• ISSN: 0036-8075; 1095-9203
• DOI: 10.1126/science.abc5312

A public-private partnership and platform for harmonized clinical trials aims to accelerate licensure and distribution There is an unprecedented need to manufacture and distribute enough safe and effective vaccine to immunize an extraordinarily large number of individuals in order to protect the entire global community from the continued threat of morbidity and mortality from severe acute respiratory syndrome–coronavirus 2 (SARS-CoV-2). The global need for vaccine and the wide geographic diversity of the pandemic require more than one effective vaccine approach. Collaboration will be essential among biotechnology and pharmaceutical companies, many of which are bringing forward a variety of vaccine approaches ( 1 ). The full development pathway for an effective vaccine for SARS-CoV-2 will require that industry, government, and academia collaborate in unprecedented ways, each adding their individual strengths. We discuss one such collaborative program that has recently emerged: the ACTIV (Accelerating COVID-19 Therapeutic Interventions and Vaccines) public-private partnership. Spearheaded by the U.S. National Institutes of Health (NIH), this effort brings together the strengths of all sectors at this time of global urgency. We further discuss a collaborative platform for conducting harmonized, randomized controlled vaccine efficacy trials. This mechanism aims to generate essential safety and efficacy data for several candidate vaccines in parallel, so as to accelerate the licensure and distribution of multiple vaccine platforms and vaccines to protect against COVID-19 (coronavirus disease 2019).