1. A research and development (R&D) roadmap for broadly protective coronavirus vaccines: A pandemic preparedness strategy.
- Author
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Moore KA, Leighton T, Ostrowsky JT, Anderson CJ, Danila RN, Ulrich AK, Lackritz EM, Mehr AJ, Baric RS, Baylor NW, Gellin BG, Gordon JL, Krammer F, Perlman S, Rees HV, Saville M, Weller CL, and Osterholm MT
- Subjects
- Animals, Humans, SARS-CoV-2, COVID-19 Vaccines, Pandemics prevention & control, Research, COVID-19 prevention & control, Vaccines
- Abstract
Broadly protective coronavirus vaccines are an important tool for protecting against future SARS-CoV-2 variants and could play a critical role in mitigating the impact of future outbreaks or pandemics caused by novel coronaviruses. The Coronavirus Vaccines Research and Development (R&D) Roadmap (CVR) is aimed at promoting the development of such vaccines. The CVR, funded by the Bill & Melinda Gates Foundation and The Rockefeller Foundation, was generated through a collaborative and iterative process, which was led by the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota and involved 50 international subject matter experts and recognized leaders in the field. This report summarizes the major issues and areas of research outlined in the CVR and identifies high-priority milestones. The CVR covers a 6-year timeframe and is organized into five topic areas: virology, immunology, vaccinology, animal and human infection models, and policy and finance. Included in each topic area are key barriers, gaps, strategic goals, milestones, and additional R&D priorities. The roadmap includes 20 goals and 86 R&D milestones, 26 of which are ranked as high priority. By identifying key issues, and milestones for addressing them, the CVR provides a framework to guide funding and research campaigns that promote the development of broadly protective coronavirus vaccines., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: [Galit Alter: Employed by Moderna. Dan Barouch: Co-inventor on vaccine patents that have been licensed to Janssen. Ralph Baric: Holds IP on sarbecovirus universal vaccine design, on the SAB for VacArt, and has collaborated with Adiago and NIH on Moderna mRNA vaccines. Norman Baylor: Provides regulatory advice and strategy to the regulated biopharma industry. Luciana Borio: In addition to holding a position at the Council on Foreign Relations, is a venture partner at Arch Venture Partners, an early-stage life sciences and biotechnology venture firm. Rachel Chikwamba: Has a grant with the Bill & Melinda Gates Foundation on localizing biologics manufacturing in South Africa. Cheryl Cohen: Has received grant support from Sanofi Pasteur, the US Centers for Disease Control and Prevention (CDC), Wellcome Trust, the Programme for Applied Technologies in Health (PATH), the Bill & Melinda Gates Foundation, and the South African Medical Research Council (SA-MRC). Bruce Gellin: Works for The Rockefeller Foundation, which is one of the funders of this work. Jonathan Heeney: Funded by CEPI and the Bill & Melinda Gates Foundation/Flu Lab to develop pre-pandemic vaccines for coronaviruses and influenza, respectively. Florian Krammer: The Icahn School of Medicine at Mount Sinai has filed patent applications relating to SARS-CoV-2 serological assays (US Provisional Application Numbers: 62/994,252, 63/018,457, 63/020,503 and 63/024,436) and NDV-based SARS-CoV-2 vaccines (US Provisional Application Number: 63/251,020) which list FK as co-inventor. Patent applications were submitted by the Icahn School of Medicine at Mount Sinai. Mount Sinai is seeking to commercialize a mucosal NDV-based SARS-CoV-2 vaccine; therefore, the institution and its faculty inventors could benefit financially. Mount Sinai has spun out a company, Kantaro, to market serological tests for SARS-CoV-2. FK has consulted for Merck, Seqirus, Curevac, and Pfizer, and is currently consulting for Pfizer, Third Rock Ventures, Merck, and Avimex. The FK laboratory is also collaborating with Pfizer on animal models for SARS-CoV-2. Teresa Lambe: Vaccine Taskforce via NIHR Support: Grant to support the running of the trial paid to University of Oxford. AstraZeneca Support: Support for medical writing. Vaccitech Consultant Fees for an unrelated project. Seqirus honoraria: Meeting relating to influenza meeting—unrelated work. Named as an inventor on a patent application for a vaccine against SARS CoV-2. Jason McLellan: Is an inventor on patents and patent applications regarding coronavirus vaccines and antibodies. Angela Mehr: Holds small amount of shares in AstraZeneca and Moderna. Kayvon Modjarrad: Current affiliation is as an employee of Pfizer, Inc. Peter Openshaw: Has participated in scientific advisory boards for GSK, Moderna, Janssen, Seqirus, and Pfizer. Peter Paradiso: Consultant to Pfizer, Member of Board of Directors at Dynavax. Stanley Plotkin: Consultant to Moderna, Sanofi, Merck, Janssen, Inovio, NTx Bio, Codagenix, Vaxinnity, Valneva, Meissa, and Rational. Gregory Poland: Offers consultative advice on COVID-19 vaccine development to AstraZeneca, Pfizer, Medicago, Johnson&Johnson/Janssen, Novavax, and Moderna. GAP has received grant funding from ICW Ventures for preclinical studies on a peptide-based COVID-19 vaccine for which he holds a patent. These activities have been reviewed by the Mayo Clinic Conflict of Interest Review Board and are conducted in compliance with Mayo Clinic Conflict of Interest policies. Andrew Pollard: Oxford University has an agreement with AstraZeneca for development of a COVID-19 vaccine. AJP led the clinical development of the Oxford-AstraZeneca vaccine. He is chair of the UK Government's Joint Committee on Vaccination and Immunisation, but does not participate in the COVID-19 committee. Melanie Saville: Has shares with Sanofi, a vaccine company; is an employee of CEPI, an organization that funds SARS CoV 2 and broadly protective coronavirus vaccine development. Lin-fa Wang: Co-inventor of patents on test, vaccine, and monoclonal antibodies for SARS-related coronaviruses. Daniela Weiskopf: The La Jolla Institute for Immunology has filed for patent protection for various aspects of T-cell epitope and vaccine design work. E. John Wherry: Is a member of the Parker Institute for Cancer Immunotherapy. EJW is an advisor for Danger Bio, Janssen, Merck, Marengo, New Limit, Pluto Immunotherapeutics, Related Sciences, Santa Ana Bio, Synthekine, and Surface Oncology. EJW is a founder of and holds stock in Surface Oncology, Danger Bio, and Arsenal Biosciences. Michael Worobey: Has received consulting fees on SARS-CoV-2 and the COVID-19 pandemic.], (Copyright © 2023 The Author(s). Published by Elsevier Ltd.. All rights reserved.)
- Published
- 2023
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