dziakj1
commented
4 years ago Summary
This is an editorial or think-piece, not an empirical study. However, it is in a very high-impact journal and has a star-studded cast of authors from Hutch and the NIH, including Anthony Fauci and Francis Collins. It also describes issues of very great importance. So it seems to me that it may be worth citing.
They say that cooperation will be needed between industry, government, academia and philanthropy, and they introduce a recently proposed public-private partnership led by the NIH, "ACTIV (Accelerating COVID-19 Therapeutic Interventions and Vaccines)".
They outline some of the requirements which would have to be met by successful clinical trials of a vaccine, and what the trial endpoints might be. In particular, they mention the need to investigate the "theoretical risk" that individuals who are vaccinated but later become infected anyway may have more severe symptoms due to "vaccine-induced immune enhancement."
They mention the possibility of "controlled human challenge trials" but mention that there would be both ethical concerns and possible drawbacks to generalizability.
They briefly describe the variety of current work being done by several companies on developing a vaccine, although they warn that "No single vaccine or vaccine platform alone is likely to meet the global need, and so a strategic approach to the multi-pronged endeavor is absolutely critical." Possible vaccines include nucleic acid vaccines, and/or recombinant versions of the COVID spike protein.
They argue, "There is an emerging consensus that vaccine trials need to either use common independent laboratories or contribute samples and data for ... generating surrogate markers that ultimately speed licensure and an overall comparison of efficacy. A common Institutional Review Board as well as a common cross-trial Data and Safety Monitoring Board (DSMB) should be used. As vaccine candidates are poised to enter phase 1, the collective planning for phase 3 must be undertaken."
They also describe the need to prepare to massively scale up production of a vaccine if it is developed, so that it can be deployed globally.
They conclude, "To return to a semblance of previous normality, the de-velopment of SARS-CoV-2 vaccines is an absolute necessity. To achieve this goal, all the resources in the public, private, and philanthropic sectors need to participate in a strategic manner. The ACTIV public-private partnership and collabo-rative harmonized efficacy trials are enabling models to achieve our common goal."
Title: A strategic approach to COVID-19 vaccine R&D
General Information
Please paste a link to the paper or a citation here:
Link: https://science.sciencemag.org/content/early/2020/05/12/science.abc5312
What is the paper's Manubot-style citation?
Citation: @doi:10.1126/science.abc5312
Is this paper primarily relevant to Background or Pathogenesis?
Please list some keywords (3-10) that help identify the relevance of this paper to COVID-19
Please note the publication / review status
Which areas of expertise are particularly relevant to the paper?