Global S&T Development Trend Analysis Platform of Resources and Environment
| DOI | 10.1126/science.abf4851 |
| Transparency is key to ethical vaccine research | |
| Preston W. Estep; George M. Church | |
| 2020-12-18 | |
| 发表期刊 | Science
 |
| 出版年 | 2020 |
| 英文摘要 | The Rapid Deployment Vaccine Collaborative (RaDVaC) is a free and open-source project that designs, tests, and shares vaccine designs and protocols. In their Policy Forum “Self-experimentation, ethics, and regulation of vaccines” (25 September, p. [1570][1]), C. J. Guerrini and colleagues suggest that RaDVaC activities will cause a loss of public trust in all vaccines. An earlier Editorial (“The danger of DIY vaccines,” A. L. Caplan and A. Bateman-House, 28 August, p. [1035][2]) asserted that the RaDVaC project will cause people to lose trust not only in vaccines but also in science and public health efforts. However, restricting vaccine information and access to a privileged elite might be more likely to cause loss of public trust.
An article cited by the Policy Forum and the Editorial says that scientists are privately protecting themselves with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines, but the authors don't criticize these scientists for their unpublished vaccine designs and private vaccinations ([ 1 ][3]). Instead, they express concern about RaDVaC's “do-it-yourself (DIY)” vaccines. Given that we have created unrestricted access for all—non-profits, companies, governments, and individuals—this model is more accurately described as free and open-source than as DIY. RaDVaC's rapid iteration of vaccine designs and self-experimentation, although incompatible with typical institutional review board oversight and standard clinical trial testing, are among the project's foundational strengths, providing critical advantages in agility and alacrity at a time when delays are extremely costly in human life and welfare.
Both Guerrini et al. and Caplan and Bateman-House assert that our approach skirts safety considerations and suggest that vaccine safety will be established through clinical trials. However, they don't differentiate between short-term and long-term safety—or even mention the long-term risks that most concern scientists. As a result, their overall statements about safety are misleading. Over one hundred testers have contributed to a growing short-term safety profile for RaDVaC vaccines, which is very similar to the high degree of safety seen in earlier clinical trials of comparable nasal vaccines ([ 2 ][4]). As for long-term safety, certain vaccines have exacerbated subsequent infection, a phenomenon called vaccine-enhanced disease (VED) ([ 3 ][5], [ 4 ][6]). The probability of detecting or predicting VED in pre-approval phases of clinical trials is very low. VED science is complex and still uncertain, but specific vaccine attributes are known to increase risks. RaDVaC-affiliated scientists have published analyses of VED risks and possible mitigation strategies, which RaDVaC has incorporated into its vaccine designs ([ 4 ][6], [ 5 ][7]). We have less confidence in first-to-market vaccines because their designs do not include important discoveries made beyond the earliest weeks of the pandemic—a result of those vaccines being locked in place as required by the regulatory processes RaDVaC critics reflexively extol. Despite shortcomings in certain vaccines, we believe future retrospective analyses will show that vaccines adhering to good design principles and VED mitigation strategies are vastly safer than exposure to the virus, especially for people at highest risk.
All recent progress in vaccine research and development, including our own, has depended completely on accepted practices of science—especially the rapid and open sharing of scientific information. The claim that RaDVaC undermines public trust in vaccines, science, and public health efforts is analogous to criticizing firefighters for freely sharing their knowledge to help others fight their own fires—at a time when most of the world is engulfed in raging conflagrations.
We believe our actions could not be more clearly pro-vaccine, pro-science, and pro-public health. As we work to establish rapid response methods for producing safe and effective vaccines, our first ethical duty is to not restrict access to a privileged inner circle. Instead, we share information openly for broad deployment and maximum positive impact.
1. [↵][8]1. A. Regalado
, “Some scientists are taking a DIY coronavirus vaccine, and nobody knows if it's legal or if it works,” MIT Tech. Rev. (2020).
2. [↵][9]1. A. Smith et al
., Hum. Vaccines Immunother. 10, 797 (2014).
[OpenUrl][10]
3. [↵][11]1. N. Eroshenko et al
., Nat. Biotechnol. 38, 789 (2020).
[OpenUrl][12]
4. [↵][13]1. B. Graham
, Immunol Rev. 239, 149 (2011).
[OpenUrl][14][CrossRef][15][PubMed][16]
5. [↵][17]1. P. W. Estep et al
., “SARS-CoV-2 (2019-nCoV) vaccine version 3-3-1” (2020); |
| 领域 | 气候变化 ; 资源环境 |
| URL | 查看原文 |
| 引用统计 | |
| 文献类型 | 期刊论文 |
| 条目标识符 | http://119.78.100.173/C666/handle/2XK7JSWQ/308339 |
| 专题 | 气候变化 资源环境科学 |
| 推荐引用方式 GB/T 7714 | Preston W. Estep,George M. Church. Transparency is key to ethical vaccine research[J]. Science,2020. |
| APA | Preston W. Estep,&George M. Church.(2020).Transparency is key to ethical vaccine research.Science. |
| MLA | Preston W. Estep,et al."Transparency is key to ethical vaccine research".Science (2020). |
| 条目包含的文件 | 条目无相关文件。 | |||||
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