Concerns over political interference in the COVID-19 vaccine candidate evaluation process addressed during Senate hearing

The Oval Office, biopharmaceutical executives, and federal agencies have signaled that COVID-19 vaccines could be ready to go this fall; however,leadingexpertsbelieve that proof of a safe and effective vaccine before Election Day is unlikely. President Trump has说“我们可能在10月的某个时候可以使用[Covid-19-19疫苗]。”辉瑞和Biontech高管thinkthey could know whether their joint COVID-19 vaccine candidate works by the end of October, and that the Food and Drug Administration (FDA)将要授予其紧急使用授权（EUA）。疾病控制与预防中心（CDC）希望各州准备好distribute10月下旬，一种Covid-19-19疫苗，在11月1日之前发行了分销场所。虽然被启示分发挽救生命的疫苗肯定很重要，但是more实际的scenario is that thorough analyses determining the safety and efficacy of COVID-19 vaccine candidates should be possible at the very end of this year, or beginning of next year.

Nevertheless, extremely optimistic COVID-19 vaccine approval timelines that converge with Election Day are being broadcast to the American public, and during Wednesday’s Senate Health, Education, Labor, and Pensions (HELP) Committeehearing, lawmakers demanded assurances that scientific data, not political agendas, will drive the COVID-19 vaccine approval process.

III期Covid-19疫苗候选疫苗的前进道路

美国人可以提供的三名候选疫苗候选者是现在在第三阶段临床试验中，他们的前进道路依赖于actions由疫苗制造商，FDA，卫生与公共服务部（HHS，FDA的母公司）和总统采取的。

尽管仅生物制药公司就已经设计和执行了疫苗候选临床试验，但COVID-19监督by the US Government. To gauge if any of the vaccine candidates prevent or decrease the severity of disease with at least 50 percent efficacy – the bar FDAset在6月底 - 每次Covid-19候选疫苗III期临床试验中，成千上万的人正在招募。实际上，在星期六，辉瑞建议的to FDA that it enroll up to 44,000 participants, almost 50 percent more than the initial target of 30,000. Half are dosed with the vaccine candidate, the other half are dosed with placebo, and, to prevent bias, only a select group of experimentalists – not the trial participants, not the professionals administering the doses – know who gets what. During Wednesday’s hearing, Dr. Francis Collins, the director of the National Institutes of Health, asserted (2:26:10 mark in视频) that once 150 people in the entire trial havedevelopedsymptomatic disease, it should be possible to determine whether a vaccine candidate is 50 percent effective. However, some experts say that even the point at which the trial reaches 150 cases of disease isunlikely提供足够的时间来证明疫苗候选安全性。

Each individual COVID-19 vaccine candidate trial istracked由uniqueData Safety and Monitoring Board (DSMB). DSMBs are多学科与疫苗制造商和联邦政府无关的群体，由临床试验专家，生物阶级主义者，生物伦理学家，免疫学家，疫苗接种学家和病毒学家组成。随着试验的进行，DSMB定期reviewthe data as they accumulate, and make recommendations to the公司并FDAabout whether a vaccine has met safety and efficacy standards. Ultimately, DSMBs are only advisory groups, and it is up to the公司as to whether it提交FDA的生物制品许可证申请（BLA），以供其Covid-19候选疫苗。

FDA willreviewthe clinical trial data in the BLA for safety and efficacy. Following FDA’s review, the company and the FDA have the选项向FDA的疫苗和相关生物产品咨询委员会（VRBPAC）提出发现，这是另一个独立于联邦政府和疫苗制造商的专家机构。如果经过咨询，VRBPAC将为FDA提供有关疫苗安全性和功效的建议。无论如何，FDA都可以批准或否认疫苗候选者的使用。

或者，疫苗制造商可以要求an EUA from FDA, which opens up the possibility of a vaccine being approved for use before the conclusion of the clinical trial, which could complicate the trial’s full evaluation of safety and efficacy. Another tool FDA could possibly use is Accelerated Approval, a过程that could base vaccine approval only on antibody levels or another surrogate biochemical marker produced in trial participants, rather than measuring actual protection from disease. Notably, HHS, or possibly President Trump, could evenoverruleFDA对EUA请求的拒绝。

Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases,believesthere would be a moral obligation to end a trial early and make a vaccine accessible if the data from the trial were to be overwhelming that the vaccine candidate is safe and effective.

Federal officials testify that COVID-19 vaccine decisions will be based only on science

During the hearing, Senator Bernie Sanders (D, VT) pressed (1:14:27 mark in视频）证人确认Covid-19-19疫苗批准过程仅由科学驱动。柯林斯博士承诺，他和美国所有政府科学家将仅根据科学进行疫苗的评估和评估，否则他将没有参与这一过程。他还表达了谨慎的乐观情绪，即美国将在今年年底之前生产安全有效的疫苗，并补充说：“当然，试图预测它是否发生在11月初或特定日期之前的特定一周或之后发生的疫苗远远超出any scientist right now could tell you and be confident that they know what they’re saying.”

Vice Admiral Jerome Adams, the US Surgeon General, concurred with this sentiment, stating that a COVID-19 vaccine will not be moved along unless it is proven to be safe and effective, that shortcuts will not be taken, and that once approved or authorized by FDA, he and his family would not hesitate to receive the vaccine.

随着选举日的临近，单词会转化为行动吗？

柯林斯博士和副海军上将亚当斯并不是唯一给出的保证科学而不是政治影响力的人会推动COVID-19疫苗的批准。FDA的职业公务员重申了他们的resolve“与代理领导人合作，以维持FDA坚定地确保我们的决策的坚定承诺将继续受到最佳科学的指导。”扭曲速度行动负责人（美国为加速Covid-19-19疫苗开发的努力），Moncef Slaoui博士，说he will “immediately resign if there is undue interference in this process.” And nine COVID-19 vaccine-making companies havepledged“坚持科学发展过程的完整性as they work towards potential global regulatory filings and approvals of the first COVID-19 vaccines.”

随着选举日的临近，我们将密切跟踪此问题，并一定会提醒社区采取新的发展。要审查本周听证会的整个点击这里.