希望在秋季获得安全有效的19次疫苗，但政治压力的幽灵隐约可见

Come Tuesday, November 3rd – Election Day – Americans will exist in one of two realities: One reality in which COVID-19 vaccines deemed safe and effective are available to the electorate, or a different reality in which vaccines are still unavailable. Biopharma companies are optimistic their COVID-19 vaccines could be available as early as the fall. At the same time, Congress is concerned political interference from the White House could result in the approval of substandard vaccines. This tension was on full display at yesterday’s House Energy and Commerce Subcommittee on Oversight and Investigationshearingfeaturing leaders from COVID-19 vaccine-makers AstraZeneca, Johnson & Johnson (J&J), Merck, Moderna, and Pfizer.

COVID-19-19疫苗可用性的政治干预前景

如果一切顺利，可能会有数百万的共同疫苗剂量准备好to be distributed to Americans this fall. AstraZeneca may have hundreds of millions of doses available as soon as September. Moderna has its sights set on having millions of doses produced by the fall. Pfizer could provide 100 million doses by the end of this year. These hopes are contingent on these companies’ vaccinesprovingsafe and effective in phase three trials involving tens of thousands of people.

But what if US safety and efficacy standards are adjusted, or even disregarded, to serve political interests? That’s the concern Representative Frank Pallone (D, NJ-06), chair of the full committee, raised with the five officials from vaccine-making companies.

6月底，食品和药物管理局（FDA）establishedguidance for the approval of COVID-19 vaccines. The guidance states that any vaccine must prove at least 50 percent more effective for COVID-19 prevention when compared against placebo. (The flu vaccine varies between 40 and 60 percent efficacy from one year to another.) Efficacy of 50 percent or more for a COVID-19 vaccine must be shown in a clinical trial enrolling at least 30,000 people of all different races and ethnicities.

椅子palloneraised the possibilitythat President Trump could pressure FDA to lower official COVID-19 vaccine standards to well below 50 percent efficacy, or to surreptitiously approve a vaccine even if a company’s internal data show it’s less effective than FDA’s public requirements. The Chair was looking for assurances from the vaccine-makers that they will help guard against possible political interference from the White House. Dr. Mene Pangalos, AstraZeneca’s executive vice president of biopharmaceuticals research and development,强调that all his company’s clinical data will be published openly, and that since the vaccine will be marketed globally, it will be vetted by many countries’ regulators, in addition to FDA. Moderna’s president, Dr. Stephen Hoge, alsocommittedto publishing his company’s data regardless of whether the vaccine succeeds in clinical trials, and added that independent investigators on a National Institutes of Health (NIH) Data Safety MonitoringBoardare conducting oversight of Moderna’s trials. Even so, White House influence on FDA is expected to be monitored closely as the US heads toward Election Day.

白宫尚未避免迫使联邦机构响应19009年的大流行。本月初，特朗普总统破坏Centers for Disease Control and Prevention (CDC) guidelines for reducing the risk of spreading COVID-19 at schools. In May, the Administration搁置CDC recommendations “with step-by-step advice to local authorities on how and when to reopen restaurants and other public places.” In April, a research grant funding the study of coronaviruses’ transmission from bats to people was终止because the White House told NIH to cancel it. And finally, FDA is not immune to pressure from the Administration: A举报人alleges自从敏锐的紧急使用授权允许治疗Covid-19患者hydroxychloroquinewas granted as a result of political interference, and there is证据FDA专员斯蒂芬·哈恩（Stephen Hahn）采取了不寻常的步骤，以协助纽约医生获得该药物。国会发现，在FDA的Covid-19-19疫苗批准过程中，白宫的政治干预可能非常令人担忧。

加快疫苗制造的关键

疫苗是很少发展甚至不到五年。自新疾病的出现以来，安全有效的疫苗的开发及其在不到一年的时间内开发了其分布的开始是革命性的。为了加快Covid-19-19疫苗制造，已经实施了三项关键策略。

For one, bureaucratic steps are being精简更快地移动疫苗测试过程。试验阶段之间的不必要的延迟已被消除，而对疫苗安全性和有效性的严格研究已被维持。

其次，在先前的疫苗工作中开发的一些“插件”技术已经应用to SARS-CoV-2 (the coronavirus that causes COVID-19). For example, Moderna’s vaccine development platform had been used previously toproduceinfluenza virus and Zika virus vaccine candidates, and during the hearing, J&J’s Janssen Vaccines head of clinical development and medical affairs, Dr. Macaya Douoguih,citedher company’s accelerated program that produced an Ebola vaccine as critical to J&J’s efforts to produce 100 million COVID-19 vaccine doses by March 2021.

第三，公司已经在扩大生产潜在的COVID-19疫苗与测试阶段并行，因此，如果Covid-19候选疫苗在试验中已证明是成功的，则将立即获得数百万剂。称为处于危险的制造业 - 如果候选疫苗不通过召集，数百万剂量将是毫无价值的 - 疫苗制造商正在实施这种资本密集型策略，因为迫切需要安全有效的Covid-19疫苗以保护民众。

疫苗制造商非常乐观，即今年年底将获得数以千计的Covid-19疫苗剂量。但是，美国政府的公平和公平疫苗分配计划尚未发布。CDC领先planning对于19日，与美国人民的疫苗基础设施和疫苗分配，国防部正在支持疾病预防控制中心的物流。确保所有美国人都可以接种疫苗，以疫苗接种COVID，要求密集的地方国家联邦协调，以及公共部门与私营部门之间的合作。尽管生物制药公司继续迅速采取针对Covid-19的疫苗，但有充分的希望和警惕。

To review the full House Energy and Commerce Subcommittee on Oversight and Investigations hearing,点击这里.