美国有线电视新闻网报道说,阿斯利康在一个多月之后才向美国食品与药品管理局提供了这部分信息——所花的时间格外漫长。阿斯利康表示,自己也花了很大力气才从牛津大学那里得到了美国食品与药品管理局要求的数据。 但无论出于何种原因,无论再怎么拖延美国试验的重启过程,都无益于增强人们对该公司疫苗的信心。 欧洲的麻烦 实际上,这所有的问题都只会让人们对阿斯利康的疫苗越来越没有信心。出了这么多的问题,以至于在欧洲的许多地区,即便阿斯利康的疫苗是唯一的选择,许多人也不愿意接种,许多剂量都用不完。 欧洲的许多政界人士和德国的医药监管机构都公开质疑过,在美国以外的地区开展的临床试验中是否包含了足够多的老年人样本,让人们对该疫苗在65岁以上人群中的保护效力有信心——然而阿斯利康的表现并没有让他们满意。 最近,又有一些欧洲国家的医疗机构叫停了该疫苗的接种,因为一小部分人在接种之后出现凝血功能异常的问题。对此,阿斯利康又不得不为自己的疫苗辩护。 欧洲医药管理局重申,即使凝血问题与该疫苗有关(到目前为止,并无明确证据表明二者有关),这种副作用也是极为罕见的——疫苗也仍然是安全的:不打疫苗,感染重症新冠肺炎的风险更大,后果也严重得多。 但在那些叫停该疫苗的欧洲监管机构看来,几乎可以肯定的是,这里的风险评估是错误的:问题在于,此前阿斯利康公布其试验结果的方式有误,已经大大削弱了人们对该疫苗的信心,并让人们怀疑该公司在凝血问题上给出的说法是否完全属实。 阿斯利康总是不肯向公众和盘托出其疫苗的全部事实,在一些商业问题上也是如此。他们称将“在整个疫情期间”以成本价提供疫苗,而这实属夸大其词:《金融时报》报道称,他们在与各国政府洽谈供应时,就有权单方面宣布疫情在2021年7月前结束——而这也是该公司从未公开提及的事实。 阿斯利康可谓状况不断——他们在比利时的一家疫苗承包制造厂又出现生产上的问题,再次引起了欧盟官员的愤怒,因为这意味着他们将只能够向欧盟提供承诺疫苗剂量的一小部分。 而这起事件的恶劣之处又表现在两个方面:首先,公司在问题出现的几周之后才通知欧盟,称自己需要时间来给问题定性,以便估计会带来多大程度的影响;其次,苏博科的说辞也激怒了欧盟官员,称其供应合同仅表示,该公司将“尽最大努力”在约定的时间交付。 阿斯利康公司的管理层私下里也承认,公众对新冠疫苗的关注程度几近狂热,一举一动都在他们的严苛监督之下,这让他们的传统公关策略失灵——而这在以往开发常规药物时,可能效果很好。 他们还表示自己也很沮丧——因为公司生产疫苗其实无利可图,而且为了确保可以在全球的公平接种计划中发挥核心作用,战线已经拉得太长。此外,在和英国以外的媒体或政客无休无止的周旋中,他们也已经有点倦怠了。 这些来自阿斯利康的内部人士说,和人们以为的相反,该公司受到的审查似乎更加严格。有一些高管抱怨道,辉瑞公司宣布他们仅在2021年就能够从疫苗中赚取150亿美元时,公众却似乎没有什么反应。 确实,话又说回来,辉瑞也曾经试图夸大其临床试验数据,却并没有引发公众的口诛笔伐。(财富中文网) 编译:陈聪聪、杨二一
If there were a crisis line for corporate self-harm, AstraZeneca ought to be reported: the company can't seem to stop hacking away at its own credibility. Every time the Anglo-Swedish pharma giant has seemed on the verge of a major triumph in its COVID-19 vaccine drive, it has managed to turn glory into ignominy, committing a series of largely self-inflicted blunders, or worse. The latest example occurred on March 22 when AstraZeneca announced the long-awaited results of its large clinical trial conducted in the U.S. as well as Peru and Chile. The company said that preliminary analysis of its results from the 32,500 person-study showed its vaccine was 79% effective in preventing coronavirus infections. But in the early morning hours of March 23, the U.S. National Institute of Allergy and Infectious Diseases (NIAID) issued a highly-unusual statement saying that AstraZeneca may have used “outdated information” that “provided an incomplete view of the efficacy data.” It said it took this action after an independent panel of medical experts that works under the National Institutes of Health to help monitor the AstraZeneca trial informed the agency that it had problems with the numbers the company had used in its press release on March 22. The language used by the independent panel, known as the Data and Safety Monitoring Board, was stark, according to a copy of the letter the board sent the company which The Washington Post obtained. “The point that is clear to the board is that the [vaccine efficacy number] ... they chose to release was the most favorable for the study as opposed to the most recent and most complete. Decisions like this are what erode public trust in the scientific process,” the DSMB said according to the newspaper. The letter indicated that the more up-to-date data showed an efficacy of between 69% and 74%, and that AstraZeneca knew this and yet chose to go with the older 79% figure. The company says that the numbers used in its announcement were based on a “pre-specified” cut-off date of February 17. It also said that more up to date results were “consistent” with what they announced Monday. It said it was “now completing the validation of the statistical analysis” and was talking to the DSMB to share its analysis of this more up-to-date data with them, with the results to be published within 48 hours. Some commentators have been quick to condemn the company, saying the latest snafu is inexcusable. Eric Topol, a cardiologist who is a prominent commentator on medical affairs, took to Twitter to call AstraZeneca's response to NIAID's statement "unacceptable," saying they clearly knew what the more current data indicated and that "it should not take 48 hours to sort out." Anthony Fauci, the head of NIAID, told The Washington Post that he was "shocked" by the DSMB's concerns. “The irony of this is that it’s very likely a very good vaccine, and this sort of thing does nothing but cloud the picture. I don’t think it reflects on the vaccine,” Fauci told the newspaper. |