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      FDA前局长:新冠疫苗推广本来可以避免失败

      FDA前局长:新冠疫苗推广本来可以避免失败

      BRETT HAENSEL 2021年10月11日
      “我们把和平时期的做法用于公共卫生突发紧急情况下的战时环境,而没有好好想想怎样做才是最佳流程?!?/div>

      美国食品和药品监督管理局(FDA)前局长斯科特·戈特利布博士(Dr. Scott Gottlieb)称,在推出新冠加强针时,美国的监管机构和公共卫生官员犯了个错误——如果采取不同的做法,就能大大打消老百姓的疑虑。

      过去的几个月里,美国联邦机构各部门关于新冠疫苗加强剂的信息传递一直不一致。拜登政府将9月20日定为向所有美国成年人提供加强针的目标日期,而美国食药监局的专家小组在一个月后对这一雄心勃勃的计划提出了异议,他们建议为更多的特定人群提供第三剂辉瑞公司的疫苗,包括老年人和患有严重疾病的高风险人群。

      之后不久,美国疾控中心(CDC)的一个顾问小组提出了自己的建议,然而随后该中心主任罗谢尔·瓦伦斯基(Rochelle Walensky)博士似乎推翻了该小组的建议,他批准为更多人提供加强剂,包括那些生活在高接触风险环境中(如监狱或流浪者收容所)或者在医疗卫生机构工作的18至64岁的人。

      联邦政府不同部门的意见分歧在疫情爆发之前也许是有意义的,但如果公共卫生?;丫涎?,戈特利布博士认为需要采取不同的方法。

      戈特利布告诉《财富》杂志:“我们把和平时期的做法用于公共卫生突发紧急情况下的战时环境,而没有好好想想怎样做才是最佳流程?!备晏乩家彩腔匀鸸镜亩禄岢稍?。

      就最佳流程而言,戈特利布作为在特朗普政府担任了两年的美国食药监局前局长,认为美国食药监局与疾控中心在新冠疫苗决策方面应该取得更大的一致性,进行更紧密的合作。

      戈特利布说,在正常情况下,疫苗的授权和批准往往被特地设计成“一个深思熟虑的”和“漫长的”过程,他最近写了一本关于美国对新冠疫情的反应出了问题的书,书名为《不受控制的传播》。 由于儿童疫苗是最常被评估的疫苗,监管机构和卫生专家不会急于批准儿童疫苗,而会在很长一段时间内收集大量数据,以确保儿童疫苗的安全和有效。

      他说:“在发生公共卫生全球?;拇蟊尘跋?,我们采用了目前审批儿童疫苗的流程,用来决定是否向成人提供紧急使用的疫苗,而且成人可以自行决定是否接种这一疫苗。这是一项非常不同的工作?!?/p>

      戈特利布说,更何况在没有发生大规模疫情的情况下,美国食药监局局长(通常是政治任命的人物)和疾控中心主任(历来是领域内的专家)会共同对某种疫苗是否应该获批以及获批的限制条件做出决定。他称,美国食药监局在审批疫苗时较为宽松,而疾病防控中心的态度更加谨慎,通常倾向于在特定人群中分阶段推广疫苗。这两种不同的疫苗审批方式自然会导致冲突——戈特利布说,这在通常情况下是健康和必要的。

      戈特利布说:“由于美国食药监局和疾控中心分别对同一个问题作出决定,但它们需要从不同的角度给出意见,自然会产生分歧。这个系统的设计初衷就是为了如此,因为人们认识到,大部分需要审批的疫苗是会强制要求接种的儿童疫苗,你希望有一个极为审慎、仔细、周到的过程,并有很多制衡措施。因为这些都是重要的决定?!?/p>

      但在公共卫生?;谋尘跋?,戈特利布说,我们没有让人怀疑的余地,因为“它将被那些想制造混乱和想播种怀疑的人利用,以此向老百姓不适当地传递一个信息,即公共卫生官员们没有达成一致意见?!?/p>

      这位美国食药监局前负责人认为,鉴于新冠疫情的特殊情况,这两个机构从一开始就应该通力合作。

      戈特利布说:“在一个理想的世界里,我认为应该让食药监局和疾控中心在一个统一的流程中保持一致,他们从一开始就并肩工作,提出一致的建议。我们的法规或法律中,没有任何规定说我们不能在这种情况下设计一个合并的流程?!?/p>

      混合接种

      当被问及其它新冠疫苗加强针的时间表时,戈特利布指出,有关Moderna和强生公司疫苗的加强针的数据很快就会出来。他补充说,这两家公司都在积极努力地向美国食药监局申请审批,强生公司的加强针数据“看起来非常好”。

      不过,美国国家卫生研究院(NIH)与此同时正在进行一项关于“混合交替使用不同疫苗”的研究,戈特利布说?;痪浠八?,美国国立卫生研究院正在研究那些先注射一种疫苗(如Moderna)、再注射另一种疫苗(如辉瑞)的人的数据。

      戈特利布说:“根源在于存在大量替代的疫苗选择,这就是为什么美国国家卫生研究院开展了这项研究。有些情况下是被故意换了一种疫苗,也就是说人们拿到的疫苗和之前注射过的不是同一种,但更多的是无心之失。在一个大国里,绝对有一些人在使用Moderna后又使用了辉瑞,而使用辉瑞的人又使用了Moderna,因为他们没有很好地跟踪接种记录?!?/p>

      戈特利布说,如果这项研究的结果(他相信很快就会有结果)显示,混合接种不会对健康产生不利影响,那么它可以为那些患有严重疾病的高危人群提供另一种途径来接受强化治疗。

      不过,戈特利布认为人们不应该“期待看到美国食药监局或疾控中心大规模建议老百姓可以、而且应该交替使用新冠疫苗”。他还希望,在这个 "奇怪的时期",许多人都在等待Moderna和强生公司的加强针和美国国家卫生研究院研究的结果,“不会超过几个星期”。

      目前,只有辉瑞公司的加强针得到了美国食药监局和疾控中心的批准。

      德尔塔疫情终结

      戈特利布最近还预测,最新的德尔塔变体带给美国的一波疫情将在感恩节前结束。

      “这可能是最后一波主要的疫情。我认为德尔塔毒株在感恩节之前将在美国全国范围内逐渐平息,”戈特利布告诉CNN?!安《静换嵯?,但是流行程度将下降到一个更容易管理的水平?!?/p>

      德尔塔毒株导致最近几个月新冠病例明显增加,特别是在美国南方地区,尽管戈特利布说未来几周病例在其它地区也还会增加。疾控中心估计,在截至2021年9月18日的一周内,美国全国归因于德尔塔毒株的病例比例将超过98%。(财富中文网)

      译者:珠珠

      美国食品和药品监督管理局(FDA)前局长斯科特·戈特利布博士(Dr. Scott Gottlieb)称,在推出新冠加强针时,美国的监管机构和公共卫生官员犯了个错误——如果采取不同的做法,就能大大打消老百姓的疑虑。

      过去的几个月里,美国联邦机构各部门关于新冠疫苗加强剂的信息传递一直不一致。拜登政府将9月20日定为向所有美国成年人提供加强针的目标日期,而美国食药监局的专家小组在一个月后对这一雄心勃勃的计划提出了异议,他们建议为更多的特定人群提供第三剂辉瑞公司的疫苗,包括老年人和患有严重疾病的高风险人群。

      之后不久,美国疾控中心(CDC)的一个顾问小组提出了自己的建议,然而随后该中心主任罗谢尔·瓦伦斯基(Rochelle Walensky)博士似乎推翻了该小组的建议,他批准为更多人提供加强剂,包括那些生活在高接触风险环境中(如监狱或流浪者收容所)或者在医疗卫生机构工作的18至64岁的人。

      联邦政府不同部门的意见分歧在疫情爆发之前也许是有意义的,但如果公共卫生?;丫涎?,戈特利布博士认为需要采取不同的方法。

      戈特利布告诉《财富》杂志:“我们把和平时期的做法用于公共卫生突发紧急情况下的战时环境,而没有好好想想怎样做才是最佳流程?!备晏乩家彩腔匀鸸镜亩禄岢稍?。

      就最佳流程而言,戈特利布作为在特朗普政府担任了两年的美国食药监局前局长,认为美国食药监局与疾控中心在新冠疫苗决策方面应该取得更大的一致性,进行更紧密的合作。

      戈特利布说,在正常情况下,疫苗的授权和批准往往被特地设计成“一个深思熟虑的”和“漫长的”过程,他最近写了一本关于美国对新冠疫情的反应出了问题的书,书名为《不受控制的传播》。 由于儿童疫苗是最常被评估的疫苗,监管机构和卫生专家不会急于批准儿童疫苗,而会在很长一段时间内收集大量数据,以确保儿童疫苗的安全和有效。

      他说:“在发生公共卫生全球?;拇蟊尘跋?,我们采用了目前审批儿童疫苗的流程,用来决定是否向成人提供紧急使用的疫苗,而且成人可以自行决定是否接种这一疫苗。这是一项非常不同的工作?!?/p>

      戈特利布说,更何况在没有发生大规模疫情的情况下,美国食药监局局长(通常是政治任命的人物)和疾控中心主任(历来是领域内的专家)会共同对某种疫苗是否应该获批以及获批的限制条件做出决定。他称,美国食药监局在审批疫苗时较为宽松,而疾病防控中心的态度更加谨慎,通常倾向于在特定人群中分阶段推广疫苗。这两种不同的疫苗审批方式自然会导致冲突——戈特利布说,这在通常情况下是健康和必要的。

      戈特利布说:“由于美国食药监局和疾控中心分别对同一个问题作出决定,但它们需要从不同的角度给出意见,自然会产生分歧。这个系统的设计初衷就是为了如此,因为人们认识到,大部分需要审批的疫苗是会强制要求接种的儿童疫苗,你希望有一个极为审慎、仔细、周到的过程,并有很多制衡措施。因为这些都是重要的决定?!?/p>

      但在公共卫生?;谋尘跋?,戈特利布说,我们没有让人怀疑的余地,因为“它将被那些想制造混乱和想播种怀疑的人利用,以此向老百姓不适当地传递一个信息,即公共卫生官员们没有达成一致意见?!?/p>

      这位美国食药监局前负责人认为,鉴于新冠疫情的特殊情况,这两个机构从一开始就应该通力合作。

      戈特利布说:“在一个理想的世界里,我认为应该让食药监局和疾控中心在一个统一的流程中保持一致,他们从一开始就并肩工作,提出一致的建议。我们的法规或法律中,没有任何规定说我们不能在这种情况下设计一个合并的流程?!?/p>

      混合接种

      当被问及其它新冠疫苗加强针的时间表时,戈特利布指出,有关Moderna和强生公司疫苗的加强针的数据很快就会出来。他补充说,这两家公司都在积极努力地向美国食药监局申请审批,强生公司的加强针数据“看起来非常好”。

      不过,美国国家卫生研究院(NIH)与此同时正在进行一项关于“混合交替使用不同疫苗”的研究,戈特利布说?;痪浠八?,美国国立卫生研究院正在研究那些先注射一种疫苗(如Moderna)、再注射另一种疫苗(如辉瑞)的人的数据。

      戈特利布说:“根源在于存在大量替代的疫苗选择,这就是为什么美国国家卫生研究院开展了这项研究。有些情况下是被故意换了一种疫苗,也就是说人们拿到的疫苗和之前注射过的不是同一种,但更多的是无心之失。在一个大国里,绝对有一些人在使用Moderna后又使用了辉瑞,而使用辉瑞的人又使用了Moderna,因为他们没有很好地跟踪接种记录?!?/p>

      戈特利布说,如果这项研究的结果(他相信很快就会有结果)显示,混合接种不会对健康产生不利影响,那么它可以为那些患有严重疾病的高危人群提供另一种途径来接受强化治疗。

      不过,戈特利布认为人们不应该“期待看到美国食药监局或疾控中心大规模建议老百姓可以、而且应该交替使用新冠疫苗”。他还希望,在这个 "奇怪的时期",许多人都在等待Moderna和强生公司的加强针和美国国家卫生研究院研究的结果,“不会超过几个星期”。

      目前,只有辉瑞公司的加强针得到了美国食药监局和疾控中心的批准。

      德尔塔疫情终结

      戈特利布最近还预测,最新的德尔塔变体带给美国的一波疫情将在感恩节前结束。

      “这可能是最后一波主要的疫情。我认为德尔塔毒株在感恩节之前将在美国全国范围内逐渐平息,”戈特利布告诉CNN?!安《静换嵯?,但是流行程度将下降到一个更容易管理的水平?!?/p>

      德尔塔毒株导致最近几个月新冠病例明显增加,特别是在美国南方地区,尽管戈特利布说未来几周病例在其它地区也还会增加。疾控中心估计,在截至2021年9月18日的一周内,美国全国归因于德尔塔毒株的病例比例将超过98%。(财富中文网)

      译者:珠珠

      The former head of the U.S. Food and Drug Administration (FDA) Dr. Scott Gottlieb says regulators and public health officials erred in their rollout of the COVID booster vaccine—and that a different approach could have reduced much of the public confusion and skepticism that plagued widespread inoculation.

      COVID booster messaging has been inconsistent across federal agencies over the last few months. After the Biden Administration set September 20 as the target date to make boosters available to all U.S. adults, an FDA panel of experts threw a wrench into that ambitious plan a month later, recommending a third dose of the Pfizer vaccine for a more select group, including the elderly and those at high risk of severe disease.

      Not long after, a panel of advisers to the Centers for Disease Control (CDC) made its own recommendations before CDC Director Dr. Rochelle Walensky seemed to overrule the panel and approve boosters for an expanded group that included those 18 to 64 years old who live in institutional settings that increase their risk of exposure, such as prisons or homeless shelters, or are employed as health care workers.

      While this back-and-forth exchange of differing federal opinions may have made sense in pre-pandemic times, according to Gottlieb, a different approach is required in the midst of a public health crisis.

      “We took a peace-time construct and applied it to a wartime setting in a public health emergency, without taking a step back and saying what would be the optimal process,” Gottlieb, who is also a Pfizer board member, told Fortune.

      As far as the optimal process goes, Gottlieb—who served as commissioner of the FDA for two years during the Trump Administration—thinks there should have been greater alignment and cooperation between the FDA and the CDC about COVID vaccine decision-making.

      In normal times, authorization and approval of a vaccine is intentionally “designed to be a deliberative” and “prolonged” process, according to Gottlieb, who recently authored a book on what he believes went wrong with the nation's response to COVID titled, Uncontrolled Spread. Because pediatric vaccines are most often the shots up for evaluation, regulators and health experts make an effort not to rush the process, instead collecting large amounts of data over an extended period of time to ensure childhood immunizations are safe and effective.

      "We took the system that exists for adjudicating what pediatric vaccines should be in the childhood immunization schedule, and we adopted that system for making decisions about the distribution of a vaccine that's being offered on an emergency use basis in the setting of a global public health crisis to adults, who have discretion over whether or not they take the vaccine," he said. "That's a very different exercise."

      Plus, in non-pandemic circumstances, Gottlieb said both the FDA commissioner (usually a politically appointed figure) and the CDC director (historically a subject matter expert) get to render a verdict on whether a vaccine should be approved and to what extent. While the FDA usually makes broad approvals for vaccines, according to Gottlieb, the CDC tends to err on the side of caution, generally favoring a more staged rollout of vaccines to specific demographics. These two different approaches to vaccine approval naturally lead to conflict—something Gottlieb said is healthy and necessary in usual times.

      “So by virtue of the fact that [the FDA and CDC are] each being asked to render a verdict on the same question, but being asked to look at it through a different prism, you're going to get conflict,” Gottlieb said. “That system is designed to do that, because people, in good wisdom, recognize that when you're making decisions around distributing a vaccine, largely to a pediatric population where you're mandating childhood vaccinations, you want a highly deliberative, careful, thoughtful process with a lots of checks and balances. Because these are weighty decisions.”

      But in the setting of a public health crisis, Gottlieb said there is no room for the perception of conflict, as “it's going to be used by people who want to sow confusion and want to sow doubt as a way to inappropriately send a message to consumers that public health officials are discordant and not in agreement.”

      Instead, the former FDA head thinks the two agencies should have made an effort to work co-dependently from the very beginning given the extenuating circumstances of a pandemic.

      “In an ideal world, I think you would have gotten the FDA and CDC aligned to come up with a unified recommendation,” Gottlieb said. “There's nothing in regulation or law saying that we can't design a hybrid process here.”

      Mixing and match vaccines

      When asked about the timeline for other boosters of other COVID vaccines, Gottlieb noted that data regarding booster shots for both the Moderna and the Johnson & Johnson vaccines is going to be available very soon. He added that both companies are actively working to adjudicate their applications with the FDA and that data on the Johnson & Johnson booster "looked very good."

      In the meantime, though, the National Institutes of Health (NIH) is undertaking a study looking at "mixing and matching and using the different vaccines interchangeably," according to Gottlieb. In other words, he said the NIH is studying data on people who take an initial dose of one vaccine, such as Moderna, before getting a booster of another, such as Pfizer.

      "The bottom line is there's a lot of substitution going on," Gottlieb said. "And that's why NIH undertook this study looking at the mixing and matching because some of that substitution is deliberate—people going out and getting a different vaccine than what they got. But a lot of it is inadvertent. In a big country, there are absolutely people who had Moderna who are getting Pfizer, and people who had Pfizer who are getting Moderna because they're not keeping track well."

      Gottlieb said that should results of this study, which he believes are on the way soon, show that there are no adverse health effects associated with mixing and matching, it could provide another avenue for those at high risk for serious illness to receive a booster.

      Still, Gottlieb doesn't think people should "expect to see a broad recommendation from either the FDA or CDC saying you can and should be using these vaccines interchangeably." He's also hopeful that this "weird period" in which many are awaiting the results of both the Moderna and Johnson & Johnson booster shots and the NIH study "won't last more than a couple of weeks."

      Currently, only Pfizer has had a booster vaccine approved by the FDA and CDC.

      An end to the Delta wave

      Gottlieb also recently predicted that the latest Delta variant wave in the U.S. will have run its course in the country by Thanksgiving.

      "This may be the last major wave of infection. I think by Thanksgiving you'll have seen this move its way through the country," Gottlieb told CNN. "The virus isn’t going away, but prevalence levels will decline to a level that feels more manageable.”

      The Delta variant has led to a rise in COVID cases in recent months, particularly in the South, though Gottlieb also said other regions will see an uptick over the coming weeks. The CDC estimates the national proportion of cases attributed to the Delta variant to be greater than 98% for the week ending September 18, 2021.

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