周二,拜登政府在推荐了一个暂停强生疫苗以下问题各州州长私下警告白宫,这一决定可能会对公众对疫苗的信心造成致命打击。
白宫和联邦高级监管机构坚称,这个问题可能会在几天内得到解决,最新的举措证明,该系统正在努力确保疫苗是安全的。
白宫还指出,该国疫苗的推出不太可能受到相当大的冲击——至少目前是这样——J&J疫苗仅占总供应量的5%。政府官员预言了这个国家仍能跟上步伐在问题解决之前,每天300万次注射完全依赖于辉瑞和莫德纳疫苗。
乔·拜登总统告诉记者:“我就疫苗问题向美国人民传达的信息是,我已经告诉你们了,我确保我们有6亿剂……不是约翰逊和约翰逊,也不是阿斯利康。”。“所以有足够的疫苗。对于每一个孤独的美国人来说,这基本上是100%毫无疑问的。”
但是两党的州长周二都暗示对政府行动过快感到沮丧,并警告白宫公众的信心一般来说,疫苗可能永远不会恢复。
坏消息是在大流行的关键时刻出现的,在该国的一些地区,病例激增,全国平均每天67,000例。在一年内死亡超过50万人之后,新冠肺炎(新型冠状病毒肺炎)现在被认为是美国第三大死亡原因
与此同时,根据疾病控制和预防中心发布的数据,患这种罕见血凝块的几率不到百万分之一,约为一半的人被闪电击中的几率。
“听着,我向疾控中心致敬,因为它在给予每个人信心的问题上过于谨慎,”康涅狄格州州长、民主党人奈德·拉蒙特(Ned Lamont)周二在州长和白宫之间的一次通话后说。
“许多州长认为白宫团队在他们说‘这只是一个暂停,然后我们重新启动引擎’时有点天真,”他补充说。
拉蒙特指的是该国州长和高级政府官员之间的私人电话,包括疾控中心主任罗谢尔·瓦伦斯基;安东尼·福奇博士,美国最高传染病专家和乔·拜登总统的高级顾问;杰夫·赞茨,白宫联邦新冠肺炎反应协调员。
美国广播公司新闻获得了电话录音,但没有向公众发布。在那次电话中,福奇告诉各州州长,罕见反应的概率为685万分之6,不到百万分之一。
福奇的评论引起了新罕布什尔州共和党州长克里斯·苏努努的强烈反对。他说,人们严重怀疑政府会因为一种“统计上无足轻重”的反应而停止救生疫苗
苏努努对白宫表示:“我认为,必须赞赏的是,在发生类似情况后,州长恢复信心的能力,比一开始暂停要困难100倍。”
斯科特·艾森/盖蒂图像,文件
新罕布什尔州州长克里斯托弗·苏努努在剪彩仪式上发表讲话
福奇回应说,虽然他们认为血栓非常罕见,但监管机构需要确认问题的范围没有扩大。按下注射暂停按钮也给了政府时间来警告医疗保健提供者不要用肝素治疗这些反应,肝素是一种常用的血液稀释剂,据信会恶化症状。
希望卫生官员能在本周末解决这个问题,为卫生保健提供者发布一系列建议,说明如何识别这种罕见的反应并使用肝素以外的治疗方法。
“当你暂停接种疫苗时,美国食品药品监督管理局和疾控中心就有时间来确定是否有超过6例的病例,”福奇告诉州长们。
在周二发布的一份声明中,J&J表示将推迟该疫苗在欧洲的推广,并暂停使用该疫苗的临床试验,直到能够提供更多信息。
“使用我们产品的人的安全和健康是我们的第一要务,”该公司在一份声明中表示。
当被问及J&J的注射可能在多长时间后恢复时,瓦伦斯基告诉州长,审查过程可能会很快。
瓦伦斯基说:“我们希望并预计这种暂停将持续几天到几周,而不是几周到几个月。”。
但两党都感到沮丧的是,由政治任命者监管的食品和药物管理局和疾病预防控制中心动作太快。
纽约民主党政府安德鲁·科莫他警告白宫,如果人们拒绝J&J,他预计对辉瑞和莫德纳的需求将会上升,即使在那些注射恢复之后。
阿肯色州共和党州长阿萨·哈钦森(Asa Hutchinson)补充说,此举使免疫某些弱势群体的努力变得复杂,如工厂工人,他们可能喜欢简单的一针。
“停顿越长,犹豫就越多。我真的希望我们能尽快解决这个问题,”哈钦森告诉白宫。
马萨诸塞州州长查理·贝克说,他已经接到医疗保健提供者的电话,他们想知道如何区分接种疫苗后可能出现的典型流感样症状和这些罕见的反应。
“我确实担心整件事会被混为一谈。贝克说:“任何头痛的人,任何患流感的人都将被认为是得到了更重要或更糟糕的东西的人。”。
瓦伦斯基说,一个人可以判断他们是否因为时间而经历了不寻常的反应。疫苗接种后常见的流感样症状会在24至48小时内触发。但这些罕见的凝血病例通常出现在第6天或之后。
汤姆·布伦纳/路透社
乔·拜登总统在椭圆形办公室会见国会黑人核心小组成员
暂停之际,J&J一直在努力建立稳定的剂量供应,如下制造问题在巴尔的摩的一个机构。由于与血栓无关的原因,预计本周输送到各州的剂量将下降约85%。
受影响的包括国防部。由于供应数量减少,五角大楼已经计划暂时转向现代航空。但是军方最终还是希望用这种一次性疫苗来免疫海外的军队和家庭,因为J&J的疫苗更容易运输和储存。
现在,这一努力处于悬而未决的状态。
“此时,我们不知道暂停会持续多久。五角大楼新闻秘书约翰·柯比说:“随着我们了解到更多的情况,我们将继续与部队沟通。”。
拜登的COVID协调员齐恩斯说,白宫正在与各州和地方官员合作,重新安排计划接种J&J疫苗的人接种辉瑞或莫德纳疫苗。
“我们有大量的供应品,我们有大量的运输工具来运送这些供应品,无论是通过联邦药房渠道,还是通过流动单位、社区卫生中心。所有这些都有能力提供现代疫苗和辉瑞疫苗。
州长们说,尽管真正艰难的战斗将是向公众保证他们得到的疫苗是安全的。
“作为全国各地的州长,我们非常努力地工作...为了让人们相信接种疫苗是正确的,现在就接种吧。“接种疫苗比暂停或等待安全一百万倍,”拉蒙特说。
Governors question Biden decision on J&J, warn of potential hit to vaccine confidence
The Biden administration faced pushback Tuesday after recommending atemporary suspensionof the Johnson & Johnson vaccinefollowing concernsthat it could trigger an exceedingly rare blood clot, with state governors privately warning the White House that the decision could deal a fatal blow to public confidence in the vaccine.
The White House and senior federal regulators insisted that the issue would likely be resolved in a matter of days and that the latest move was evidence that the system is working to ensurevaccinesare safe.
The White House also noted that the nation's vaccine rollout was unlikely to take a sizable hit -- at least for now -- with J&J vaccine representing only 5% of the total supply. Administration officials predicted the nationcould still keep paceat 3 million shots a day relying entirely on Pfizer and Moderna vaccines until the issue was resolved.
"My message to the American people on the vaccine is, I told you all I made sure we have 600 million doses … not of either Johnson and Johnson and-or AstraZeneca," President Joe Biden told reporters. "So there is enough vaccine. That is basically 100% unquestionable, for every single, solitary American."
But state governors from both sides of the aisle hinted at frustration Tuesday that the administration acted too quickly and warned the White House thatpublic confidencein vaccines, in general, might never recover.
The bad news comes at a critical time in the pandemic in which cases are surging in some parts of the country with a national daily average of 67,000. And, after more than a half a million deaths in one year,COVID-19is now considered the third leading cause of death in the U.S.
Meanwhile, the chance of developing this rare type of blood clot was a less than one in a million -- about half a person's chances of getting hit by lightning, according to data released by the Centers for Disease Control and Prevention.
"Look, I salute the CDC for erring on the side of caution to give everybody that sense of confidence," said Connecticut Gov. Ned Lamont, a Democrat, Tuesday following a call between the governors and the White House.
"A number of the governors thought though that the White House team was a little naive when they said, 'This is just gonna be a pause and then we restart our engines,'" he added.
Lamont was referring to a private call among the nation's governors and senior administration officials, including CDC Director Rochelle Walensky; Dr. Anthony Fauci, the nation's top infectious disease expert and senior adviser to President Joe Biden; and Jeff Zients, the White House coordinator for the federal COVID-19 response.
ABC News obtained an audio of the call, which was not released to the public. In that call, Fauci told the state governors that the chances of the rare reaction was 6 out of 6.85 million – or less than one in a million.
Fauci's comment prompted strong pushback from New Hampshire Republican Gov. Chris Sununu who said there's serious skepticism that the government would halt life-saving vaccines for a reaction that is so "statistically insignificant."
"I think what has to be appreciated is the ability for governors to reinstill confidence after something like this, is 100 times harder than putting the pause on in the first place," Sununu told the White House.
Fauci responded that while they believe the blood clots are extraordinarily rare, regulators needed to confirm that the scope of problem wasn't bigger. Hitting the pause button on injections also gives the government time to warn health care providers not to treat these reactions with heparin, a commonly used blood thinner which is believed to worsen symptoms.
The hope was that health officials could resolve the issue by the end of the week by releasing a set of recommendations for health care providers on how to recognize the rare reaction and use treatments other than heparin.
"When you put a pause (on the vaccine), it gives the (Food and Drug Administration) and the CDC time to determine if there are more cases than just six," Fauci told the governors.
In a statement released Tuesday, J&J said it would delay its rollout of the vaccine in Europe and pause clinical trials using the vaccine until it can provide more information.
"The safety and well-being of the people who use our products is our number one priority," the company said in a statement.
When asked how long before J&J injections might resume, Walensky told the governors the review process will likely be fast.
"We are hoping and anticipating that this pause is going to be on the order of days to weeks and not weeks to months," Walensky said.
But frustration was bipartisan that the FDA and CDC, both overseen by political appointees, moved too quickly.
New York Democratic Gov.Andrew Cuomowarned the White House that he expects demand for Pfizer and Moderna will go up if people refuse J&J, even after those injections resume.
Arkansas Republican Gov. Asa Hutchinson added that the move complicates efforts to immunize certain vulnerable populations like factory workers who might favor the ease of a single shot.
"The longer the pause the more hesitance that will come out. And I do hope that we can get a handle on this quickly," Hutchinson told the White House.
Massachusetts Gov. Charlie Baker said he's already getting phone calls from health care providers wanting to know how they are supposed to distinguish the typical flu-like symptoms that can occur after a vaccination and these rare reactions.
"I do worry that this whole thing is going to get conflated. And anybody who gets a headache, anybody gets the flu is going to be deemed to be somebody who's gotten something far more significant, or worse," Baker said.
Walensky said a person can tell whether they are experiencing an unusual reaction because of timing. Flu-like symptoms that are common following the vaccine are triggered within 24 to 48 hours. But these rare blood clotting cases present typically at or after the 6-day mark.
The pause comes as J&J has struggled to build up a steady supply of doses, followingmanufacturing problemsat a Baltimore facility. The number of doses delivered to states was expected to drop some 85% this week anyway for reasons unrelated to the blood clots.
Among those impacted is the Defense Department. The Pentagon was already planning a temporary switch to Moderna due to the lower supply numbers. But the military eventually had wanted the one-shot vaccine to immunize troops and families overseas because the J&J doses are easier to ship and keep in storage.
Now, that effort is in limbo.
"At this time, we do not know how long the pause will last. We will continue to communicate to the force as we learn more," said Pentagon press secretary John Kirby.
Zients, Biden's COVID coordinator, said the White House is working with states and local officials to reschedule people who were slated for a J&J vaccine to get the Pfizer or Moderna shot instead.
"We have plenty of supply and we have plenty of vehicles for delivering that supply, whether it's through the federal pharmacy channel, whether it's mobile units, community health centers. And all of those are equipped to deliver the Moderna and Pfizer vaccines," Zients told reporters.
The governors said though the real uphill battle will be assuring the public that the vaccines they are getting are safe.
"We're working really hard as governors across the country ... to give people confidence that it's the right thing to do to get vaccinated, get vaccinated now. It's a million times safer getting vaccinated, than pausing or waiting," Lamont said.