疾病控制和预防中心和美国食品药品监督管理局取消了强生疫苗的10天暂停，但将向医疗提供商发布一份概况介绍，警告他们极罕见但严重的血凝块的可能性。

官员们说，J&J一剂疫苗的再次提供将不会有什么延迟。

美国食品和药物管理局生物制品评估和研究中心主任彼得·马克斯博士说，注射应该能够在“宣布后不久”恢复。...我预计他们可能会在明天早上恢复，甚至。”

马克斯说，在过去的几天里，美国食品和药物管理局已经提前为提供者和患者准备了修订后的概况介绍。

他说:“那些情况说明书现在实际上已经被批准了。“这就是电子世界和按需印刷的美妙之处。”

欧罗巴新闻/通过盖蒂图像的欧罗巴新闻

2021年4月22日，在西班牙纳瓦拉的潘普洛纳，一名健康专家拿着一小瓶让桑新冠肺炎疫苗。

当天早些时候，一个政府顾问小组以该国急需接种疫苗为由，建议该国恢复注射J&J疫苗。

疾控中心主任罗谢尔·瓦伦斯基博士表示支持取消暂停，并宣布她已经签署了免疫实践咨询委员会的建议。

“最重要的是，你的健康和安全是第一位的，”瓦伦斯基说。“我们疾控中心和美国食品和药物管理局花了必要的时间来全面调查这个问题。...这种疫苗的暂停使我们能够确保医疗保健提供者和其他患者得到适当的治疗。”

为疾控中心提供建议的委员会以10比4的投票结果，其中一人弃权，决定继续前进。投票反对该计划的小组成员希望对女性发出更具体的警告，因为女性似乎更容易受到血栓的影响。但其他人说，他们不想给女性任何具体的警告来阻止她们接种疫苗，因为这种类型的凝血是如此罕见。

该小组主席、阿肯色州卫生部主任何塞·罗梅罗博士说:“取消一种可以单剂量给药的疫苗是有害的，这种疫苗是我们社区的拉丁裔人的首选。”。

根据疾控中心的说法，目前已有15份确诊的罕见疾病报告，包括接种J&J疫苗后血小板计数低的血凝块，其中十几个血凝块出现在大脑表面附近的静脉中，这种疾病称为“脑静脉窦血栓形成”。

这是最初报道的促使联邦监管机构建议暂停的案件的两倍多。

专家警告说，这种反应很少见。这15个病例是在近800万次J&J注射中发现的。但是50岁以下的女性似乎也更容易受到这些异常反应的影响。

约翰·洛克尔/美联社档案

2021年2月17日，新冠肺炎疫苗在拉斯维加斯注射。

疾病预防控制中心新冠肺炎特别工作组成员汤姆·岛津博士疫苗他告诉专家组，所有15起案件都是妇女。虽然年龄在18岁至59岁之间，但大多数人都在30多岁。三名妇女死亡。

J&J表示，它将继续与疾病预防控制中心和联邦监管机构合作，“以确保这一非常罕见的事件能够得到早期发现和有效治疗。我们仍然致力于全世界人民的健康和安全。”

美国国立卫生研究院院长弗朗西斯·科林斯博士当天早些时候说，他准备好看到J&J疫苗接种恢复。

柯林斯说:“我认为重要的是要指出，如果你马上意识到这是一种可以治疗的疾病。”。

在讨论如何向前推进时，专家组拒绝包括对50岁以下女性不要接种疫苗的具体警告。一些成员担心这样做可能会阻止妇女接种疫苗。

该小组的联络代表詹森·高德曼博士说，他赞成让疫苗在一个不会被误解的更全面的警告下向前发展。

“我坚信完美永远不应该是好的敌人。我认为这种疫苗的风险和益处清楚地表明，我们正在预防巨大的疾病，”高盛说。

成员们还驳回了将疫苗仅限于男性的想法。

缅因州疾病控制和预防中心主任尼拉夫·沙阿博士说:“在我们试图在任何给定的时间内给尽可能多的人接种疫苗的时候，这可能会减慢速度，甚至几个百分点都可能产生影响。”

马克·伦尼汉/美联社，档案

在这张2021年3月3日的档案照片中，展示了一小瓶强生新冠肺炎疫苗...阅读更多

相反，专家组同意推荐食品药品监督管理局授权的疫苗。作为该计划的一部分，美国食品和药物管理局将为医疗保健专业人员和接受者提供概况介绍，详细说明所涉及的风险，并给出治疗指南。

投票后，一些成员表示，他们仍然担心公众不一定会阅读概况介绍。小组成员贝丝·贝尔博士投票赞成这一举措，但他说，这取决于疾控中心和其他公共卫生官员对公众的教育。

“我担心的是...尤其是这个年龄段的女性，食品和药物管理局不会给她们足够的信息。

贝尔博士说:“我们真的依赖公共卫生机构和合作伙伴组织来确保人们真正了解情况并获得权力，他们实际上获得了平衡的观点。”

J&J让桑制药公司的全球研发负责人马泰·马蒙警告说，限制疫苗的可获得性将损害世界实现“群体免疫”的机会

在上周的一次紧急会议上，咨询小组的成员表示，他们掌握的数据太少，无法做出任何建议，包括年轻女性是否面临更大的风险。顾问们说，在做出决定之前，他们想看看最近几周接受这种疫苗的大约300万人中是否出现了更多的病例。

疫情爆发的关键时刻出现了混乱，新冠肺炎近一半地区的死亡率和住院率都在上升。卫生专家警告说，这种病毒的变体更容易传播，影响到年轻患者，在新的变体出现之前，迅速为更多的人接种疫苗至关重要。

与此同时，联邦监管机构希望提醒医生和医院警惕并发症，并知道如何治疗它们。肝素，一种常用的血液稀释剂，似乎恶化了病情。

CDC, FDA lift pause on Johnson & Johnson vaccine with warning of risks

The Centers for Disease Control and Prevention and Food and Drug Administration have lifted a 10-day pause on the Johnson & Johnson vaccine, but will issue a fact sheet to medical providers warning them of the potential for extremely rare but serious blood clots.

There will be little delay in the J&J one-dose shots being offered again, officials said.

Dr. Peter Marks, director of FDA's Center for Biologics Evaluation and Research, said shots should be able to resume "shortly after this announcement. ... I would expect them to resume probably by tomorrow morning, even."

Marks said the FDA had been prepping revised fact sheets over the past few days in advance for both providers and patients.

"Those fact sheets are now actually approved, and out there," he said. "That's the beautiful thing about the electronic world and printing on demand."

Earlier in the day, citing an urgent need to vaccinate the country, a government advisory panel had recommended that the nation resume injections of the J&J vaccine.

CDC Director Dr. Rochelle Walensky, voiced her support for lifting the pause and announced she had already signed the Advisory Committee on Immunization Practices' recommendation.

"Above all else, your health and safety come first," Walensky said. "We at the CDC and FDA took the time needed to fully investigate this issue. ... The pause of this vaccine allowed us to ensure that the health care providers and additional patients were treated appropriately."

The panel, which advises the CDC, voted 10-4 with one abstaining to move forward. Panel members voting against the plan wanted a more specific warning to women, who appeared to be more vulnerable to the blood clots. But others said they didn't want any specific warning to women to deter them from getting vaccinated because this type of clotting was so rare.

"Removing a vaccine that can be given as a single dose and is a preference among Latinos in our communities would be a detriment," said Dr. Jose Romero, chair of the panel and the director of Arkansas Health Department.

There are now 15 confirmed reports of a rare condition that includes blood clots with low platelet counts following the J&J vaccine, with a dozen of the clots occurring in veins near the surface of the brain, a condition called “cerebral venous sinus thrombosis,” according to the CDC.

That’s more than double the cases initially reported that prompted federal regulators to recommend a temporary suspension.

Experts caution the reactions are rare. The 15 cases are out of the nearly 8 million J&J shots given. But women under age 50 also seem to be significantly more vulnerable to these abnormal reactions.

Dr. Tom Shimabukuro, a member of the CDC’s task force on COVID-19vaccines, told the panel that all of the 15 cases were women. Most of them were in their 30s, although the age range was 18 to 59. Three of the women died.

J&J said it would continue to work with the CDC and federal regulators "to ensure this very rare event can be identified early and treated effectively. We remain committed to the health and safety of people worldwide."

Dr. Francis Collins, director of the National Institutes of Health, said earlier in the day that he was ready to see J&J vaccinations resume.

“I think it is important to point out that this is a treatable condition if you recognize it right away," Collins said.

In debating how to move forward, the panel declined to include a specific warning to women under 50 not to take the vaccine. Several members expressed concern that doing so could deter women from getting vaccinated at all.

Dr. Jason Goldman, a liaison representative to the panel, said he favors allowing the vaccine to move forward with a more general warning that can’t be misinterpreted.

"I’m a firm believer that the perfect should never be the enemy of the good. I think the risks and benefits of this vaccine clearly show that we're preventing tremendous disease," Goldman said.

Members also dismissed the idea of restricting the vaccine to men only.

"In a time when we're trying to vaccinate as many folks as possible in any given period of hours, it might slow things down, even a couple of percentage points may have an impact," said Dr. Nirav Shah, director of the Maine Center for Disease Control and Prevention.

Instead, the panel agreed to recommend the vaccine as authorized by the Food and Drug Administration. As part of that plan, the FDA would provide fact sheets for health care professionals and recipients that detail the risks involved and give guidelines for treatment.

Following the vote, several members said they remain concerned that the public won’t necessarily read the fact sheets. Dr. Beth Bell, a member of the panel, voted in favor of the move but said it’s up to the CDC and other public health officials to educate the public.

"I am concerned that ... women in this age group in particular will not be adequately informed just by the FDA," Bell said.

"We really are depending on the public health agencies and the partner organizations to make sure that people actually are informed and are empowered, and that they actually get a balanced perspective," Dr. Bell said.

Mathai Mammen, global head of research and development at J&J’s Janssen Pharmaceuticals, warned that limiting availability of the vaccine would hurt the world’s chances of achieving "herd immunity."

In an emergency meeting last week, members of the advisory panel said they had too little data to make a recommendation either way, including whether younger women were more at risk. The advisers said they wanted to see if more cases emerged from the estimated 3 million people who received that vaccine in recent weeks before making a decision.

The disruption came at a critical time of the pandemic, with death and hospitalization rates tied to COVID-19 on the rise in nearly half the country. Health experts warned that variants of the virus were spreading more easily, impacting younger patients and that it's critical to vaccinate the broader population quickly before new variants might take hold.

At the same time, federal regulators wanted to alert doctors and hospitals to be on the lookout for complications and to know how to treat them. Heparin, a commonly used blood thinner, appeared to worsen conditions.