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                美国加强针获批,可能出现这些副作用

                美国加强针获批,可能出现这些副作用

                Sy Mukherjee 2021年08月20日
                美国的联邦卫生官员在很大程度上仍然对新冠疫苗加强剂的副作用持观望态度。

                新冠疫苗加强剂已经在美国成为现实。根据拜登政府于8月18日宣布的一项新的新冠免疫计划,从9月20日的一周开始,所有尚未接种过辉瑞(Pfizer)或Moderna基于mRNA的第二剂疫苗至少8个月的美国成年人,将可以获得新冠疫苗增强剂,等待美国食品与药品管理局(Food and Drug Administration)和美国疾病控制中心(Centers for Disease Control)的监管批准。至于注射了强生(Johnson & Johnson)疫苗的人,相关潜在加强剂的政策仍然在审查中,因为强生的疫苗依赖于另外一种技术,而非mRNA。此前,8月13日,美国食品与药品管理局和美国疾病控制中心已经为一些完全接种疫苗的美国民众批准了第一批新冠疫苗增强剂,尽管其针对的是一小部分免疫系统受损的美国民众。

                但在未来几个月,随着在技术上有资格获得第三剂辉瑞或Moderna新冠疫苗的接种人数从老年人扩大到医护人员,最终扩大到年轻、健康的普通个人,以及越来越多的民众愿意插队去接受第三针加强剂——了解新冠疫苗加强剂的副作用是否与我们在第一轮疫苗注射中看到的相同、不同或更严重,将变得十分重要。

                现在,加强剂的授权甚至还没有到一周,而且还尚未出现足够的数据以表明完全接种疫苗的人在第三次注射后可能会有什么副作用。早期指标表明,他们的情况与许多人在最初几轮疫苗接种后的情况基本一致,但医学专家对最容易出现非常罕见且相当严重的副作用的人群表示担忧。

                不同的人经历新冠疫苗副作用的形式不同,从疲劳、注射部位手臂疼痛、头痛、头晕、注射周围红肿到几天后出现的延迟效应,例如身体各部位的肌肉疼痛(特别是在注射第二剂mRNA疫苗后)、头晕、恶心、发冷和发烧等等。在难受了几天之后,这些症状往往会消失。根据美国疾病控制中心的说法,这些可能也是加强剂会产生的情况,人们会经历一些类似于流感的较温和的副作用。

                “关于接受额外剂量疫苗风险的信息有限,额外剂量新冠疫苗在免疫缺陷人群中的安全性、有效性和益处将继续受评估。”该机构表示,“到目前为止,第三剂mRNA疫苗剂量后报告的反应与前两次剂量相似:注射部位的疲劳和疼痛是最常见的副作用,且总体上属于轻到中度。但是,与两剂疫苗一样,严重的副作用很少,但仍然可能会发生。”

                严重或延迟的副作用尤其需要关注。据凯撒健康新闻(Kaiser Health News)报道,有证据表明,对于极少数对疫苗有危险反应的人来说(比如心肌炎或心脏肿胀),第二次注射后副作用更为常见。第三剂疫苗是否会扩大这一罕见的结果,或导致在加强剂注射前的免疫过程中就观察到的血凝块和过敏反应,目前仍不清楚。但是,美国西北大学范伯格医学院(Northwestern University Feinberg School of Medicine)的流行病学家和心脏病学家萨迪娅?汗等医生质疑,额外的剂量是否会使心肌炎的风险更为明显,尤其是在年轻和健康的人群中,他们可能会产生严重的心脏副作用。此外,他们还怀疑加强剂的优点是否值得这些人冒潜在风险。

                在接下来的几周和几个月里,还有许多关于加强剂副作用的重要考虑有待追踪,包括接受强生疫苗的1300万美国民众。公共卫生官员和监管机构表示,现在就建议强生疫苗接种者接受加强剂还为时过早,因为目前信息还不够多。而且这种特殊的疫苗从3月才开始供应,这意味着其距离美国政府8个月的疫苗补充窗口期还差几个月。

                “目前还没有足够的数据来确定接受强生公司的杨森(Janssen)新冠疫苗的免疫功能低下人群,在额外注射相同疫苗后是否也有更好地抗体反应。”美国疾病控制中心表示。但越来越多的专家一致认为,每个人最终都需要加强剂,包括强生疫苗的接种者。他们担心强生疫苗与其他新冠疫苗相比之下的有效性,以及对抗新毒株(例如德尔塔变异毒株)的效力。除非强生疫苗获得更可靠的指导和数据,包括加强剂应该是强生疫苗的第二剂还是辉瑞或Moderna的mRNA疫苗,在此之前,官方无法正式跟踪这些美国民众的加强剂副作用。

                联邦卫生官员在很大程度上仍然对新冠疫苗加强剂的副作用持观望态度。他们表示,过去一周的行动表明,加强剂的潜在好处可能超过其风险。但是,如果你选择接种加强剂,为了获得额外的保护而不得不忍受几天的昏昏沉沉和手臂疼痛,也请你不要感到惊讶。(财富中文网)

                编译:杨二一

                新冠疫苗加强剂已经在美国成为现实。根据拜登政府于8月18日宣布的一项新的新冠免疫计划,从9月20日的一周开始,所有尚未接种过辉瑞(Pfizer)或Moderna基于mRNA的第二剂疫苗至少8个月的美国成年人,将可以获得新冠疫苗增强剂,等待美国食品与药品管理局(Food and Drug Administration)和美国疾病控制中心(Centers for Disease Control)的监管批准。至于注射了强生(Johnson & Johnson)疫苗的人,相关潜在加强剂的政策仍然在审查中,因为强生的疫苗依赖于另外一种技术,而非mRNA。此前,8月13日,美国食品与药品管理局和美国疾病控制中心已经为一些完全接种疫苗的美国民众批准了第一批新冠疫苗增强剂,尽管其针对的是一小部分免疫系统受损的美国民众。

                但在未来几个月,随着在技术上有资格获得第三剂辉瑞或Moderna新冠疫苗的接种人数从老年人扩大到医护人员,最终扩大到年轻、健康的普通个人,以及越来越多的民众愿意插队去接受第三针加强剂——了解新冠疫苗加强剂的副作用是否与我们在第一轮疫苗注射中看到的相同、不同或更严重,将变得十分重要。

                现在,加强剂的授权甚至还没有到一周,而且还尚未出现足够的数据以表明完全接种疫苗的人在第三次注射后可能会有什么副作用。早期指标表明,他们的情况与许多人在最初几轮疫苗接种后的情况基本一致,但医学专家对最容易出现非常罕见且相当严重的副作用的人群表示担忧。

                不同的人经历新冠疫苗副作用的形式不同,从疲劳、注射部位手臂疼痛、头痛、头晕、注射周围红肿到几天后出现的延迟效应,例如身体各部位的肌肉疼痛(特别是在注射第二剂mRNA疫苗后)、头晕、恶心、发冷和发烧等等。在难受了几天之后,这些症状往往会消失。根据美国疾病控制中心的说法,这些可能也是加强剂会产生的情况,人们会经历一些类似于流感的较温和的副作用。

                “关于接受额外剂量疫苗风险的信息有限,额外剂量新冠疫苗在免疫缺陷人群中的安全性、有效性和益处将继续受评估。”该机构表示,“到目前为止,第三剂mRNA疫苗剂量后报告的反应与前两次剂量相似:注射部位的疲劳和疼痛是最常见的副作用,且总体上属于轻到中度。但是,与两剂疫苗一样,严重的副作用很少,但仍然可能会发生。”

                严重或延迟的副作用尤其需要关注。据凯撒健康新闻(Kaiser Health News)报道,有证据表明,对于极少数对疫苗有危险反应的人来说(比如心肌炎或心脏肿胀),第二次注射后副作用更为常见。第三剂疫苗是否会扩大这一罕见的结果,或导致在加强剂注射前的免疫过程中就观察到的血凝块和过敏反应,目前仍不清楚。但是,美国西北大学范伯格医学院(Northwestern University Feinberg School of Medicine)的流行病学家和心脏病学家萨迪娅?汗等医生质疑,额外的剂量是否会使心肌炎的风险更为明显,尤其是在年轻和健康的人群中,他们可能会产生严重的心脏副作用。此外,他们还怀疑加强剂的优点是否值得这些人冒潜在风险。

                在接下来的几周和几个月里,还有许多关于加强剂副作用的重要考虑有待追踪,包括接受强生疫苗的1300万美国民众。公共卫生官员和监管机构表示,现在就建议强生疫苗接种者接受加强剂还为时过早,因为目前信息还不够多。而且这种特殊的疫苗从3月才开始供应,这意味着其距离美国政府8个月的疫苗补充窗口期还差几个月。

                “目前还没有足够的数据来确定接受强生公司的杨森(Janssen)新冠疫苗的免疫功能低下人群,在额外注射相同疫苗后是否也有更好地抗体反应。”美国疾病控制中心表示。但越来越多的专家一致认为,每个人最终都需要加强剂,包括强生疫苗的接种者。他们担心强生疫苗与其他新冠疫苗相比之下的有效性,以及对抗新毒株(例如德尔塔变异毒株)的效力。除非强生疫苗获得更可靠的指导和数据,包括加强剂应该是强生疫苗的第二剂还是辉瑞或Moderna的mRNA疫苗,在此之前,官方无法正式跟踪这些美国民众的加强剂副作用。

                联邦卫生官员在很大程度上仍然对新冠疫苗加强剂的副作用持观望态度。他们表示,过去一周的行动表明,加强剂的潜在好处可能超过其风险。但是,如果你选择接种加强剂,为了获得额外的保护而不得不忍受几天的昏昏沉沉和手臂疼痛,也请你不要感到惊讶。(财富中文网)

                编译:杨二一

                COVID vaccine boosters are now a reality in America. Under a new Biden administration coronavirus immunization plan announced Aug. 18, COVID-19 boosters would be made available to all fully vaccinated U.S. adults who are at least eight months out from getting their second dose of Pfizer's or Moderna's mRNA-based jabs beginning the week of Sept. 20, pending regulatory blessings from the Food and Drug Administration (FDA) and the Centers for Disease Control (CDC). The policy regarding potential boosters for those who received one dose of Johnson & Johnson's shot, which relies on a different kind of technology, is still under review. The FDA and CDC already green-lit the first batch of COVID booster shots for some fully vaccinated Americans on Aug. 13, albeit for a tiny slice of the American populace who have compromised immune systems.

                But as the number of vaccinated people technically eligible to get a third dose of Pfizer's or Moderna's two-dose COVID vaccines swells in the coming months from the elderly to health care workers and eventually to young, healthy individuals—or as more people become willing to jump the line and get themselves a booster early like more than 1 million Americans already have—it will be important to keep track of whether or not COVID boosters have the same, different, or more severe side effects than what we've seen with the initial round of shots.

                Booster shots haven't even been authorized for a full week, and there's not much data yet on what side effects fully vaccinated people could experience with a third dose. The early indicators suggest they're largely in line with what many experienced after their initial rounds of vaccination, but medical experts have some concerns about those most at risk for very rare but serious side effects.

                Different people experience COVID vaccine side effects differently, and they run the gamut from fatigue, arm pain at the injection site, headache, dizziness, and redness and swelling around the injection to delayed effects that present a few days later, like muscle pain in various body parts (particularly after the second dose of an mRNA vaccine), loopiness, nausea, chills, and fever. Those symptoms tend to go away within a day or two but can be unpleasant for those few days. That could be the case for booster doses, too, with people experiencing some milder side effects that resemble the flu, according to the CDC.

                "There is limited information about the risks of receiving an additional dose of vaccine, and the safety, efficacy, and benefit of additional doses of COVID-19 vaccine in immunocompromised people continues to be evaluated," per the agency. "So far, reactions reported after the third mRNA dose were similar to that of the two-dose series: fatigue and pain at injection site were the most commonly reported side effects, and overall, most symptoms were mild to moderate. However, as with the two-dose series, serious side effects are rare, but may occur."

                Serious or delayed side effects will be particularly important to keep an eye on. There is some evidence that for the very small number of people who experience dangerous reactions to the vaccines such as myocarditis, or heart swelling, the side effect was more common after a second dose, Kaiser Health News reports. Whether or not a third dose could amplify that rare outcome or cause blood clots and allergic reactions that have been observed in some during the pre-booster immunization process is still unknown. But physicians such as Northwestern University Feinberg School of Medicine epidemiologist and cardiologist Sadiya Khan question whether the myocarditis risk specifically could become more pronounced with additional doses, especially among younger and healthier people who could develop the serious cardiac side effect, and whether a booster's benefit is worth the potential risk for those individuals.

                There are still many important considerations about booster side effects left to track in coming weeks and months, including for the 13 million Americans who received Johnson & Johnson's COVID vaccine. Public health officials and regulators say it's too early to advise J&J shot recipients on what to do about a booster because there isn't enough information yet. And that particular vaccine has been available only since March, which means it falls a few months short of the administration's eight month post-vaccination window for a booster.

                "There is not enough data at this time to determine whether immunocompromised people who received the Johnson & Johnson’s Janssen COVID-19 vaccine also have an improved antibody response following an additional dose of the same vaccine," per the CDC. But there is growing expert consensus that everyone will eventually need a booster dose, including J&J recipients who have concerns about its effectiveness compared to other COVID vaccines and potency against new coronavirus strains like the Delta variant. It won't be possible to officially track booster side effects for these Americans until there's more solid guidance and data around the J&J vaccine, including whether a booster should be a second dose of the Johnson & Johnson product or one of Pfizer's or Moderna's mRNA jabs.

                Federal health officials largely remain in wait-and-see mode on COVID booster side effects and have signaled the potential benefits of boosters likely outweigh their risks through the past week's actions. But if you are someone who qualifies for an additional shot, don't be surprised if you have to deal with a few days of grogginess and arm pain in exchange for the added protection.

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