8月11日,作为首批获得美国食品与药品管理局紧急授权的新冠疫苗制造商,辉瑞及其合作伙伴BioNTech的股价双双暴跌。原因是,妙佑医疗国际(Mayo Clinic)发布了一项令人沮丧的新研究,从而迫使投资者纷纷质疑辉瑞疫苗在预防冠状病毒感染,以及保护接种者免受德尔塔(Delta)变异毒株感染方面的有效性究竟还能够持续多久。
数据显示,对于“突破性感染”(意指完成疫苗接种超过14天后新冠病毒检测结果呈阳性),辉瑞疫苗的有效性可能远不如Moderna疫苗——辉瑞/BioNTech疫苗的有效性为42%,而Moderna疫苗的有效性为76%。辉瑞股价在当天下跌了近4%,德国BioNTech公司的股价下跌了13.76%。但投资者的反应如此紧迫,也从一个侧面凸显了德尔塔毒株浪潮的严重性,以及这种在美国市场销售了整整9个月的开创性疫苗所面临的不确定性。
这项研究尚未在同行评议的医学期刊上发表。它提出了一个关键问题:对于数百万接种了两剂辉瑞疫苗的美国人来说,是否有必要再打一剂辉瑞加强针(无论是目前可用的加强针,还是某种更新版本)来跟上病毒的突变,或者预防再次感染老的冠状病毒毒株。到2022年春季,根据与美国政府达成的供应协议,辉瑞预计将交付总额达5亿剂的新冠疫苗。有鉴于此,如果美国人使用辉瑞公司的产品进行免疫,他们是否应该担心感染德尔塔变异毒株,或者将病原体传播给其他人?
简而言之:现在有越来越多的证据表明,随着时间的推移,像辉瑞和Moderna这样的mRNA(即信使核糖核酸)疫苗会失去保护效力,特别是面对德尔塔变异毒株的时候。而辉瑞疫苗的效力下降得尤为厉害。
妙佑医疗国际的研究发现,与今年早些时候相比,在妙佑医疗国际卫生系统(Mayo Clinic Health System)7月接诊的病患中,mRNA疫苗预防感染的能力显著下降——当月,在这家著名医疗机构所处的明尼苏达州,德尔塔感染病例在本地新增感染病例的占比超过了70%。1月至7月,Moderna疫苗在预防这一人群感染方面的有效性为86%,辉瑞疫苗的有效性为76%。但仅在7月,Moderna和辉瑞疫苗的有效率就分别降至76%和42%。研究人员发现,在明尼苏达州以外的疫情重灾区,比如佛罗里达州,辉瑞疫苗的有效率也出现了类似的下降。(令人稍感欣慰的是,事实证明,Moderna和辉瑞疫苗在预防新冠感染患者必须入院治疗方面仍然非常有效,有效性分别为92%和85%。)
这些都是令人担忧的数字。但有几点需要注意。首先,考虑到德尔塔感染病例的激增是一种相对较新的现象,我们仍然需要更多的数据来了解这种毒株正在对疫情造成何种影响,以及它对现有的新冠治疗方案有何反应等问题。在美国,这些信息的收集面临一个漫长的滞后期,因为各地信息汇总到美国疾病控制中心数据库的速度非常缓慢。
另一个原因是,该机构在5月决定停止追踪那些可能会导致完全接种者出现症状,但还没有因为感染新冠而住院治疗或死亡的“突破性感染”病例,这造成了一个信息黑洞。此外,追踪一种疫苗在较长时间内对任何病毒株的效力有多大,以及它可能丧失多少免疫能力和丧失的速度,往往受困于对实地情况进行实时监测的能力。
但公共卫生专家指出,如果这一趋势被更多的同行评议研究证实,制药商和医疗机构就必须得反思他们对抗高传染性德尔塔变异毒株的方法。潜在的方案包括打加强针、接种为德尔塔这类毒株量身定制的改良疫苗,或者像英国“混打”阿斯利康(AstraZeneca)疫苗和mRNA疫苗那样尝试新冠疫苗的不同组合。
在对抗德尔塔这类恶性变异毒株方面,以辉瑞为代表的mRNA疫苗究竟表现如何?随着这方面的信息不断浮现,著名医生、科学家,斯克里普斯研究转化研究所(Scripps Research Translational Institute)的创始人及所长埃里克•托波尔直言不讳地表达了他的看法。
托波尔在8月11日发推文称:“现在需要道出真相:在预防有症状的德尔塔感染病例方面,mRNA疫苗的保护效力显著降低。在德尔塔毒株出现前,它的有效性是95%。许多人声称其有效性仍然高达80%左右。绝非如此。从所有来源(不包括美国,因为我们没有这方面的数据)提供的信息来看,预计有效性最多也就是50%至60%。”他还附上了一张亲身编撰的表格,逐一列举mRNA疫苗、强生和阿斯利康疫苗在对抗德尔塔毒株方面的有效率数据。
托波尔接着指出,以色列等高接种率国家一直在密切关注辉瑞的mRNA免疫效果,鉴于这些国家的经历,他预计美国的数据一旦出炉,肯定会更加糟糕。尽管mRNA疫苗在预防住院治疗和死亡方面的成就不可否认,但患病数天乃至数周仍然是一件令人惊恐的事情,对于像免疫力低下这类高危人群来说,这更是一个公共卫生问题。
对于那些担心辉瑞疫苗对德尔塔毒株无效的人来说,首要的信息是践行公共安全指导意见,例如在室内有其他人时戴口罩,在拥挤的地方保持社交距离,还要遵循一些常识,比如咳嗽或打喷嚏时捂住嘴,在拥挤闷热的房间内除了戴口罩之外,还要保持良好通风。如果你还没有接种疫苗,现在就是最好的时机。大多数人现在都可以选择接种三种疫苗,即辉瑞、Moderna和强生疫苗(12岁以上人群可接种辉瑞疫苗)。现在实现充分免疫,将为制药商和政府机构找到推行加强针的最佳方式赢得宝贵的时间。
关于这一点,辉瑞和Moderna表示,其新冠疫苗接种者可能需要再打一剂加强针,接种时间很可能在2021年冬天之前,特别是那些距离完全接种已经过了4、6或9个月的群体,或者新冠重症高风险人群。这两家公司正在对其现有疫苗和新型疫苗进行加强针试验。Moderna报告称,在已接种人群中,三种不同的实验性候选加强针都产生了“强有力的”免疫效果。辉瑞和BioNTech宣称,在接种现有疫苗的第三剂之后,接种者对其他冠状病毒变种的抗体反应有所增强。他们相信第三剂疫苗将对德尔塔毒株产生类似效果。预计辉瑞将在本月向美国食品与药品管理局提交第三剂疫苗的使用授权申请,并且已经开始寻求其疫苗获得全面使用批准。
此外,辉瑞和BioNTech在一份声明中表示,鉴于mRNA治疗方法具有高度可修改性,“只要获得监管部门批准,他们有信心、有能力在做出决定后大约100天内开发和生产针对德尔塔毒株的定制疫苗。”但我们仍然需要熬过一段时间才能够知道,疫苗“混打”、保持目前的接种方式,或者打一剂全新的加强针,最终是否会彻底驯服德尔塔变异毒株。(财富中文网)
译者:任文科
8月11日,作为首批获得美国食品与药品管理局紧急授权的新冠疫苗制造商,辉瑞及其合作伙伴BioNTech的股价双双暴跌。原因是,妙佑医疗国际(Mayo Clinic)发布了一项令人沮丧的新研究,从而迫使投资者纷纷质疑辉瑞疫苗在预防冠状病毒感染,以及保护接种者免受德尔塔(Delta)变异毒株感染方面的有效性究竟还能够持续多久。
数据显示,对于“突破性感染”(意指完成疫苗接种超过14天后新冠病毒检测结果呈阳性),辉瑞疫苗的有效性可能远不如Moderna疫苗——辉瑞/BioNTech疫苗的有效性为42%,而Moderna疫苗的有效性为76%。辉瑞股价在当天下跌了近4%,德国BioNTech公司的股价下跌了13.76%。但投资者的反应如此紧迫,也从一个侧面凸显了德尔塔毒株浪潮的严重性,以及这种在美国市场销售了整整9个月的开创性疫苗所面临的不确定性。
这项研究尚未在同行评议的医学期刊上发表。它提出了一个关键问题:对于数百万接种了两剂辉瑞疫苗的美国人来说,是否有必要再打一剂辉瑞加强针(无论是目前可用的加强针,还是某种更新版本)来跟上病毒的突变,或者预防再次感染老的冠状病毒毒株。到2022年春季,根据与美国政府达成的供应协议,辉瑞预计将交付总额达5亿剂的新冠疫苗。有鉴于此,如果美国人使用辉瑞公司的产品进行免疫,他们是否应该担心感染德尔塔变异毒株,或者将病原体传播给其他人?
简而言之:现在有越来越多的证据表明,随着时间的推移,像辉瑞和Moderna这样的mRNA(即信使核糖核酸)疫苗会失去保护效力,特别是面对德尔塔变异毒株的时候。而辉瑞疫苗的效力下降得尤为厉害。
妙佑医疗国际的研究发现,与今年早些时候相比,在妙佑医疗国际卫生系统(Mayo Clinic Health System)7月接诊的病患中,mRNA疫苗预防感染的能力显著下降——当月,在这家著名医疗机构所处的明尼苏达州,德尔塔感染病例在本地新增感染病例的占比超过了70%。1月至7月,Moderna疫苗在预防这一人群感染方面的有效性为86%,辉瑞疫苗的有效性为76%。但仅在7月,Moderna和辉瑞疫苗的有效率就分别降至76%和42%。研究人员发现,在明尼苏达州以外的疫情重灾区,比如佛罗里达州,辉瑞疫苗的有效率也出现了类似的下降。(令人稍感欣慰的是,事实证明,Moderna和辉瑞疫苗在预防新冠感染患者必须入院治疗方面仍然非常有效,有效性分别为92%和85%。)
这些都是令人担忧的数字。但有几点需要注意。首先,考虑到德尔塔感染病例的激增是一种相对较新的现象,我们仍然需要更多的数据来了解这种毒株正在对疫情造成何种影响,以及它对现有的新冠治疗方案有何反应等问题。在美国,这些信息的收集面临一个漫长的滞后期,因为各地信息汇总到美国疾病控制中心数据库的速度非常缓慢。
另一个原因是,该机构在5月决定停止追踪那些可能会导致完全接种者出现症状,但还没有因为感染新冠而住院治疗或死亡的“突破性感染”病例,这造成了一个信息黑洞。此外,追踪一种疫苗在较长时间内对任何病毒株的效力有多大,以及它可能丧失多少免疫能力和丧失的速度,往往受困于对实地情况进行实时监测的能力。
但公共卫生专家指出,如果这一趋势被更多的同行评议研究证实,制药商和医疗机构就必须得反思他们对抗高传染性德尔塔变异毒株的方法。潜在的方案包括打加强针、接种为德尔塔这类毒株量身定制的改良疫苗,或者像英国“混打”阿斯利康(AstraZeneca)疫苗和mRNA疫苗那样尝试新冠疫苗的不同组合。
在对抗德尔塔这类恶性变异毒株方面,以辉瑞为代表的mRNA疫苗究竟表现如何?随着这方面的信息不断浮现,著名医生、科学家,斯克里普斯研究转化研究所(Scripps Research Translational Institute)的创始人及所长埃里克•托波尔直言不讳地表达了他的看法。
托波尔在8月11日发推文称:“现在需要道出真相:在预防有症状的德尔塔感染病例方面,mRNA疫苗的保护效力显著降低。在德尔塔毒株出现前,它的有效性是95%。许多人声称其有效性仍然高达80%左右。绝非如此。从所有来源(不包括美国,因为我们没有这方面的数据)提供的信息来看,预计有效性最多也就是50%至60%。”他还附上了一张亲身编撰的表格,逐一列举mRNA疫苗、强生和阿斯利康疫苗在对抗德尔塔毒株方面的有效率数据。
托波尔接着指出,以色列等高接种率国家一直在密切关注辉瑞的mRNA免疫效果,鉴于这些国家的经历,他预计美国的数据一旦出炉,肯定会更加糟糕。尽管mRNA疫苗在预防住院治疗和死亡方面的成就不可否认,但患病数天乃至数周仍然是一件令人惊恐的事情,对于像免疫力低下这类高危人群来说,这更是一个公共卫生问题。
对于那些担心辉瑞疫苗对德尔塔毒株无效的人来说,首要的信息是践行公共安全指导意见,例如在室内有其他人时戴口罩,在拥挤的地方保持社交距离,还要遵循一些常识,比如咳嗽或打喷嚏时捂住嘴,在拥挤闷热的房间内除了戴口罩之外,还要保持良好通风。如果你还没有接种疫苗,现在就是最好的时机。大多数人现在都可以选择接种三种疫苗,即辉瑞、Moderna和强生疫苗(12岁以上人群可接种辉瑞疫苗)。现在实现充分免疫,将为制药商和政府机构找到推行加强针的最佳方式赢得宝贵的时间。
关于这一点,辉瑞和Moderna表示,其新冠疫苗接种者可能需要再打一剂加强针,接种时间很可能在2021年冬天之前,特别是那些距离完全接种已经过了4、6或9个月的群体,或者新冠重症高风险人群。这两家公司正在对其现有疫苗和新型疫苗进行加强针试验。Moderna报告称,在已接种人群中,三种不同的实验性候选加强针都产生了“强有力的”免疫效果。辉瑞和BioNTech宣称,在接种现有疫苗的第三剂之后,接种者对其他冠状病毒变种的抗体反应有所增强。他们相信第三剂疫苗将对德尔塔毒株产生类似效果。预计辉瑞将在本月向美国食品与药品管理局提交第三剂疫苗的使用授权申请,并且已经开始寻求其疫苗获得全面使用批准。
此外,辉瑞和BioNTech在一份声明中表示,鉴于mRNA治疗方法具有高度可修改性,“只要获得监管部门批准,他们有信心、有能力在做出决定后大约100天内开发和生产针对德尔塔毒株的定制疫苗。”但我们仍然需要熬过一段时间才能够知道,疫苗“混打”、保持目前的接种方式,或者打一剂全新的加强针,最终是否会彻底驯服德尔塔变异毒株。(财富中文网)
译者:任文科
On August 11, Pfizer and partner BioNTech, makers of the United States’ first Food and Drug Administration (FDA) emergency authorized COVID vaccine, saw their share prices plummet as discouraging new research from the Mayo Clinic forced investors to question how long the Pfizer vaccine remains effective at preventing coronavirus infections and protecting those who are vaccinated from getting sick with a Delta variant case.
Pfizer’s shot may be significantly less effective than Moderna’s against breakthrough infections (42% efficacy for Pfizer/BioNTech versus 76% for Moderna), according to the data, and Pfizer stock ended the day down nearly 4% while Germany’s BioNTech slipped 13.76%. But the urgency of the investor reaction underscores the gravity of the Delta wave and uncertainty surrounding a pioneering vaccine that's been on the U.S. market for exactly nine months.
One key issue raised by the study, which has yet to be published in a peer-reviewed medical journal, for the millions of Americans who received two doses of Pfizer’s treatment is whether or not a Pfizer booster dose—either of the currently available jab or a new and updated version—is necessary to keep up with mutations or prevent COVID-19 reinfection from older coronavirus strains. Given that Pfizer expects to have delivered 500 million doses of its COVID vaccine under supply agreements with the U.S. government by the spring of 2022, should Americans be worried about catching a nasty case of the Delta variant or spreading the pathogen to others if they're immunized with Pfizer's product?
In short: There is now mounting evidence that mRNA-based vaccines such as Pfizer's and Moderna's lose potency over time and especially against the Delta variant, and that the Pfizer vaccine's efficacy drop is significantly more dramatic. The Mayo Clinic study noted a wide shortfall in the mRNA vaccines' ability to prevent infections among patients using the Mayo Clinic Health System for the month of July, when Delta variant cases made up more than 70% of new local infections in its home state of Minnesota, compared with earlier in the year. Between January and July, Moderna's jab was 86% effective at preventing infection in this population while Pfizer's was 76% effective. But for July alone, those numbers fell to 76% for Moderna and 42% for Pfizer, and the researchers observed similar drops for the Pfizer shot outside of Minnesota in states with high COVID counts such as Florida. (On a brighter note, both the Moderna and Pfizer vaccines still proved highly effective at preventing the need for COVID infection-related hospitalization at 92% and 85% efficacy, respectively.)
Those are concerning figures. But it's important to note several caveats. For one, we still need more data on how the Delta variant is shaping the pandemic and interacting with available COVID treatments given that mutation's surge is still relatively new. Collecting this information has a long lag time in the U.S. as local information trickles up to the Centers for Disease Control (CDC) database, and the agency's decision in May to stop tracking breakthrough infections that may cause symptoms but not coronavirus-related hospitalization or death among the fully vaccinated has created an information black hole. Furthermore, tracking how strong a vaccine is against any viral strain over an extended period, and how much immunizing power it may lose and how quickly, is inherently handicapped by having to monitor how the situation plays out on the ground in real time.
But public health experts note that if this trend continues to hold true in more peer-reviewed research, drugmakers and medical institutions will have to rethink their approach to fighting the highly infectious Delta variant, potentially through boosters, modified vaccines specifically tailored toward strains like Delta, or by trying different combinations of COVID vaccines as the U.K. has done with AstraZeneca's shot in concert with an mRNA-based vaccine.
Prominent physician-scientist and Scripps Research Translational Institute founder and director Eric Topol didn't mince words about the steady drip of new information on mRNA jabs such as Pfizer's and how they fare against this vicious variant.
"There needs to be truth-telling about the reduced protection of mRNA vaccines vs symptomatic Delta infections. It was 95% pre-Delta. Many are claiming it's still ~80%. It isn't. 50-60% is best estimate from all sources (not US, since we don't have the data)," wrote Topol in a tweet on August 11, attaching a table he compiled of the available efficacy data on mRNA vaccines and the Johnson & Johnson and AstraZeneca jabs when it comes to fighting the Delta strain.
Topol goes on to say he expects the numbers in the U.S., once more of them come out, to be even worse given the experiences of more vaccinated countries like Israel, which are keeping close tabs on how strong Pfizer's mRNA immunization remains over time. While the prevention of hospitalization and death is still an undeniable win, the prospect of getting sick for a few days or weeks is still cumbersome and a public health concern for high-risk individuals such as the immunocompromised.
The overarching message for those worried about their Pfizer vaccine being ineffective against the Delta variant is to practice public safety guidelines such as wearing masks around others indoors and maintaining distance in crowded areas, as well as commonsense practices like covering your mouth if you cough or sneeze and keeping stuffy, crowded rooms well ventilated on top of masking. And if you haven't been vaccinated yet, there's no time like the present. The three COVID shots from Pfizer, Moderna, and Johnson & Johnson are all available to most of the public (including for those 12 years and older for the Pfizer vaccine), and getting fully immunized now would buy precious time as drugmakers and government agencies figure out the best way to proceed with boosters.
On that note, Pfizer and Moderna have stated that their COVID vaccines will likely require booster doses down the line, possibly before winter 2021, and especially for people who are four, six, or nine months out from when they became fully vaccinated or have high risk for serious COVID illness. The companies are conducting booster trials of both their existing vaccines and new types, with Moderna reporting "robust" immunization from three separate, experimental booster candidates among those who had already been vaccinated. Pfizer and BioNTech have touted increased antibody response against other coronavirus variants after a third dose of their existing vaccine and believe they will see similar effects against Delta. Pfizer is expected to request FDA authorization for a third dose this month and has already applied for full approval of its vaccine.
Furthermore, Pfizer/BioNTech said in a statement they expect to be able to "develop and produce a tailor-made vaccine against that [Delta] variant in approximately 100 days after a decision to do so, subject to regulatory approval" given the highly modifiable nature of mRNA-based treatments. But we're still a ways from knowing whether the mix-and-match shots approach, the stay-the-course-on-current-jabs method, or a new kind of booster shot entirely will ultimately tame the COVID Delta variant.