巴西试验数据发布了:中国疫苗Sinovac有效率为78%。几经推迟

wei_cheng

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如果我没有记错的话,辉瑞和Moderna 的超过90%的两个数据都是指有效率吧?只要无症状阳性都算有效。
有关 efficacy analysis:

Pfizer/BioNTech: First COVID-19 occurrence from 7 days after Dose 2 in participants without evidence of prior SARS-CoV-2 infection. Confirmed cases were determined by Reverse Transcription-Polymerase Chain Reaction (RT-PCR) and at least 1 symptom consistent with COVID-19 (symptoms included: fever; new or increased cough; new or increased shortness of breath; chills; new or increased muscle pain; new loss of taste or smell; sore throat; diarrhea; vomiting).

Moderna: COVID-19 in participants 18 years of age and older starting 14 days after dose 2 per adjudication committee assessments (symptomatic COVID-19 requiring positive RT-PCR result and at least two systemic symptoms or one respiratory symptom. Cases starting 14 days after Dose 2. )

Sinovac: For efficacy, the study aims to detect COVID-19 cases, defined as symptomatic SARS-CoV-2 infections, after the second week post-immunization schedule.

Sinopharm:
中东四国45000人:The incidence of COVID-19 cases after two-doses of vaccination [ Time Frame: From 14 days after the second dose to 6 month after the second dose ]
阿根廷3000人:Incidence of COVID-19 cases after two-doses of vaccination [ Time Frame: 14 days after the full course of vaccination] All confirmed COVID-19 cases 14 days after the full course of vaccination among healthy population aged between 18 and 85 years old.
 
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有关 efficacy analysis:

Pfizer: First COVID-19 occurrence from 7 days after Dose 2 in participants without evidence of prior SARS-CoV-2 infection. Confirmed cases were determined by Reverse Transcription-Polymerase Chain Reaction (RT-PCR) and at least 1 symptom consistent with COVID-19 (symptoms included: fever; new or increased cough; new or increased shortness of breath; chills; new or increased muscle pain; new loss of taste or smell; sore throat; diarrhea; vomiting).

Moderna: COVID-19 in participants 18 years of age and older starting 14 days after dose 2 per adjudication committee assessments (symptomatic COVID-19 requiring positive RT-PCR result and at least two systemic symptoms or one respiratory symptom. Cases starting 14 days after Dose 2. )

Sinovac: For efficacy, the study aims to detect COVID-19 cases, defined as symptomatic SARS-CoV-2 infections, after the second week post-immunization schedule.
不是很懂,这几种疫苗定义的有效率都相同吗?是针对病毒阳性,还是按照有无症状判别?
 

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Sinovac: For efficacy, the study aims to detect COVID-19 cases, defined as symptomatic SARS-CoV-2 infections
也是有症状感染,不过可能跟其他定义不一样
 

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你不服还是咋地?
你能你去搞个更好的?
你脑子有问题
我只是称述事实,没说好坏。
 

wei_cheng

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都要求核酸 RT-PCR 确诊,加上 Pfizer 要求至少1种症状,Moderna 要求呼吸系统症状或至少2种其它系统性症状,Sinovac 要求有症状,Sinopharm 的临床试验注册里面没有写 (可以等文章出来,估计也要求有症状)。Efficacy 可以理解为取反。

追踪的时间也有差别。

不是很懂,这几种疫苗定义的有效率都相同吗?是针对病毒阳性,还是按照有无症状判别?
Sinovac: For efficacy, the study aims to detect COVID-19 cases, defined as symptomatic SARS-CoV-2 infections
也是有症状感染,不过可能跟其他定义不一样
 

lindamy

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都要求核酸 RT-PCR 确诊,加上 Pfizer 要求至少1种症状,Moderna 要求呼吸系统症状或至少2种其它系统性症状,Sinovac 要求有症状,Sinopharm 的临床试验注册里面没有写 (可以等文章出来,估计也要求有症状)。Efficacy 可以理解为取反。

追踪的时间也有差别。
似乎各种疫苗定义的有效率并不完全相同,他们有权做各自的考虑,如果并没有一个公用的国际标准。

所以我反对贵圈张口就骂无耻。谁比谁的标准更宽松还不一定呢。
 
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superlover

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78%有效率还是高于阿利斯康/牛津的70%,早点发布可能就不能用91.25%来浑水摸鱼了
 

wei_cheng

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Sinopharm 在中东四国居然要追踪 6个月内出现的新冠确诊,计算有效率比较吃亏。
似乎各种疫苗定义的有效率并不完全相同,他们有权做各自的考虑,如果并没有一个公用的国家标准。

所以我反对贵圈张口就骂无耻。谁比谁的标准更宽松还不一定呢。
 

billwanhua

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78%有效率还是高于阿利斯康/牛津的70%,早点发布可能就不能用91.25%来浑水摸鱼了
阿利斯康/牛津也是浑水摸鱼吧。总体有效率为70%,较低组的有效率为62%,较高组的有效率为90%。
而且90%的有效率明显有问题,需要打半剂,第二针打全剂。就像韦德西韦用时间久的病人反而没有效果,无法解释。90%有效的疫苗打法英国卫生部们直接不承认。
主要两个美国疫苗搞高了其他疫苗只有乱来了。
 

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似乎各种疫苗定义的有效率并不完全相同,他们有权做各自的考虑,如果并没有一个公用的国际标准。

所以我反对贵圈张口就骂无耻。谁比谁的标准更宽松还不一定呢。
骂的就是100百分之。
 

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你脑子有问题
我只是称述事实,没说好坏。


你精心挑选的几个所谓的部分事实,已经暴露了你的立场和邪恶用心。
 

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这个疫苗,已经是中国医学科技的一次进步。而且也的确有帮助。支持。但是

最让人恶心的就是,科技人员拼命做出来的东西,非要被某些人拿去,吹嘘和透支!

那些无脑官员和宣传口,不停地制造虚假或者误导性的报道,搞水军式的自我宣传和抹黑对手。

不能说这帮人无耻,我只能说这帮人是实实在在的恨国党。
 

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骂的就是100百分之。
这个不是100%?

Moderna Announces Primary Efficacy Analysis in Phase 3 COVE Study for Its COVID-19 Vaccine Candidate and Filing Today with U.S. FDA for Emergency Use Authorization​

November 30, 2020 at 6:59 AM EST
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Primary efficacy analysis of the Phase 3 COVE study of mRNA-1273 involving 30,000 participants included 196 cases of COVID-19, of which 30 cases were severe
Vaccine efficacy against COVID-19 was 94.1%; vaccine efficacy against severe COVID-19 was 100%
mRNA-1273 continues to be generally well tolerated; no serious safety concerns identified to date
Phase 3 COVE Study has exceeded 2 months of median follow-up post vaccination as required by the U.S. FDA for Emergency Use Authorization (EUA)
Moderna plans today to request EUA from the U.S. FDA, to apply for a conditional marketing authorization with the European Medicines Agency (EMA) and to progress with the rolling reviews, which have already been initiated with international regulatory agencies
FDA has told Company to expect VRBPAC meeting for mRNA-1273 likely on December 17, 2020

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov. 30, 2020-- Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that the primary efficacy analysis of the Phase 3 study of mRNA-1273 conducted on 196 cases confirms the high efficacy observed at the first interim analysis. The data analysis indicates a vaccine efficacy of 94.1%. Safety data continue to accrue and the study continues to be monitored by an independent, NIH-appointed Data Safety Monitoring Board (DSMB). The Company also announced that today, Moderna plans to request an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) and conditional approval from the European Medicines Agency (EMA). The Phase 3 study, known as the COVE study, enrolled more than 30,000 participants in the U.S. and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.
The primary endpoint of the Phase 3 COVE study is based on the analysis of COVID-19 cases confirmed and adjudicated starting two weeks following the second dose of vaccine. Vaccine efficacy has been demonstrated at the first interim analysis with a total of 95 cases based on the pre-specified success criterion on efficacy. Today’s primary analysis was based on 196 cases, of which 185 cases of COVID-19 were observed in the placebo group versus 11 cases observed in the mRNA-1273 group, resulting in a point estimate of vaccine efficacy of 94.1%. A secondary endpoint analyzed severe cases of COVID-19 and included 30 severe cases (as defined in the study protocol) in this analysis. All 30 cases occurred in the placebo group and none in the mRNA-1273 vaccinated group. There was one COVID-19-related death in the study to date, which occurred in the placebo group.
Efficacy was consistent across age, race and ethnicity, and gender demographics. The 196 COVID-19 cases included 33 older adults (ages 65+) and 42 participants identifying as being from diverse communities (including 29 Hispanic or LatinX, 6 Black or African Americans, 4 Asian Americans and 3 multiracial participants).
The safety profile of the Phase 3 study of mRNA-1273 was previously described on November 16. A continuous review of safety data is ongoing and no new serious safety concerns have been identified by the Company. Based on prior analysis, the most common solicited adverse reactions included injection site pain, fatigue, myalgia, arthralgia, headache, and erythema/redness at the injection site. Solicited adverse reactions increased in frequency and severity in the mRNA-1273 group after the second dose.
The Company will submit data from the Phase 3 COVE study to a peer-reviewed publication.
“This positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with 94.1% efficacy and importantly, the ability to prevent severe COVID-19 disease. We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalizations and death,” said Stéphane Bancel, Chief Executive Officer of Moderna. “I want to thank the thousands of participants in our Phase 1, Phase 2 and Phase 3 studies, as well as the staff at clinical trial sites who have been on the front lines of the fight against the virus. I would again like to thank our partners at NIH, NIAID, BARDA and Operation Warp Speed who have helped us advance the clinical development of mRNA-1273. Finally, I want to thank the Moderna team and our suppliers and partners for their tireless work on the research, development and manufacturing of our vaccine. We will file today for an Emergency Use Authorization from the FDA and continue forging ahead with the rolling reviews that have already been initiated with several regulatory agencies around the globe.”
Today, Moderna will submit for an EUA with the U.S. FDA and an application for Conditional Marketing Authorization (CMA) with the European Medicines Agency. The Company has already initiated the rolling review process with the EMA, Health Canada, SwissMedic, the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA), Ministry of Health in Israel, and Health Sciences Authority in Singapore and intends to seek Prequalification (PQ) and/or Emergency Use Listing (EUL) with the World Health Organization (WHO).
Additionally, Moderna announced that the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting to review the safety and efficacy data package for mRNA-1273 will likely be scheduled for Thursday, December 17. The Company expects that the U.S. Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) will make a recommendation on immunization priorities. The Company anticipates that the shipping of mRNA-1273 to designated distribution points throughout the U.S. will occur shortly after an Emergency Use Authorization is granted.
Moderna is working with the U.S. CDC, Operation Warp Speed and McKesson (NYSE: MCK), a COVID-19 vaccine distributor contracted by the U.S. government, as well as global stakeholders to be prepared for distribution of mRNA-1273, in the event that it receives an EUA and similar global authorizations and approvals. By the end of 2020, the Company expects to have approximately 20 million doses of mRNA-1273 available in the U.S. The Company remains on track to manufacture 500 million to 1 billion doses globally in 2021. On November 10, the American Medical Association (AMA) issued a Current Procedural Terminology (CPT) code to report vaccination with mRNA-1273 (code: 91301). Moderna recently announced further progress towards ensuring the distribution, storage and handling of the vaccine can be done using existing infrastructure.
To learn more about Moderna’s work on mRNA-1273, visit www.modernatx.com/COVID19.
About the Phase 3 COVE Study
The Phase 3 COVE trial is a randomized, 1:1 placebo-controlled study testing mRNA-1273 at the 100 µg dose level in 30,000 participants in the U.S., ages 18 and older. The primary endpoint is the prevention of symptomatic COVID-19 disease. Key secondary endpoints include prevention of severe COVID-19 disease and prevention of infection by SARS-CoV-2. The trial will continue to accrue additional data relevant to safety and efficacy even after an EUA is submitted. The final estimates of vaccine efficacy for both primary and secondary endpoints will depend on the totality of data that will accumulate to inform the final analysis. Moderna worked closely with BARDA and the NIH, including NIAID’s COVID-19 Prevention Network (CoVPN), to conduct the Phase 3 COVE study under Operation Warp Speed. Moderna’s partner PPD (Nasdaq: PPD), a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services, has also been essential to the successful execution of the COVE study.
The Phase 3 COVE study was designed in collaboration with the FDA and NIH to evaluate Americans at risk of severe COVID-19 disease and completed enrollment of more than 30,000 participants ages 18 and older in the U.S. on October 22, including those at high risk of severe complications of COVID-19 disease. The COVE study includes more than 7,000 Americans over the age of 65. It also includes more than 5,000 Americans who are under the age of 65 but have high-risk chronic diseases that put them at increased risk of severe COVID-19, such as diabetes, severe obesity and cardiac disease. These medically high-risk groups represent 42% of the total participants in the Phase 3 COVE study. The study also included communities that have historically been under-represented in clinical research and have been disproportionately impacted by COVID-19. The study includes more than 11,000 participants from communities of color, representing 37% of the study population, which is similar to the diversity of the U.S. at large. This includes more than 6,000 participants who identify as Hispanic or LatinX, and more than 3,000 participants who identify as Black or African American.
About mRNA-1273
mRNA-1273 is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein, which was co-developed by Moderna and investigators from NIAID’s Vaccine Research Center. The first clinical batch, which was funded by the Coalition for Epidemic Preparedness Innovations, was completed on February 7, 2020 and underwent analytical testing; it was shipped to the NIH on February 24, 42 days from sequence selection. The first participant in the NIAID-led Phase 1 study of mRNA-1273 was dosed on March 16, 63 days from sequence selection to Phase 1 study dosing. On May 12, the FDA granted mRNA-1273 Fast Track designation. On May 29, the first participants in each age cohort: adults ages 18-55 years (n=300) and older adults ages 55 years and above (n=300) were dosed in the Phase 2 study of mRNA-1273. On July 8, the Phase 2 study completed enrollment.
Results from the second interim analysis of the NIH-led Phase 1 study of mRNA-1273 in the 56-70 and 71+ age groups were published on September 29 in The New England Journal of Medicine. On July 28, results from a non-human primate preclinical viral challenge study evaluating mRNA-1273 were published in The New England Journal of Medicine. On July 14, an interim analysis of the original cohorts in the NIH-led Phase 1 study of mRNA-1273 was published in The New England Journal of Medicine. mRNA-1273 currently is not approved for use by any regulatory body.
BARDA is supporting the continued research and development of mRNA-1273 with $955 million in federal funding under Contract no. 75A50120C00034. BARDA is reimbursing Moderna for 100 percent of the allowable costs incurred by the Company for conducting the program described in the BARDA contract. The U.S. government has agreed to provide up to $1.525 billion to purchase supply of mRNA-1273 under U.S. Department of Defense Contract No. W911QY-20-C-0100.

 

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哎,骂不醒装睡的人
 

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