好了好了,说了这些,请直接回答下,辉瑞的三期临床试验,计算有效率,到底有没有计入核酸阳性但无症状的病例? 有的话请提供证据。
我看的报道都是没有的
因为你看的都不是官方文章。如今互联网上垃圾遍地。除了CDC,FDA,以及专业医学杂志,其他文章都没啥可信度。
我建议你,以后凡是非各国审批机构,专业医学杂志,就不要引用了,英文的也不行。一样垃圾遍地。
下面是FDA审批文件里对于“确诊新冠病例”的定义,核酸检测阳性是必须的。
同样,科兴巴西疫苗确诊标准,核酸检测阳性也是必须的。
这些标准,全世界监管机构,都是一样的;
制定这些审批标准的,是CDC,FDA,各国医疗监管部门,不是辉瑞也不是科兴;
For the primary efficacy endpoint, the case definition for a confirmed COVID-19 case was the presence of at least one of the following symptoms and a positive SARS-CoV-2 NAAT within 4 days of the symptomatic period:
• 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.
For a secondary efficacy endpoint, a second definition, which may be updated as more is learned about COVID-19, included the following additional symptoms defined by CDC (listed at
https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html):
• Fatigue;
• Headache;
• Nasal congestion or runny nose;
• Nausea.
For another secondary endpoint, the case definition for a severe COVID-19 case was a confirmed COVID-19 case with at least one of the following:
• Clinical signs at rest indicative of severe systemic illness (RR ≥30 breaths per minute, HR ≥125 beats per minute, SpO2 ≤93% on room air at sea level, or PaO2/FiO2 <300 mm Hg);
• Respiratory failure (defined as needing high-flow oxygen, noninvasive ventilation, mechanical ventilation, or ECMO);
• Evidence of shock (SBP <90 mm Hg, DBP <60 mm Hg, or requiring vasopressors)
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Pfizer-BioNTech COVID-19 Vaccine Emergency Use Authorization Review Memorandum
• Significant acute renal, hepatic, or neurologic dysfunction;
• Admission to an ICU; • Death.
Evaluation of safety
The primary safety objective for all phases was to de