在花了数周时间仔细研究了辉瑞，政府科学家周二承认新文件他们相信有充分的证据表明第一个新冠肺炎疫苗对16岁以上的人有效且安全。
虽然这一评估并不是国家一直在等待的令人垂涎的绿灯，但简报显示，机构工作人员没有警告任何最后一刻的停顿，紧急授权完全在国家掌握之中。
它还表明，疫苗可能不像最初预期的那样仅限于18岁以上的人。政府发现一剂后保护很强，尽管两剂都被推荐为最强的保护。
美国食品和药物管理局写道:“大约38，000名[大于或等于] 16岁的参与者随机1:1接种疫苗或安慰剂，在第二次给药后平均随访2个月，他们的安全性数据显示出良好的安全性，没有发现任何特定的安全性问题，因此无法颁发EUA证书。”。
该报告指出，最常见的反应是注射部位的皮肤反应，其次是疲劳或头痛。16岁至55岁之间的受试者中，约有一半出现了疲劳或头痛等副作用，约三分之一的受试者报告出现了寒战或肌肉疼痛。在55岁以上的临床试验参与者中，约一半报告疲劳，三分之一报告头痛，约四分之一报告寒战或肌肉疼痛。
数据还表明，疫苗对男性和女性以及不同种族和民族的人同样有效。
美国食品和药物管理局指出，在某些领域，关于辉瑞疫苗的数据还不够，例如它如何在患有艾滋病毒/艾滋病等疾病的人、从新冠肺炎感染中康复的人身上发挥作用，或者保护作用持续多长时间。
该报告还强调，虽然辉瑞疫苗可以防止受试者出现新冠肺炎症状，但目前还没有足够的数据表明这种疫苗是否能有效防止这种疾病的所有传播，最终取代戴口罩、社交距离和避免大型室内聚会的需要。因此，即使你是疫苗的早期接受者，保持这些降低风险的技术来保护他人也是很重要的。
简报文件是由美国食品和药物管理局在12月10日与独立咨询委员会的会议之前准备的。如果咨询委员会同意疫苗有效且安全，美国食品和药物管理局可能会授权将疫苗运送到全国各地。
授权之后，一个与疾病控制和预防中心相关的独立顾问小组预计将建议健康长期护理机构中的护理人员和老年人首当其冲。
政府官员建议他们希望疫苗下周分发
FDA scientists to report Pfizer vaccine safe and effective
After spending weeks poring over data provided byPfizer,government scientists on Tuesday acknowledged ina new documentthat they believe there is ample evidence that the firstCOVID-19 vaccineworks and is safe in people over the age of 16.
While that assessment isn’t the coveted green light the nation has been waiting for, the briefing suggests agency staff aren't warning of any last-minute hiccups and that an emergency authorization is well within the nation’s grasp.
It also suggests that the vaccine might not just be limited to people over the age of 18 as was initially expected. And the government found protection was strong after just one dose, though both doses are recommended for the strongest protection.
"Safety data from approximately 38,000 participants [greater than or equal to] 16 years of age randomized 1:1 to vaccine or placebo with a median of 2 months of follow up after the second dose suggest a favorable safety profile, with no specific safety concerns identified that would preclude issuance of an EUA," the FDA wrote.
The report notes the most common reaction was a skin reaction at the injection site, followed by fatigue or headaches. About half of recipients between 16 and 55 experienced side effects like fatigue or headaches and about a third reported chills or muscle pain. Of clinical trial participants over 55 about half reported fatigue, a third reported headache, and about a quarter reported chills or muscle pain.
The data also indicates the vaccine works equally men in men and woman, and among people of different races and ethnicities.
FDA noted there are some areas where there isn't enough data on the Pfizer vaccine, such as how it works in people with medical conditions like HIV/AIDS, in people who have recovered from COVID-19 infection, or how long the protection lasts.
The report also highlights that while the Pfizer vaccine prevents recipients from getting sick with symptoms of COVID-19, there isn't enough data yet to know if the vaccine is effective enough at preventing all transmission of the disease that would eventually replace the need to wear masks, socially distance, and avoid large, indoor gatherings. So even if you are an early recipient of the vaccine it will be important to maintain these risk lowering techniques to protect others.
The briefing document was prepared by the FDA ahead of a Dec. 10 meeting with an independent advisory board. If the advisory board agrees the vaccine works and is safe, it’s likely the FDA will authorize that the vaccine be shipped nationwide.
Following the authorization, a separate advisory panel tied to the Centers for Disease Control and Prevention is expected to suggesthealthcare workers and older people in long-term care facilities get the first doses.
Administration officials suggest they hope the vaccine is then distributed next week
