3.FDA Approves First COVID-19 Vaccine. FDA http://4.USCovid-19 vaccine approval is 'seismic'...
[1]FDA,FDA Approves First COVID-19 Vaccine,FDA Approves First COVID-19 Vaccine ...
来源:https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine 当地时间8月23日,美国FDA宣布正式批准首款 COVID-19 疫苗上市,该疫苗来自Pfizer-BioNTech 针对COVID-19研发的 mRNA疫苗BNT162B2。获批后,BNT162B2疫苗商品名被正式命名为Comirnaty,用于预防16 岁及以上人群的 COV...
FDA要求Comirnaty疫苗生产商做上市后研究以进一步评估接种该疫苗引发心肌炎的远期健康影响。 同时,FDA也要求该疫苗生产商做更广泛的上市后安全性研究,包括在妊娠妇女中使用该疫苗对妊娠和胎儿安全性影响。 参考文献:https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine 来源:US...
there continues to be a need for safe and effective COVID-19 treatment options for this population,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Today’s approval of t...
FDA Approves First COVID-19 Vaccine https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine 2.CNN FDA grants full approval to Pfizer/BioNTech Covid-19 vaccine, opening door to more vaccine mandates https://edition.cnn.com/2021/08/23/health/fda-approval-pfizer...
参考资料: 1.FDA Approves First COVID-19 Vaccine 2.PFIZER-BIONTECH COVID-19 VACCINE COMIRNATY® RECEIVES FULL U.S. FDA APPROVAL FOR INDIVIDUALS 16 YEARS AND OLDER
当地时间8月23日,美国FDA宣布正式批准首款 COVID-19 疫苗上市,该疫苗来自Pfizer-BioNTech COVID-19 疫苗,获批后,该疫苗商品名被正式命名为Comirnaty,用于预防 16 岁及以上人群的 COVID-19 疾病。此外,该疫苗还可以根据紧急使用授权 (EUA) ,继续为12至15岁的青少年以及某些免疫功能低下的群体提供第三剂疫苗。
To more closely target SARS-CoV-2 variants currently circulating in the US, the US Food and Drug Administration (FDA) authorized an updated formula of the messenger RNA (mRNA) COVID-19 vaccine, the agency announced in mid-August. Under its Emergency Use Authorization, the FDA a...
This action makes Veklury the first approved COVID-19 treatment for children less than 12 years of age, said the FDA. Veklury is approved for young children who are hospitalized, or have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, according to ...