The request for federal approval of a booster shot by Pfizer-BioNTech comes days after the FDA granted full approval of their COVID-19 vaccine — now known as the Comirnaty vaccine — for people aged 16 and older. The new name for the Pfizer COVID-19 vaccine comes from Brand Insti...
BioNTech's ability to obtain and maintain regulatory approval for BioNTech's product candidates; the ability of BioNTech’s COVID-19 vaccines to prevent COVID-19 caused by emerging virus variants; BioNTech's and its counterparties’ ability to manage and source necessary energy ...
“BioNTech”) today announced that theU.S. Food and Drug Administration(“FDA”) has approved the supplemental Biologics License Application for individuals 12 years of age and older (COMIRNATY® (COVID-19 Vaccine, mRNA)), and granted emergency use authorization for ...
2023年9月11日,Moderna、Pfizer、BioNTech同时宣布XBB.1.5新冠mRNA疫苗获得FDA批准,临床前研究表明这两款疫苗对XBB.1.5、BA.2.86(Pirola)、EG.5.1(Eris)流行株均有保护效力。 关于Moderna Moderna宣布美国食品和药物管理局(FDA)已批准Spikevax®用于12岁及以上年龄的补充生物制剂许可申请(sBLA)。6个月至11岁的个体...
文:科志康 2021年8月23日,FDA批准Pfizer-BioNTech COVID-19疫苗,用于16岁及以上人群预防COVID-19。同时,在紧急使用授权(EUA)情况下,该疫苗仍可用于12至15岁的个体以及某些免疫功能低下个体的第三次注射。Pf…
2021年8月23日，美国食品药品监督管理局（FDA）正式批准了辉瑞-BioNTech的COVID-19疫苗，适用于16岁及以上的群体预防COVID-19。该疫苗在紧急使用授权（EUA）下，亦可用于12至15岁的个体以及某些免疫功能低下个体的第三次注射。疫苗商品名为Comirnaty。Comirnaty疫苗的批准基于对约40,000名临床试验参与...
Pfizer and BioNTech announced Wednesday that they are seeking FDA approval for a booster dose of their messenger RNA COVID-19 vaccine for people aged 16 years or older. The companies said they have initiated a supplemental biologics license application with the FDA that should be finished...
The FDA has granted approval to Pfizer-BioNTech's COVID-19 vaccine Comirnaty for use in adolescents aged 12 to 15 years, according to a company press release.Infectious Disease News
U.S. regulators approved Pfizer-BioNTech's COVID-19 booster shot for healthy American children ages 5 through 11. The U.S. Food and Drug Administration announced the expanded approval on Tuesday. Pfizer’s booster shot is recommended at least five months after the initial two-dose se...
Pfizer-BioNTech (COMIRNATY) received U.S. Food and Drug Administration (FDA) approval on August 23, 2021, for individuals 16 years of age and older. Once vaccines are approved by the FDA, companies can market the vaccines under brand names. COMIRNATY is the brand name for the Pfizer-Bio...