Pfizer-BioNTech seek FDA approval for Covid-19 booster dose


2021-08-26 18:30:13 PHARMACEUTICAL


Pfizer and its partner BioNTech are seeking approval from the US Food and Drug Administration for their booster dose of Covid-19 vaccine, Comirnaty, for individuals aged 16 years and above. The companies have initiated the rolling submission of a supplemental biologics license application (sBLA) to the FDA. The latest move follows the receipt of full approval from FDA to Pfizer/BioNTech’s Covid-19 vaccine for individuals aged 16 years and older. The submission of the sBLA is anticipated to be completed by the end of this week. It includes data from a Phase III clinical trial which was conducted on 306 subjects aged from 18 to 55 years. The booster dose elicited robust neutralising antibodies to the wild-type strain in participants who were without evidence of SARS-CoV-2 infection after one-month. The participants were given the third Covid-19 vaccine dose between 4.8 and eight months after completion of the initial two doses. It is found that a 3.3 times greater count of SARS-CoV-2 50% neutralising titers after the third dose was observed after the second dose. Additionally, 99.5% of subjects had a four-fold response after the booster dose compared to 98% response observed after the second dose. Currently, Pfizer-BioNTech’s third vaccine dose is not authorised for broad use in the US. In the coming weeks, the companies also plan to submit the data to the European Medicines Agency (EMA) as well as other regulatory authorities across the world. Recently, FDA has authorised the third Pfizer-BioNTech Covid-19 vaccine doses for individuals aged 12 and above with compromised immune systems under emergency use authorization (EUA).
辉瑞及其合作伙伴生物技术公司(BioNTech)正在寻求美国食品药品监督管理局(FDA)的批准,为16岁及以上的个人提供新冠肺炎疫苗Comirnaty的强化剂量。 这些公司已经开始向美国食品和药物管理局滚动提交补充生物制品许可证申请(sBLA)。 此前,美国食品和药物管理局已完全批准辉瑞/生物技术公司针对16岁及以上个人的新冠肺炎疫苗。 sBLA的提交预计将于本周末完成。 它包括一项III期临床试验的数据,该试验对306名年龄在18岁至55岁之间的受试者进行。 强化剂量在一个月后没有新型冠状病毒感染证据的参与者中引发了对野生型菌株的强大中和抗体。 在完成最初的两剂疫苗后的4.8至8个月内,参与者接受了第三剂新冠肺炎疫苗。 发现在第二次剂量后,观察到第三次剂量后新型冠状病毒50%中和滴度的3.3倍大计数。 此外,99.5%的受试者在加强剂量后有四倍的反应,而在第二次剂量后观察到的反应为98%。 目前,辉瑞-生物技术公司的第三剂疫苗尚未被授权在美国广泛使用。 在未来几周,这些公司还计划将数据提交给欧洲药品管理局(EMA)以及世界各地的其他监管机构。 最近,美国食品和药物管理局根据紧急使用授权(EUA)为12岁及以上免疫系统受损的个人授权了第三剂辉瑞-生物技术公司新冠肺炎疫苗。