欧盟药品管理局9日宣布,该机构已开始就辉瑞/BNT(Pfizer/BioNTech)针对新冠亚型变异株研发的更新版疫苗进行滚动式审查。
这款二价疫苗锁定SARS-CoV-2病毒在中国发现的原始病毒株,以及近期成为欧洲主流的Omicron亚型变异株BA.4和BA.5。
滚动式审查(rolling review)意味欧盟药品管理局(European Medicines Agency,EMA)已开始评估所有可用资料,这项程序将持续进行至药厂提出足够资料,以申请正式上市许可为止。
较早前,欧盟药品管理局曾宣布开始滚动式审查辉瑞/BNT的另一款更新版疫苗,该疫苗锁定SARS-CoV-2原始病毒株和Omicron亚型变异株BA.1。
虽然现有疫苗仍能有效预防住院和死亡,但随著病毒不断进化,疫苗的有效性正受到打击。
欧盟官员希望在秋季接种计划中推出二价疫苗,现在区域的多数病例都与BA.5变异株有关。
欧盟药品管理局预计,更新版疫苗将于9月获得使用授权。不过,由于BA.4和BA.5专用疫苗的临床研发进度落后,EMA已暗示,下一波接种计划亦可使用针对BA.1的疫苗。
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