发现和开发COVID-19疫苗和治疗方法:非临床观点
Nasir Khan1, Jean Sathish2, Cynthia M Rohde2
1Pfizer Research and Development, Pfizer Inc, Groton, CT, USA.
The Journal of toxicological sciences
|March 3, 2024
概括
COVID-19疫苗BNT162b2和治疗性Paxlovid的开发展示了加速的创新. 协作和适应性战略使得对疫情准备的快速监管审查成为可能.
科学领域:
- 病毒学和免疫学 病毒学和免疫学
- 制药发展 制药发展
- 监管科学 监管科学
背景情况:
- 由于COVID-19的流行,疫苗和治疗方法的快速开发成为必要.
- 对SARS-CoV-2生物学的现有知识为BNT162b2和Paxlovid的目标选择提供了信息.
- 加快创新对于全球卫生安全至关重要.
研究的目的:
- 突出BNT162b2和Paxlovid的开发和监管审查过程.
- 确定在疫情期间能够加速创新的关键策略.
- 为未来的流行病准备提供见解.
主要方法:
- 利用对SARS-CoV-2和相关病毒的现有知识来识别目标 (尖端蛋白和主要蛋白酶).
- 对BNT162b2和治疗候选药物 (lufotrelvir,nirmatrelvir) 的免疫性和安全性的严格非临床评估.
- 行业,监管机构和公共卫生组织之间的密切合作.
主要成果:
- BNT162b2 (COVID-19疫苗) 和Paxlovid (COVID-19治疗药物) 经历了成功的开发和监管审查.
- 进行了全面的非临床安全性和免疫性评估.
- 该过程证明了通过战略方法加速时间表的可行性.
结论:
- 对BNT162b2和Paxlovid的开发途径是快速医疗创新的基准.
- 关键策略包括并行处理,基于风险的投资和灵活的平台利用.
- 加强合作和适应性监管方法对于疫情准备至关重要.
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