Section of Pharmacology, Department of Diagnostics and Public Health, University of Verona, Piazzale L.A. Scuro 10, 37134, Verona, Italy.
Section of Pharmacology "L. Donatelli", Department of Experimental Medicine, Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, University of Campania "Luigi Vanvitelli", Naples, Italy.
Drug Saf. 2021 Dec;44(12):1247-1269. doi: 10.1007/s40264-021-01131-6. Epub 2021 Nov 5.
To date, four vaccines have been authorised for emergency use and under conditional approval by the European Medicines Agency to prevent COVID-19: Comirnaty, COVID-19 Vaccine Janssen, Spikevax (previously COVID-19 Vaccine Moderna) and Vaxzevria (previously COVID-19 Vaccine AstraZeneca). Although the benefit-risk profile of these vaccines was proven to be largely favourable in the general population, evidence in special cohorts initially excluded from the pivotal trials, such as pregnant and breastfeeding women, children/adolescents, immunocompromised people and persons with a history of allergy or previous SARS-CoV-2 infection, is still limited. In this narrative review, we critically overview pre- and post-marketing evidence on the potential benefits and risks of marketed COVID-19 vaccines in the above-mentioned special cohorts. In addition, we summarise the recommendations of the scientific societies and regulatory agencies about COVID-19 primary prevention in the same vaccinee categories.
截至目前,已有 4 种疫苗获得欧洲药品管理局的紧急使用授权和有条件批准,可用于预防 COVID-19:Comirnaty、COVID-19 Vaccine Janssen、Spikevax(前称 COVID-19 Vaccine Moderna)和 Vaxzevria(前称 COVID-19 Vaccine AstraZeneca)。尽管这些疫苗在普通人群中的获益-风险比已被证明基本是有利的,但最初在关键性试验中被排除在外的特殊人群,如孕妇和哺乳期妇女、儿童/青少年、免疫功能低下者以及有过敏史或先前 SARS-CoV-2 感染史的人群,其证据仍有限。在本叙述性综述中,我们批判性地回顾了上市 COVID-19 疫苗在上述特殊人群中的潜在获益和风险的上市前和上市后证据。此外,我们还总结了科学协会和监管机构关于同一疫苗接种人群 COVID-19 初级预防的建议。