Abstract
It is time to include real-world effectiveness data on medicinal product labels
Highlights
In late 2020 and early 2021, ChAdOx1 nCoV-19 was temporarily authorised by many regulatory agencies for individuals aged 18 years or older, with a dosing interval of 4–12 weeks between two vaccine doses
The clinical effectiveness of ChAdOx1 nCoV-19 was estimated in older adults (≥65 years) via real-world mass observational studies done in the UK, with individuals receiving one or two vaccine doses.[4]
In the European Medicines Agency (EMA)’s updated summary of product characteristics, vaccine efficacy in older people is discussed only in the section devoted to describing study D8110C00001.1 The statement regarding the lack of clinical data preventing an estimation of vaccine efficacy in older adults, which was introduced in the first issued summary of product characteristics, was deleted in this updated version
Summary
In late 2020 and early 2021, ChAdOx1 nCoV-19 was temporarily authorised by many regulatory agencies for individuals aged 18 years or older, with a dosing interval of 4–12 weeks between two vaccine doses.
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