Covid-19: AstraZeneca vaccine is approved in EU with no upper age limitBMJ 2021; 372 doi: https://doi.org/10.1136/bmj.n295 (Published 01 February 2021) Cite this as: BMJ 2021;372:n295
- Ingrid Torjesen
The European Medicines Agency authorised Astra Zeneca’s SARS-CoV-2 vaccine for use in all adults aged over 18 on 29 January, just days after German newspapers suggested that the vaccine would be limited to adults aged under 65 because of poor efficacy in older people.
The EMA’s Committee for Medicinal Products for Human Use announced that the AstraZeneca and Oxford University vaccine was safe and effective at preventing infection in people from 18 years of age, on the basis of data from four clinical trials conducted in the UK, Brazil, and South Africa. The two doses can be given between four and 12 weeks apart.
The vaccine’s safety was shown in all four studies, which included around 24 000 people, but the efficacy decision was based on results from only two of the trials. Results from two others were excluded because each had fewer than six cases of covid-19.
Also, only data from patients who received two standard doses of the vaccine between four and 12 …