This document was acquired with a FOIA request submitted by the Informed Consent Action Network (ICAN) to the United Kingdom’s FDA equivalent – the Medicines and Healthcare Products Registry Agency (MHRA) -- in April 2022. The request sought information relating to the MHRA’s authorization of the AstraZeneca, Janssen, Moderna, and Pfizer COVID-19 vaccines.
“6.2 Risks of AZD1222
The updated evaluation of the safety of AZD1222 is based on the pooled population from 4 ongoing studies, comprising 24244 male and female adults aged from [REDACTED] years to [REDACTED] years…
Long-term follow-up of the ongoing clinical studies (up to 1 year) will provide data to further characterise the safety profile of AZD1222. Moreover, since people with severe immunodeficiencies, severe underlying comorbid disease, and pregnant/lactating women were excluded from the studies, the safety of AZD1222 in these groups is currently unknown.”