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Animal data and Omicron booster vaccines

Updated: Oct 5, 2022

The first booster vaccines, targeting the Omicron variant of Covid-19, have been authorised by regulators across the world solely using data from animal testing.

Commonly regulators would require human clinical trials before approval, however manufacturers Moderna and the Pfizer-BioNTech supplied data from testing on mice which has been accepted for emergency use authorisation by the European Medicines Agency, the US Food & Drug Administration (FDA) and the UK’s MHRA.

Science reported that at a meeting with the FDA, Pfizer showed that compared with the mice that received the original vaccine as a booster, the animals showed an increased response to all Omicron variants tested.

The companies say clinical trials will begin next month - clinical data is still needed for full approval of the vaccines.

The action by regulators is in line with procedures for annually reformulated influenza vaccines, which do not have to undergo new clinical trials unless the manufacturers significantly change the way they make the vaccine.

EARA executive director, Kirk Leech, said: “Despite the criticisms of opponents, this is a welcome validation of the confidence that regulators continue to have in animal data.”



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