Home Highlights European regulator contemplates approval of Pfizer’s vaccine for covid-19 variants

European regulator contemplates approval of Pfizer’s vaccine for covid-19 variants

The EU’s medicines regulatory body said Wednesday (10) that it is aiming to approve in the autumn boreal season a Pfizer/BioNTech vaccine adapted for two rapidly spreading subvariants of the omicron strain of Covid-19.

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The BA.4 and BA.5 variants are causing a wave of new cases in Europe and the United States, prompting the World Health Organization (WHO) to warn that the pandemic is far from over.

The European Medicines Agency (EMA) announced Monday it has launched a review of an adapted version of Pfizer’s vaccine aimed at these two variants, which are more transmissible and immune system resistant than previous versions of covid-19.

“The EMA expects to receive an application for the adapted BA.4/5 vaccine developed by Pfizer/BioNTech, which will be evaluated for possible early approval in the fall,” an EMA spokesperson told AFP in an emailed statement.

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This is expected to arrive “shortly after” the expected approval of two more tailored vaccines by Pfizer and its rival Moderna aimed at the original covid-19 strain and the BA.1 subvariant before omicron, the spokesman said.

Pfizer and Moderna submitted applications for approval separately for these vaccines on July 22, the spokesman said.

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