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Pfizer’s vaccine against covidGetty
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The European Medicines Agency (EMA) announced this Wednesday the start of ongoing review the Pfizer-BioNTech vaccine adapted to the new variants of SARS-CoV-2, the virus that causes COVID-19. Pfizer and BioNTech are evaluating several vaccines tailored to variants of the virus. Details about the vaccine, such as whether it will specifically target one or more variants or sub-variants, are yet to be defined.
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The final composition will be discussed with global regulatory bodies, as well as the World Health Organization (WHO), to determine its use as a booster dose during the fall season. The companies will also submit this data from their variant-adapted vaccine to the US Food and Drug Administration (FDA) “in the coming weeks,” according to a statement.
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Therefore, this EMA review will initially focus on the chemistry, manufacturing and controls that relate to the manufacture of the vaccine. As Pfizer and BioNTech move forward with their vaccine development, the European Medicines Agency will receive more data, including those related to the immune response to the vaccine, as well as those of efficacy against omicron subvariants.
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By initiating an ongoing review, the EMA will be able to assess these data as they become available. Ongoing review will continue until there is enough data for companies to make a formal request for authorization.
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A rolling review is a regulatory tool that the EMA uses to speed up the evaluation of data on a medicine or vaccine during a public health emergency.
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