Paul-Ehrlich-Institut

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Rolling Re­views Have Start­ed for Adapt­ed COVID-19 mR­NA Vaccines from BioN­Tech (Comir­naty) and Mod­er­na (Spike­vax)

The Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) has begun rolling reviews for COVID-19 mRNA vaccines adapted for Omicron. The reviews began on 15 June 2022 for the mRNA vaccine Comirnaty from the German manufacturer BioNTech Manufacturing GmbH and 17 June 2022 for the mRNA vaccine Spikevax from Moderna Biotech Spain, S.L. The adapted versions of the two mRNA vaccines are intended to provide better protection against COVID-19 caused by certain SARS-CoV-2 variants.

COVID-19 Vaccines (Source: insta photos/shutterstock.com)

New Blueprints for the mRNA Variant Vaccines

The details on the adapted Comirnaty vaccine, e.g. whether it will be specifically directed against one or more SARS-CoV-2 variants or sub-variants, have not yet been established.

The adapted Spikevax vaccine is already known to be a bivalent vaccine that targets both the original strain of SARS-CoV-2 and the Omicron variant.

Assessment of Quality and Manufacturing Data

Experts from the national medicines authorities on the Committee for Medicinal Products for Human Use (CHMP) at the EMA will initially focus on data regarding chemistry, manufacturing, and controls (CMC). In the case of the bivalent Spikevax vaccine, it will also be possible to evaluate initial non-clinical data. Data on immune response and efficacy against the Omicron variant will be made available and assessed over the course of the review.

Determination of the Parent Composition of COVID-19 Variant Vaccines at International Level

According to the EMA Secretariat, the composition of the adapted COVID-19 vaccines will ultimately depend on the recommendations of the health authorities and the World Health Organization (WHO), as well as on the considerations of the medicines authorities in the International Coalition of Medicines Regulatory Authorities (ICMRA). The Paul-Ehrlich-Institut is a member of ICMRA.

Updated: 21.06.2022