The European Medicines Agency (EMA) has started a rolling review for a Spikevax (Moderna) vaccine adapted to provide better protection against specific variants of SARS-CoV-2.
The Ministry of Health said the review concerns a bivalent vaccine, meaning it will target two strains of SARS-CoV-2, the original strain and the Omicron variant of concern.
The review will initially focus on laboratory studies (non-clinical data) and data on chemistry, manufacturing and controls (CMC), which relate to vaccine manufacturing.
As the company progresses in developing its bivalent vaccine, EMA will receive more data, including data on the immune response against the original strain and the Omicron variant of concern.
By starting a rolling review, EMA will be able to assess these data as they become available.
The review will continue until there is enough data for a formal application.
The composition of adapted COVID-19 vaccines will ultimately depend on the recommendations of public health authorities and the World Health Organization (WHO).
This rolling review process is one of the ways authorities in the EU are working to ensure that Member States have timely access to adapted COVID-19 vaccines they may need to combat current and emerging SARS-CoV-2 variants.
Moderna’s new version of its COVID-19 vaccine, which targets two virus variants including Omicron, has outperformed the company’s original Spikevax shot in a head-to-head clinical trial.
The new vaccine contains mRNA coding for the spike protein of the original wild-type SARS-CoV-2 virus and the Omicron variant.
It is being positioned as a second booster shot that could be used in forthcoming immunisation campaigns.
Pfizer and BioNTech are also working on a new vaccine to update their Comirnaty shot to target Omicron.
Last month, they pushed the delivery of promised supplies to European countries until September.
According to the European Commission, the delay will help match supply and demand and ensure the security of supply. It will also increase the possibility that an updated Omicron-targeting version will be authorised in the meantime.
