The European Medicines Agency (EMA) has started a rolling review for a version of Spikevax adapted to provide better protection against specific variants of SARS-CoV-2, the virus that causes COVID-19.
In a press release, the Ministry of Health in Cyprus has said the review concerns a bivalent vaccine. This means it will target two strains of SARS-CoV-2, in this case the original strain and the Omicron variant of concern.
The review will initially focus on data from laboratory studies (non-clinical data) and data on chemistry, manufacturing and controls (CMC), which relate to the manufacturing of the vaccine. As the company makes progress in the development of 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. EMA will communicate further on the outcome of the rolling review or an eventual application.
The composition of adapted COVID-19 vaccines will ultimately depend on recommendations of public health authorities and the World Health Organization (WHO) as well as the considerations of regulatory bodies such as EMA and other members of the International Coalition of Medicines Regulatory Authorities (ICMRA). These bodies are working closely together to determine the appropriate strains for adapted COVID-19 vaccines.
This rolling review process is one of the ways authorities in the EU are working to ensure that EU Member States have timely access to adapted COVID-19 vaccines they may need to combat current and emerging SARS-CoV-2 variants.
Spikevax works by preparing the body to defend itself against COVID-19.
Source: Cyprus News Agency