EMA’s human medicines committee (CHMP) has started a rolling review of COVID-19 HIPRA vaccine. A rolling review is a regulatory tool that the EMA uses to expedite the assessment of a promising medicine or vaccine during a public health emergency.
The CHMP decision to initiate continuing review is based on preclinical development and preliminary results from clinical trials. Preliminary results show that the immune response is effective against SARS-CoV-2, including variants of concern such as Omicron.
The purpose behind RBDCOV project is to offer a new tool to control the pandemic at short-medium and long term, and to manufacture and test the first recombinant protein-based vaccine to be authorised in Europe.
RBDCOV is a EU-funded vaccine-focused research project that brings together the expertise of several European groups and companies in rational design of animal and human vaccine immunogens, vaccine manufacturing, distribution and commercialisation, cellular and humoral immune responses, clinical trials, regulatory issues, stakeholders’ involvement and patients’ perspective. Asphalion is proud Regulatory partner of the project.
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EMA starts rolling review of HIPRA COVID-19 vaccine – RBDCOV