Yesterday, EMA published a Reflection paper on the regulatory requirements for vaccines intended to provide protection against variant strain(s) of SARS-CoV-2. This paper is a guidance document for the manufacturers developing variant vaccines from already authorized vaccines against SARS-CoV-2, and it details which information should be provided to support its approval, covering quality, nonclinical and clinical data. These requirements apply only when the parent vaccine has been granted a Marketing Authorisation in the EU and the manufacturing process and controls and the facilities for vaccine production are the same or very similar to those for the parent vaccine.
As a summary, the information to include is:
- For Module 3: Update of the starting materials, justification of any changes to the registered specifications, demonstration of manufacturing consistency and confirmation of the suitability of the active substance and finished product registered shelf-life.
- For Module 4: no need to perform additional in vitro or in vivo studies.
- For Module 5: data on the efficacy of the variant vaccine. Regarding its safety, the data collected during the immunogenicity trials with the variant vaccine shall suffice, unless there were safety concerns for the parent vaccine or safety concerns emerge from trials with the variant vaccine.
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