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In brief

On 25 February 2021, the EMA’s (European Medicine Agency) committee for Medicinal Products for Human Use (CHMP) published new guidelines for manufacturers of COVID-19 vaccines that intend to adapt them to SARS-CoV-2 virus variants.


  • The guidelines define an accelerated regulatory process for adapting the same vaccines to ensure protection against current or future variants. According to the guidelines, variant vaccines should be developed from the same technology used for the original vaccine — already approved in the EU for the prevention of SARS-CoV-2 — through a modification of the specific structure (i.e., the antigen) selected to trigger an immune response in the human body.

In this regard, the guidelines also detail the laboratory (non-clinical), clinical, quality and manufacturing data needed to support the approval of such variant vaccines.

Author

Roberto Cursano is a counsel in Baker Mckenzie since 2007 in Rome, Italy office. His practice focus more in pharmaceutical and healthcare law matters and compliance, and assists in tender procedures, the negotiation of public contracts and litigation before administrative courts.

Author

Riccardo Ovidi is an associate in Baker McKenzie's Rome office.