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Italy: The EMA guidelines for adapting Covid-19 vaccines to SARS-CoV-2 variants

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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.

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Author

Roberto Cursano has been a lawyer in Baker McKenzie since September 2007. He focuses on healthcare law and compliance, and assists in tender procedures, the negotiation of public contracts and litigation before administrative courts. Mr. Cursano is a former administrative officer in the Italian Ministry of Health and helps clients work closely with the Italian Public Administration. He is admitted to the bar before the Italian Supreme Court and the Council of State. As well as training and tutoring in the master’s degree program on clinical trials of pharmaceutical products at the University of Rome Sapienza, Mr. Cursano regularly publishes articles and scientific contributions. He also frequently hosts and participates in seminars and presentations on pharmaceutical and administrative law matters.

Author

Riccardo Ovidi is an Associate in Baker McKenzie Rome office.

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