Health
EMA releases guidance for COVID variant vaccine development – Regulatory Focus
The guidance does not foresee the need for large-scale clinical trials to examine safety and efficacy, but rather calls for smaller immunogenicity studies to look…
Posted 25 February 2021 | By Kari Oakes
The European Medicines Agency (EMA) has published a reflection paper laying out what data are needed to support approval of vaccines that protect against variants of SARS-CoV-2, the virus that causes COVID-19.“[I]t is an urgent public health priority to define an expedited regulatory process for the adaptation of vaccines to protect against current or future variants,” wrote the agency in announcing the new guidance. The document comes less than 2 weeks after…
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