Tuesday, 11 May 2021

EU Regulator Begins Real-Time Review of CureVac’s COVID-19 Vaccine

(Reuters) – Europe’s drugs regulator said on Friday it had launched a real-time review of CureVac’s COVID-19 vaccine to speed up potential approvals and bring more shots to the region reeling from a surge in infections.

The human medicines committee of the European Medicines Agency (EMA) will review data from ongoing trials of the German biopharmaceutical firm’s vaccine until there is enough clinical data for approval, the regulator said.

Having started mass testing of its vaccine candidate, which uses next-generation mRNA technology, in Europe and Latin America in December, CureVac expects an initial readout from the study in March or April.

The EMA said its decision to start the “rolling review” of the vaccine, CVnCoV, was based on its preliminary results from laboratory studies and early clinical studies in adults. (https://bit.ly/3ddSKh4)

CureVac is also working with Britain’s GSK to develop a COVID-19 vaccine from next year that could target several variants with one shot, as new, more contagious mutations of the coronavirus have emerged.

“Rolling reviews” speed up the process of approving a successful vaccine by allowing researchers to submit their findings in real-time, even before the final trial data is ready.

All COVID-19 vaccine approvals in Europe so far have been based on rolling reviews.

Source: Read Full Article