Vaccine makers should start studies on tweaked vaccines “sooner rather than later”, the US regulator has urged, as it said they could avoid lengthy trials for a new approval if they need to adapt Covid-19 shots.
The Food and Drug Administration said pharmaceutical companies could do trials with just a few hundred people, perhaps only taking two or three months, rather than the large phase 3 trials that were required for the original emergency use authorisations (EUA).
Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said vaccine makers should get prepared now, as the variants spread very quickly.
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