miércoles, 2 de septiembre de 2020

Experts see chance for Covid-19 vaccine approval this fall — if done right

Experts see chance for Covid-19 vaccine approval this fall — if done right

Morning Rounds

Shraddha Chakradhar

Inside STAT: Experts see a chance for a Covid-19 vaccine approval this fall — if it’s done right

What happens if the FDA, under political pressure, approves a Covid-19 vaccine before there are robust safety and efficacy data to suggest its wide use in people? Giving the green light to a vaccine that doesn't live up to the potential shown by early data could have devastating consequences, but waiting for data from large, Phase 3 trials may not also be the only other option. Experts think there could be a middle ground, especially since the FDA has laid out some criteria for what it will take for vaccine approval, such as reducing the rate of symptomatic Covid-19 by at least 50%. "There are mechanisms by which products that have a good amount of data can be made available in a controlled way,” vaccine design expert Natalie Dean tells STAT's Matthew Herper. Read more here

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