Here’s how we could get a working Covid-19 vaccine by fall
There’s widespread concern that U.S. regulators, under political pressure, will approve a Covid-19 vaccine before it has demonstrated safety and efficacy, which could have disastrous consequences. But there’s a chance, debatably remote, for a vaccine to demonstrate its worth in just a matter of months.
As STAT’s Matthew Herper reports, it all comes down to the design of ongoing clinical studies. Trials from Moderna, Pfizer, and other drug makers are programmed to have interim analyses, benchmark points at which outside experts can take a look at the data without spoiling the study.
The trigger for those analyses is a certain number of confirmed cases of Covid-19. Let’s say experts take a look at the data when there are 150 cases. If the vast majority of those came in the placebo group, that might be enough evidence to say the vaccine protects against infection.
But even if a vaccine shows such strong early signs of efficacy, it still might not be ready for widespread use, experts cautioned. Some side effects take months to present themselves, and the only way to be certain of a vaccine’s long-term safety is to allow clinical trials to play out as planned.
Read more.
As STAT’s Matthew Herper reports, it all comes down to the design of ongoing clinical studies. Trials from Moderna, Pfizer, and other drug makers are programmed to have interim analyses, benchmark points at which outside experts can take a look at the data without spoiling the study.
The trigger for those analyses is a certain number of confirmed cases of Covid-19. Let’s say experts take a look at the data when there are 150 cases. If the vast majority of those came in the placebo group, that might be enough evidence to say the vaccine protects against infection.
But even if a vaccine shows such strong early signs of efficacy, it still might not be ready for widespread use, experts cautioned. Some side effects take months to present themselves, and the only way to be certain of a vaccine’s long-term safety is to allow clinical trials to play out as planned.
Read more.
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