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We cannot skip phase 3 vaccine trials



I wrote a blog post over the weekend that generated a huge boost, including an option in New York Times as well as thousands of comments on Twitter.

In my previous post, I suggested that while pursuing phase 3 of several promising vaccines against Covid-1

9, we could simultaneously offer the same, unapproved vaccines to a wider community of volunteers, as long as those volunteers are fully informed. The benefits of moving fast, I argued, would outweigh the risks.

I was wrongAfter reading many of the answers to my article, some of which outline the risks in more detail, I concluded that (1) the risks are greater than I imagined, and (2) the benefits are not as great as I thought.

There are several risks in point 1 that I did not emphasize enough. One is that although the phase 1 and 2 tests have established safety, they do not tell the whole story. Phase 3 also looks at safety, and since many more people are involved, phase 3 can identify less common side effects that can still be very bad. (One example is ADE, which can make a viral illness worse than it would otherwise be.) These less common side effects are a big risk of moving too fast.

Another risk is the risk of Trust: As many people have pointed out on Twitter, if we expand the spread of vaccines too quickly and then the vaccine doesn’t work, we can seriously undermine public confidence in any vaccine that really works. This in turn will reduce the number of people willing to be vaccinated, which can cause serious damage to public health.

On the benefit side, my article suggests that we can quickly make millions of doses available before the Phase 3 trials are over. We can and must increase vaccine production before the end of the Phase 3 trials – and several manufacturers are doing just that with government support. But these vaccines are not yet available in large quantities, and by the time they are, Phase 3 will be much further.

One thing I learned as a scientist is that if you get something wrong, you have to admit it, learn from experience, and move on. I was wrong.

Disclaimer: The content on this site is my personal opinion and does not depend on my affiliation with Johns Hopkins University.

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