A Covid-19 vaccine, amazingly, is close. Why am I so worried?

It’s a truly impressive a feat and a testament to the power of basic and applied medical sciences. Under normal circumstances, vaccine approvals are measured in decades. Milestones that once took months or years have been achieved in days or weeks. If these efforts are successful, the Covid-19 vaccine could take a place alongside the Apollo missions as one of history’s greatest scientific achievements.

I’m optimistic. And yet, as someone who studies drug development, I want to temper expectations with a dose of realism and perhaps a bit of angst. Behind the proud declarations, many science and medical professionals have been whispering concerns. These whispers have escalated into a murmur. It’s time to cry them loudly:

Hey, Food and Drug Administration: Don’t be rash! Premature approval of a sub-standard Covid-19 vaccine could have dire implications, and not just for this pandemic. It could harm public health for years, if not generations, to come.

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This is one of the problems with the way the Trump administration is handling things. Even if everything is done carefully, it is going to look as if the vaccine was rushed and not adequately tested.

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Every nation is “rushing” a vaccine in… And all politicians across the spectrum are promising that a vaccine will help everyone return to normal.

This means that most people are going to welcome a vaccine.
No one (at least the vast majority) is going to complain unless the vaccine actually causes harmful side effects.
Any vaccine will be administered on an unprecedent scale and things could get very ugly if the vaccine causes serious sicknesses in people.
So there shouldn’t be a problem as long as no one buckles to the pressure and cuts corners.

Just added the NPR segment.

You underestimate the influene of the anti-vaxxers. A recent survey showed that no less than 1 in 6 Britons would refuse a COVID-19 vaccination. Andrew Wakefield has a whole lot to answer for.

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The phase II trials have 10’s of thousands of people in them so if there are major issues it should show up in those trials. However, serious adverse reactions in just 1 in 10,000 people is still going to be an issue when we are talking about 100’s of millions of people.

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Yes, it’s a scary proposition. Considering that most countries will target atleast 60% of the population.

This is especially scary because there will be a lot of peer pressure to go for the vaccine. There are news reports suggesting that the indian government might even arrest people who refuse a vaccine.

Quite frankly, there’s no way around it. This is true for almost every medication. At some point a medication needs to be released into the real world, and then we see what happens. You have to vigilantly track adverse reactions and pull the medication if there are issues. Vioxx is a good example of this where the adverse reactions took a long time to show up and were rare enough that they didn’t appear in the clinical trials. If medicines and treatments had to prove they are 100% safe before being approved then none would be approved. In fact, medications with side effects are approved all the time as long as the benefits outweigh the adverse reactions.

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