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Gates Package, p.1037 · gates:exh:00447
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extremely rare side effect,
You may recall that after COVID vaccines hit the market, there were reports that some of
them appeared to raise very slightly the risk of a condition in which small blood clots form in the
blood vessels, causing bruises, fever, and shortness of breath. The risk turned out to be tiny: Out
of 100,000 vaccinated people, the first dose of a vaccine might cause this condition in one
person. The second dose didn't cause any extra risk. You were more likely to be killed by
lightning than to get a clot from a vaccine.18
After reviewing the evidence, even the most stringent regulators decided that this risk
was outweighed by the benefits of getting a vaccine--especially because the odds of developing
similar blood clots were much higher in people who caught COVID. The vaccine manufacturers
added a warning label to the labels on the vaccines, and both of them stayed on the market.
Some people saw this incident as proof that the safety system wasn't working. But I see it
as proof that the system did work--because we were able to detect an extremely rare side effect,
assess the evidence, and weigh the risks and benefits.
Another reason COVID vaccines got approved so quickly is that the people responsible
for approving them worked insanely hard, reducing a process that can take years into a matter of
months. Government employees in Washington, D.C., Geneva, London, and other cities worked
around the clock to examine data from vaccine trials and go through those hundreds of thousands
of pages of documents. Keep this in mind the next time you hear someone bad-mouthing
government bureaucrats. If you were one of the people who got a COVID vaccine fast, and if
you felt confident that it wouldn't seriously hurt you, you have many unsung heroes at the FDA
working over the Christmas holidays to thank for it.
As for how we might accelerate trials and approvals even faster next time, the efforts that
I mentioned in Chapter 5 to prepare for trials ahead of time--agreeing on protocols and setting