Is safety testing for vaccines rigorous enough?

Is safety testing for vaccines rigorous enough?

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Vaccines are tested more extensively than any other drugs before they're approved for the public because they're given so widely to healthy people. The U.S. Food and Drug Administration is responsible for approving new vaccines and for monitoring them after they're put into use.

Vaccines go through several rounds of safety testing: first in computer models, then in animals, and next in a small group of human volunteers. They're then tested on a larger scale in a stage known as clinical trials. The manufacturing process is also reviewed for safety.

By the time a new vaccine is put on the market, it's been tested on thousands of people, including children. But because the rate of serious adverse effects can be so small – in some cases, fewer than one in a million – even the largest clinical trials (which may include more than 80,000 people) sometimes can't detect them.

About 4 million babies are born in the United States every year. A problem that affects 400 of them – 1 in 10,000 – might not show up at all in a clinical trial of 10,000 people. This is why vaccines are monitored closely even after they're approved.

And that's why it wasn't until 900,000 children received the first rotavirus vaccine that a potential problem began to emerge. In this case, the government became concerned and the manufacturers recalled the vaccine after only 15 reports that children had developed a blockage in their intestines within a week of getting the vaccine. The vaccine wasn't reintroduced because it couldn't be proven safe.

Now there are two new rotavirus vaccines, quite different from the recalled vaccine. RotaTeq and RotaRix are licensed for use in the United States and have been given safely to millions of children.

These vaccines will go a long way toward reducing the 70,000 hospitalizations caused by rotavirus every year in the United States, as well as the 2,000 deaths per day caused by rotavirus in the developing world.

Watch the video: When Will the World Have Enough Covid Vaccines? (May 2022).

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