How Are Vaccines Made and Approved?

How Are Vaccines Made and Approved?

Safety is a top priority at every step

The new COVID-19 vaccines give us an amazing opportunity to stop the spread of COVID-19. If enough people get the vaccine, it could become very rare to get COVID-19 in the United States.

Because the COVID-19 vaccines are brand new and developed with record speed, some people are worried about their safety. These concerns are understandable, but it’s important to know that these vaccines are just as trustworthy as any other vaccine. All vaccines go through the same development process, where safety is a top priority at every stage.

How Vaccines Get Made

All vaccines start with research in a lab. If that research suggests that a vaccine is promising, it is tested on animals. Vaccines only make it to the next stage, clinical trials, if the initial research shows it will be safe and effective in humans.

There are 3 stages of clinical trials. These trials use human volunteers to test how safe and effective the vaccine will be.

  • Phase 1 is only about 20 to 100 people and is mainly used to test basic safety.
  • Phase 2 has hundreds of volunteers. In this phase, researchers are looking to see how well the vaccine works, how many doses will be needed, and how safe it is.
  • Phase 3 typically involves thousands of people. With this many people, researchers can gather lots of data on how safe and effective the vaccine is.

If a vaccine is successful in all 3 clinical trials, it is ready to begin the FDA review and approval process. A vaccine only gets an FDA license if it’s safe, effective, and the benefits outweigh the risks.

COVID-19 Vaccines: A Speedy But Safe Development

The COVID-19 vaccines were made much faster than any vaccine had been made before. And researchers did not compromise safety to get to that landmark achievement. Here are the main reasons the COVID-19 vaccines were developed so quickly:

  • Other coronaviruses have been around for decades. Scientists have been studying viruses similar to COVID-19 for over 50 years, so they had a head start.
  • Global teamwork. Scientists around the world shared their findings on COVID-19 which greatly sped up the research process. They also had the benefit of lots of government funding.
  • New technology was used that didn’t require some of the time consuming steps of past techniques.

Rest assured, no corners were cut while developing the COVID-19 vaccines. Their speed is a reflection of the power of new technology and what can happen when people work together to solve our biggest problems.


CDC. Ensuring the Safety of Vaccines in the United States

CDC. Vaccine Safety: Ensuring Safety

Gallup. More Americans Now Willing to Get COVID-19 Vaccine

Medical News Today. How did we develop a COVID-19 vaccine so quickly?

Washington Post. Your questions about the coronavirus vaccine, answered

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