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How vaccines get made and approved in the US | Health and Fitness


ws of vaccine trials from companies such as Pfizer, Moderna, and AstraZeneca.

Already there have been some promising developments. On Nov. 16, Moderna released the results of a study that showed their vaccine has a 94% rate of effectiveness. While the results of their 30,000-person Phase 3 trial have not yet been published, researchers said that the results show that the vaccine is safe and effective. On Nov. 18, Pfizer and its partner BioNTech announced it concluded its Phase 3 study (which began July 27) and determined their vaccine is 95% effective. Pfizer and BioNTech will submit a request for Emergency Use Authorization by the FDA as soon as possible and plans to share their data with global regulatory agencies.

The news from both companies has given people hope that the SARS-CoV-2 virus that causes COVID-19 can eventually be controlled. However, there is also mistrust surrounding vaccines, and often a lack of understanding about how they are created, how they are tested, and how safe they are. If people don’t trust the vaccine, then people won’t take it, and the pandemic could go on longer.

Some of this lack of trust comes from a lack of information or misinformation. In order to demystify vaccines and the vaccine manufacturing and approval process in the United States, Stacker consulted the Food & Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), and other public health sources to better understand and explain vaccines to the general public.

After going through these authoritative health information sources, Stacker identified some key terms to help readers better understand the types of vaccines and how they work, and then listed the many steps involved in the creation, approval, and distribution of new vaccines in the U.S. We then created a list of 30 key terms and steps, showing how intensive and precise the vaccine creation and approval process is, and ultimately that vaccines are safe and effective tools for fighting disease.

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