Years of research into vaccines have brought us to where we are today. Researchers began working on vaccines for earlier versions of the coronavirus starting with Severe Acute Respiratory Syndrome (SARS) 2003 and Middle East Respiratory Syndrome (MERS) in 2012. When these viruses disappeared, interest in finding a coronavirus vaccine decreased. Lessons learned from this earlier vaccine research have been used to inform strategies for developing a COVID-19 vaccine. Now the global focus on eliminating this new coronavirus and ending the pandemic, combined with funding has helped speed up the research process to create a safe and effective vaccine.
Both the Pfizer-BioNTech vaccine and the Moderna vaccine have received Emergency Use Authorization from U.S. Food and Drug Administration.
STEP 1: VACCINE SAFETY
With a brand new vaccine, researchers give it to a small number of volunteers — usually 20 to 100 — to test for any serious side effects. This step also helps determine the right dose or amount of vaccine to use.
STEP 2: VACCINE EFFECTIVENESS
Once they know a vaccine isn’t likely to cause any serious side effects, researchers then give it to hundreds of people to determine how well the vaccine works (or its effectiveness). Researchers continue to monitor for any short-term side effects.
STEP 3: DOUBLE CHECK SAFETY & EFFECTIVENESS
This is the last step before researchers can apply for approval from the FDA and begin to use it. To make sure the vaccine is safe and effective for people across ages, ethnicities, genders, and other factors, they give it to tens of thousands of people. This uncovers less common side effects and confirms once again that it’s safe and works well for everyone.
STEP 4: CONTINUE TO CHECK SAFETY & EFFECTIVENESS:
Even after researchers have answered the big questions, they keep studying the vaccine. They gather longer-term data to make sure the vaccine continues to work well.
Sometimes, when a vaccine is urgently needed, researchers combine steps to speed up the approval process. This doesn’t mean that they’re skipping any important steps. It does mean researchers and public health organizations are working together at an extraordinary level to get a safe, effective vaccine to the people who need it the most.