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How a Vaccine is Approved

There has been a lot of talk recently about developing and implementing a vaccine for COVID-19.  Right now, scientists are working on developing a vaccine that will be safe, effective, and help the world combat this disease; however this may take some time because there are many steps involved in creating and approving a vaccine.  Here is a quick rundown of how a vaccine is normally created. 

  1. Lab testing: a potential vaccine is tested rigorously in a lab for 3-5 years prior to it being tested on humans.  Many vaccines are researched, but very few make it through this development phase.
  2. Human clinical trials: Vaccines go through 3 phases of human clinical trials.  Phase I involves few volunteers, about 20-80 people.  Phase II involves several hundred people.  Phase III involves thousands or tens of thousands of people.  All of these trials are used to determine the safety of the vaccine for the target age group. 
  3. Developing and distributing: Once a vaccine is found to be safe and effective, it is submitted to the FDA for approval.  Once the FDA approves the vaccine, it can be given to the general public. 

After the vaccine has been determined to be safe and effective, the vaccine can then be distributed.  There are times when the process will be quicker than this timeframe, such as developing a vaccine for COVID-19, but vaccines are usually developed over many years.  But how does a vaccine get added to the immunization schedule?  The Advisory Committee on Immunization Practices (ACIP) meets once a year to determine if a vaccine should be added to the immunization schedule.  They look at the following things:

  1. How safe is the vaccine when given at certain ages?
  2. How well does the vaccine work at certain ages?
  3. How serious is the disease this vaccine prevents?
  4. How many children would get this disease if we did not give this vaccine?

All of these are considered before recommending a vaccine to be added to the immunization schedule.  In addition, they look at the current recommended vaccines to make sure they are still safe and needed in the United States.

After the vaccine is approved, data is collected about any harm that happens due to this vaccine.  The Vaccine Adverse Events Reporting System (VAERS) is a reporting system that anyone in the Unites States can use to report vaccine related problems.  This is tracked and monitored to make sure the vaccine continues to be safe and effective against disease.  As you can see, there is a lot involved in making sure vaccines are safe and effective prior to them being released to the public.  Vaccines are critical in preventing disease in children and adults, and are extensively tested prior to being released for the public.

As it will take time to get a vaccine for COVID-19, there are important steps we can do to help slow the spread.  Slowing the spread helps our healthcare system from being overwhelmed by many sick people at the same time.  We can all do our part to help slow the spread by performing some tasks. 

  1. Wash your hands.  Make sure that you wash your hands often, for at least 20 seconds with soap and water.
  2. Cover your cough.  When you need to cough or sneeze, do so into your elbow to help prevent germs from flying through the air.
  3. Social distancing- Stay home unless you need to go out for something essential.  Essential includes groceries, medications, doctor appointments, and work.  When you are out doing essential errands, make sure you maintain a distance of 6 feet between yourself and others.  Wear a mask and keep the mask on while in public. Wash your hands after each store that you visit.   
  4. Up to date information can be found at through the CDC's website. Navigate to CDC's Website.

With these measures in place, we can keep ourselves and our communities from having a sharp increase in COVID-19 cases.  While we cannot be guaranteed to get a vaccine during this initial outbreak, there are promising research studies that are now being conducted. Until the vaccine is distributed, continue to stay home and stay safe.