Before a new vaccine is ever given to people, extensive lab testing is done that can take several years.  Once testing in people begins, it can take several more years before clinical studies are complete and the vaccine is approved.

The FDA sets rules for the three phases of clinical trials to ensure the safety of the volunteers.  Researchers test vaccines with adults first.

Phase 1 trials enroll 20 – 100 people and the studies tell us if the vaccine is safe, does it promote antibody production, are there side effects, and how the dosage size relate to the observed side effects.

Phase 2 trials enroll several hundred people to further evaluate safety issues and to more fully evaluate the immune response triggered by the vaccine.

Having fully analyzed the safety concerns, the FDA requires large efficacy trials in the form of a Phase 3 study.  The trials evaluate how people receiving the vaccine compare to people receiving a placebo, if the vaccine is effective and safe in a broad sampling of the population, and if there are side effects related to a patient’s underlying conditions.

Vaccines are further tracked and reviewed after the FDA approves them for release.  Physicians and scientist review data to identify vaccines that might be recommended to routine immunization schedules.  Safety is continuously monitored after a vaccine has been released to the public by tracking adverse events and elevating concerns to various safety committees.

Watch a video describing this process from the CDC.

Routine immunization in the United States has nearly eradicated diseases that once were common.  Both children and adults need to stay current on vaccines in order to stay protected. Click here for a list of frequently asked questions published by the Immunization Action Coalition.

Qualmedica works with several vaccine manufactures to provide high quality vaccine research.  Visit our “Studies” page for a list of active infant and adult vaccine studies.  Vaccines save lives.  Join a study today!

Watch a 2-minute video on development of an expanded meningococcal vaccine to prevent meningitis in infants and toddlers.

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