What Does It Take for a Vaccine to Receive FDA Approval?

All vaccines given to children and adults in the United States are subject to approval by the Food and Drug Administration (FDA). The FDA approval process is intended to ensure that vaccines and other drugs are both effective and safe for their intended use.

Having been proven safe and effective, however, does not mean that a vaccination is 100% free from any and all risk of illness or injury that may be associated with vaccines. From allergies to shoulder injury related to vaccine administration (SIRVA), there are a number of injuries that may result from even the most common vaccines.  Even so, FDA approval is an important and critical step in protecting consumers and ensuring the safety and effectiveness of vaccines.

When Did Today’s Vaccines Receive FDA Approval?

While many of the vaccines available today have been approved for many years, others have received FDA approval more recently than you might think.  Noted below are approval dates for some of the most common vaccines administered in the United States:

  • Energix-B (Hepatitis B) – 1998
  • Havrix (Hepatitis A) – 2005
  • M-M-R II (Measles, Mumps and Rubella) – 2008
  • Recombivax HB (Hepatitis B) – 1999
  • Twinrix (Hepatitis A) – 2001
  • Varivax (Chickenpox) – 1995
  • Influenza Vaccines – 2002 (Fluzone), 2003 (FluMist), 2005 (Fluarix), 2005 (Fluvirin)

A complete list can be found on the FDA’s website.

The FDA Drug Approval Process

Vaccine manufacturers are required to complete a series of five Phases of independent scientific research in order to receive FDA approval for their vaccines:

  • Phase 0: Exploratory research with limited human exposure and no therapeutic or diagnostic testing.
  • Phase 1: Studies that typically use healthy volunteers to identify any serious side effects.
  • Phase 2: Studies focused on measuring the vaccine’s effectiveness at immunizing recipients, as well as ongoing safety evaluations.
  • Phase 3: Continuing effectiveness and safety research, using different populations of test subjects and testing the vaccine in combination with other drugs.
  • Phase 4: After the vaccine goes on the market (following a successful Phase 3), continuing research must be conducted to evaluate its safety and any potential side effects not previously identified.

In addition, once each of the Phases are complete, the FDA reviews the vaccines’ labeling and inspects the manufacturers’ facilities to ensure that the labels include all necessary warnings and that the facility manufacturing the vaccine has meet the FDA’s manufacturing standards. The length of the approval process is largely dependent upon the efficiency and results of the clinical testing conducted during the various Phases. Very often it can take years for a new vaccine to receive FDA approval.

Compensation for Injuries from FDA-Approved Vaccines

As discussed above, FDA approval does not ensure that a vaccine is 100% free of the risk of causing potential harm or injury. If you or your child has suffered an injury or illness linked to a childhood vaccination that is recommended by the Centers for Disease Control, you may be eligible to receive compensation under the National Vaccine Injury Compensation Program (VICP). The Vaccine Program is a no cost, no fault, compensation program that was created to provide vaccine injured persons with a quick and efficient means to recover money for vaccine-related illnesses and injuries, while paying the cost of their legal fees.

To Find Out if You May Be Eligible for Compensation – Contact Law Offices of Leah V. Durant, P.L.L.C. Today

To find out if you may be eligible to file for compensation under the National Vaccine Injury Program, contact Leah Durant at the Law Offices of Leah V. Durant, P.L.L.C. for a free consultation.  Our services are paid for by the Vaccine Program, so our representation comes at little or no financial cost to you.  Contact our vaccine injury lawyer today, by calling (202) 800-1711 or tell us about your vaccine injury online to learn if compensation is available for you.



Categories: Centers for Disease Control and Prevention, Food and Drug Administration, National Vaccine Injury Compensation Program

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