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Vaccine

How are vaccines regulated?

Like all products regulated by FDA, vaccines undergo a rigorous review of laboratory and clinical data by highly trained scientists and clinicians to help ensure the safety, purity, and potency of these products. From an FDA regulatory perspective, there are four stages in vaccine development: the pre-investigational new drug (pre-IND) stage (before the product is used in people), the IND stage (where human use occurs under limited study conditions), the license application stage for vaccines (where FDA reviews the results of the clinical studies and the manufacturing process), and the post-licensure stage (following approval of the product for marketing).

Vaccines are not entirely risk-free. While serious complications are rare, they can occur. Vaccines are unique medical products in that they are generally administered to a large number of healthy individuals, primarily children. Therefore, it is very important to identify even rare adverse reactions. CBER and the Centers for Disease Control and Prevention (CDC) jointly manage the Vaccine Adverse Event Reporting System (VAERS), a cooperative program for vaccine safety.

FDA takes steps to reduce Thimerosal in Vaccines

FDA, together with other U.S. public health agencies, recognizes and supports the goal of reducing exposure to mercury from all sources. Consistent with this goal, FDA has encouraged manufacturers for several years to develop new vaccines without thimerosal as a preservative and to remove or reduce the thimerosal content of existing, licensed vaccines. This joint effort by manufacturers and FDA is reflected by the licensure of thimerosal-free products such as Comvax [Haemophilus b Conjugate Vaccine and Hepatitis B Vaccine (Recombinant) manufactured by Merck & Company, Inc.], licensed October 2, 1996, Infanrix [Diphtheria and Tetanus Toxoids and Acellular Pertussis (DTaP) manufactured by GlaxoSmithKline], licensed January 29, 1997, and Prevnar (Pneumococcal 7-valent Conjugate Vaccine manufactured by Wyeth-Lederle Vaccines and Pediatrics), licensed on February 17, 2000, and the removal or reduction of thimerosal from previously licensed products.

FDA's efforts over approximately the past year and a half to accomplish this goal include the licensure of a Thimerosal free Hepatitis B Vaccine (Recombinant) manufactured by Merck and Company in August 1999. FDA licensed another hepatitis B vaccine with trace amounts of Thimerosal, manufactured by GlaxoSmithKline in March 2000. A supplement for a new formulation of Aventis Pasteur's DTaP Vaccine with only a trace amount of Thimerosal was approved in March 2001. Additionally, Wyeth-Lederle Vaccines and Pediatrics now only markets a single-dose, Thimerosal-free formulation of its Haemophilus b Conjugate Vaccine in the U.S.

Therefore, all routinely recommended U.S. licensed pediatric vaccines are now available in either Thimerosal-free formulations or in formulations that contain only trace amounts of Thimerosal. The routinely recommended vaccines include hepatitis B Vaccine, Haemophilus b Conjugate Vaccine, Measles Mumps and Rubella Vaccine, Pneumococcal Conjugate Vaccine, DTaP Vaccine, Inactivated Polio Vaccine, and Varicella Vaccine.

New vaccines contain less or no Thimerosal

Prior to the recent initiative to reduce or eliminate Thimerosal from childhood vaccines, the maximum cumulative exposure to mercury via routine childhood vaccinations during the first six months of life was 187.5 micrograms.

Studies clearly demonstrated that exposure to more than 62.5 micrograms of mercury within the first three months of life significantly increased a child's risk of developing autism. With the newly formulated vaccines, the maximum cumulative exposure during the first six months of life will now be less than three micrograms of mercury; this represents a greater than 98 percent reduction in the amount of mercury a child would receive from vaccines in the first six months of life.

The vaccines with trace amounts of Thimerosal licensed to date contain less than 0.5 micrograms of mercury per dose, that is, a given dose of vaccine contains less than 1 part per million. Visit the FDA website for more information.

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