No recall of vaccines containing mercury

Opening Statement Dan Burton (R-IN), Chairman Government Reform Committee - “Mercury in Medicine – Are We Taking Unnecessary Risks?”

One would think that the FDA would have moved aggressively to remove vaccines that contained mercury from the market immediately.  They did not. 

On July 9, 1999, the American Academy of Pediatrics and the United States Public Health Service issued a joint statement recommending the removal of thimerosal from vaccines.[1]  On May 31, 2000, the Food and Drug Administration notified vaccine manufacturers that their review of mercury compounds in drugs and foods concluded that reducing or eliminating thimerosal from vaccines is merited.[2]  However, there has been no mandatory action.  These vaccines are still in use. 

The FDA continues to allow the mercury-containing vaccines to remain on the market.  Today, over eight thousand children in America may be given a toxic dose of mercury in their vaccines.[3]   

Thimerosal in Vaccines—An Interim Report to Clinicians (RE9935) - American Academy of Pediatrics

RISKS OF WITHHOLDING VACCINES

Children who do not receive recommended immunizations are at increased risk of acquiring serious diseases.²³ When immunization acceptance has declined, epidemics of vaccine-preventable diseases have occurred as evidenced by the measles outbreaks in the United States in 1989-1991; resurgence of pertussis in Japan, Sweden, and the United Kingdom in the late 1970s; and the recent diphtheria epidemic in the former Soviet Union.^23,24 Children who acquire diphtheria have a 3% to 23% chance of dying; 25% of children with pertussis are hospitalized, 22% develop pneumonia, and 3% have encephalopathy and often suffer permanent sequelae or death. Hepatitis B kills several thousand Americans every year attributable to liver cancer and cirrhosis of the liver.²⁵ Hib vaccines have resulted in the near elimination of meningitis, pneumonia, and sepsis from this organism. Approximately 5% of children with Hib meningitis die, and 50% of the survivors have neurologic sequelae, including deafness, impaired vision, and mental retardation.²⁶ Although these diseases have been reduced to record low numbers, the organisms that cause these diseases are still present, and unvaccinated children will be at risk. These serious diseases can be prevented through immunization. If thimerosal-free vaccines are not available, physicians and parents must balance the known risks of serious complications from these diseases against the unknown but much smaller risks associated with thimerosal in some vaccines. In high-risk situations, such as infants born to hepatitis B surface antigen (HBsAg)-positive mothers, the known risks of serious consequences from the preventable infections far outweigh the risks of adverse consequences from vaccines, even if thimerosal-free products are not available.

Still using a mercury thermometer?  AAP supports elimination of mercury-containing thermometers

In response to the FDA Modernization Act of 1997, the FDA is reviewing the use of mercury in biologic and pharmaceutical products.As a precautionary measure, thimerosal, a mercury-containing preservative is being eliminated from vaccines as quickly as manufacturers can alter their production processes and obtain FDA approval. Currently, none of the vaccines in the recommended childhood immunization schedule contain thimerosal as a preservative.

ACIP Working Group on Thimerosal recommends delay in exclusive use of thimerosal-free vaccines until April 2002, in direct contradiction of IOM recommendations.

The recommendation of the Working Group is to state a preference for thimerosal-free DTaP, Hib, and Hep B vaccines as of March 31, 2002, which is when the 2002 Routine Infant Immunization Schedule is scheduled to be announced.  The Working Group is asking that this recommendation be issued as a joint statement by ACIP, AAP, AAFP, and PHS, and be approved by these organizations by November 30, 2001.

A study by the CDC was conducted during the week of September 10-17, 2001 among a sample of healthcare providers covering 225 sites in 16 states.  The survey asked providers to physically check their inventory of DTaP, Hib, and Hepatitis B vaccines and to record the number of doses in the refrigerators, the brand, and the lot numbers. With the assistance of the vaccine manufacturers, the lot numbers were matched to production records to determine whether the vaccine contained thimerosal or not. Nearly 66,000 doses were evaluated.

Among these doses, 5.5% contained thimerosal.  The breakdown by vaccine type was as follows: among the DTaPs, 9% contained thimerosal; among the DTaP-Hib combination vaccine, it was 36%; among the Hibs - 2.7%; among the Hep B-Hib combinations - 0%; and among the pediatric Hep Bs - 4.6%.

The CDC also conducted a study of thimerosal vaccines still in depots or warehouses. They sampled two suppliers, each of which has contracts with 8-12 states. Data collection occurred during September 10-17, 2001. Just 1% of vaccines contained thimerosal. There was considerable variation by state, ranging from 0% to 12.3% of vaccines having thimerosal. Among the overall 1% average, 80% was DTaP, 6% was Hep B, and 14% was DTaP-Hib combination.