Thimerosal in Vaccines: A Joint Statement of the American Academy of Pediatrics and the Public Health Service

Details

• Alternative Title:
  MMWR. Morbidity and Mortality Weekly Report, Vol. 48, No. 26, July 9, 1999: Thimerosal in Vaccines: A Joint Statement of the American Academy of Pediatrics and the Public Health Service
• Journal Article:
  MMWR. Morbidity and Mortality Weekly Report
• Corporate Authors:
  Centers for Disease Control and Prevention (U.S.)
• Description:
  The Food and Drug Administration (FDA) Modernization Act of 1997 called for FDA to review and assess the risk of all mercury-containing food and drugs. In line with this review, U.S. vaccine manufacturers responded to a December 1998 and April 1999 FDA request to provide more detailed information about the thimerosal content of their preparations that include this compound as a preservative. Thimerosal has been used as an additive to biologics and vaccines since the 1930s because it is very effective in killing bacteria used in several vaccines and in preventing bacterial contamination, particularly in opened multidose containers. Some but not all of the vaccines recommended routinely for children in the United States contain thimerosal.
  
  There is a significant safety margin incorporated into all the acceptable mercury exposure limits. Furthermore, there are no data or evidence of any harm caused by the level of exposure that some children may have encountered in following the existing immunization schedule. Infants and children who have received thimerosal-containing vaccines do not need to be tested for mercury exposure.
  
  The recognition that some children could be exposed to a cumulative level of mercury over the first 6 months of life that exceeds one of the federal guidelines on methyl mercury now requires a weighing of two different types of risks when vaccinating infants. On the one hand, there is the known serious risk of diseases and deaths caused by failure to immunize our infants against vaccine-preventable infectious diseases; on the other, there is the unknown and probably much smaller risk, if any, of neurodevelopmental effects posed by exposure to thimerosal. The large risks of not vaccinating children far outweigh the unknown and probably much smaller risk, if any, of cumulative exposure to thimerosal-containing vaccines over the first 6 months of life.
  
  Nevertheless, because any potential risk is of concern, the Public Health Service (PHS), the American Academy of Pediatrics (AAP), and vaccine manufacturers agree that thimerosal-containing vaccines should be removed as soon as possible. Similar conclusions were reached this year in a meeting attended by European regulatory agencies, European vaccine manufacturers, and FDA, which examined the use of thimerosal-containing vaccines produced or sold in European countries.
  
  PHS and AAP are working collaboratively to assure that the replacement of thimerosal-containing vaccines takes place as expeditiously as possible while at the same time ensuring that our high vaccination coverage levels and their associated low disease levels throughout our entire childhood population are maintained.
  
  The key actions being taken are: 1. A formal request to manufacturers for a clear commitment and a plan to eliminate or reduce as expeditiously as possible the mercury content of their vaccines; 2. A review of pertinent data in a public workshop; 3. Expedited FDA review of manufacturers’ supplements to their product license applications to eliminate or reduce the mercury content of a vaccine; 4. Provide information to clinicians and public health professionals to enable them to communicate effectively with parents and consumer groups; 5. Monitoring immunization practices, future immunization coverage, and vaccine-preventable disease levels; and, 6. Studies to better understand the risks and benefits of this safety assessment.
  
  
• Subjects:
  Ethylmercury Compounds Mercury Methylmercury Compounds Preservatives, Pharmaceutical Safety Thimerosal Vaccines
• Keywords:
  Vaccine Safety
• Series:
  Weekly Report: Morbidity and Mortality Weekly Report (MMWR)
• ISSN:
  0149-2195 (print) ; 1545-861X (digital)
• Publisher:
  Centers for Disease Control and Prevention (CDC) (U.S.)
• Document Type:
  Text
• Genre:
  Journal Article
• Place as Subject:
  United States
• Rights:
  Public Domain
• Location:
  North America
• Pages in Document:
  6 pdf pages
• Volume:
  48
• Issue:
  26
• CAS Registry Number:
  Thimerosal (CAS RN 54-64-8) ; Mercury (CAS RN 7439-97-6) ; Ethylmercury (CAS RN 21687-36-5) ; Methylmercury(1+) (CAS RN 22967-92-6)
• Collection(s):
  Morbidity and Mortality Weekly Report (MMWR)
• Main Document Checksum:
  urn:sha-512:1a5d99767f23fe3daac66dde58e8b96f5a3bf3b2d9a9d21d948aeab7aa4c5880e7480fb7b96d3ed06cfccb974b27887cad02e1037f4cf9062deeba151bc3a1a2
• Download URL:
  https://stacks.cdc.gov/view/cdc/253142/cdc_253142_DS1.pdf
• File Type:
  [PDF - 104.64 KB ]