epiTRENDS
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epiTRENDS |
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A new influenza A virus strain, first identified in April 2009, has now caused a global pandemic. This strain is not included in this year’s seasonal influenza vaccines. Immunization with a vaccine specifically for this new 2009 H1N1 influenza virus will be the major disease control measure for this new virus.
Production of the 2009 H1N1 monovalent influenza vaccine uses the same manufacturing processes and quality testing used for all seasonal influenza vaccines. In addition, the new vaccine is administered at the same dosage and uses the same diluent as current seasonal influenza vaccines. In 2009, all seasonal and pandemic influenza vaccines in the United States will be produced from egg cultures; none contain an adjuvant. As a result, this 2009 H1N1 influenza vaccine has the same precautions and contraindications as the current seasonal influenza vaccine and has been approved for use by the U.S. Food and Drug Administration using the same criteria as for seasonal influenza vaccine.
More testing has been done for the 2009 H1N1 vaccine than is usually done for seasonal influenza vaccine. This testing has been to determine the proper administration intervals relative to seasonal influenza vaccine administration and immunogenicity.
The Vaccine Adverse Event Reporting System (VAERS) is the primary system to collect and analyze voluntary reports of adverse events following receipt of 2009 H1N1 monovalent vaccine. VAERS is a national program that monitors the safety of vaccines after they are licensed. VAERS is managed by the U.S. Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA).
Influenza vaccines prevent infection, serious illnesses and death in persons who receive them. Despite this clear benefit, anyone who receives flu vaccine should still be informed about both the benefits and risks of vaccination. Each year, after an influenza vaccine is licensed, VAERS has been used as one way to monitor the “adverse events” that happen after influenza vaccination.
Guillain-Barré Syndrome (GBS), an autoimmune disease in which the body damages its own nerves to cause muscle weakness and paralysis, has been reported as a possible complication of influenza, influenza-like illness due to other viruses, and influenza vaccine. The risk of GBS after influenza vaccine is estimated to be only 0.1 per 100,000 vaccine doses. For comparison, the incidence of GBS after influenza-like illness is more than 10 times greater than GBS after influenza vaccine and the overall risk of death due to influenza-specific illness is 120 per 100,000 infections.
Since 1990, VAERS has been used to continuously monitor the occurrence of GBS following receipt of influenza vaccine. CDC’s Advisory Committee on Immunization Practices has reviewed these data and has stated that the potential benefits in preventing serious illness and death greatly outweigh the risk of developing GBS related to flu vaccine.
In addition to VAERS, several other adverse event monitoring systems have been established (http://www.cdc.gov/h1n1flu/vaccination/vaccine_safety_qa.htm).
Despite this history of safety, because no vaccine (or medicine) is completely free of risk, adverse events are possible and should be monitored. Some of these adverse events are so rare that, even with careful studies before licensing, adverse events may not be found until a vaccine is given to millions of people.
Adverse events following receipt of a licensed vaccine should be reported through VAERS. Patients, parents, vaccine manufacturers, health care providers and others can submit a report. FDA and CDC encourage anybody who experiences any problems after vaccination to provide a VAERS report. Healthcare providers are required by law to report certain problems such as an adverse event listed by the vaccine manufacturer as a contraindication to receiving further doses of the vaccine or as a specific severe reaction associated with a particular vaccine.
By continual monitoring, VAERS helps to make sure that the benefits of vaccines are far greater than the risks. However, VAERS is unable to determine whether a vaccine actually caused a reported adverse event. Sometimes people who are vaccinated get sick from another reason unrelated to the vaccine. Despite this limitation, the reports to VAERS give FDA and CDC important information that might signal a problem with a vaccine. In some cases FDA and CDC investigate the reports further.
CDC has packaged influenza vaccination cards that will be sent to vaccine providers at the same time 2009 H1N1 monovalent vaccine is distributed. CDC encourages the use of these cards throughout the country. All vaccine and healthcare providers, the vaccinee, and other partners should be aware of the important information included on them.
These cards contain space to document influenza vaccination location, date, vaccine type, lot number and dose. The cards will also be pre-populated with key information regarding an adverse event and how to report clinically significant adverse events to VAERS.
The cards are intended to be given to the vaccinee (or parent or caregiver) when they receive their first 2009 H1N1 monovalent vaccination. They should be kept by the vaccinee for one year after they receive their last influenza vaccine in the 2009-10 season.
It is very easy to report to VAERS ( http://vaers.hhs.gov/esub/index#fax ).
Online: You can report on-line at https://secure.vaers.org
Reporting forms: Report forms are available for printing at www.vaers.hhs.gov/resources/vaers_form.pdf or by calling the VAERS information line at 1-800-822-7967 (9:00 a.m. to 5:00 p.m. Eastern time Monday through Friday)
Fax: Completed report forms can be faxed to 1-877-721-0366 or
Mail: Completed report forms can be mailed to:VAERS
P.O. Box 1100
Rockville, MD, 20849After you submit a form, VAERS staff may contact you for additional information.
Below is a facsimile of both sides of the Vaccine Adverse Event Reporting System (“VAERS”) form.
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