Rigorous process ensures vaccine safety

EDITOR'S NOTE: This column appears in the Nevada Appeal Wednesday health pages throughout the flu season. Readers interested in knowing more about this topic are urged to visit www.cdc.gov/h1n1flu or www.flu.gov.

Q: Is the H1N1 vaccine really safe?

A: Dr. Anne Schuchat, Director at the Centers for Disease Control and Prevention (CDC) says, "Based on what I know, the risk of getting influenza or having a complication from influenza is much higher than any theoretical risk from the vaccine."

Let's take a look at the safety information that allows Dr. Schuchat to make this statement.

Within hours of the H1N1 vaccine being identified, the CDC began to create a seed strain to help vaccine production. Clinical trials began right away to investigate safety, whether the vaccine would induce a protective immune response, and what the correct dosage levels should be for various population groups. Vaccine safety data was collected in real time, sent to a central data base, and audited daily by a safety monitoring committee. After a couple of weeks, it was determined that that H1N1 vaccine was just like regular seasonal flu vaccine in terms of its ability to safely protect and also very similar in terms of side effects.

The 2009 H1N1 influenza vaccine shows a similar safety profile to seasonal flu vaccines, which have a very good safety track record, according to the CDC. During the years, millions of seasonal vaccines have been given, and also millions of H1N1 vaccinations have been given - and the most common side effects are mild, such as soreness, redness, tenderness or swelling at the shot site.

The CDC and the Food and Drug Administration (FDA) closely monitor for any signs that the vaccine is causing unexpected adverse events. They work with state and local health officials to investigate any unusual events. The purpose of vaccine safety monitoring is timely identification of "clinically significant adverse effects" following immunization that may be of public health concern. Adverse events following immunization may be coincidental (occurring around the same time but not related to vaccination) or caused by vaccination.

Two of the primary monitoring systems are the Vaccine Adverse Event Reporting System (VAERS) and the Vaccine Safety Datalink (VSD) Project. VAERS is a national program managed by the CDC and FDA to monitor the safety of all vaccines licensed in the United States. You can learn more about monitoring at http://vares.hhs.gov and www.cdc.gov search "VSD project." Additionally, CDC works with numerous partners including other federal agencies, state and local health departments, professional organizations, and academic institutions to actively follow individuals after vaccination to monitor for any potential adverse effects.

Questions about flu vaccine safety also result from vaccine recalls, or have been caused by the presence of additives in the vaccine. There were two H1N1 vaccine recalls in 2009, but these were not safety issues. Tests showed that some lots were not quite as strong over time as the manufacturers wanted them to be. Both recalls were "non-safety voluntary" recalls.

Adjuvants are agents sometimes added to vaccine to increase effectiveness. Only unadjuvanted vaccines are being used in the United States during the 2009 flu season. Some vaccine manufacturers are producing 2009 H1N1 influenza vaccine in single-dose units, which do not require the use of thimerosal, a preservative used to prevent potential contamination after a vial is opened.

"It's important to know," says Schuchat, "that not getting vaccinated also puts you at risk."

It is also important to know that it is not too late for an H1N1 vaccination. In Nevada, flu season typically peaks in February and lasts until May. See below for details on where you can get vaccinated soon.

CARSON CITY AREA H1N1 VACCINE CLINICS

WHAT: Carson City H1N1 vaccination clinic

WHERE: Carson City Health and Human Services, 900 East Long St.

HOURS: 8:30 a.m.-11:30 a.m. and 1 p.m.- 4:30 p.m. every Thursday (closed for lunch).

There is no charge for H1N1 vaccinations

WHAT: Douglas County H1N1 Vaccination Clinic

WHERE: Fire Station 7, 940 Mitch Drive, Gardnerville Ranchos

HOURS: 9 a.m.-1 p.m., Saturday, Feb. 6.

There is no charge for H1N1 vaccinations

• Pam Graber is the public information officer at Carson City Health and Human Services.