vaccines.gov

Question 1

vaccine

Answer 1

prepares your body to fight the disease faster and more effectively so you won’t get stick, is made from very small amounts of weak or dead germs that can cause disease

Question 2

vaccination

Answer 2

the act of getting a vaccine, usually as a shot

Question 3

immunization

Answer 3

the process of becoming immune to (protected against) a disease

Question 4

How are vaccines tested for safety?

Answer 4

vaccines go through years of safety testing:

• testing and evaluation of the vaccine before it’s licensed by the FDA and recommended for use by the CDC
• monitoring the vaccine’s safety after it is recommened for infants, children, or adults

Question 5

clinical trail for vaccines

Answer 5

volunteers (start with 20-100) agree to get vaccinated, tests take several years and end with thousands of volunteers, answers questions like:

• is the vaccine safe?
• what dose (amount) works best?
• how does the immune system react to it?

Question 6

the company that makes the vaccine test each batch to ensure:

Answer 6

• Potent (It works like it’s supposed to)
• Pure (Certain ingredients used during production have been removed)
• Sterile (It doesn’t have any outside germs)

Question 7

what happens once the vaccine is released to the public?

Answer 7

Once a vaccine is licensed and recommended for use, FDA, CDC, and other federal agencies continue to monitor its safety.

Question 8

what are the different parts of the vaccine monitoring system?

Answer 8

• Vaccine adverse events reporting system (VAERS)
• The Vaccine Safety Datalink (VSD)
• Post-licensure Rapid immunization safety monitoring system (PRISM)
• Clinical immunization safety assessment project (CISA)
• the Department of Defense and the V.A.
• CDC and FDA

Question 9

Vaccine adverse events reporting system

Answer 9

-an early warning system managed by CDC and FDA that is designed to find possible vaccine safety issues. Patients, health care professionals, vaccine companies, and others can use VAERS to report side effects that happen after a patient received a vaccine. Some side effects might be related to vaccination while others might be a coincidence (happen by chance). VAERS helps track unusual or unexpected patterns of reporting that could mean there’s a possible vaccine safety issue that needs further evaluation.

Question 10

The Vaccine safety datalink

Answer 10

• a collaboration between CDC and several health care organizations across the nation. VSD uses databases of medical records to track vaccine safety and do research in large populations. By using medical records instead of self-reports, VSD can quickly study and compare data to find out if reported side effects are linked to a vaccine.

Question 11

Post-licensure Rapid immunization safety monitoring system

Answer 11

-is part of the Sentinel Initiative, which is FDA’s national system for monitoring medical products after they’re licensed for use. PRISM focuses on vaccine safety — it uses a database of health insurance claims to identify and evaluate possible safety issues for licensed vaccines.

Question 12

Clinical immunization safety assessment project (CISA)

Answer 12

-CISA is a collaboration between CDC and a national network of vaccine safety experts from medical research centers. CISA does clinical vaccine safety research and — at the request of providers — evaluates complex cases of possible vaccine side effects in specific patients.