Vaccines FAQs- I have heard a number of conflicting reports regarding increased safety concerns about vaccine inoculation. In light of the recent safety reports, why should my child be vaccinated?
- Under the National Childhood Vaccine Injury Act (NCVIA), are health care providers and vaccine manufacturers required to report adverse events following the administration of vaccines?
- Why don't we give parents a choice in deciding if they want to vaccinate their children?
- What is Human Papillomavirus (HPV)?
- How is Gardasil administered?
- Gardasil is a recombinant vaccine. What is a recombinant vaccine?
- What was the concern in the Republic of Ireland about polio vaccine and vCJD?
- Can males use Gardasil?
- What has FDA done to address the issue of mercury containing preservatives in vaccines?
- If I receive FluMist, is it possible that I will get the flu from the vaccine?
- Where can I find a list of FDA licensed vaccines?
- Can the expiration date of a vaccine be extended?
- Are all events reported to VAERS caused by vaccinations?
- In addition to the data available on the approved product labeling, how do I obtain adverse event information regarding the vaccine my child received?
- Is it possible to become infected with HPV from Gardasil?
- What does "monovalent" mean?
- Which bovine derived materials are used in vaccine manufacture?
- Why is the definition of "event" defined as any "adverse event?"
- Does FDA make vaccination recommendations?
- FDA's 6/30/2006 warning letter to Sanofi Pasteur identifies several issues noted during a March 2005 inspection that were not corrected prior to the 2006 inspection. Why didn't FDA issue a Warning Letter for these issues in 2005?
- What events should be reported to VAERS?
- When should Gardasil be given?
- What is thimerosal?
- Is there a site that I can search for adverse events that have been reported with vaccines?
- How do I find out if a vaccine adverse event has been reported to VAERS?
- Why did FDA issue a warning letter to Sanofi Pasteur on 6/30/2006?
- What adverse reactions can occur after vaccination with Dryvax?
- When did FDA license Gardasil?
- I understand that the Institute of Medicine (IOM) has reviewed the issue of thimerosal in vaccines. What were the IOM's findings?
- Do the issues outlined in the 6/30/2006 warning letter affect Sanofi Pasteur's efforts to develop an avian (H5N1) influenza vaccine?
- Does Gardasil contain thimerosal?
- What is FluMist approved for?
- What is VAERS?
- How well does the FluMist vaccine work?
- Does FluMist contain thimerosal?
- What is meant by lot release for vaccines and what are the steps involved?
- Why is exposure to mercury a concern?
- Are there certain people who should not receive FluMist?
- Why are animal products used in the manufacture of vaccines?
- Are other smallpox vaccines available?
- What is being done about the thimerosal content of other vaccines and other biological products given to infants, children, and pregnant women?
- Can migratory birds bring highly pathogenic avian influenza (HPAI) H5N1 to North America?
- What does CDC do when someone wants to exempt out of vaccinations?
- Does Gardasil protect against all HPVs?
- If a female already has a disease related to HPV types 6, 11, 16 or 18, will Gardasil help treat it?
- Why did FDA wait until mandated by Congress under FDAMA 1997 to examine the use of preservatives containing mercury?
- How did the FDA discover that some vaccine manufacturers are not universally following letters, Points to Consider (PTC) and guidance documents on sourcing of bovine materials?
- What is the chance or possibility that some vaccines on the market in the US may be contaminated with the BSE agent?
- If vaccines are safe and manufacturers of injectable medicinal products were implementing guidance regarding the sourcing of bovine materials, why did the UK recall their polio vaccine?
- What is being done to ensure the United States' vaccine supply is safe from BSE causing materials?
- What is sterility testing for vaccines?
- Are there any possible adverse reactions associated with the use of Gardasil?
- Since the flu shot is recommended for many people over the age of 49, why isn't FluMist recommended for individuals 50 years of age and older?
- How are VAERS reports analyzed?
- What if I can't tell if a reaction was caused by a vaccine or another medication - should I report to VAERS?
- Are other Sanofi Pasteur manufacturing facilities included in the 6/30/2006 warning letter?
- Can information reported to VAERS cause a recall of a vaccine?
- Is VAERS involved in the Vaccine Injury Compensation Program?
- Who should not be immunized with Gardasil?
- What is smallpox?
- What vaccines are licensed for vaccination against smallpox?
- What is the indication for Dryvax vaccine?
- What is known about the efficacy of Dryvax?
- How does the smallpox vaccine work and why does it cause all these side effects?
- When did FDA learn of Sanofi Pasteur's sterility failues as referenced in the 6/30/2006 warning letter?
- What are the contraindications to vaccination with Dryvax (who should not normally receive the vaccine)?
- What does "trivalent" mean?
- Does FDA's 6/30/2006 warning letter mean that that Sanofi Pasteur's flu vaccine was contaminated?
- What does Gardasil protect against?
- How can I report a serious side effect with Gardasil, or other vaccines, to FDA?
- What are preservatives and why are they added to vaccines?
- What progress has been made towards the goal of eliminating thimerosal from vaccines?
- Is it safe for children to receive an influenza vaccine that contains thimerosal?
- Is it safe for pregnant women to receive an influenza vaccine that contains thimerosal?
- Could anyone in Europe diagnosed with the newly recognized variant of CJD (vCJD) have acquired this from vaccines?
- Who can report to VAERS?
- How many doses of FluMist are recommended per season?
- Can I get the flu from the inactivated influenza vaccine?
- What is the best time of year to receive the flu vaccine?
- Will I need to receive a flu vaccine every year?
- If I would like to obtain additional information about influenza and the vaccine, where can I find it?
- What is FDA doing now to assure that vaccine companies follow guidance, letters, and PTC documents on sourcing of bovine materials?
- What does the vaccination site look like after vaccination with Dryvax?
- When will vaccine manufacturers finish replacing cow-derived materials in vaccines with materials obtained from countries free of BSE?
- What are the contraindications for immunization during a smallpox emergency or following possible exposure to smallpox?
- What are the most common side affects of FluMist?
- Why are children continuing to be vaccinated with a vaccine that may be contaminated with BSE causing materials?
- Why should I report to VAERS?
- Is there more recent information regarding the use of Dryvax?
- What steps did the agency take after Sanofi notified FDA of sterility failures (6/30/2006 warning letter)?
- Are bovine derived materials from North America used in the manufacture of vaccines?
- Are Pap tests still needed even though Gardasil is approved?
- Do all bovine materials, including those used in the manufacture of vaccines, have the same risk of transmitting the BSE agent?
- Have there been vaccines produced using cow materials from countries where there is a significant risk of BSE?
- How common is HPV infection?
- How did FDA derive its risk estimates and decide the risk of vCJD from vaccines was remote and theoretical?
- How does FDA evaluate vaccines to make sure they are safe?
- My child was just immunized. Should I be worried about the risk of contamination of the BSE agent in my child's vaccine?
- Shouldn't all vaccine potentially contaminated with the BSE agent be destroyed?
- What is the difference between live attenuated influenza virus (LAIV) and the flu shot that is made from inactivated viruses?
- What is the expected availability of influenza vaccines for the 2006-2007 flu season?
- What is the risk of getting vCJD if a vaccine contained the BSE agent?
- What measures have the FDA taken to ensure that people are not exposed to the BSE agent in vaccines?
- Why are some vaccines noted to be "thimerosal-free" while some are "thimerosal-reduced"? What is the difference between "thimerosal-free" and "preservative-free"?
- Why did FDA leave on the market vaccines that did not follow its own recommendations regarding sourcing of bovine derived materials?
- Will Gardasil help a female who already has a vaccine type HPV?
Last revised: March 29, 2007 | 
