What You Need to Know
The objective of this page is to distill the facts that we at PDSA feel will be most useful to those with ITP and other platelet disorders and provide references for additional research. Because there is new information on this topic published daily, we will update this page as more is known. For advice on your unique medical condition, please consult a health care professional.H1N1 vaccine priorities
One of the most important and difficult questions is when or if to get the H1N1 vaccine. The Centers for Disease Control (CDC) suggests the following people receive the H1N1 flu vaccine before anyone else: people from ages 25 through 64 years who are at higher risk for novel H1N1 because of chronic health disorders or compromised immune systems, persons between the ages of six months through 24 years of age, and pregnant women. (1) (see Note 1)
Facts about the vaccines
The H1N1 vaccine is a special vaccine to counteract the H1N1 (swine flu) virus, made in the same manner as the usual annual flu vaccine. In addition to this special vaccine, companies will continue to offer their annual flu vaccine. These are not to be mixed. (2)
On September 15, 2009, the FDA approved the H1N1 vaccines made by four companies, injectable vaccines from CSL Biotherapies, Novartis and Sanofi Pasteur, plus a nasal vaccine from MedImmune. (8) There are many similarities between the injectable vaccines and some significant differences between the injectables and the nasal vaccine.
The injectable vaccines come in several formulations. In general, the injectables are packaged in preservative-free, pre-filled syringes or multi-dose vials that contain the preservative thimerosal, a mercury derivative (see Note 2). (3) (4) (5) The injectable vaccines contain deactivated (dead) viruses.
The FDA approvals are based on prior clinical trials. The results of these trials may be different from the new H1N1 vaccine. In the past, each company has tested their vaccines on different age groups. In total, there have been clinical tests for the injectables on people from six months of age to seniors. Sanofi is the only company that offers a half dose (in pink) for children less than three years of age. (3) (4) (5)
The nasal (nose spray) vaccine contains a live virus, which can also infect immune compromised people in contact with the person receiving this type of vaccine. The nasal vaccine is only approved for people from 2 to 49 years of age. (6)
The H1N1 vaccine may not protect all individuals from getting this flu. (3) (4) (5) (6)
Special vaccine considerations for the immune compromised or immune suppressed
Immunocompromised persons or those on immunosuppressive therapy may have a diminished immune response to the vaccine. (3) (4) (5)
“It is important to carefully assess the risk before giving the live virus to immune compromised individuals. Safety has not been established in individuals with underlying medical conditions predisposing them to wild-type influenza infection complications.” (6)
The CDC recommends that splenectomized individuals get a pneumococcal vaccination to help prevent pneumonia that may be secondary to H1N1. (7)
Warnings and side effects
(Since the new H1N1 flu vaccine has not been tested in large numbers of people nor has had much time to be monitored for longer term effects, the FDA’s warnings list is based on information from prior flu vaccine studies)
Transient thrombocytopenia and vasculitis have been reported. (3) (4) (5)
Usual side-effects include tenderness, pain, or swelling at the injection site.
The H1N1 vaccine is not recommended for people who are allergic to eggs or chicken protein, neomycin (active ingredient in Neosporin), or polymyxin (a type of antibiotic). (3) (4) (5)
The H1N1 vaccine is not recommended for anyone who has had a life-threatening reaction to previous influenza vaccination. (3) (4) (5)
If Guillain-Barré Syndrome has occurred within 6 weeks of previous influenza vaccination, it is important to weigh the risks and benefits of the vaccine. (3) (4) (5)
The live nasal vaccine should not be administered to anyone with asthma, wheezing, or children younger than five with recurrent wheezing. (6)
In addition to egg allergies, the live nasal vaccine should not be administered to those with allergies to gentamicin (a type of antibiotic), gelatin, or arginine (an amino acid). (6)
Medical advisor advice
The PDSA medical advisors suggest those with ITP, especially splenectomized individuals, receive the H1N1 vaccine. There may be some exceptions depending on individual medical situations.
Vaccine critics’ concerns – use of adjuvants
Adjuvants are boosters added to vaccines to make them more potent. When the H1N1 vaccines were developed, it was unclear whether they would require adjuvants to prompt immunity against H1N1. Some clinical trials concerning the use of adjuvants are available (15), others are on-going. (10)
The MF59 adjuvant has been know to affect macrophages and cell death. (11). Adjuvants may also affect autoimmunity. (12)(13)
The CDC states that “It is unlikely H1N1 vaccine will be adjuvanted. Definitive information will be available once clinical trial data are available. [If the vaccine is adjuvanted] formulation will vary by provider. For Novartis, vaccine may be preformulated with adjuvant. For CSL, GSK and Sanofi Pasteur, mixing of vaccine and adjuvant at the site of administration will be necessary. Specific information on storage requirements and procedures for mixing vaccine and adjuvant will be provided by CDC. MedImmune vaccine will not be adjuvanted.” (14)
Preventing the flu
Here are some tips to help prevent the flu or contain the infection.
- Cover your nose and mouth with a tissue when you cough or sneeze. Throw the tissue in the trash after you use it. If a tissue is not available, cough or sneeze into your elbow.
- Avoid touching your eyes, nose or mouth.
- Try to avoid close contact with sick people.
- Wash your hands often with soap and water, especially after you cough or sneeze. Alcohol-based hand cleaners are also effective.
- If you are sick, stay home for seven days after your symptoms begin or until you have been symptom-free for 24 hours, whichever is longer. This is to keep from infecting others and spreading the virus further.
- Follow public health advice regarding school closures, avoiding crowds and other social distancing measures.
- If you must have close contact with a sick person (for example, hold a sick infant), try to wear a facemask or N95 disposable respirator. (9)
- Stay as healthy as possible by eating vitamin-rich foods, getting regular exercise, reducing stress,and getting sufficient sleep.
Additional H1N1 Resources
American Society of Hematology
Journal Watch / New England Journal of Medicine
National Library of Medicine/PubMed
National Vaccine Information Center
Notes
Note 1: The safety and efficacy of the H1N1 vaccines have not been studied in pregnant women. It is also not known whether these vaccines can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 2009 Monovalent Vaccine should be given to a pregnant woman only if clearly needed. (3) (4) (5)
Note 2: “Since 2001, no new vaccine licensed by FDA for use in children has contained thimerosal as a preservative, and all vaccines routinely recommended by CDC for children under six years of age have been thimerosal-free, or contain only trace amounts, except for some formulations of influenza vaccine. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5819a1.htm
References
(1) http://www.cdc.gov/media/pressrel/2009/r090729b.htm
(2) http://www.fda.gov/BiologicsBloodVaccines/Vaccines/QuestionsaboutVaccines/ucm182335.htm
(3) http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM182401.pdf (CSL package insert)
(4) http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM182242.pdf (Novartis package insert)
(5) http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM182404.pdf (Sanofi Pasteur package insert)
(6) http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM182406.pdf (MedImmune package insert)
(7) http://www.cdc.gov/h1n1flu/guidance/ppsv_h1n1.htm
(8) http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm182399.htm
(9) http://www.flu.gov/individualfamily/prevention/index.html
(10) http://med.stanford.edu/ism/2009/august/flu-trial.html
(11) http://www3.interscience.wiley.com/journal/85513637/abstract
(12) http://www.ncbi.nlm.nih.gov/pubmed/14718649
(13) Matsumoto, Gary. Vaccine A: The Covert Government Experiment That's Killing Our Soldiers--And Why GI's Are Only The First Victims
(14) http://www.cdc.gov/h1n1flu/vaccination/statelocal/qa.htm
