Influenza

HOA! Just finished reading the “prestigious” Infectious Diseases in Children publication tagged as “The Pediatrician’s No. 1 News source.”
Lead article: Influenza Vaccine ‘Desperately’ Needs improvement
Quotes like, “We wish it were better,” from CDC Director Thomas R Frieden, MD, MPH and “This is a vaccine that desperately needs to be redone,” by Michael T. Osterholm, PhD, MPH , director of the Center for Infectious Disease Research and Policy were included. You seek they know it is not very effective. Last years the CDC numbers were given as 47% effective, and the year previous was a whopping 23% effectiveness. Just think about this. Apply these numbers to anything you do that is important to you. Say, your computer only worked 23% of the time, or your car managed to start 47% of the time. Crazy. And you would buy this product and have it injected into your body, to your children’s body, how about pregnant moms at their 28 week check-up?

Ok, so from the package insert regarding pregnancy:
ALURIA influenza vaccine
334 8.1 Pregnancy
Pregnancy Category B: A reproductive and developmental toxicity study has been performed in female rats at a dose approximately 265 times the human dose (on a mg/kg basis) and revealed no evidence of impaired female fertility or harm to the fetus due to AFLURIA. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, AFLURIA should be given to a pregnant woman only if clearly needed.
Then as an medical experiment on human beings, let’s give it to a bunch of pregnant women and monitor outcomes, to see if this is a good thing or not.
51 Pregnancy exposure and safety surveillance
352 An exposure and surveillance study which monitors pregnancy outcomes in women exposed to
353 AFLURIA during pregnancy has been established. Women who are vaccinated with
354 AFLURIA during pregnancy should be encouraged to contact the pregnancy study center by
355 calling 1-877-311-8972 or visit the website http://www.pregnancystudies.org.

How about these warnings and precautions?

————————WARNINGS AND PRECAUTIONS————————-
Administration of CSL’s 2010 Southern Hemisphere influenza vaccine was associated with increased rates of fever and febrile seizures in children predominantly below the age of 5 years as compared to previous years. Febrile events were also observed in children 5 through 8 years of age. (5.1)
If Guillain-Barré Syndrome (GBS) has occurred within 6 weeks of previous influenza vaccination, the decision to give AFLURIA should be based on careful consideration of the potential benefits and risks. (5.2)
Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine. (5.3)
Immunocompromised persons may have a diminished immune response to AFLURIA. (5.4)

Maybe I am just picking on one vaccine manufacturer, let’s see what Fluarix has to say:
—————- WARNINGS AND PRECAUTIONS —————-
• If Guillain-Barré syndrome has occurred within 6 weeks of receipt of a prior influenza vaccine, the decision to give FLUARIX should be based on potential benefits and risks. (5.1)
• Syncope (fainting) can occur in association with administration of injectable vaccines, including FLUARIX. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope. (5.2)

——————— USE IN SPECIFIC POPULATIONS —————-
• Safety and effectiveness of FLUARIX have not been established in pregnant women or nursing mothers. (8.1, 8.3)
• Register women who receive FLUARIX while pregnant in the pregnancy registry by calling 1-888-452-9622. (8.1)
• In a clinical trial of children younger than 3 years, antibody titers were lower after FLUARIX than after an active comparator. (8.4)
• Geriatric Use: Antibody responses were lower in geriatric subjects who received FLUARIX than in younger subjects. (8.5)
So once again it is time to make an informed decision whether to receive this vaccination for ourselves, our children, and even our parents. What say you?