The U.S. Food and Drug Administration has announced that it is investigating the fluzone vaccine after data from the Vaccine Adverse Events Reporting System (VAERS) showed that a higher number of children up to the age of two have suffered febrile seizures after the shot.
This comes after Australia suspended the child flu vaccine program after a record number of children were taken to the ER suffering fits and one child, 2-year-old Ashlee Epapara, died the morning after her shot, despite being previously healthy. Her twin sister also suffered fever and vomiting after the shot.
Ashlee’s father said “We don't know much about what happened at this stage, but it seems too much of a coincidence for a healthy girl, after having this vaccine, to just pass away. It is shocking."
Although the vaccine is recommended for all U.S. people aged 6 months and up, the fluzone vaccine is different from previous years. It contains H1N1 flu, a strain not added until 2009-2010. This particular strain has not been tested on children. The safety information that manufacturers and the government have relates to the 2003-2004 version of the vaccine, which did not contain H1N1. Even the testing of the regular fluzone flu vaccine only involved 31 children, a number too small to determine safety.
The most recent product information sheet, dated July 2010, says:
"The 2003-2004 formulation of Fluzone vaccine was studied in 19 children 6 to 23 months of age and in 12 children 24 to 36 months of age, given in 2 doses one month apart. Local reactions and systemic events were solicited for 3 days after each dose. Most local and systemic reactions were mild. The proportions of local and systemic reactions in children were similar to the proportions in adults. No reported local or systemic reaction required a therapeutic intervention other than analgesics."
In addition to this, the vaccine has been recommended for pregnant women, yet it hasn’t been tested on pregnant women and hasn’t even been tested on animals. The data sheet goes on to say:
"Animal reproduction studies have not been conducted with Fluzone vaccine. It is also not known whether Fluzone vaccine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Fluzone vaccine should be given to a pregnant woman only if clearly needed."
Therefore when the FDA said the benefits to a pregnant woman outweigh the risks, they really have no evidence for that assumption because they have not done the studies that show the vaccine is safe, and even admit "As with many other vaccine products, the manufacturers did not conduct clinical studies specifically to evaluate the influenza vaccines in pregnant women prior to approval of these vaccines."
They go on to say that this is why they put a warning about it in the product information. But is it really acceptable to give an experimental drug to vulnerable groups of the population on a mass scale just because they printed a written warning?
Recent evidence has shown that vaccines are capable of crossing the placenta. In a study published in Archives of Pediatrics and Adolescent Medicine found that unborn babies received vaccine antibodies after their mothers had a shot. But if the antibodies can cross the placenta, what about the vaccine ingredients? What if the actual vaccine viruses could cross the placenta too?
Veterinarians have already recognized that this can happen if a pregnant animal is vaccinated, as one veterinary group wrote:
"Live feline panleucopenia virus vaccine can cross the placenta and may cause abortion or developmental abnormalities in fetuses if it is administered to a pregnant cat."
The flu shot is not approved for infants under six months, so if it’s not suitable for them, why would it be suitable for an unborn baby to receive via his mother?
Apart from the total lack of clinical studies, the Crochrane Review found that influenza vaccines were not very effective at reducing clinical influenza in adults or the number of working days lost:
"Twenty five reports of studies involving 59,566 people were included. The recommended live aerosol vaccines reduced the number of cases of serologically confirmed influenza by 48% (95% confidence interval (CI) 24% to 64%), whilst recommended inactivated parenteral vaccines had a vaccine efficacy of 70% (95% CI 56% to 80%). The yearly recommended vaccines had low effectiveness against clinical influenza cases: 15%(95% CI 8% to 21%) and 25% (95% CI 13% to 35%) respectively. Overall the percentage of participants experiencing clinical influenza decreased by 6%. Use of the vaccine significantly reduced time off work but only by 0.16 days for each influenza episode (95% CI 0.04 to 0.29 days); Analysis of vaccines matching the circulating strain gave higher estimates of efficacy, whilst inclusion of all other vaccines reduced the efficacy.
REVIEWERS' CONCLUSIONS: Influenza vaccines are effective in reducing serologically confirmed cases of influenza. However, they are not as effective in reducing cases of clinical influenza and number of working days lost. Universal immunisation of healthy adults is not supported by the results of this review."
The American Thoracic Society also reported in 2009 that children who received the flu shot were hospitalized for flu-like illnesses and respiratory disease at a rate three times higher than children who hadn’t received it. The risk for asthmatic children was even greater.
The FDA and other medical bodies need to have concrete safety and efficacy data on the use of influenza vaccines in pregnant women, babies and children before they recommend them and they should at the very least ensure they have been tested in those groups before they give them out on a large scale.
Sources: http://www.scribd.com/doc/25341129/Fluzone%C2%AE-Package-Insert-injectable-sanofi-pasteur
FDA: Questions about Vaccines - http://www.fda.gov/BiologicsBloodVaccines/Vaccines/QuestionsaboutVaccines/ucm188099.htm
http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/ucm240037.htm
International Business Times, 25th April 2010 - http://www.ibtimes.com/contents/20100425/flu-vaccine-flu-shots-ashlee-epapara.htm
My Local Health Guide, December 20th 2010 - http://mylocalhealthguide.com/flu-shot-protects-mom-and-baby/
Pro Vet Vaccine Information - http://www.provet.co.uk/petfacts/healthtips/Vaccinations.htm
Cochrane Database Syst Rev. 2004;(3):CD001269 - http://www.ncbi.nlm.nih.gov/sites/entrez?db=pubmed&uid=15266445&cmd=showdetailview&indexed=google
American Thoracic Society (2009, May 20). Children Who Get Flu Vaccine Have Three Times Risk Of Hospitalization For Flu, Study Suggests - http://www.sciencedaily.com/releases/2009/05/090519172045.htm
Joanna is a freelance health writer for The Mother magazine and Suite 101 with a column on infertility, http://infertility.suite101.com/. She is author of the book, 'Breast Milk: A Natural Immunisation,' and co-author of an educational resource on disabled parenting, in addition to running a charity for people damaged by vaccines or medical mistakes.
‘