H1N1 Vaccine Unsafe For Pregnant Women And Children?
By Katherine Smith As you may know, the Ministry of Health is starting an A/H1N1 ("swine flu") influenza vaccination campaign in February. According to the Sunday Star Times, the targets of this campaign will be health professionals, pregnant women "and all children aged from six months to five years enrolled in GP practices in poorer areas or with high proportions of Maori or Pacific Islanders".
I am taking the time to write to you about this vaccination campaign because I have serious concerns about the safety of the A/H1N1 influenza vaccines, especially for pregnant women and children.
Are H1N1 influenza vaccines safe for pregnant women?
If you are pregnant, or planning to become pregnant, you should be aware that according to information provided to the Ministry of Health by Baxter about its A/H1N1 influenza vaccine ("Celvapan") "The safety of CELVAPAN in pregnancy and lactation has not been assessed in clinical trials."
http://www.medsafe.govt.nz/profs/Datasheet/c/Celvapaninj.pdf
Women in North America who have been vaccinated against A/H1N1 influenza have reported foetal death and miscarriages following the shots.
http://preventdisease.com/news/09/110709_H1N1_vaccine_miscarriage_reports.shtml
http://www.theflucase.com/index.php?option=com_content&view=article&id=2593%3Ais-the-h1n1-swine-flu-vaccine-causing-miscarriages&catid=1%3Alatest-news&Itemid=64⟨=en
Are the A/H1N1 influenza vaccines safe for children?
Parents of young children who may be offered the A/H1N1 influenza vaccine should be aware that there is little information available about the safety of the A/H1N1 influenza vaccines for children.
The datasheet for Baxters A/H1N1 influenza vaccine ("Celvapan") states:
"From clinical studies limited safety data are available for Celvapan (H1N1) in healthy
adult and elderly subjects and in children." [emphasis added]
http://www.medsafe.govt.nz/profs/Datasheet/c/Celvapaninj.pdf (Page 1)
What's more, the datasheet states that for children and adolescents
"data are only available after the first dose at this time. "
http://www.medsafe.govt.nz/profs/Datasheet/c/Celvapaninj.pdf (Page 8 – The date on the last page of the datasheet is 28/1/10))
In fact, according to the Clinical Trials registry of the United States, Baxter is still recruiting participants aged "2 Months and older" into a study (NCT00950456) of their A/H1N1 influenza vaccine.
http://clinicaltrials.gov/ct2/show/NCT00950456?term=H1N1+influenza+vaccine+%2B+Baxter&rank=2
http://clinicaltrials.gov/ct2/show/NCT00976469?term=H1N1+influenza+vaccine+%2B+Baxter&rank=3
As you can see by clicking onto the link above for trial NCT0076469, most of the children in the study will receive two injections given three weeks apart, while a few will be given a third injection as a "booster". The children will be followed up for only one week after each injection to assess safety. Their immune response to the vaccine will also be studied. The estimated study completion date is May 2010.
If you click on the link below for trial NCT009080850 you will see another trial. Children in this study will be followed up for three weeks after each dose. It's a bit better than the trial discussed above, but certainly not long enough of a follow up period to see whether the vaccine causes any long term side effects. The estimated completion date for this trial is September 2010.
http://clinicaltrials.gov/ct2/show/NCT00980850?term=Baxter+%2B+H5N1+%2B+vaccine&rank=8
What's more, even though the registration of Baxter's A/H1N1 influenza vaccine was based on Baxter's A/H5N1 influenza vaccine (also called "Celvapan") it seems that the trials for this vaccine aren't yet complete either.
The trial NCT01052402 of the effects of the H5N1 influenza vaccine on infants, children and adolescents that you can view at the link below is still recruiting participants and won't be completed until August 2011!
http://clinicaltrials.gov/ct2/show/NCT01052402?term=Baxter+%2B+H5N1+%2B+vaccine&rank=9
In fact, as of this writing, Baxter hasn't even finished its Phase 3 trial of adults who have received the H5N1 influenza vaccine. The trials below won't be complete until February 2010 and November 2010 respectively.
See: http://www.clinicaltrials.gov/ct2/show/NCT00462215?term=Baxter+%2B+H5N1+%2B+Phase+III&rank=2
http://www.clinicaltrials.gov/ct2/show/NCT00711295?term=Baxter+%2B+H5N1+%2B+Phase+III&rank=1
What sorts of side effects can A/H1N1 influenza vaccines cause?
The potential side effects of Baxter's A/H1N1 influenza vaccine "Celvapan" may be read on the datasheet. Potential side effects of concern for Celvapan include sudden hearing loss, paresthesia, arthralgia (from H5N1 influenza vaccine trials) while post marketing surveillance of H1N1 influenza vaccine recipients included reports of convulsions, anaphylaxis and influenza-like illness, among other side effects, in vaccine vaccine recipients.
http://www.medsafe.govt.nz/profs/Datasheet/c/Celvapaninj.pdf
NB: If you are unfamiliar with medical terms, a medical dictionary can be accessed online at: http://www.nlm.nih.gov/medlineplus/mplusdictionary.html
Special concerns about Baxter's A/H1N1 influenza vaccine "Celvapan". Could it cause cancer?
Baxter's A/H1N1 influenza vaccine ("Celvapan") is produced in "Vero cells" which are derived from green monkey kidney tissue.
http://en.wikipedia.org/wiki/Vero_cell
Cell lines of this type have the potential to be contaminated with viruses such as Simian Virus 40 (SV40) a monkey virus of known oncogenic (tumour producing) potential. (For information about SV40 and cancer in humans please see: http://www.sv40foundation.org/Alexander.html
The Minister of Health responded to a request made under the Official Information Act (OIA) by stating that the Vero cell line used by Baxter has been tested and found to be free from SV40. However, he refused to release the documents necessary to prove this assertion. (This refusal is currently the subject of a complaint to the Ombudsman.)
Moreover, the Vero cell line used to culture the A/H1N1 influenza viruses for Baxter's "Celvapan" vaccine, is a neoplastic cell line. The FDA is currently investigating whether residual DNA from neoplastic cells (like Vero cells) used in vaccine manufacture can cause cancer in vaccine recipients.
http://www.fda.gov/BiologicsBloodVaccines/ScienceResearch/BiologicsResearchAreas/ucm127304.htm
The NZ Minister of Health is aware of this risk. However, he has no plans to cooperate "at this time" with the US FDA on research on this issue. According to the Minister, the Vero cells line used by Baxter in the production of "Celvapan" is one that minimises the possible cancer risk from the vaccine. However, he refused to release any of the documents to prove this assertion.
Moreover, he stated that the NZ Ministry of Health would not conduct independent testing of Baxter's A/H1N1 influenza vaccine prior to its use in New Zealand. Such testing could provide vaccine recipients with assurance that the vaccine is not contaminated with H5N1, SV40, any other adventitious microorganisms, oncogenic DNA fragments or any other inadvertent contaminants that could pose a health risk. In other words, The Ministry of Health is relying solely on information supplied by Baxter – which has a massive financial interest in its products – attesting to the safety and efficacy of "Celvapan".
Does the company that the Ministry of Health
chose as a supplier for A/H1N1 influenza vaccines
for New Zealand (Baxter International)
have a good safety record?
In 2008 Baxter produced and marketed contaminated Heparin which caused at least 4 deaths and made hundreds of other people ill.
http://www.medicalnewstoday.com/articles/99662.php
An investigation into this debacle found that Baxter was sourcing raw materials from an uncertified Chinese factory that had never been inspected by the Chinese drug regulators.
http://www.medicalnewstoday.com/articles/97598.php
In February 2009, Baxter distributed to sixteen labs in four different countries a bulk seasonal (H3N2) influenza vaccine product that was contaminated with live bird flu (H5N1) viruses. This could potentially have sparked a deadly H5N1 influenza pandemic, but fortunately staff in a Czech laboratory discovered the problem in time.
http://www.torontosun.com/news/canada/2009/02/27/8560781.html
The Czech Republic subsequently refused to enter into a contract with Baxter for A/H1N1 influenza vaccine as Baxter refused to guarantee the vaccine's safety nor take responsibility for compensating recipients who might suffer side effects from the vaccine's use.
http://www.ceskenoviny.cz/tema/zpravy/baxter-not-to-provide-anti-swine-flu-vaccine-to-czechs/391210
How well do influenza vaccines work to prevent illness?
Influenza vaccines have a long history of producing disappointing results in terms of preventing influenza or influenza like illness. A recent article published in the British Journal of Medicine stated that:
"In children under 2 years inactivated vaccines had the same field efficacy as placebo,8 and in healthy people under 65 vaccination did not affect hospital stay, time off work, or death from influenza and its complications.9"
The author also expressed surpise at the lack of safety studies:
"A Cochrane Database Systematic Review found only one old trial with data from 35 participants aged 12-28 months.8 In the general population of elderly people, despite a dataset of several million observations, safety was only reported in five randomised controlled trials (2963 observations in total) on local and systemic adverse events seen within a week of giving parenteral inactivated vaccine."
He recommended that in light of the evidence poor effectiveness of inactivated influenza vaccine, poor methodology of some studies and the surprisingly small amount of information relating to vaccine safety, that a "a re-evaluation [of influenza vaccination programmes] should be urgently undertaken."
http://www.bmj.com/cgi/content/full/333/7574/912
What lifestyle choices help reduce the incidence of influenza and its complications?
Good nutrition, getting enough sleep and keeping fit assist the immune system to function effectively. Avoiding alcohol – particularly heavy or binge drinking – is also important as consumption of large amounts of alcohol depresses your immune system.
Sufficient sun exposure to the skin – without wearing sunscreen – is necessary to synthesis sufficient vitamin D to keep your immune system functioning properly. (This is one of the reasons that flu is more prevalent in winter as the cold weather means people have to wear more clothing and can easily become vitamin D deficient.) If your lifestyle precludes sufficient time outdoors in the sun, it is a good idea to have a blood test to check your vitamin D status checked. (Estimates of how long it is necessary to spend outside in light clothing vary as it depends on the time of year, latitude and the colour of your skin, with people with dark skin requiring more sun exposure to synthesise vitamin D.) If necessary, to correct a deficiency, vitamin D3 supplements may be taken. (These are available in both over the counter formulations and on prescription.) Prescription vitamin D tablets of high potency need to be kept out of reach of children since they are toxic if taken in excessive dosages, such as might be taken by a young child who mistakes them for lollies.
http://en.wikipedia.org/wiki/Vitamin_D
http://en.wikipedia.org/wiki/Vitamin_D_and_influenza
http://www.usnews.com/health/family-health/articles/2008/06/23/time-in-the-sun-how-much-is-needed-for-vitamin-d.html
If you do get the flu, it is important to ensure good hydration and to rest. Vitamin C taken in high dosages (the bowel tolerance method works well) from the very start of the symptoms will usually prevent the disease from becoming serious. There are a few people who have genetic conditions such as glucose-6-dehydrogenase deficiency who cannot tolerate high doses of vitamin C. (There are blood tests that can be used to determine whether or not this rare genetic deficiency is present.) In a very serious case of influenza intravenous vitamin C may be needed.
http://orthomolecular.org/library/jom/1999/articles/1999-v14n03-p143.shtml
http://findarticles.com/p/articles/mi_m0ISW/is_258/ai_n8592742/
Herbal medicines can boost the immune system and help relieve symptoms. Some also have constituents that have direct antiviral activity.
NB: If you are pregnant or breastfeeding you should seek professional advice before taking high dosages of vitamin C or taking herbal medicines. You should also get professional advice if you have underlying health problems and/or are taking prescription drugs as some herbs and drugs can interact to cause adverse effects. Dr John McKenna's book "Natural Alternatives to Antibiotics" has useful information on the scientific basis of herbal medicine and is also a good guide to the wholistic treatment of infections. The link below gives traditional home remedies for cold and flu.
http://www.holisticonline.com/Remedies/Flu/cold_herbal-remedies-for-cold.htm
As a general rule medications like aspirin or paracetamol should not be taken to reduce fever since reducing the fever can reduce the efficiency of the immune response to the virus. (Aspirin should never be given to children since there is a risk of Reyes syndrome which is potentially fatal.)
A recent review of the use of antipyretics (fever-lowering drugs) stated:
"Antipyretics may be harmful
Immunity
Too many parents and health workers think that infection is bad, infection causes fever, and that therefore fever is bad. In fact, fever is often a beneficial host response to infection, and moderate fever improves immunity.11Therefore, it may not be a good idea to give drugs that reduce temperature to patients with severe infection. I have recently reviewed 1 the results of 9 controlled trials in mammals of the effect of paracetamol or aspirin on mortality or virus excretion. Four trials found that aspirin increased mortality in bacterial or viral infection. Viral shedding was increased by paracetamol or aspirin in 3 studies, possibly increased in one, and not affected in two (one used only pharyngeal washings, and one had only 9 subjects in the aspirin and placebo groups). One study found that antibody production was impaired by both paracetamol and aspirin, but no effect on antibody production was detected in the study with only 9 subjects in the aspirin and placebo groups. This evidence suggests that aspirin and paracetamol increase mortality in severe infection, and that they may prolong the infection and reduce the antibody response in mild disease." [Emphasis added]
http://www.australianprescriber.com/magazine/18/2/33/5/
NB: It is important to realise the paracetamol can be fatal in overdose and to keep all products containing paracetamol (especially the attractively flavoured syrups) out of reach of children.
Homoeopathy can also be a very useful treatment for the flu. Records from the 1918 influenza pandemic shows that patients treated with homoeopathic medicine were much more likely to survive than those treated with conventional medicine. Homoeopathic medicines are safe to take while pregnant and breast feeding.
http://www.nesh.com/main/nejh/samples/winston.html
(A new theory suggests that one of the reasons that the mortality rate was so high among conventionally treated patients during the 1918 influenza pandemic was due to doctors giving their patients excessive doses of aspirin.)
http://www.journals.uchicago.edu/doi/abs/10.1086/606060
I hope that this letter gives you some starting points for investigating the A/H1N1 influenza vaccine programme for yourself – or at least gives you some information to help you make a more informed decision about its use.
Yours sincerely,
Katherine Smith
PS: For an electronic copy of this letter with live links please email me at jon.boy@ihug.co.nz
Further information on the A/H1N1 influenza "pandemic" may be found at www.theflucase.com