Whether or not to have the swine flu vaccine is a difficult and ultimately personal decision. There is so much conflicting information out there, with health authorities assuring us that it is safe whilst others are claiming it is not. I have done a lot of research to help me reach my own decision, and hope that sharing this information will help others to make their own decisions. Please don't turn this into a debate about whether or not the vaccine is safe, as I just want to provide resources which may help others who will also have to make this difficult decision.
I have only looked into the Pandemrix vaccine, as that is the one that most pregnant women in the UK will be offered. All resources linked are primary sources and I have completely avoided both government and controversy sites to reduce any bias. Where squalene and thiomersal are concerned, I have selected a few of the best articles presenting both sides of the argument and included relevant quotes in some cases (apologies if the articles are rather scientific!). When doing your own research,
Wikipedia can be useful to give a basic explanation of terminology and
PubMed is very useful to search for scientific articles (remember to filter for "Links to free full text" or you may only be able to view the abstracts).
The Pandemrix Vaccine
Pandemrix is a pandemic influenza vaccine (split virion, inactivated, adjuvanted) produced by GlaxoSmithKline.
The three main parts making up the vaccine are the antigen, the adjuvant and the excipients. The main controversy surrounding swine flu vaccines concerns the adjuvant and the thiomersal excipient, so I will cover these specific aspects in more detail.
The antigen contains inactivated split influenza virus. The principle behind vaccination is that antigens cause the immune system to produce antibodies, which will then provide protection against that particular virus in the future.
Adjuvants and Squalene
The adjuvant stimulates the immune system and increases the response to a vaccine, meaning that the vaccine will take effect faster and less antigen is needed to produce the vaccine. Pandemrix uses the AS03 adjuvant containing squalene, DL-α-tocopherol and polysorbate 80.
Squalene is a chemical that occurs naturally in the human body. There has been some concern that squalene in vaccines may be linked to autoimmune disorders. Studies on mice and rats have shown that adjuvants containing squalene can cause disorders where the body produces antibodies that attack itself, such as lupus and arthritis. There is still little research about the effects on humans.
Vaccines with the MF59 adjuvant do not stimulate antibody responses against squalene Distinctive patterns of autoimmune response induced by different types of mineral oil Induction of lupus autoantibodies by adjuvants - abstract only. “The potential to induce autoimmunity may complicate the use of oil adjuvants in human and veterinary vaccines. “
Autoimmunity induced by adjuvant hydrocarbon oil components of vaccine - abstract only. “Whether this is relevant in human vaccination is a difficult issue due to the complex effects of vaccines and the fact that immunotoxicological effects vary depending on species, route, dose, and duration of administration. Nevertheless, the potential of adjuvant hydrocarbon oils to induce autoimmunity has implications in the use of oil adjuvants in human and veterinary vaccines as well as basic research.“
Thiomersal
The excipients are used to stabilise the active ingredients of the vaccine. Pandemrix contains polysorbate 80, octoxynol 10, thiomersal, sodium chloride, disodium hydrogen phosphate, potassium dihydrogen phosphate, potassium chloride, magnesium chloride and water.
Pandemrix contains 5 micrograms of thiomersal. Thiomersal contains ethylmercury, which is an organic compound of mercury. There is an established link between mercury exposure and impaired childhood cognitive development and early motor skills. However, the amount of thiomersal in the vaccine is small and no studies have documented any adverse effects beyond hypersensitivity reactions (products containing thiomersal are more likely to cause anaphylaxis and immune-complex-mediated disorders, but it is uncertain whether thiomersal is responsible for this). Thiomersal has been removed from many routine childhood vaccinations as a precautionary measure to help reduce total environmental exposure to mercury, but any risk remains purely theoretical.
Fish consumption, methylmercury and child neurodevelopment - worth scrolling down to read the section on vaccines and ethylmercury. "Overall, the highest-quality data available do not support conjectures that thimerosal may account for the recent increase in autism spectrum disorders or other adverse neurodevelopmental outcomes in children."
Thimerosal exposure in infants and deveoplental disorders: a prospective cohort study in the United Kingdom does not support a causal association Modeling neurodevelopment outcomes and ethylmercury exposure from thimerosal-containing vaccines - basically points out that the safety studies were done on 2 month old babies, whereas newborn babies (particularly low-birth weight babies) have immature excretory systems, meaning that mercury may not be eliminated as quickly and therefore is more likely to cross the blood-brain barrier, although still in very small quantities.
Other Useful Resources Medicines and Healthcare products Regulatory Agency - contains links to patient information leaflets and summary of product characteristics for both Celvapan and Pandemrix vaccines, along with weekly reports of all suspected side effects.