Dla wytrwałych – dłuższy tekst w języku angielskim demistyfikujący “swalenową” teorię pochodzenia tzw. Syndromu Zatokowego:

http://www.fda.gov/ohrms/DOCKETS/dockets/80n0208/80n-0208-c000037-15-01-...

Warto też pamiętać, że (WHO):

Over 22 million doses of squalene-containing flu vaccine have been administered. The absence of significant vaccine-related adverse events following this number of doses suggests that squalene in vaccines has no significant risk. This vaccine has been given primarily to older age groups. As this vaccine and new squalene-containing vaccines are introduced in other age groups, postmarketing follow-up to detect any vaccine-related adverse events will need to be performed.
The WHO reports that AS03 has been evaluated in 45,000 people. An integrated summary of safety from 15,400 people with a 6-month follow up suggests an increase in local reactogenicity, (injection site pain, swelling, redness etc) but no increase in immune-mediated events above background rates.

I takie głównie są proporcje “kontrowersyjności”:

Argumenty za adiuwantem swalenowym:

22 miliony szczepień bez statystycznego związku powikłań z obecnością skwalenowego adiuwanta oraz badania kliniczne na 45 tys. ludzi, przy czym ponad 15 tysięcy było pod obserwacją sześciomiesięczną.

Argumenty przeciw:

Pojedyncze przypadki odnotowane przez pojedyncze ośrodki bez żadnego statystycznego znaczenia.

W przypadku adiuwantów glinowych sytuacja ma się jeszcze bardziej beznadziejnie dla zwolenników tezy o ich szkodliwości. Tutaj statystyki szczepień idą w setki milionów a badań klinicznych monitorujących działanie różnych szczepionek, w których stosowano tego typu adiuwanty – po prostu setki.

I znowu – krytycy mają do pokazania wyłacznie pojedyncze przypadki w rodzaju 67 letniej kobiety, która zeszła na Alzheimera i w patologicznych zmianach mózgowych wykryto duże ilości aluminium (co wg innych badań są po prostu typowe dla Alzheimera).

Badać trzeba, ale trzeba też umieć zachowywać rezerwę wobec słowa “kontrowersyjny” !

I na koniec poważne opracowanie z wiarygodnego pisma Molecules (27 stron) w języku angielskim:

Squalene Emulsions for Parenteral Vaccine and Drug Delivery
Christopher B. Fox
Infectious Disease Research Institute, 1124 Columbia St, Ste 400, Seattle, WA 98104, USA;

http://www.mdpi.com/1420-3049/14/9/3286/pdf

Opracowanie wyczerpująco uzasadnia dlaczego stosuje się skwalen w szczepionkach oraz informuje na temat różnych formulacji w poszczególnych szczepionkach. Jest też osobny dział na temat bezpieczeństwa, z którego zaczerpnąłem ten cytat:

Perhaps the strongest case for the safety of squalene in a vaccine setting is the well documented safety record of MF59®, which has been reviewed elsewhere [63]. Approximately 27 million doses of MF59® have been injected into humans of all age groups (including infants) with little or no adverse side effects.
It has been licensed for use in 20 countries as a component of Fluad® influenza vaccine (the first licensed adjuvant since aluminum). MF59® has also been tested in many preclinical animal models which showed low severity inflammation and other minor, reversible
reactogenicity, but was not genotoxic, teratogenic, or sensitization-inducing. Clinical data, mostly from Fluad® trials and postmarket analysis, show a low/acceptable incidence rate of adverse events incident with MF59® injection, the most common complaint being pain at injection site.
A controversial claim regarding the safety of squalene concerns allegations that the The Gulf War Syndrome (GWS) is typified by high squalene antibodies in anthrax vaccine recipients [103,134-137]. However, these claims were regarded as inconclusive based on several reasons, including the use of an unvalidated assay, lack of proper controls, small sample sizes, and the fact that the vaccine was found to contain no squalene [132,138-140]. A validated, quantitative squalene antibody assay was developed and used to show that anthrax or MF59® vaccination recipients did not have higher levels of IgG or IgM squalene antibodies and that squalene antibodies occur naturally in humans [63,141-145].
There are studies regarding some oils, including squalene, that have been found to induce autoimmunity indications when 500 µL of the pure oil was injected intraperitoneally in mice [144,146], or 200 µL of pure oil intradermally in rats [147], or that neural damage in rats was induced after 20g/kg squalene per day for 4 days [148]. Similarly, one report suggested that excessive intake of oral squalene tablets caused lipoid pneumonia in a human patient [149]. Of course, all of these reports involve excessive amounts of non-emulsified squalene and so their relevance for administration of minute amounts of emulsified squalene such as would be injected in a vaccine is questionable.
In summary, there is significant evidence that squalene vaccine emulsions such as MF59® have an excellent safety record. Any indication of squalene toxicity at low doses is inconclusive.