New Adjuvanted Vaccines in Pregnancy: What is Known About Their Safety?

Carla Herberts; Barbro Melgert; Jan Willem van der Laan; Marijke Faas

Expert Rev Vaccines. 2010;9(12):1411-1422.

Five-year View

In the coming years, epidemiological data on the safety of recently introduced vaccines will become available, especially for the H1N1 vaccine (the first analyses from the pregnancy registries that have been set up during the recent pandemic influenza mass vaccination campaigns are expected in early 2011). It is extremely important to use these data to increase our knowledge on the safety of adjuvanted vaccines during pregnancy. It will provide valuable information needed to estimate the risk of the use of such adjuvanted vaccines during pregnancy. This will aid the benefit–risk evaluation and may change the recommendations on the use of these vaccines during pregnancy. In addition to these clinical data, it is also important to perform animal studies on the safety of the adjuvanted vaccines, with special attention to the effects of primary vaccination and early pregnancy. We hope that the discussion on the safety of the use of adjuvanted vaccines may change the design of nonclinical reproductive toxicity testing of vaccines. We anticipate that more knowledge on the mechanisms of action of adjuvants, and of their effects on the Th1/Th2 balance in particular, will become available. This might also increase the confidence in the estimation of the risk of the use of adjuvanted vaccines during pregnancy. Moreover, more fundamental research on the function of the immune system in establishing and maintaining a successful pregnancy is ongoing, which will lead to a better understanding of the immunological paradox of pregnancy.

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Financial & competing interests disclosure
The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.
No writing assistance was utilized in the production of this manuscript.

Cite this: New Adjuvanted Vaccines in Pregnancy: What is Known About Their Safety? - Medscape - Dec 01, 2010.

Table 1. Overview of adjuvants that are part of EU-registered vaccines.
Adjuvant	Composition	Vaccine	Antigen
AS03	Squalene, DL-α-tocopherol and polysorbate 80	Pandemrix® (GSK Biologicals, Rixensart, Belgium) Prepandrix® (GSK Biologicals) Arepanrix® (GSK Biologicals)	Influenza Influenza Influenza
MF59	Squalene, polysorbate 80 and sorbitan triolate	Fluad® (Chiron Vaccines, Siena, Italy) Aflunov®/Focetria® (Novartis, Siena, Italy)	Influenza Influenza
AS04	MPL and aluminium hydroxide/phosphate	Cervarix® (GSK Biologicals) FENDrix® (GSK Biologicals)	HPV Hepatitis B
AF03	Squalene, sorbitan oleate, polyethylene cetostearyl ether and mannitol	Humenza® (Sanofi Pasteur SA, Lyon, France)	Influenza
Aluminium	Aluminium hydroxide or aluminium phosphate or aluminium hydroxyphosphate sulfate	Ambirix® (GSK Biologicals) Daronrix® (GSK Biologicals) Fluarix® GSK Biologicals) Gardasil® (Sanofi Pasteur MSD, Lyon, France)/Silgard®(Merck Sharp & Dohme Ltd., Hertfordshire, UK) HBvaxPRO® (Sanofi Pasteur MSD) Hexavac® (Sanofi Pasteur MSD) Infanrix® hexa (GSK Biologicals) Infanrix® penta (GSK Biologicals) Synflorix® (GSK Biologicals)	Hepatitis A and hepatitis B Influenza Influenza HPV Hepatitis B Diphtheria, tetanus, pertussis, hepatitis B, polio virus, Haemophilus influenzae type b Diphtheria, tetanus, pertussis, hepatitis B, polio virus, Haemophilus influenzae type b Diphtheria, tetanus, pertussis, hepatitis B, polio virus Pneumococcal polysaccharide

GSK: GlaxoSmithKline; HPV: Human papillomavirus.
All registered vaccines in this table can be found at [209].

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