Vaccine safety


Influenza vaccine is very safe in pregnant women.

The robust safety profile of multiple inactivated influenza vaccine preparations over many decades, and the potential complications of influenza disease during pregnancy, support the WHO recommendations that pregnant women should be vaccinated against influenza [15]. As with most live-virus vaccines, live attenuated influenza vaccines are not currently indicated for use in pregnant women.

Seasonal influenza vaccines do not usually contain adjuvants, although some newer influenza vaccine formulations may have novel adjuvants that increase the immune response. Among these are oil in water microemulsions such as MF59 and ASO3. Evaluation of the reproductive and developmental toxicity of MF59 alone and of a candidate MF59-adjuvanted H5N1 vaccine in animals demonstrated no evidence of teratogenicity or impact on fetal or early perinatal development. The utilization of MF59 adjuvanted vaccines during the 2009 H1N1 influenza pandemic allowed for the evaluation of their safety and efficacy in different populations, including pregnant women. However, decreased immunogenicity responses have been reported in previously naive pregnant women when compared to non-pregnant women. Therefore, inactivated vaccines with novel adjuvants considered for pregnant women may need to be considered and evaluated individually given their recent introduction. The Global Advisory Committee on Vaccine Safety issues regularly recommendations on the use of these novel vaccines.


The WHO Global Advisory Committee on Vaccine Safety (GACVS) report on Safety of immunization during pregnancy presents an overview of relevant safety data found in the literature on the use of influenza vaccine in pregnant women.

The Global manual on surveillance of adverse events following immunization provides guidance on setting up surveillance systems for adverse events following immunization (AEFI) with standardized methodologies and tools.

Information sheets on observed rate of vaccine reactions of influenza vaccine provide details found in the literature on rates of vaccine reactions in pregnant women.

No adverse reactions have been reported from co-administration with other vaccines given during pregnancy, such as for tetanus.


Which of the following statements are true about the safety of influenza vaccine for pregnant women and their babies? Mark all that are true.

A. Influenza vaccine is perfectly safe for pregnant women and their babies.
B. Influenza vaccine during pregnancy is associated with minor or very rare adverse vaccine reactions.
C. Live influenza vaccines should not be given to pregnant women.
D. Co-administering influenza vaccine and tetanus vaccine during pregnancy has been associated with adverse vaccine reactions.


Answers B and C are correct.