Table 3.
Product information of the three influenza vaccines available in Australia for pregnant women in 2017 and 2019
| Influenza vaccines available in Australia (2017) extracts from product information |
Influenza vaccines available in (2019) extracts from product information | |
|---|---|---|
| Afluria Quad (Seqirus) QIIV Non-adjuvanted |
Use in pregnancy: Category B2 The safety and effectiveness of Afluria Quad™ vaccine has not been established in pregnant women. Therefore careful consideration should be made regarding the benefits and risks prior to administration of Afluria Quad™ vaccine to pregnant women who are pregnant or plan to become pregnant. |
Use in pregnancy: Category A Influenza vaccination is recommended for pregnant women during any stage of pregnancy. This recommendation is based on the known adverse consequences of influenza infection during pregnancy and the large body of data showing that large numbers of women have been vaccinated during pregnancy with inactivated influenza vaccines with no increased risk of adverse fetal or maternal outcomes attributable to the vaccine. Afluria® Quad vaccine should be given to a pregnant woman following an assessment of the risks and benefits. |
| FluQuadri (Sanofi-Aventis) QIIV Non-adjuvanted |
Use in Pregnancy: Category B1 Data from worldwide use of inactivated influenza vaccines in pregnant women and experience of use of TIV in countries where inactivated influenza vaccines are recommended in all stages of pregnancy do not indicate any adverse fetal and maternal outcomes attributable to the vaccine. FluQuadri should be given to a pregnant woman following an assessment of the risks and benefits. Health authorities recommend vaccination of pregnant women. |
Use in Pregnancy: Category A Data from studies involving large numbers of women (> 80,000) vaccinated during pregnancy with inactivated influenza vaccines do not indicate any adverse fetal and maternal outcomes attributable to the vaccine. FluQuadri should be given to a pregnant woman following an assessment of the risks and benefits. Because of the known adverse consequences of influenza infection in pregnant women, health authorities recommend vaccination of pregnant women. |
| Fluarix Tetra (GSK) QIIV Non-adjuvanted |
Use in Pregnancy: Category B1 The safety of Fluarix Tetra when administered to pregnant women has not been evaluated. A reproductive and developmental toxicity study in which female rats were administered Fluarix Tetra by IM injection (0.2 mL dose per rat, approximately 80x the human dose on the basis of bodyweight) twice prior to mating, four times during gestation, and once on lactation day 7, showed no adverse effects on female fertility, pregnancy, parturition, lactation, and embryofoetal and pre-weaning development. Vaccine antigen-specific antibodies were detected in fetuses and pups of treated rats. Fluarix Tetra should be used during pregnancy only when clearly needed, and when the possible advantages outweigh the potential risks for the mother or fetus. |
Unchanged at the time of publication |