Table 2.

Influenza vaccine manufacturers, vaccines, sales revenue and package insert wording.

Company	Vaccine	Estimated sales	Package insert information on pregnancy	PI Year
Abbott	Influvac	$188 million	Inactivated influenza vaccines can be used in all stages of pregnancy. Larger datasets on safety are available for the second and third trimester, compared with the first trimester; however, data from worldwide use of influenza vaccine do not indicate any adverse foetal and maternal outcomes attributable to the vaccine	2014/15
AstraZeneca	FluMist	$162 million	… no evidence of impaired fertility or harm to the fetus due to FluMist Quadrivalent. There are however, no adequate and well controlled studies in pregnant women. Because animal studies are not always predictive of human response FluMist Quadrivalent should be administered during pregnancy only if clearly needed	2014/15
GlaxoSmithKline	FluLaval/Fluviral	$375 million	…no evidence of impaired female fertility or harm to the fetus due to FLULAVAL QUADRIVALENT. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, FLULAVAL QUADRIVALENT should be given to a pregnant woman only if clearly needed	2014/15
Johnson & Johnson	Inflexal V	$35 million	Limited data from flu vaccinations in pregnant women do not indicate that the vaccine would have harmful effects on the pregnancy or the baby. The use of this vaccine may be considered from the second trimester of pregnancy. For pregnant women with medical conditions that increase their risk of complications from the flu, administration of the vaccine is recommended, irrespective of their stage of pregnancy	2011/12
Laboratorios Farmacéuticos ROVI	Levrison	$3 million	No info found
Mitsubishi Tanabe Pharma	BIKEN HA	$108 million	No info found
Novartis	OptaFlu	$71 million &	In general data from influenza vaccinations in pregnant women do not indicate adverse foetal and maternal outcomes attributable to the vaccine. Animal studies do not indicate reproductive toxicity. The use of Optaflu may be considered from the second trimester of pregnancy. For pregnant women with medical conditions that increase their risk of complications from influenza, administration of the vaccine is recommended, irrespective of their stage of pregnancy	2014/15
Novartis	Fluvirin	$359 million	No evidence of impaired fertility or harm to the fetus due to FLUVIRIN®. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this vaccine should be used during pregnancy only if clearly needed	2014/15
Sanofi	Fluzone (sold as Vaxigrip outside the US)	$1.343 billion	Animal reproduction studies have not been conducted with Fluzone. It is also not known whether Fluzone can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Fluzone should be given to a pregnant woman only if clearly needed	2014/15
Sinovac Giotech	Anflu	$10 million	This product is forbidden to use for the groups below: (3) Women during pregnancy	2010