Registry for CELTURA® vaccine during pregnancy.
Vaccines against influenza A (H1N1) virus
Available data
CELTURA® is a vaccine directed against the pandemic H1N1 flu virus (containing surface antigens, inactivated, and the adjuvant MF59). Unlike both other vaccines available on the Swiss market (PANDEMRIX® and FOCETRIA®), which contain viral particles obtained using ovalbumine (egg) matrix, this vaccine is obtained though cell culture using a more recent technology. Inactivated viral particles have no infectious potential, and no embryo-fetal infection is to be feared from influenza A H1N1 vaccination during pregnancy.
There are no published data on women exposed to the Influenza A H1N1 vaccine during pregnancy. However, data are numerous and reassuring regarding the seasonal flu vaccine, independent of the age of pregnancy at time of vaccination. These vaccines are relatively similar to those used for influenza A H1N1 flu, except for the adjuvant. It can be noted that adjuvants have been used for decades in other vaccines and are considered safe (not considered dangerous?) in pregnancy. Pre-clinical trials in several animal species have not shown the viral particles or adjuvants to be teratogenic or foetotoxic.
For these reasons, it is possible, and even advisable, to vaccinate pregnant women against the influenza A H1N1 virus, preferably from the second trimester. Pregnant women are indeed considered among those groups presenting an increased risk of developing complications of this pandemic flu, probably because of diminished natural immune defenses characteristic of late pregnancy. However, data of exposures of pregnant women to vaccines against the influenza H1N1 vaccine are still scarce. While registries are being set up in foreign countries for PANDEMRIX® and FOCETRIA®, none has yet been established for CELTURA®, whose market is limited to a few countries. This has determined the Swiss authorities (Swissmedic) to require opening a registry for exposures to CELTURA® during pregnancy. This mandate was entrusted to the STIS.
In order to improve yet our knowledge concerning this vaccine, it is therefore encouraged that prescribers notify all exposures, including those without noticeable adverse events or complications.
Notification of exposure to CELTURA® without complication in pregnant women
CELTURA® pregnancy registry 
In the current influenza A H1N1 flu pandemic situation, the STIS in collaboration with Swissmedic has set up a Swiss pregnancy registry of exposures to CELTURA®, aimed to improve our knowledge regarding this vaccine, and confirm the safety of its use in pregnant women though a significant number of observations.
What is the aim of the CELTURA® pregnancy registry?
Currently, available data are very scarce for the use if this vaccine in pregnancy. This prospective survey, conducted on a voluntary basis, is aimed to collect, assess and report on the course and outcome of pregnancies exposed to CELTURA®.
Why should I include my patient in this registry?
Participation in this registry will contribute to acquire relevant safety data concerning the use of CELTURA® during pregnancy. The information collected will help in answering questions from healthcare professionals and in counseling future patients regarding the use of these drugs during pregnancy to the best of our knowledge.
How can I participate in this pregnancy registry? Notifications of exposure to CELTURA® can be sent to us at any stage of pregnancy, including cases were the antiviral treatment was prescribed prior to awareness of pregnancy.
We invite you to notify all cases of exposure to CELTURA® in pregnant women by downloading and filling out the form intended for the notification of drug exposure in pregnancy. The form is to be sent by post mail, fax or e-mail to:
Swiss Teratogen Inforamation Service STIS
Division de pharmacologie et toxicologie cliniques
Hôpital de Beaumont 6ème étage
1011 Lausanne CHUV
Fax : 021.314.42.67
Information requested under each heading of this form is necessary to determine whether the pregnancy outcome might bare any relation with vaccine exposure. It is notably essential for us to receive information regarding:
- Name and address of the notifying healthcare professional, to complete information concerning the course of pregnancy, its outcome, as well as fetal and neonatal health status.
- At least the initials and birth date of the mother, which will allow for identification and gathering of follow-up data at the expected time of delivery.
- Patient co-morbidities and co-medications
Please pay attention to the confidentiality clause, inform the patient of her inclusion and make sure of her approval.
Upon receiving your notification, we will address you a follow-up form which will allow us to collect information concerning the course of the pregnancy, delivery and neonatal health status. We would be grateful if you return this form at the time of delivery or of any other pregnancy outcome.
Notification of adverse events during pregnancy
According to the legislation, healthcare professionals are required to notify clinically relevant adverse events occurring in patients taking CELTURA®. This is done using the form intended for notification of suspected drug adverse events elaborated by Swissmedic. This form can be downloaded from the Swissmedic internet site (www.swissmedic.ch) or can be found annexed to the Swiss Physician’s Desk Reference (Compendium Suisse des Medicaments).
In the case of an adverse event occurring in a pregnant woman, we invite you to send this form by post mail, fax or e-mail to:
Swiss Teratogen Information Service STIS
Division de pharmacologie et toxicologie cliniques
Hôpital de Beaumont 6ème étage
1011 Lausanne CHUV
Fax: 021.314.42.66