Smallpox vaccine Pregnancy and Breastfeeding Warnings
Smallpox vaccine Pregnancy Warnings
A National Smallpox Vaccine in Pregnancy Registry has been established by the Centers for Disease Control, Food and Drug Administration, and Department of Defense to collect reports of exposure to vaccine during pregnancy. As of April 2003, there have been 103 reports of inadvertent exposure. Of 6 women who were exposed to vaccine during pregnancy or conceived within 4 weeks after vaccination, two had miscarriages. Two pregnant women had close contacts who were recently vaccinated; however, neither had symptoms of vaccinia exposure.
Smallpox vaccine has been assigned to pregnancy category C by the FDA. Animal studies have not been reported. The vaccine is not known to be teratogenic. Vaccinia virus may very rarely cause fetal infections after vaccination, resulting in stillbirth or neonatal death. Less than 50 cases of fetal vaccinia have been reported. In a nonemergency situation, pregnant women or women who may become pregnant within 4 weeks of vaccination, who have not been exposed to smallpox, should not be routinely vaccinated until after delivery. Close contacts of pregnant women (household or sexual contacts) should also not be routinely vaccinated. However, the vaccine should be administered to pregnant women who have been exposed to smallpox. There are no contraindications to receiving the vaccine in case of an outbreak emergency. Because the risk of maternal serious illness or death, prematurity, miscarriage, or stillbirth from a smallpox infection are greater than the risk of the vaccination, smallpox vaccine is recommended and should be offered to pregnant women in case of an outbreak emergency.
Smallpox vaccine Breastfeeding Warnings
There are no data on the excretion of smallpox vaccine antigens or antibodies into human milk. The vaccine is not recommended for lactating mothers in nonemergency situations.
Tertiary contact vaccinia has been reported in a breast-feeding infant of a wife of a vaccinee (the father). The vaccinee had a normal primary reaction on days 6 to 8 after vaccination. The mother developed vesicles on both areolas approximately 2 weeks after her husband was vaccinated, but continued to breast-feed. The infant started developing lesions 25 days after the father's vaccination, which were confirmed to be contact vaccinia. The Centers for Disease Control and Prevention have stated that it is safe for a mother to breast-feed after a close household contact is vaccinated, as long as standard precautions to prevent contact spread (handwashing, vaccination site care) are followed.
- Smallpox Vaccine use while Breastfeeding (in more detail)
- smallpox vaccine Consumer Information
- Pregnancy Support Group
- FDA Pregnancy Categories
- Medicine use during Pregnancy
- Medicine use while Breastfeeding
- Safe Medications during Breastfeeding
Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and Drugs.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This drug information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information in contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.