The H1N1 Primer for Pregnant Women
by Maryl Smith
© 2009 Midwifery Today, Inc. All rights reserved.
I am thinking about getting the immunization. Is the H1N1 shot safe and effective?
"...One way to investigate safety is to read the actual vaccine label or package insert that is provided to your physician. One company states [brackets mine] that the vaccine has not "been evaluated for carcinogenic or mutogenic potential, or for impairment of fertility....
...Concerning administration to pregnant women, the insert reads: "Pregnancy: Animal reproduction studies have not been conducted with Influenza A (H1N1) 2009 monovalent vaccine. It is also not known whether these vaccines can cause fetal harm when administered to pregnant women or can affect reproduction capacity. Influenza A (H1N1) 2009 monovalent vaccine should be given to a pregnant woman only if clearly needed." Based upon that statement, one would typically view administration of the H1N1 vaccine to pregnant women as an "off-label" use…except for the tiny loophole-comment tagged on the end....
...Public health experts said that there's no way to know if any rare side effects will occur in the new vaccine until millions of people are vaccinated. Those unknowns certainly can make an expectant mom concerned about being able to make an informed choice. Reports are beginning to come in from around the world of vaccine side effects ranging from rashes and rare muscle-weakness disorders to anaphylactic shock and death. The percentage of vaccinated people who experience severe complications has yet to be calculated.
Just recently, web postings have been starting to accumulate from women who have suffered miscarriage 1–4 days after receiving the H1N1 vaccine in the first and early second trimesters of pregnancy. There is not enough clinical data available to know if this is coincidental or causal, but the numbers of postings are growing and may eventually generate further investigation."