FDA Prepares to Fast Track New Vaccines Targeting Pregnant Women

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Health Impact News


vaccination-during-pregnancy

by Barbara Loe Fisher
National Vaccine Information Center

Following is a public comment made by Barbara Loe Fisher, NVIC Co-founder & President, at the Nov. 13, 2015 meeting of the FDA Vaccines & Related Biological Products Advisory Committee (VRBPAC) on proposed changes to FDA requirements for licensure of vaccines intended for use during pregnancy

Birth defects, chromosomal damage, premature birth, low birth weight, pregnancy complications and sudden infant death syndrome, not infectious diseases, are the leading causes of death for about 23,000 infants dying before their first birthday in the US every year, with half of those deaths occurring on the first day of life. 1   2  Women getting pregnant and delivering babies in America today have more than twice the risk of dying during pregnancy, childbirth or within one year of giving birth than they did three decades ago, with heart failure, high blood pressure and stroke, diabetes, and blood clots being among the leading causes of death. 3   4

In 2006, CDC officials directed doctors to give all pregnant women a flu shot 5  and, in 2011, a Tdap shot during every pregnancy, no matter how little time has elapsed between pregnancies. 6   Prior to FDA licensure, influenza, diphtheria, tetanus and pertussis vaccines were not tested in or proven safe and effective for pregnant women in large clinical trials when given during every pregnancy either singly or simultaneously. 7   8

Categorized by FDA as Pregnancy Category B and C biologicals 9   because it is not known whether the vaccines are genotoxic and can cause fetal harm or can affect maternal fertility and reproduction, administering influenza and Tdap vaccines to pregnant women is an off-label use of these vaccines. 10   11   12   It is a policy that assumes maternal vaccination is necessary, safe and effective without proving it. 13

 

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