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FDA Prepares to Fast Track New Vaccines Targeting Pregnant Women

Rapier

Well-Known Member
V.I.P.
http://vaccineimpact.com/2015/fda-prepares-to-fast-track-new-vaccines-targeting-pregnant-women/
I don't want to impede the fast track for those who find the dangers of vaccines a trifle.
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
Tdap vaccine was licensed by FDA as a single dose pertussis booster shot in individuals over 10 or 11 years old, and pertussis containing vaccine injuries and deaths are the most compensated claim in the federal vaccine injury compensation program (VICP) for infants and children, while influenza vaccine-related injuries and deaths are the most compensated claim for adults. 14 And yet, in the absence of credible biological mechanism and epidemiologic evidence pre-licensure proving these vaccines are safe for all pregnant women, their fetuses and newborns, female health care workers are being fired for refusing to be injected with them while they are pregnant. 15
 
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