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FDA Prepares to Fast Track New Vaccines Targeting Pregnant Women

Posted: 11/17/2015 5:30:38 PM | with 22 comments

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

Pregnancy Health ConcernsBirth 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

Epidemiology and Public HealthThis maternal vaccination policy is a violation of the precautionary principle to “first, do no harm,” 16   and it is of grave concern to women having babies in America, especially pregnant health care workers. When federal vaccine use recommendations are being turned into laws that punish Americans refusing to obey them with denial of a school education, medical care and employment, 17   18  maintaining high FDA vaccine licensing standards is absolutely essential.

There have been no well designed prospective, long term case controlled studies enrolling large groups of American women who get influenza and Tdap vaccines during pregnancy and comparing their health and the viability of their fetuses and newborns to women who do not get vaccinated. There are no published studies to identify unresolved vaccine-induced inflammation in the brains and bodies of the fetus, mother and newborn; or to measure atypical changes in brain and immune function and chromosomal integrity, including evaluating the numbers of de novo mutations present before and occurring after vaccination.

Maternal vaccination policy has preceded vaccine safety science. Now, there are proposals on the table here in this Committee and in the 21st Century Cures Act backed by FDA and industry to lower FDA licensing standards to ensure that vaccine Vaccine safety science is necessarypolicy can continue to precede vaccine safety science in the future. 19   Considerable discussion today about making a priori assumptions that complications and fetal death following maternal vaccination are only coincidentally and not causally related to vaccination 20   is a big red flag for vaccine consumers in the absence of credible pathological evidence to conclusively determine what is and is not vaccine induced.

The National Vaccine Information Center is opposed to FDA retroactively licensing influenza and Tdap vaccines for use in pregnant women and fast tracking RSV 21   and group strep B 22   vaccines to licensure by using small clinical trials; adaptive trial designs; Baysian methods of data analysis; biomarkers and surrogate endpoint measures rather than actual clinical endpoints; or using clinical experience instead of good bench science and randomized controlled clinical trials with long term follow-up to prove effectiveness and safety.

The fact that vaccine manufacturers, regulators, policymakers and providers are completely shielded from civil liability for vaccine injuries and deaths 23   makes it even more important for FDA standards for proof of vaccine safety and effectiveness to be very high, especially when licensing vaccines targeting pregnant women and their unborn babies.

Posted: 11/17/2015 5:30:38 PM | with 22 comments


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