EYE ON THE HILL
FDA Prepares to Fast Track New Vaccines
Targeting Pregnant Women
Vaccine manufacturers and federal health officials want to fast track to licensure new experimental vaccines targeting pregnant women with the goal of preventing certain kinds of infections in newborn infants. On Nov. 13, 2015, the FDA Vaccines & Related Biological Products Advisory Committee (VRBPAC) convened a one day public meeting at the FDA headquarters in Silver Spring, MD to discuss proposed changes to FDA requirements for licensure of vaccines intended for use during pregnancy.
NVIC representatives attending the FDA meeting were Vicky Pebsworth, PhD, RN, who served as the consumer member on the vaccine advisory committee, and NVIC president Barbara Loe Fisher and Marco Caceres, Managing Editor of NVIC’s bi-weekly journal,The Vaccine Reaction. The rest of those attending the meeting were primarily government and pharmaceutical industry employees.
Why Close Barn Door After Horse is Out?
During the meeting, Vicky Pebsworth pointed out that CDC officials have already told doctors to give pregnant women influenza and Tdap vaccines that were not specifically licensed for use during pregnancy and asked, “Why worry about closing the barn door once the horse is out?” She expressed opposition to FDA changing new maternal vaccine licensing standards, such as using surrogate endpoints, that “would lower the bar for proving effectiveness” and added, “No stone should be left unturned to make sure that health and safety and not harms come to these infants.”
Public Comment: Assuming Safety Without Proving It
Following is a verbal five-minute referenced public comment that Barbara Loe Fisher presented during the Nov. 13, 2015 meeting opposing fast track licensing of vaccines for pregnant women:
“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. 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.
In 2006, CDC officials directed doctors to give all pregnant women a flu shot and, in 2011, a Tdap shot during every pregnancy, no matter how little time has elapsed between pregnancies. 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.
Categorized by FDA as Pregnancy Category B and C biologicals 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. It is a policy that assumes maternal vaccination is necessary, safe and effective without proving it…”