WASHINGTON, D.C., Feb. 11, 2019—In response to a Freedom of Information Act (FOIA) lawsuit, the FDA has admitted, for the first time, that government agencies, including the CDC, are recommending vaccines for pregnant women that have neither been licensed for pregnant mothers by FDA nor tested for safety in clinical trials. The lawsuit, filed by Children’s Health Defense (CHD) attorney, Robert F. Kennedy, Jr. on behalf of Informed Consent Action Network (ICAN), a vaccine safety advocacy group, sought all clinical trial data used by FDA to approve influenza vaccines for pregnant women. The FDA’s terse reply: “We have no records responsive to your requests.”
The manufacturers of flu and Tdap vaccines warn against their use for pregnant mothers since their safety has never been established. Package inserts state that it is “not known” whether the vaccines “will harm an unborn baby” and there are “insufficient data” on use in pregnant women to inform vaccine-associated risks. FDA regulations strictly prohibit pharmaceutical companies from marketing products for “off-license” uses. Noncompliant companies are routinely prosecuted criminally and civilly, paying billions in lawsuits and settlements.
The CDC nevertheless has actively recommended influenza vaccination during any trimester of pregnancy since 2004 and has told pregnant women to get Tdap shots (for tetanus, diphtheria and pertussis) since 2011. The FDA is responsible for vaccine safety and licensing, but, in the just-released court documents, it admits that it has no safety data to back up the CDC’s “off-license” pregnancy recommendations. FDA’s website states that it has never formally approved any vaccines “specifically for use during pregnancy to protect the infant.”
CDC data show that women who received certain flu shots from 2010 to 2012 had a 7.7 times greater risk of miscarriage than women who did not receive those vaccines. CDC published the study in Vaccine but omitted those findings from its press release, leaving pregnant women ignorant of the vaccines’ true risks. CHD’s Chairman Robert F. Kennedy, Jr. notes that most flu shots given to pregnant women still contain a mercury-based preservative thimerosal. Thimerosal is acknowledged by Proposition 65 in California as a reproductive toxicant and exposure during pregnancy can cause learning and behavioral problems. Tdap contains aluminum, which FDA regulates as a toxin in parenteral nutrition but not in vaccines.FDA Admits That Government Is Recommending Untested, Unlicensed Vaccines for Pregnant Women • Children’s Health Defense