FDA Admits to Recommending Untested Vaccines to Pregnant Women



Quinn Summerville, Reporter

In response to a Freedom of Information Act (FOIA) lawsuit, the FDA has admitted 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, which was filed by Children’s Health Defense (CHD) attorney, Robert F. Kennedy, Jr. on behalf of Informed Consent Action Network(ICAN), a safety group, sought all clinical trial data used by FDA to approve influenza vaccines for pregnant women. The FDA had a shocking reply: “We have no records responsive to your requests.”

The CHD Requested the records of any clinical trials on the vaccines from the FDA, specifically asking for “A copy of the report for each clinical trial relied upon by the FDA when approving for use by pregnant women any influenza vaccine currently approved by the FDA.”

The FDA, in response, revealed that they, “have no records responsive to your requests.”

The manufacturers of flu and Tdap vaccines warn against their use for pregnant mothers due to the lack of evidence of safety. Package inserts state that it is “not known” whether the vaccines “will harm an unborn baby” and there is “insufficient data” to inform vaccine-associated risks to pregnant women. FDA regulations strictly prohibit pharmaceutical companies from marketing products for “off-license” uses.Companies that do not take the safety measures are routinely charged and pay billions in court.The CDC nevertheless has actively recommended influenza vaccination during any trimester of pregnancy since 2004 and has repeatedly recommended women to get Tdap shots (for tetanus, diphtheria and pertussis) since 2011. The FDA is responsible for all vaccine safety and licensing, but, in the just-released court documents, it admits that it has no safety data whatsoever to back up the pregnancy recommendations. FDA’s own website states that it hasn’t ever formally approved any vaccines “specifically for use during pregnancy to protect the infant.”

The FDA’s admission that CDC is recommending untested and unlicensed vaccines follows another disclosure forced by an ICAN/CHD lawsuit. The Department of Health and Human Services confessed that it has not once complied—with statutory requirements for regular review of childhood vaccine safety, nor reported to Congress on measures to improve safety in 30 years.