Have you heard?
There is a new bombshell from anti-vaccine folks!
It turns out, they say, that the FDA has admitted that the government is recommending untested, unlicensed vaccines for pregnant women.
Is that true?
Did the FDA Admit That the Government Is Recommending Untested, Unlicensed Vaccines for Pregnant Women?
Of course not!
Their evidence?
A response to a Freedom of Information Act request for vaccines that don’t exist. That’s right, neither Tdap nor flu vaccines are currently FDA approved for use by pregnant women.
Of course, that doesn’t mean that Tdap and flu vaccines aren’t recommended for use by pregnant women.
Wait, why the difference?
Why are pregnant women being given a vaccine that isn’t formally FDA approved for their use?
Well, vaccine manufacturers have to seek FDA approval for their products. The FDA doesn’t just up and approve new products or give them new indications. And none have ever sought approval in pregnancy.
But that doesn’t keep health experts from making off-label recommendations, such as getting a flu vaccine when you are pregnant.
“In prelicensure evaluations, the safety of administering a booster dose of Tdap to pregnant women was not studied. Because information on use of Tdap in pregnant women was lacking, both manufacturers of Tdap established pregnancy registries to collect information and pregnancy outcomes from pregnant women vaccinated with Tdap. Data on the safety of administering Tdap to pregnant women are now available.”
Updated Recommendations for Use of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine (Tdap) in Pregnant Women and Persons Who Have or Anticipate Having Close Contact with an Infant Aged <12 Months — Advisory Committee on Immunization Practices (ACIP), 2011
As important as FDA approval is a recommendation from the Advisory Committee on Immunization Practices (ACIP). In fact, even after a vaccine gets approved by the FDA, it still has to get a recommendation from the ACIP before it gets on the immunization schedule and is used routinely!
“Flu shots have been given to millions of pregnant women over many years with a good safety record. There is a large body of scientific studies that supports the safety of flu vaccine in pregnant women and their babies.”
Flu Vaccine Safety and Pregnancy
Getting a flu vaccine during pregnancy is a recommendation that has been evolving since 1983. It was known to be safe then, and we are even more confident that it is safe now.
A Tdap shot has been recommended since 2011, although it was first suggested in 2008 that pregnancy was not a contraindication for receiving Tdap.
How do we know these vaccines are safe during pregnancy?
The Vaccine Safety Datalink has published more than 14 studies “related to pregnancy and vaccination during pregnancy” and has used “data to study the health of children born to women who were vaccinated during pregnancy.”
Despite what Robert F. Kennedy, Jr and his ironically named Children’s Health Defense organization might think, Tdap and flu shots in pregnancy have been well studied and have been found to be safe.
- First Trimester Influenza Vaccination and Risks for Major Structural Birth Defects in Offspring.
- Tdap Vaccination During Pregnancy and Microcephaly and Other Structural Birth Defects in Offspring.
- Risk of Preterm or Small-for-Gestational-Age Birth After Influenza Vaccination During Pregnancy: Caveats When Conducting Retrospective Observational Studies.
- Safety of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis and Influenza Vaccinations in Pregnancy.
- Receipt of pertussis vaccine during pregnancy across 7 Vaccine Safety Datalink sites.
- Safety of influenza vaccination during pregnancy: a review of subsequent maternal obstetric events and findings from two recent cohort studies.
- Vaccinations given during pregnancy, 2002-2009: a descriptive study.
- Predictors of seasonal influenza vaccination during pregnancy.
- Inactivated influenza vaccine during pregnancy and risks for adverse obstetric events.
- Assessing the safety of influenza immunization during pregnancy: the Vaccine Safety Datalink.
- Identifying pregnancy episodes, outcomes, and mother-infant pairs in the Vaccine Safety Datalink.
- Impact of maternal influenza vaccination during pregnancy on the incidence of acute respiratory illness visits among infants.
- Effectiveness of influenza vaccine during pregnancy in preventing hospitalizations and outpatient visits for respiratory illness in pregnant women and their infants.
- Trivalent inactivated influenza vaccine and spontaneous abortion.
- Maternal influenza vaccine and risks for preterm or small for gestational age birth.
- Adverse events in pregnant women following administration of trivalent inactivated influenza vaccine and live attenuated influenza vaccine in the Vaccine Adverse Event Reporting System, 1990-2009.
Ignoring all of the above studies, Kennedy highlights a few that he thinks found problems with flu shots in pregnancy, including one that showed “a suggestion of increased ASD risk among children whose mothers received an influenza vaccination in their first trimester,” a suggestion that was not statistically significant and which was not found in the other trimesters. And another that found an increased risk of spontaneous abortion in women who had also received a flu shot in the previous season, a safety signal that has never been seen before and which continues to be investigated.
Not surprisingly, his latest bombshell is landing with as big of a thud as his HHS lawsuit, as have most of his statements these days…
“CHD’s Chairman Robert F. Kennedy, Jr. notes that most flu shots given to pregnant women still contain a mercury-based preservative thimerosal.”
FDA Admits That Government Is Recommending Untested, Unlicensed Vaccines for Pregnant Women
Has Kennedy missed the fact that 80% of flu vaccines are now thimerosal free? It makes you wonder how he defines the word “most?”
“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
And what is he concerned about in thimerosal-free flu shots which also don’t contain aluminum? Are those okay in his book?
Mostly, after several flu seasons in which so many people have died, you have to wonder what his goal is here. Does Robert F. Kennedy, Jr. expect folks to skip getting a flu shot when they are pregnant and instead risk getting the flu? Should they skip their Tdap shot and risk their baby dying of whooping cough?
Or should they just stop listening to this type of anti-vaccine propaganda?
More on Did The FDA Admit That The Government Is Recommending Untested, Unlicensed Vaccines For Pregnant Women?
- VAXOPEDIA – How Does a Mother’s Flu Shot Protect a Newborn Baby?
- VAXOPEDIA – Vaccines in Pregnancy
- VAXOPEDIA – What Shots Do You Need to Be Around a Newborn?
- VAXOPEDIA – The History of Flu Vaccine Recommendations
- VAXOPEDIA – Your Baby’s First Vaccines
- VAXOPEDIA – Anti-Vaccine Points Refuted A Thousand Times
- Flu vaccine lawsuit – a non-win, non-revelation regarding pregnant women
- CDC – Summary of Maternal Immunization Recommendations
- CDC – Maternal Vaccines: Part of a Healthy Pregnancy
- CDC – Flu Vaccination & Possible Safety Signal
- ACOG – It is Safe to Receive Flu Shot During Pregnancy
- MMWR – Updated Recommendations for Use of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine (Tdap) in Pregnant Women — Advisory Committee on Immunization Practices (ACIP), 2012
MMWR – Updated Recommendations for Use of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine (Tdap) in Pregnant Women and Persons Who Have or Anticipate Having Close Contact with an Infant Aged <12 Months — Advisory Committee on Immunization Practices (ACIP), 2011 - MMWR – Prevention of Pertussis, Tetanus, and Diphtheria Among Pregnant and Postpartum Women and Their Infants
- Does the flu vaccine cause miscarriages?
- Influenza Vaccine Has Been Studied in Pregnant Women
- Safety of Flu and Pertussis Vaccines in Pregnancy Assessed
- The real story on the flu vaccine during pregnancy
- Pregnancy and influenza – new data shows death rate of 25% for those who get critically ill
- Influenza Vaccination in the First Trimester of Pregnancy and Risk of Autism Spectrum Disorder—Reply
- CDC – Questions and Answers About Vaccines During Pregnancy
- CDC – Immunization and Pregnancy chart
- CDC – Common Misperceived Contraindications to Vaccination
- Study – Trivalent inactivated influenza vaccine and spontaneous abortion.
- Tdap vaccine is not linked to autism, just like any other vaccine (including the flu vaccine)
- No, the thimerosal in the flu vaccine does not explain why autism rates did not go down
- Flu vaccine during pregnancy – unrelated to autism
- Robert F. Kennedy, Jr. promotes an awful epidemiology study linking vaccines and neurological conditions from…Yale?
- Vaccines Still Not Linked to Autism
- Flu shots are safe for pregnant women
What a bunch of bullshit you write.
If it is not approved by the FDA, it is not approved by the FDA. Don’t inject poison to people to make money off their disease. Assholes!
1. “Despite what Robert F. Kennedy, Jr and his ironically named Children’s Health Defense organization might think, Tdap and flu shots in pregnancy have been well studied and have been found to be safe.”
Are you suggesting that the FDA is lying when they say “We have no records responsive to your request”, or are you suggesting that the FDA is ignorant to this plethora of information that you seem to be privy to?
2. “including one that showed “a suggestion of increased ASD risk among children whose mothers received an influenza vaccination in their first trimester,” a suggestion that was not statistically significant and which was not found in the other trimesters.”
No one suggested it was “found in other trimesters”. As it clearly states, the concern was about the FIRST trimester. Even a “suggestion” is important for MY child. I think most would wait for the second trimester if it were proven and shared as being more safe. Perhaps your interpretation is different. Parents deserve to know and decide if that is a risk they wish to take.
3. “a safety signal that has never been seen before and which continues to be investigated.”
Who exactly is “continuing to investigate this topic”? I would sincerely be interested in knowing.
4. “Has Kennedy missed the fact that 80% of flu vaccines are now thimerosal free?”
From where did you get this statistic? In 2015-2016, the multi-dose vaccine (which does contain thimerosal) represented over 70% of manufactured product. To reduce that amount to 20% would be a significant feat. What would cause such a shift in policy, if it is indeed true?
5. “Getting a flu vaccine during pregnancy is a recommendation that has been evolving since 1983. It was known to be safe then, and we are even more confident that it is safe now.”
It was “known”? It does not appear that the FDA “knew” or had knowledge that it was safe or of preexisting studies to determine recommended use with pregnant women. Who is this “we”? It cannot be the FDA as they admit they rely on no studies for this alleged “safety”. This would appear to be an appeal to ignorance.
In conclusion, I do not know if you are suggesting Mr. Kennedy is evil or ignorant. I doubt he is either. I would assume he has questions and concerns, just as many others do. Perhaps a little less condescension in the discussion would increase productivity. I merely suggest “informed consent” and not force compliance by caring parents to give in to the will of the pharmaceutical companies, who are held legally blameless by law when their products do harm (oh, to be so blessed as a company)(and I know you wouldn’t claim they do no harm with the present payout of vaccine injury compensation program being over $4 billion). Kindest regards.
Did you even read these studies? I clicked on 4 of the gagillion provided here and they are NOT scientific studies. They are epidemiological at best, and at worst, are derived from surveys. Just look at the package insert and you will see these vaccines were NOT tested to be safe for pregnant women.
This site is routinely used as a reference for Dorit Reiss, henchman for prOFFIT and pHARMa. She is a law professor at UC Hastings. She has shares in GSK and advocates police arresting and imprisoning those who do not consent to medical procedures.