Tag: HHS

Did the FDA Admit That the Government Is Recommending Untested, Unlicensed Vaccines for Pregnant Women?

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.

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?

Vaccines and the Government Shutdown

Think that everything related to vaccines and vaccine-preventable diseases are exempted during a government shutdown?

“A shutdown furlough (also called an emergency furlough) occurs when there is a lapse in appropriations, and can occur at the beginning of a fiscal year, if no funds have been appropriated for that year, or upon expiration of a continuing resolution, if a new continuing resolution or appropriations law is not passed. In a shutdown furlough, an affected agency would have to shut down any activities funded by annual appropriations that are not excepted by law. Typically, an agency will have very little to no lead time to plan and implement a shutdown furlough.”

Pay & Leave Forlough Guideance

Nearly half of government employees have been furloughed without pay since the beginning of the most recent government shutdown, while some others are working without pay.

Vaccines and the Government Shutdown

Among those government employees who have been furloughed include nearly 40% of the staff at U.S. Department of Health and Human Services (HHS).

It would have been much more if much of HHS’s operating divisions, representing about 60% of HHS staff, had not already been funded through September 2019. So the CDC and NIH should be working as usual.

Some HHS divisions that are funded through Agriculture and Interior appropriations were hit by the shutdown though, including the EPA, FDA, and Indian Health Service.

The FDA works to regulate and approve vaccines. Will that work be affected by the shutdown?

Some of the work at the FDA is done via user fees instead of government funding, but that money is running out and they can't accept new user fees!
Some of the work at the FDA is done via user fees instead of government funding, but that money is running out and they can’t accept new user fees!

Maybe…

Most other vaccine programs likely won’t be affected though.

  • Center for Biologics Evaluation and Research (CBER) – regulates vaccine products and is financed by user fees, so doesn’t depend on government funding. Except that they can’t accept new user fees!
  • Vaccines For Children Program – already funded through the Centers for Medicare & Medicaid Services (CMS) to the Centers for Disease Control and Prevention
  • National Vaccine Injury Compensation Program – funded by an excise tax on vaccines
  • VAERS – co-administered by the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA), it is still up and running…
  • National Vaccine Program Office – funded through HHS
  • National Science Foundation – closed and no new funding opportunities will be issued and no payments will be made.
  • National Institutes of Health – funded

We are already hearing stories about what is happening as the Indian Health Service goes unfunded.

What happens if CBER runs out of money? Unfortunately, we may soon find out.

More on Vaccines and the Government Shutdown

Did Trump Lay the Groundwork to Ban Mandatory Vaccinations?

Have you heard that Donald Trump is going to ban mandatory vaccinations?

Or that he is going to ban childhood vaccinations all together?

Guess what?

That’s right, neither is true.

Did Trump Lay the Groundwork to Ban Mandatory Vaccinations?

To be sure, anti-vaccine folks were likely excited when Donald Trump was elected President.

Donald Trump's vaccine and autism tweet.

In addition to his tweets that tried to associate vaccines with autism, there were reports that he was going to set up a committee on vaccine safety that would be headed by Robert F Kennedy, Jr!

So the idea that he might try to ban vaccines was probably thought of as a safe bet for some.

Fortunately, it wasn’t.

Which vaccines kids need to go to daycare and school are mandated by state law. Despite what some folks might think, there are no federal vaccine mandates.

While there is a new a new Conscience and Religious Freedom Division in the HHS Office for Civil Rights, it doesn't ban vaccinations.
While there is a new Conscience and Religious Freedom Division in the HHS Office for Civil Rights, it doesn’t ban vaccinations.

And even with the announcement of a new Conscience and Religious Freedom Division in the HHS Office for Civil Rights (OCR), there is no ban on mandatory vaccinations across the United States.

“The creation of the new division will provide HHS with the focus it needs to more vigorously and effectively enforce existing laws protecting the rights of conscience and religious freedom, the first freedom protected in the Bill of Rights.”

HHS Announces New Conscience and Religious Freedom Division

Could you interpret this is laying the groundwork for allowing religious exemptions to vaccines?

Again, vaccine mandates are set by state law, so no, you shouldn’t. Anyway, almost all states already allow religious exemptions to getting vaccinated, even though no major religion is actually against vaccinating and protecting kids from life-threatening vaccine-preventable diseases.

“Conscience protections apply to health care providers who refuse to perform, accommodate, or assist with certain health care services on religious or moral grounds.”

Conscience Protections for Health Care Providers

A proposed rule, Protecting Statutory Conscience Rights in Health Care; Delegations of Authority, that might have affected vaccines funded by Federal medical assistance programs, never took effect. In fact, the White House urged HHS to not finalize the rule after the Office of Management and Budget said they weren’t complying with necessary rules to get it implemented on time.

 “The AAP wishes to underscore its recognition of the important role of religion in the personal,spiritual, and social lives of many individuals, including health providers. Balancing that role with efforts to ensure children have appropriate access to needed health and social services is critical to meeting their health needs and supporting their health and well being. As HHS considers potential changes to regulations and policy guidance to encourage the provision of grants and contracts to faith-based organizations, we urge you to ensure that federal policy does not undermine children’s access to needed care and services.”

Collen Kraft, MD, FAAP, President of the American Academy of Pediatrics

Not surprisingly, major medical associations were against the proposed rule, and not just because of potential effects on vaccines, even though it wouldn’t have actually banned vaccines.

“The proposal would dramatically expand the discretion that religious or moral objectors have to refuse care without meaningful safeguards to ensure that the rights of those receiving care are protected.”

AMA on HHS should withdraw proposal on health care conscience rights

Sadly, as Kennedy and many anti-vaccine folks focus and what they think are toxins and poisons in vaccines, they seem to be ignoring the fact that Donald Trump is going to expose our kids to many more real toxins and poisons through his efforts to slash Clean Water Act protections and other EPA regulations.

At least we can look forward to no bans on mandatory vaccines, even though many parents continue to abuse existing vaccine exemptions, putting us all at risk.

More on Trump and Vaccine Policy

Has the CDC Been Hiding and Destroying Evidence About Vaccine Safety?

Has the CDC ever been caught destroying and hiding evidence about vaccine safety?

Have you seen the movie Vaxxed? They talk about a big coverup over a study about vaccines and autism, don’t they? And how the CDC whistleblower’s coauthors destroyed a bunch of evidence…

Except that they didn’t.

And no, the CDC never hid data about mercury, vaccines, and autism either.

Has the CDC Been Hiding and Destroying Evidence About Vaccine Safety?

Why do some folks continue to bring up these anti-vaccine talking points that have been refuted a thousand times already?

Does anyone else think of the word irony when Kelly Brogan accuses other folks of fraud?
Does anyone else think of the word irony when Kelly Brogan accuses other folks of fraud?

There are a few reasons, none of which are true.

The Verstraeten Study

First is a presentation of two abstracts about thimerosal containing vaccines (TCVs) by Thomas Verstraeten in 1999 at a Epidemic Intelligence Service (EIS) conference, which were discussed at the Simpsonwood Conference, and were later published, finding “no consistent significant associations were found between TCVs and neurodevelopmental outcomes.”

The Verstraeten abstracts.

So what’s the problem?

Anti-vaccine folks think that Phase I of the trial found statistically significant evidence of adverse events after getting thimerosal containing vaccines and that they manipulated the data to make it go away in Phase II.

“Although the analysis says the increased autism risk is not significant, testimony by Dr. Mark Geier before Congress in December 2002 said that the slope of the curve was in fact statistically significant.”

VSD Subgroup Analysis of Spring 2000 Obtained by SafeMinds from The Center for Disease Control – Summer, 2001

Many folks will find it ironic that Dr. Geier is considered an expert on manipulating data about vaccines and thimerosal, but that’s not what happened in the Verstraeten study.

The CDC Whistleblower

Of course, the other big conspiracy about the CDC destroying and hiding evidence comes from the CDC Whistleblower story.

A story in which the “whistleblower” has stated that:

“I want to be absolutely clear that I believe vaccines have saved and continue to save countless lives. I would never suggest that any parent avoid vaccinating children of any race. Vaccines prevent serious diseases, and the risks associated with their administration are vastly outweighed by their individual and societal benefits.

My concern has been the decision to omit relevant findings in a particular study for a particular sub ​ group for a particular vaccine. There have always been recognized risks for vaccination and I believe it is the responsibility of the CDC to properly convey the risks associated with receipt of those vaccines.

I have had many discussions with Dr. Brian Hooker over the last 10 months regarding studies the CDC has carried out regarding vaccines and neurodevelopmental outcomes including autism spectrum disorders. I share his belief that CDC decision-making and analyses should be transparent. I was not, however, aware that he was recording any of our conversations, nor was I given any choice regarding whether my name would be made public or my voice would be put on the Internet.”

William W. Thompson, Ph.D.

Remember, Dr. Thompson disagreed with his coauthors about how they handled some of the data, and he wanted folks to know about it.

The data wasn’t thrown out in a trash can, as some have suggested.

And unlike Brian Hooker’s study, which has been retracted, the original DeStafano study, which Thompson was talking about, has been reanalyzed and found to be sound.

Myths of Fraud at the CDC

Of course, there’s more.

At least more accusations, most of which come from the same person – Robert F. Kennedy, Jr., the guy who’s Deadly Immunity article was retracted because it contained so many errors (some described them as lies).

Enzi's investigation made it clearn that there was no conspiracy at Simpsonwood and it cleared Verstraeten too.
Enzi’s investigation made it clear that there was no conspiracy at Simpsonwood and it cleared Verstraeten too.

What Kennedy never mentions though, is that in 2005, Senator Mike Enzi and the Senate Health, Education, Labor and Pensions (HELP) Committee conducted an 18-month investigation into allegations of misconduct by the CDC, especially in connection with the CDC’s study of vaccine safety and thimerosal.

“Our investigation shows that public health officials conducted thorough, science based studies on autism and vaccines.”

Senator Mike Enzi (R-WY)

But why continue to attack the CDC?

Because that’s how propaganda works.

More on Myths of Fraud at the CDC

Did the US Government Lose a Landmark Vaccine Lawsuit?

Have you heard the big news in the anti-vaccine world?

The anti-vaccine world thinks that they won some landmark lawsuit.

Reagan didn’t do much for vaccines, but it isn’t fair to pin this one on him.

It seems that some folks think that the Department of Health and Human Services hasn’t been complying with federal vaccine safety mandates for 30 years.

The 1986 National Childhood Vaccine Injury Act includes a mandate for safer vaccines.
The National Childhood Vaccine Injury Act of 1986 includes a mandate for safer vaccines.

Really?

Which ones?

Did the US Government Lose a Landmark Vaccine Lawsuit?

While anti-vaccine folks are pushing this lawsuit victory (?) to make folks think that HHS has done absolutely nothing to promote vaccine safety in the last 30 years, that is obviously nonsense.

The lawsuit was actually just about the reporting requirements of paragraph (c) of section 2127 of the National Childhood Vaccine Injury Act of 1986.

It should be clear that the HHS has done plenty to promote vaccine safety though.

HHS Secretary Donna Shalala reported to the Senate Committee on Health Education Labor and Pensions in 1998.
HHS Secretary Donna Shalala actually reported to the Senate Committee on Health Education Labor and Pensions in 1998.

Even if no formal reports were filed, the HHS secretary did report to and appear before Congress. Come to think of it, they even sent some reports to Congress.

The Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services, has commissioned almost a dozen reports about vaccine safety over the years.
The Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services, has commissioned almost a dozen reports about vaccine safety over the years.

And the Health and Medicine Division (HMD) division (previously known as the Institute of Medicine (IOM) of the National Academies of Sciences, Engineering, and Medicine has published a number of vaccine safety reviews and reports under commission of HRSA, an agency of HHS.

Where do folks think that all of those IOM vaccine safety reports and reviews come from? Were they sent to Congress?

The Assistant Secretary for Health leads development of HHS-wide public health policy recommendations, oversees 11 core public health offices — including the Office of the Surgeon General and the U.S. Public Health Service Commissioned Corps, which has approximately 6,500 uniformed health officers who serve in nearly 600 locations around the world to promote, protect and advance the health and safety of our nation and our world. He also oversees three Presidential and 11 Secretarial advisory committees.
The Assistant Secretary for Health leads development of HHS-wide public health policy recommendations, oversees 11 core public health offices and three Presidential and 11 Secretarial advisory committees. We have had a National Vaccine Plan since 1994.

And also consider that:

Most importantly, new vaccines have been approved that protect our kids against many more now vaccine-preventable diseases.

HHS Settles Lawsuit Over Vaccine Safety Reporting

But wait, did the HHS even lose the lawsuit?

Not saying I'm surprised, but even Dr. Bob has bought into the idea that this lawsuit against HHS means something big.
Not saying I’m surprised, but even Dr. Bob has bought into the idea that this lawsuit against HHS means something big.

They actually didn’t.

They did settle a lawsuit though, a lawsuit which was then dismissed.

So like the CDC whistleblower movie that didn’t include a whistleblower, anti-vaccine folks think that they have a smoking gun about vaccine safety reports, except that it is very obvious that all kinds of reports about vaccine safety have been done over the years.

Vaccines are still safe. And they are still necessary.

What to Know About the HHS Vaccine Lawsuit

Although it does seem like HHS didn’t file the required formal reports and keep to the strict letter of the National Childhood Vaccine Injury Act of 1986, there is abundant evidence that they have actually done all of the work required to make sure that our vaccines are safe.

More on the HHS Vaccine Lawsuit