the Texas Department of Health Resources made up to 7 different vaccines
the University of Illinois made a BCG vaccine
the Michigan Department of Public Health made up to 8 different vaccines
Massachusetts Public Health Biological Laboratories (Mass Biologics) made several vaccines
These included many generic vaccines, including DPT and IPV.
In fact, the Massachusetts Public Health Biological Laboratories continues to make the last remaining generic vaccines, DT and Td.
Why Aren’t There More Generic Vaccines?
Couldn’t more pharmaceutical companies make vaccines, including more generic vaccines, so that they could be less expensive?
“In sum, although patent protection remains the major barrier to the production of affordable small-molecule generics, access to trade-secret–protected information and know-how present major additional obstacles to generic production of vaccines.”
Improving Global Access to New Vaccines: Intellectual Property, Technology Transfer, and Regulatory Pathways
Unfortunately, unlike drugs, patents aren’t the only issue when making a generic vaccine. You also need the expertise, investment, and studies to prove that your generic vaccine is as safe and effective as similar vaccines.
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.”
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.
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).
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.”
Many folks were surprised by the reports that Donald Trump had selected Robert Kennedy, Jr to head a committee on vaccine safety.
Or maybe it shouldn’t have been a surprise. Kennedy, an environmental lawyer, once wrote a discredited article on the dangers of mercury in vaccines, and like Trump, continues to believe that vaccines are linked to autism.
But what can we expect from a Kennedy vaccine safety committee?
Robert F Kennedy, Jr on Vaccines
Vaccines have been proven safe and necessary time and again. If this vaccine safety commission happens, most people expect Kennedy to push his conspiracy theories to even more people.
In addition to wasting a lot of time and money, Kennedy has the potential to scare parents away from getting their kids vaccinated and protected against vaccine-preventable diseases.
“The CDC is a subsidiary of the pharmaceutical industry. The agency owns more than 20 vaccine patents and purchases and sells $4.1 billion in vaccines annually.”
Robert F Kennedy, Jr
This is one of RFK, Jr statements about vaccines.
Surprisingly, some parts of this statement are true.
The Centers for Disease Control and Prevention (CDC) does own some vaccine patents. And the CDC does buy about $4.1 billion in vaccines each year.
They don’t sell those vaccines though. They are distributed through the Vaccines for Children program to children who can’t afford vaccines.
Other Robert F Kennedy, Jr Vaccine Conspiracy Theories
What else does Kennedy believe?
While many anti-vaccine folks believe in Big Pharma conspiracies, Kennedy takes it to an extreme and believes that they have a “broad reach” and that “virtually all the institutions that are supposed to stand between a rapacious industry and vulnerable children have been compromised,” including “Congress, the regulatory agencies, FDA and CDC, the IOM, the NIH, the AAP, the science journals, the university science departments and the press.”
Kennedy has also stated, or to be more precise, misstated that:
“Pharma’s stranglehold on the journals keeps independent vaccine safety science from ever getting published. Just this month, the Swiss journal, Frontiers in Public Health, cancelled publication of the first vaccinated/unvaccinated study. The study showed that vaccinated children had less measles and rubella, but four times as many neurological disorders—including autism –and 30 times the incidence of allergies.” – The very small study had been only provisionally accepted and was rejected upon further review. It wasn’t even the first vaccinated/unvaccinated study. That would be the “Vaccination Status and Health in Children and Adolescents Findings of the German Health Interview and Examination Survey for Children and Adolescents (KiGGS),” which looked at “whether unvaccinated children and adolescents differ from those vaccinated in terms of health.” And not surprisingly, they do. The unvaccinated kids get more vaccine preventable diseases. So what happened to the study? Like many retracted anti-vaccine studies, they republished it in another journal.
“…there is an overt conspiracy by a small group within the CDC vaccine division. It’s explicit. You can watch it unfold if you read the Simpsonwood transcripts and the related emails…” – Kennedy wrote extensively about Simpsonwood, the 2000 Scientific Review of Vaccine Safety Datalink Information conference, in his article Deadly Immunity, which was so full of obvious errors (some described them as lies), that it was eventually retracted. In addition to the obvious errors, Kennedy “quote mined the IOM report to make it seem that it said the exact opposite of what it really said.”
“…the CDC’s best and most recent science shows that autism spectrum disorder rates in Scandinavia dropped 33 percent following the removal of thimerosal in 1993.” – the article Kennedy cites is actually about recurrence risk, how likely you are to have another child with autism and “supports the role of genetics in ASDs,” and although rates seemed to decrease after a peak, they were still the same as before thimerosal was removed
“Vaccine mercury exposures to children today are comparable to exposures in the 1990s, and, for the first time, thimerosal vaccines are being administered to pregnant women in America.” – this is perhaps Kennedy’s most ridiculous claim. I think he mostly bases it on the fact that pregnant women get flu shots, but with the availability of thimerosal free flu vaccines (70% of flu vaccine dosages available this year) and the fact that only about 40% of pregnant women get the flu vaccine during flu season, it is impossible to think that “vaccine mercury exposures to children today are comparable to exposures in the 1990s,” when the hepatitis B, DTaP, and Hib vaccines could all have thimerosal and were all given to infants multiple times.
Kennedy has compared getting vaccinated to “a holocaust” and in his mind, there is a conspiracy among the CDC, doctors, and the press that is “akin to what happened to the Catholic Church during the pedophile scandal. The institution suddenly became more important than the children it was supposed to protect. Only a few individuals were actively involved in raping children and shuffling known pedophile priests to unsuspecting dioceses.” – he apologized for the holocaust statement, but not for anything else he has ever said.
“I want to apologize to all whom I offended by my use of the word to describe the autism epidemic. I employed the term during an impromptu speech as I struggled to find an expression to convey the catastrophic tragedy of autism, which has now destroyed the lives of over 20 million children and shattered their families.” – of course, his “apology” was just as offensive to many people
“First of all, vaccines are not subject to the safety rigors undergone by other pharmaceuticals in the FDA approval process. There are no large scale, double-blind, placebo-controlled studies.” – there actually are…
“…in the one 1930 human study of thimerosal that predated its use in vaccines, all the subjects injected with thimerosal died.” – all of the subjects had meningococcal meningitis, a now vaccine-preventable disease that is life-threatening even today
“Verstraeten’s original analysis of those datasets found that thimerosal exposures increased autism risk by 760%. The CDC now knew the cause of the autism epidemic.” – it didn’t, although this is a common anti-vaccine conspiracy that involves the CDC hiding data about thimerosal, vaccines, and autism
Ironically, Kennedy is the nephew of President John F Kennedy, who signed the Vaccination Assistance Act in 1962 (Section 317 of the Public Health Service Act). President Kennedy’s vaccine law started as a three year program to help get kids vaccinated against polio, diphtheria, tetanus, and pertussis, and has been continuously reauthorized ever since.
What Happened to Kennedy’s Vaccination Safety Committee
Kennedy never did get appointed to head Trump’s vaccine safety commission.
“In both of those two meetings he asked me if vaccines weren’t a bad thing because he was considering a commission to look into ill-effects of vaccines,” Gates recalled, noting that Robert Kennedy Jr. had been urging Trump to launch such an effort. Gates said he told Trump, “that’s a dead end, that would be a bad thing, don’t do that.”
In fact, Trump never even created a vaccine safety commission, perhaps because he got some good advice from Bill Gates.
What to Know About Robert F Kennedy, Jr’s Vaccination Safety Committee
Plans for a Vaccine Safety Commission, which would help Robert F Kennedy, Jr gain a bigger audience for his ideas about thimerosal and autism, seem to be on hold.
More on Robert F Kennedy, Jr’s Vaccination Safety Committee
“The CDC is a subsidiary of the pharmaceutical industry. The agency owns more than 20 vaccine patents and purchases and sells $4.1 billion in vaccines annually. Congressman Dave Weldon has pointed out that the primary metric for success across the CDC is how many vaccines the agency sells and how successfully the agency expands its vaccine program—regardless of any negative effects on human health.”
Robert F Kennedy, Jr
Wait, the CDC sells vaccines?
Myths About the CDC Selling Vaccines
The CDC doesn’t sell vaccines. That’s not their mission.
“The Centers for Disease Control and Prevention (CDC) works 24/7 to protect America from health, safety, and security threats, both foreign and in the U.S. Whether diseases start at home or abroad, are chronic or acute, curable or preventable, human error or deliberate attack, CDC fights disease and supports communities to do the same.”
CDC Mission, Role and Pledge
They do buy vaccines. A lot of vaccines.
In 2017, the CDC immunization program spent just over $4.8 billion dollars, including $4.1 billion on the Vaccines for Children program.
“…from March through December 2016, over 13,000 doses of meningococcal conjugate vaccine, purchased using CDC funding, were used to respond to a deadly outbreak of meningitis in Southern California.”
Department Of Health And Human Services Fiscal Year 2018
Did they sell all of those vaccines?
If they did, then they wouldn’t have to request money from Congress each year to buy more vaccines, now would they?
“CDC buys vaccines at a discount and distributes them to grantees—i.e., state health departments and certain local and territorial public health agencies—which in turn distribute them at no charge to those private physicians’ offices and public health clinics registered as VFC providers.”
The VFC Program: At a Glance
Instead, the vaccines that the CDC buys, at big discounts, since they are buying so many, are offered free to those kids who can’t afford vaccines in the Vaccines for Children (VFC) program and through Section 317 grants.
What About the CDC Vaccine Patents?
Is Kennedy right about the CDC vaccine patents?
“In the course of performing our mission, many CDC researchers identify novel technologies which may be of interest to commercial partners. Some of these technologies are available as a biological or other tangible material for licensing, whereas others are protected under patent.”
Office of the Associate Director for Science (OADS)
OK, so the CDC has patents…
Well, not exactly the CDC. The United States of America as represented by the Secretary of the Department of Health and Human Services has patents…
When you think of Kennedy’s claim, do you think that the CDC has the patent on 20 new vaccines? After all, that’s how it sounds, doesn’t it?
“This technology describes a method for inactivating rotavirus. Traditional inactivation strategies use chemicals that reduce antigenicity (by altering rotavirus proteins), leading to less protection against the virus. Conversely, this method preserves and/or maintains the integrity of viral particles, leading to greater protection against rotavirus. This strategy has been validated in mice, piglets and cattle and further clinical studies are underway.”
A Novel Thermal Method to Inactivate Rotavirus for Use in Vaccines
Why patent these technologies?
Because they were discovered by CDC researchers and if their intellectual properly is not patented, then someone else could patent it, use it or sell it, and keep others from using it.
“After a license is negotiated, post-license compliance must be maintained to ensure the scheduled development of the technology, payment of royalties, and compliance to the license agreement. Based on the terms negotiated in the agreement, a percentage of royalties will go to the inventor, while a portion will go to the originating laboratory for that technology. This allows funding to be reinvested into CDC for the development of additional technologies that can meet other public health needs.”
What is the Process of Technology Transfer?
Should it be a surprise that these patents might generate money?
“Certain people are not considered for ACIP membership. For example, people who are directly employed or have an immediate family member directly employed by a vaccine manufacturer, hold a patent on a vaccine or related product, or serve on a Board of Directors of a vaccine manufacturer are excluded from ACIP membership.”
The Advisory Committee on Immunization Practices (ACIP) and the Childhood Immunization Schedule
“Dr Offit did not sit on the FDA committee that approved any rotavirus vaccine and he was not a member of ACIP, as RFK Jr claims, at the time they voted to recommend adding rotavirus vaccine to the immunization schedule.”
The Truth about vaccines 6: rotavirus
Is it a surprise that Kennedy is just trying to scare folks with all of this talk about selling vaccines and vaccine patents?
What to Know About the CDC’s Vaccine Patents
While the CDC does own and license some patents related to vaccines and vaccine technologies, they don’t actually sell any vaccines.