FDA, CDC, and COVID-19 vaccines — who does what?

FDA CDC COVID-19 vaccines

This article about the role of the CDC and FDA concerning COVID-19 vaccines was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.

Professor Reiss writes extensively in law journals about the social and legal policies of vaccination. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable diseases. She is also a member of the Vaccines Working Group on Ethics and Policy.

I write this right after the FDA expert advisory committee, Vaccines and Related Biological Products Advisory Committee (VRBPAC), voted unanimously that the benefits of both Moderna and Pfizer-BioNTech’s COVID-19 vaccines for children 6 months to 5 years of age outweigh their risks, clearing a smooth path for FDA to grant emergency use authorization (EUA) to these vaccines. I was asked about the division of labor between CDC and FDA on COVID-19 vaccines, and it seems like something worth setting out.

So this is a short post about the relative roles of the FDA and CDC in getting COVID-19 vaccines to people in the USA. It is not a full picture of how vaccines get to us; there is a lot more to that. I am not even going into the full requirement for approving or authorizing a vaccine; just who does what. But this piece of the puzzle can be useful by itself.

For those looking for a full description of the vaccine approval process, I recommend either the Skeptical Raptor’s post on that topic or the description by the Vaccine Education Center of the Children’s Hospital of Philadelphia.  

Continue reading “FDA, CDC, and COVID-19 vaccines — who does what?”

CDC vaccine patents – Robert F Kennedy Jr gets this one wrong too

CDC vaccine patents

If you follow the anti-vaccine world, you will hear Robert F Kennedy Jr often claim that there are CDC vaccine patents that are so valuable that the CDC itself sets aside all morality and ethics to endorse the vaccines developed through these patents just to make more money for the CDC.

Kennedy, who once threw himself at Donald Trump in an effort to head a Vaccine Commission, has made this claim for several years now, but repeated it in an interview, stating that, “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.”

Typically, Kennedy provides absolutely nothing in the form of supporting evidence. It makes no sense to argue against an imaginary claim – this is a pretty good example of an opinion rather than facts.

But along comes Ginger Taylor, one of the most ardent and science-ignoring anti-vaccine activists around these parts. In fact, she inspired my article entitled, Vaccines and autism science say they are unrelated

Taylor, who apparently has an autistic child, believes that vaccines “damaged” her child because, as a mother, she knows more than actual scientists. She considers science to be an elitist pursuit, it’s not data and evidence that matter but only her opinion.

Seriously, Taylor has an utter lack of self-awareness, which apparently broke one of Orac’s favorite Big Pharma Irony Meters™. Her opinion of her own scientific knowledge, i.e. her Dunning-Kruger cognitive bias, is betrayed by the reality of the vast mountain of scientific knowledge supporting the safety and effectiveness of vaccines.

So this same Ginger, the vaccine-denier that she is, decided to write an article with another torturous description of the CDC vaccine patents conspiracy theory, trying to support Kennedy’s outlandish claims. And she wrote this article in GreenMedInfo, one of the most ignorant anti-science websites on the interwebs, just a bit below NaturalNews in quality.

The problems with Taylor’s article are multi-fold – but generally, like so many other anti-vaccine zealots, they think they know a lot about a topic based on their 15 minutes of Google search time, rather than doing the tens of thousands of hours of actual vaccine research using science.

Taylor is utterly uneducated about and inexperienced with not only science but also patents – she gets nearly everything about her conspiracy theory totally wrong. 

So here we go, debunking the anti-vaccine myth of the CDC vaccine patents.

Continue reading “CDC vaccine patents – Robert F Kennedy Jr gets this one wrong too”

Vaccines for Children Program – saving thousands of children’s lives

Vaccines for Children Program

The United States of America is a great country, despite the ignoramus President currently in charge, but one of its contemptible failures is the lack of a comprehensive health care insurance for all citizens. Despite this, there is a ray of shining light that has saved hundreds of thousands of children’s lives – the Vaccines for Children Program, which provides free vaccines to children who otherwise have no access to them.

I was prompted to write this article because when I was reviewing some statistics from the Centers for Disease Control and Prevention that showed a lot of unvaccinated children lacked healthcare insurance. This study showed that 17.2% of unvaccinated children were uninsured compared to 2.8% of all children. Looking at the data from another direction, over 7% of uninsured children were unvaccinated compared to only 1.0% of children on Medicaid and 0.8% of children on private health insurance.

The purpose of this article is to describe the Vaccines for Children Program and to give parents an important resource and information on how to make sure that their children are fully vaccinated against dangerous and deadly diseases. Continue reading “Vaccines for Children Program – saving thousands of children’s lives”

Vaccine coverage in USA remains high, but refusal has increased

vaccine coverage

Annually, the US Centers for Disease Control and Prevention publishes reports on vaccine coverage in the country. This year, they produced two reports – one describing vaccine coverage for children 19-35 months old, and a second one discussing vaccination coverage for children entering kindergarten.

Although vaccine coverage remains quite high across most vaccines and hasn’t changed much over the past few years, there is a bit of troubling news. A tiny, but increasing number of children in the country are not getting some or all of their recommended vaccines as a result of parental refusal to vaccinate their children. In fact, the percentage of children under 2 years old who have received none of the recommended vaccines has quadrupled since 2001.

Vaccine coverage – 19-35 months old

The first study by Holly A Hill, MD Ph.D. et al., published in the Morbidity and Mortality Weekly Report, examine vaccine coverage for Advisory Committee on Immunization Practices (ACIP) recommended vaccines in children born in 2015.

For some of the vaccines, the vaccination coverage exceeded 90%:

Unfortunately, for some ACIP-recommended vaccines, the coverage lagged:

There are a few key observations about this data. First, despite the false claims about the MMR vaccine being linked to autism, the vaccine coverage for MMR remains at historically high levels. On the other hand, hepatitis B vaccine coverage, especially at birth, is too low, despite that the fact that these vaccines are important for cancer prevention.

Vaccine coverage by state also showed some interesting information – Massachusetts has the highest vaccination rates for children born in 2015 of all states. The City of New York, considered a “state” for the purposes of this study, had the lowest rate.

However, it is troubling that, even though the proportion of children who received no vaccines by age 24 months, it has increased from 0.3% for children born in 2001 to 0.9% for children born in 2011 to 1.3% for children born in 2015. This works out to be over 100,000 children born in 2015 who aren’t vaccinated against 14 dangerous and deadly diseases. This is worrisome.

Although I do not want to give credit to the anti-vaccine religion for causing this troubling increase in vaccine refusal. The internet is filled with ignorant and scientifically inaccurate information about vaccines. Quora, where individuals can ask questions about almost anything, is filled with individuals asking questions about vaccines in good faith. Although 95% of the answers are scientifically and medically accurate, there are many individuals who use misinformation, ignorance, and outright lies to scare people about vaccines.

Eventually, this can lead to the point, where the overall vaccine coverage will drop below the level to maintain the herd effect. At that point, there are insufficient numbers of immunized people to block the spread of an outbreak or epidemic of these vaccine-preventable diseases.

On the other hand, the study points out that part of the lack of vaccination may be a result of an ongoing issue with the USA – the lack of universal health insurance, especially for the poor. This study showed that 17.2% of unvaccinated children were uninsured compared to 2.8% of all children. Looking at the data from another direction, over 7% of uninsured children were unvaccinated compared to only 1.0% of children on Medicaid and 0.8% of children on private health insurance.

This is one of the great moral failings of the country. However, there really are no reasons why any child in the USA is denied vaccines. The Vaccines for Children Program provides free vaccines for all children in the USA who otherwise have no insurance coverage. The program has saved hundreds of thousands of lives over the past 20 years.

Vaccine coverage – kindergartners

A second report, by Jenelle L Mellerson et al. and published in the Morbidity and Mortality Weekly Report, examined vaccine coverage for children entering kindergarten in 2017. The good news is that, despite somewhat lower vaccination rates in states like DC, Idaho, and Colorado, the overall vaccine coverage for the major vaccines is well over 90% for kindergartners.

The researchers found that the exemption rate was low, about 2.2%. Unfortunately, it was the third consecutive school year that a slight increase noted. The 2.2% exemption rate during the 2017-18 school year was up from 2.0% in 2016-17, and 1.9% in 2015-16.

The study does not provide a breakdown between medical (where there is a valid medical reason to not vaccinate a child with one or more vaccines) and non-medical exemptions. The non-medical exemptions, often called “personal belief” exemptions are simply refusing to vaccinate a child because of a variety of reasons – religious (no religion is opposed to vaccines) or because “we don’t like vaccines.” Most exemptions are of the non-medical variety.

Only a few states disallow these personal belief exemptions – California, Mississippi, and West Virginia. Unsurprisingly, California and Mississippi have the lowest non-medical exemption rates in the USA, at less than 0.1%. Unfortunately, California has an issue where unethical physicians are giving out (or even selling) non-medical exemptions for parents who want to put their children in danger of vaccine-preventable diseases.

Summary

These two studies show us two dangerous trends – first, too many very young children are going unvaccinated because of parental ignorance or lack of health insurance. And second, too many parents are putting their children at risk of vaccine-preventable diseases by requesting non-medical exemptions.

However, despite the pseudoscientific lies of the hysterical anti-vaccine religion, nearly 95% of children are vaccinated before they enter school. Unlike the anti-vaccine zealots, who seem to dismiss a few thousand cases of cancer or deaths from measles as unimportant or trivial, most of us on the pro-science side of vaccines want all children protected from dangerous and deadly diseases. That’s why we fight to make sure every single child is vaccinated.

Why aren’t you making sure that your children are protected from vaccine-preventable diseases?

Citations

It’s simple math – vaccines saved 700,000 children’s lives

In 1994, the Vaccines for Children program (VFC) was created by a Federal budget authorization in direct response to a measles resurgence in the United States that caused tens of thousands of cases and over a hundred deaths, despite the availability of a measles vaccine since 1963. The net effect of the VFC program was that it provided (and continues to provide) vaccines to children whose families or caregivers couldn’t otherwise afford them, such as those who are uninsured or Medicaid eligible. These are vaccines that have saved 700,000 children’s lives.

It was one of America’s great social healthcare programs in the history of the USA. VFC had an immediate and positive effect on the health of America’s children. Continue reading “It’s simple math – vaccines saved 700,000 children’s lives”

HPV cancer vaccine rates – Gardasil uptake remains low

HPV cancer vaccine

As I’ve written before, there are precious few ways to prevent cancer. But one of the best cancer prevention strategies is the HPV vaccine, which can prevent numerous cancers such as cervical, oral, penile and anal, all serious, and all dangerous. Maybe we should just rename Gardasil to “HPV cancer vaccine,” which could make everyone sit up and notice.

The HPV vaccination rate remains depressingly low in the USA. According to recent research, 39.7% of adolescent girls aged 13-17 received all three doses of the vaccine in 2014 up from 37.6% in 2013. HPV vaccination rates among teen boys are much lower than for girls, 21.6% in 2014 up from 13.4% in 2013.

There are probably a lot of reasons for the low HPV cancer vaccine uptake rate, so I thought I’d go through the most “popular” ones, debunking them one by one.

Hopefully, the reader can use this article as a checklist of the tropes and myths of the anti-Gardasil crowd with quick answers to them. Maybe you’ll convince one person to get their son or daughter vaccinated against HPV related cancers.

Continue reading “HPV cancer vaccine rates – Gardasil uptake remains low”

HPV vaccine lowers cancer risk and healthcare costs

HPV vaccine lowers cancer risk

If you overlook the plain ignorance of junk medicine pushers on the internet, it’s clear that there’s only a few things that you can do to lower your risk of cancer.  Quitting tobacco is probably the biggest one. But right up there is the fact that the HPV vaccine lowers cancer risk – and as a consequence, lowers health care costs generally.

Despite it’s clear benefit to human health, the HPV cancer preventing vaccine, also known as Gardasil, is under utilized in the USA. There seems to be a lot of reasons why HPV vaccine uptake is low, but the evidence is clear that it is safe, it reduces cancer risk, and it lowers the costs of healthcare.

So, let’s take a look at some of the data.

Continue reading “HPV vaccine lowers cancer risk and healthcare costs”

Prices of vaccines–an uncomfortable discussion

Injection of FundsSuddenly, there has been a lot of noise about the price of vaccines. Well, there’s always been over-exaggerations and outright misinformation about vaccine prices and profits from the antivaccination gang, and they must be embarrassed by the quality of their arguments. OK, I doubt that. But there is noise out there.

But when the criticism comes from the “pro-vaccine” world, I needed to stand up and see what was being said. In my world of vaccines, I believe that anyone, especially children, who needs vaccines should get them for free. This is true in the USA (which leads the world in this one facet of healthcare), thus, any argument about vaccines costing too much falls rather flat to me. I hate dropping anecdotal data on my readers, but the fact is my health insurance plan, by no means some corporate executive level concierge plan, pays for all vaccines. In fact, I asked for one vaccination out of indication (meaning I was about 10 years too young to receive it), and the insurance company paid for it immediately and without question.

In the USA, the Affordable Care Act (best known as Obamacare) mandates vaccinations for adults and children with no out-of-pocket costs. Medicaid pays for vaccines. Medicare pays for vaccines, though the rules for payment are unnecessarily bureaucratic and confusing, unless the member is in Medicare Advantage. Maybe not as of today, but certainly soon, the cost of vaccines shouldn’t matter to the average rich or poor or middle-class American. And considering the number of lives saved by vaccines, this is an incredible and modern aspect of the USA health care system. Continue reading “Prices of vaccines–an uncomfortable discussion”

My vaccine credo

I find it tiresome to repeat myself, repeatedly over and over, about the key points of vaccines. So, I decided to write out my Vaccine Credo.

What’s a credo? Well, it’s a “any formal or authorized statement of beliefs, principles, or opinions.” Since, everything I state is supported by evidence, I’m just going to call this my Formal Statement of the Principles of Vaccines.

Vaccines Save Lives

  1. Vaccines are safe.
  2. Vaccines prevent a wide range of infectious diseases.
  3. Vaccines save the lives of 42,000 people every year in the USA.
  4. These vaccine-preventable infectious diseases cause great harm to children and adults. They increase rates of hospitalization. They kill innocent people. They are not inconsequential.
  5. The safety and effectiveness of vaccines are established by evidence published in the top medical and scientific journals in the world.
  6. The consensus of medical and scientific opinion is that they are safe and effective.
  7. Vaccines do not cause autism or other neurodevelopmental conditions.
  8. Vaccines help improve fetal outcome in pregnant mothers.
  9. The safest and most effective way to protect children’s lives is following the vaccine schedules set by public health agencies like the CDC.
  10. There is no debate about the safety and effectiveness of vaccines–those who are opposed to vaccines are either ignorant of the scientific facts or are intentionally deceitful.
  11. Not vaccinating children places other children at risk–especially ones who cannot be vaccinated for medical reasons or children too young to be vaccinated.
  12. Children can get vaccines for free in the USA, no matter if they have health insurance or not. This is a right for American children, and all countries in the world should do the same.
  13. Those parents who do not vaccinate their children selfishly hide behind the herd effect–while sanctimoniously stating that we don’t have to worry about these vaccine-preventable diseases.
  14. Parents who refuse to vaccinate their children are self-centered and egocentric–putting their children intentionally in harm’s way.

vaccines-33000My Vaccine Credo may not exactly roll off the tongue. It probably is not easy to memorize. But all 14 points are supported by the vast mountains of scientific evidence not cherry picking here and there. It is based on my 35 years of scientific education and experience. It is based on the best opinions from the best physicians and scientists who focus their lives on vaccines.

All else are just inventions of ignorant and uneducated minds. Those people mean nothing to me. But let’s try to save their children, because vaccines do save lives.