Tag: Vaccine Safety Datalink

Why Aren’t Vaccines Regulated like Drugs?

Have you ever heard the argument that vaccines aren’t held to the same standards as drugs, food, or other products?

“Vaccines are not held to the same double blind gold standard of clinical testing as other pharmaceutical drugs because they are considered biological products under the Public Health Federal Food, Drug and Cosmetic Act. They meet the same standards as cosmetics.”

20 VACCINE “FACTS” you need to know to make an informed decision

Placebos, liability, testing – these are all arguments that anti-vaccine folks try to use to scare parents into thinking that vaccine development isn’t well regulated and vaccines aren’t held to the same standard as drugs.

Why Aren’t Vaccines Regulated like Drugs?

Would you be surprised to learn that part of their argument is true?

Even after approval by the FDA, a vaccine still has to be reviewed by the ACIP before it is put on the immunization schedule.
Even after approval by the FDA, a vaccine still has to be reviewed by the ACIP before it is put on the immunization schedule.

No, not the part that vaccine development isn’t well regulated!

“Current authority for the regulation of vaccines resides primarily in Section 351 of the Public Health Service Act and specific sections of the Federal Food, Drug and Cosmetic Act.”

Vaccine Product Approval Process

Federal regulations and rules ensure that our vaccines are safe.

  • Public Health Service Act (42 USC 262-63) §351
  • Food, Drug, and Cosmetic Act (21 USC 301-392)
  • Title 21 Code of Federal Regulations (CFR) 600-680 – standards for biological products
  • Title 21 CFR 314 (21 CFR 601.25[d][2], specific to biologicals – ensures adequate and well-controlled clinical trials
  • Title 21 CFR 312 – investigational new drug application (IND)
  • Title 21 CFR 210-211 – good manufacturing practices
  • Title 21 CFR 58 – good laboratory practices
  • Title 21 CFR 56 – institutional review boards
  • Title 21 CFR 50 – protection of human subjects
  • Prescription Drug User Fee Act (PDUFA) of 1992, 2002, and 2007
  • Food and Drug Agency Modernization Act (FDAMA) of 1997
  • Food and Drug Agency Amendments Act (FDAAA) of 2007

I meant the part that vaccines aren’t regulated like drugs.

While both vaccines and prescription drugs are regulated by the FDA, that work occurs within two different centers of the FDA:

  • Center for Biologics Evaluation and Research (CBER) – vaccines
  • Center for Drug Evaluation and Research (CDER) – over-the-counter and prescription drugs

Both centers work to make sure we have safe and effective vaccines and drugs to keep us healthy, even if there are some differences in how they do it.

“Vaccine clinical development follows the same general pathway as for drugs and other biologics.”

Vaccine Product Approval Process

That’s right, vaccines and drugs go through the same types of clinical trials.

After completing the three phases though, vaccine developers must then apply for a Biologics License Application (BLA), which is reviewed by a multidisciplinary FDA reviewer team. This is also when their manufacturing facility gets inspected.

“Following FDA’s review of a license application for a new indication, the sponsor and the FDA may present their findings to FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC). This non-FDA expert committee (scientists, physicians, biostatisticians, and a consumer representative) provides advice to the Agency regarding the safety and efficacy of the vaccine for the proposed indication.”

Vaccine Product Approval Process

Once approved and licensed, the FDA and CDC continue to work to make sure the vaccine is safe, including having some vaccines undergo undergo Phase 4 studies and monitoring for side effects through VAERS and the Vaccine Safety Datalink.

And then, even after approval by the FDA, new vaccines aren’t put on the immunization schedule until a review and approval by the Advisory Committee on Immunization Practices (ACIP).

“Canada, like many other countries, exercises tight regulatory oversight over vaccines because they are usually given to very large numbers of healthy individuals. Vaccines in Canada are subject to the Food and Drugs Act and the Food and Drug Regulations. Vaccines are regulated under a specific set of regulations for a subset of drugs known as biologic drugs.”

The Regulation of Vaccines for Human Use in Canada

It is also important to keep in mind that this process doesn’t just happen in the United States.

Still wondering why vaccines aren’t regulated like drugs?

“Vaccine development differs from drug development in several important ways. First, because vaccines are preventive and are given to healthy individuals – often children – they require very large clinical trials, leading to increased research and development costs. Second, vaccines are biological products that can be very complex to manufacture and are subject to stringent quality control standards, resulting in much higher capital costs. Third, unlike drugs, vaccines have no secondary markets, making it unlikely that manufacturers will generate additional profits beyond the initial target markets. Finally, unlike generic drugs, which only need to demonstrate adherence to a pre-established development process, vaccines are biologicals that require full re-development to demonstrate their equivalence. (World Health Organization, 2014). Each manufacturer is required to invest in the full regulatory approval process for their vaccine products.

Myths and Facts about Vaccine Product Price and Procurement

It’s only because vaccines are more strictly regulated than drugs and other products.

Vaccines are safe and necessary.

More on Vaccine Regulation

Can Vaccines Cause Kawasaki Disease?

Kawasaki disease is rare and there is a good chance that you have never even heard of it, even though the first case was diagnosed in 1961.

Kids with this condition are typically irritable and can develop high fever, swollen glands in their neck, red eyes, red, cracked lips, red, swollen hands and feet, and a rash.

If you have heard of it, there is a good chance it is because anti-vaccine folks are using Kawasaki disease to scare you away from vaccinating and protecting your kids. Lately, talk about Kawasaki disease and the meningococcal B vaccines have been going around.

What Causes Kawasaki Disease?

Kawasaki disease is a type of vasculitis.

Kids who develop Kawasaki disease, who are typically under age 5 years, develop inflammation of their blood vessels, which leads to many of the symptoms and complications we see.

What causes this inflammation?

“Evidence suggests that Kawasaki disease may be linked to a yet-to-be identified infectious agent, such as a virus or bacteria. However, despite intense research, no bacteria, virus, or toxin has been identified as a cause of the disease.”

AAP on Kawasaki disease

We don’t know.

Can Vaccines Cause Kawasaki Disease?

Ask about Kawasaki disease if your child has a fever for five days and other symptoms of Kawasaki disease.
Courtesy of the kdfoundation.org

Because the cause of Kawasaki disease is unknown, that leads some folks to think that it could be vaccines.

Could it?

That vaccine clinical trial data sometimes finds a higher, although not statistically significant risk for Kawasaki disease, gets some of those folks thinking about it even more, except they don’t seem to think about the fact that the risk is never statistically significant.

But aren’t there case reports of kids getting Kawasaki disease after getting a hepatitis A, yellow fever, hepatitis B, or flu vaccine?

Yes, but getting a case report published about one patient who you think got Kawasaki disease soon after getting a vaccine isn’t strong evidence that it wasn’t a coincidence.

“Childhood vaccinations’ studied did not increase the risk of Kawasaki disease; conversely, vaccination was associated with a transient decrease in Kawasaki disease incidence. Verifying and understanding this potential protective effect could yield clues to the underlying etiology of Kawasaki disease.”

Abrams et al. on Childhood vaccines and Kawasaki disease, Vaccine Safety Datalink, 1996-2006.

And not surprisingly, several studies have shown that there isn’t any extra risk for Kawasaki disease after routine vaccines.

One even showed that getting vaccinated could be protective! Another benefit of vaccines and another reason you shouldn’t skip or delay your child’s immunizations.

What to Know About Vaccines and Kawasaki Disease

While anti-vaccine folks often list Kawasaki disease among their vaccine-induced diseases, several studies have shown that vaccines are not associated with Kawasaki disease, except to maybe have a protective effective if you are fully vaccinated.

More on Vaccines and Kawasaki Disease

Vaccines and Sudden Unexplained Death in Children

Can a child be fine one day and then die the next?

Tragically, they can.

There is even a name for it – sudden unexplained death in childhood.

Sudden Death in Children

Although 10% of deaths in children over age 12 months are classified as sudden death, most have explanations, such as asthma, epilepsy, or a heart problem (congenital malformations and arrhythmias). Unfortunately, some of these conditions, especially some infections and heart problems, aren’t discovered until after the child dies.

“Most sudden cardiac deaths that remain unexplained after necropsy are probably caused by primary cardiac arrhythmias.”

Sudden death in children and adolescents

About 16% of these sudden deaths don’t have any explanation though.

Surprisingly, these types of sudden, unexplained deaths are the 5th leading cause of death in children between the ages of 1 and 4 years. That adds up to about 400 deaths a year in the United States alone!

Vaccines and Sudden Unexplained Death in Children

Have you guessed the connection with vaccines?

If up to 16% of children who die suddenly don’t have a good explanation for why they died, then that leaves some to blame vaccines, often with a little help with myths and misinformation from anti-vaccine folks.

“…making general assumptions and drawing conclusions about vaccinations causing deaths based on spontaneous reports to VAERS – some of which might be anecdotal or second-hand – or from case reports in the media, is not a scientifically valid practice.”

Miller et al on Deaths following vaccination: What does the evidence show?

That’s despite the fact that both our safety monitoring systems and other studies have shown that vaccines are not associated with sudden unexplained deaths. In fact, deaths after vaccines are very rare.

“As for vaccines causing death, again so few deaths can plausibly be attributed to vaccines that it is hard to assess the risk statistically.”

WHO on Six common misconceptions about immunization

Studies have even shown a protective effect of getting vaccinated against SIDS.

“At the present time there is not enough known about the underlying mechanisms of death in SUDC to allow prediction of which children might die suddenly and unexpectedly. Additionally, there is no way to prevent SUDC since its cause is unknown. Through research, we strive to discover the risk factors and underlying causes of SUDC that will lead to its prevention. In the meantime, optimal pediatric care recommendations, including attending well child visits, maintaining current vaccinations, and obtaining appropriate health care when clinically indicated, should be followed.”

SUDC Foundation on Frequently Asked Questions

And it’s not just SIDS. We also see a “healthy vaccinee effect” in older kids, who have lower mortality rates than the general population, which includes some folks who aren’t vaccinated.

We don’t know what causes sudden unexplained death in children, although with continued research we hopefully soon will, and can then learn to prevent them. Until then, parents should feel confident that it is not caused by the vaccines, which are safe and necessary and work to protect them from many life-threatening vaccine-preventable diseases.

What to Know About Vaccines and Sudden Unexplained Death in Children

Vaccines are not associated with sudden unexplained death in children.

More on Vaccines and Sudden Unexplained Death in Children

Can Vaccines Cause Transverse Myelitis?

Transverse myelitis is not common, so most people probably haven’t heard of it.

“The term myelitis refers to inflammation of the spinal cord; transverse refers to the pattern of changes in sensation—there is often a band-like sensation across the trunk of the body, with sensory changes below.”

Transverse Myelitis Fact Sheet

The symptoms of transverse myelitis depend on where the inflammation occurs and sometimes, on the cause. They can include back pain, weakness or paralysis of the legs and arms, paresthesias (sensory alterations in the neck, arms, or legs), and bowel and bladder dysfunction.

What Causes Transverse Myelitis?

An MRI of a teen with transverse myelitis.
An MRI of a teen with transverse myelitis that resolved after total body irradiation therapy was stopped.

Many things can cause transverse myelitis.

Possible triggers can include:

  • infections – following bacterial, viral, fungal, and parasitic infections
  • immune system disorders
  • inflammatory disorders
  • vascular disorders

Unfortunately, it isn’t usually known what causes someone to develop transverse myelitis.

There are treatments though and many people with transverse myelitis have at least a partial recovery, although it may take months to years.

Transverse myelitis is not thought to be genetic and rates are highest in two age groups – those between 10 and 19 years (when many preteens and teens get vaccinated) and those between 30 and 39 years.

Can Vaccines Cause Transverse Myelitis?

Have you heard that vaccines can cause transverse myelitis?

“Vaccines currently routinely recommended to the general population in the U.S. have not been shown to cause transverse myelitis.”

Institute for Vaccine Safety on Do Vaccines Cause Transverse Myelitis?

While there are some case reports that tell of a temporal association between getting a vaccine and later developing transverse myelitis, the evidence does not support any association.

Why do we see these case reports?

Just like SIDS, autism, type 1 diabetes, and many other conditions, transverse myelitis has a background rate of disease or a number of cases that you can expect to occur in a given population. Once you know this background rate, you can then predict how many people will coincidentally develop transverse myelitis within one, seven, forty-two, or more days after they are vaccinated.

With a background rate of about 0.36 per 100,000 people, if one million get a vaccine, you would expect:

  • at least 1 to 2 of them to develop transverse myelitis coincidentally after 1 day
  • at least 1 to 2 of them to develop transverse myelitis coincidentally after 7 days
  • at least 2 to 4 of them to develop transverse myelitis coincidentally after 42 days

If the rate is higher than that, it could indicate a problem.

Let’s do the math.

There are about 1,400 new cases of transverse myelitis in the United States each year.

How many vaccines are given? About 286 million doses – each year. Some of those are given on the same day, but that would still mean that 100s of people should be getting transverse myelitis within 1 to 7 days if vaccines were a cause.

They aren’t.

“Correlation does not imply causation.”

In fact, an Institute of Medicine report, Adverse Effects of Vaccines: Evidence and Causality, dismissed most of the evidence for an associated between vaccines and transverse myelitis as insufficient and lacking.

And further studies found no association:

  • A Vaccine Safety Datalink study, Acute Demyelinating Events Following Vaccines: A Case-Centered Analysis, looked at nearly 64 million vaccine doses of vaccines and also “found no association between TM and prior immunization.”
  • Another study, Maternal safety of trivalent inactivated influenza vaccine in pregnant women, used “a large, geographically diverse, retrospective cohort of pregnant women” and found no cases of transverse myelitis.

Not only do vaccines not cause transverse myelitis, but many vaccine-preventable diseases can. So vaccines can likely protect you from developing transverse myelitis by protecting you from these diseases!

What to Know About Transverse Myelitis

Vaccines do not cause transverse myelitis, although many vaccine-preventable diseases can.

More on Transverse Myelitis