Tag: liability

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

Anti-Vaxxers Should Be Able to Answer These Questions Correctly

There is a new meme going around suggesting that folks have no business telling anyone to vaccinate and protect their kids unless they can answer a series of questions.

I bet answers from anti-vaccine folks aren't the same as the answers from the rest of us...
I bet answers from anti-vaccine folks aren’t the same as the answers from the rest of us…

While it is certainly good to be educated about vaccines, their questions seem rather loaded.

Anti-Vaxxers Should Be Able to Answer These Questions Correctly

Since it is immoral and dangerous to push misinformation that scares parents away from vaccinating and protecting their kids, it would be nice if anti-vaccine folks would answer these questions before they tried to persuade anyone to not get vaccinated:

  1. Name 5 vaccine ingredients that you think are toxic and how exactly they can be toxic at the amounts present in vaccines.
  2. Name 5 possible complications of a vaccine-preventable disease.
  3. Are doctors and alternative health care providers who push non-standard, parent-selected, delayed protection vaccine schedules able to be held liable if their intentionally unvaccinated child suffers a vaccine-preventable disease or starts an outbreak, infecting other people?
  4. How many children died of vaccine-preventable diseases in the early 1980s, before the vaccine schedule grew to include the new vaccines we give today?
  5. Is it true that no one can force you to get vaccinated?
  6. What percentage of reports to VAERS are actually caused by vaccine reactions?
  7. How many doses of vaccines have been given since the Vaccine Court began paying for vaccine injury cases?
  8. Which vaccines must be avoided because of shedding or other concerns if you have a child with an immunodeficiency in your home?
  9. Why do some folks think that many vaccines still contain thimerosal?
  10. If today’s vaccines already contain far fewer antigens than they did in the old days, what would be the extra benefit of splitting them up even further into separate shots for each vaccine-preventable disease?
  11. Have you read all of studies on the safety and effectiveness of combination vaccines, including those that are double-blinded and placebo controlled, and the current vaccine schedule?
  12. Can you give me one other interesting fact about vaccines or vaccine-preventable diseases that was not already asked or discussed?

What’s my interesting fact?

Many on-the-fence and vaccine hesitant parents do change their mind about vaccines and decide to make the right choice and get their kids vaccinated and protected.

More Things Anti-Vaxxers Should Know

Do Kids Really Get 72 Doses of Vaccines?

Most parents vaccinate their kids according to the recommended immunization schedule.

They know that’s the best way to keep them protected.

Do Kids Really Get 72 Doses of Vaccines?

Saying kids get 72 doses of vaccines is a propaganda too to scare parents.
Saying kids get 72 doses of vaccines is a propaganda tool to scare parents.

While kids do get more vaccines than their parents did, that’s only because we have more vaccines available to protect them from more now vaccine-preventable diseases.

Do they get their kids 72 doses of vaccines?

That sounds like a lot…

It sounds like a lot because it is an inflated number that is meant to scare parents.

Kids today do routinely get:

  • 13 vaccines, including 5 doses of DTaP, 4 doses of IPV (polio), 3 or 4 doses of hepatitis B, 3 or 4 doses of Hib (the number of doses depends on the vaccine brand used), 4 doses of Prevnar, 2 or 3 doses of rotavirus (the number of doses depends on the vaccine brand used), 2 doses of MMR, 2 doses of Varivax (chicken pox), 2 doses of hepatitis A, 1 doses of Tdap, 2 or 3 doses of HPV (the number of doses depends on the age you start the vaccine series), 2 doses of MCV4 (meningococcal vaccine), and yearly influenza vaccines
  • protection against 16 vaccine-preventable diseases, including diphtheria, tetanus, pertussis, measles, mumps, rubella, polio, chicken pox, pneumococcal disease, hepatitis A, hepatitis B, meningococcal disease, HPV, rotavirus, Hib, and flu
  • about 28 doses of those vaccines by age two years (with yearly flu shots)
  • about 35 doses of those vaccines by age five years (with yearly flu shots)
  • as few as 23 individual shots by age five years if your child is getting combination vaccines, like Pediarix or Pentacel and Kinrix or Quadracel and Proquad
  • about 54 doses of those vaccines by age 18 years, with a third of that coming from yearly flu vaccines

How do you get a number like 72?

You can boost your count to make it look scarier by counting the DTaP, MMR, and Tdap vaccines as three separate vaccines each, even though they aren’t available as individual vaccines anymore.

To boost the Vaccine Doses for Children a bit more, they add pregnancy doses too.
To boost the Vaccine Doses for Children a bit more, they add pregnancy doses too.

This trick of anti-vaccine math quickly turns these 8 shots into “24 doses.”

It’s not a coincidence.

Anti-vaccine folks want to scare you into thinking that vaccines are full of toxins, that kids get too many vaccines, that we give many more vaccines than other countries, and that this is causing our kids to get sick.

Can an unvaccinated child really get tetanus after a toe nail injury?
Can an unvaccinated child really get tetanus after a toe nail injury? Photo by Petrus Rudolf de Jong (CC BY 3.0)

None of it is true.

At age four years, when your preschooler routinely gets their DTaP, IPV, MMR, and chicken pox shots before starting kindergarten, how many vaccines or doses do you think they got? Two, because they got Kinrix or Quadracel (DTaP/IPV combo) and Proquad (MMR/chickenpox combo)? Four, because they got separate shots? Or Eight, because you think you should count each component of each vaccine separately?

Know that even if you do want to count them separately, it really just means that with those two or four shots, your child got protection against eight different vaccine-preventable diseases – diphtheria, tetanus, pertussis, polio, measles, mumps, rubella, and chicken pox.

Vaccine-preventable diseases that have not disappeared, something that the “72 doses” sites don’t ever warn you about.

What to Know About Anti-Vaccine Math

Many websites use anti-vaccine math to inflate vaccine dose numbers and scare parents away from vaccinating and protecting their kids.

More on Anti-Vaccine Math

Can Parents Still Sue Vaccine Manufacturers?

Have you heard the myth that vaccine manufacturers have no liability and that you can no longer sue them

Of course, it isn’t true.

After all, isn’t there a class action lawsuit against Merck about the mumps vaccine?

Can Parents Still Sue Vaccine Manufacturers?

The Wisconsin Coalition for Informed Vaccination is pushing myths about the liability of vaccine manufacturers.
The Wisconsin Coalition for Informed Vaccination is pushing myths about the liability of vaccine manufacturers.

Vaccines are safe, but they are not without some risks, so what happens if a child does suffer a vaccine injury? Hopefully, even if it is a rare life-threatening condition, they can get treated and improve, avoiding that particular vaccine in the future.

They can also file a petition with the Vaccine Court and if the reaction is determined to be caused by a vaccine, they can be compensated.

So parents don’t usually sue vaccine manufacturers directly – they go through Vaccine Court.

But that isn’t there only option…

Parents can still sue vaccine manufacturers:

  • if the claim is not related to vaccine injury
  • in state court for vaccine injury, as long as the claim is not of design defect, and as long as they have already gone through Vaccine Court

So it certainly isn’t true that “under no circumstance may you sue a vaccine manufacturer.”

What’s the benefit of going through Vaccine Court, “a no-fault alternative to the traditional legal system for resolving vaccine injury petitions?”

For one thing, the majority of compensated claims in Vaccine Court are settled claims, in which “cannot be characterized as a decision by HHS or by the Court that the vaccine caused an injury.”

etitioners would not get to use the Althen standard if the National Childhood Vaccine Injury Act and NVICP were rescinded.
Petitioners would not get to use the Althen standard if the National Childhood Vaccine Injury Act and NVICP were rescinded.

It is likely that at least some of those claims wouldn’t win if they weren’t in Vaccine Court, where:

  • causation is presumed (you automatically win) if you are claiming a table injury
  • the rules for evidence are relaxed and expert testimony does not necessarily have to meet the  strict requirements of the Daubert standard
  • petitioners must meet a fairly lenient standard to win, the regular standard of proof for a civil trial (more likely than not), but only have to provide a plausible theory for vaccine injury. Instead of providing scientific evidence or proving causation, they simply have to provide a theory that “is ‘logical’ and legally probable, not medically or scientifically certain.”
  • you don’t have to show that the vaccine was defective to make your case

Another benefit of Vaccine Court? All lawyer fees are paid, whether you win or lose, and lawyers do not get part of the award if you win. In traditional court, lawyers might get up to thirty-three percent of your award.

What to Know About Vaccine Manufacturer Liability and Vaccine Court

Although they must usually go through Vaccine Court first, folks can still sue vaccine manufacturers in some cases.

More on Vaccine Manufacturer Liability and Vaccine Court