Tag: safe

Did a Top Cancer Scientist Suddenly Die After Getting a Yellow Fever Vaccination?

We are seeing many reports that Professor Martin Gore, an oncologist at London’s Royal Marsden Hospital for more than 35 years, died suddenly after getting a yellow fever vaccine.

Could that be true?

Could someone really die after getting a routine vaccination?

Did a Top Cancer Scientist Suddenly Die After Getting a Yellow Fever Vaccination?

Of course, it could be true.

Although vaccines are very safe, they are not 100% risk free. And tragically, they do very rarely have life-threatening side effects.

To be fair, we don’t know the full story about what happened to Prof Gore, but the media reports do say that he suffered total organ failure shortly after getting his yellow fever vaccine.

What we don’t know is how shortly after getting the vaccine or if there is any evidence for another cause for his having organ failure.

Still, although most side effects are mild, it is reported that the yellow fever vaccine, which has been available for more than 80 years, can rarely cause:

How rarely?

About 1 in 55,000 for severe allergic reactions, 1 in 125,000 for severe nervous system reactions, and 1 in 250,000 for life-threatening severe illness with organ failure.

And the risks are likely higher if you are older than age 60 years, although YEL-AND and YEL-AVD are not reported to happen with booster doses of the yellow fever vaccine.

“People aged ≥60 years may be at increased risk for serious adverse events (serious disease or, very rarely, death) following vaccination, compared with younger persons. This is particularly true if they are receiving their first yellow fever vaccination. Travelers aged ≥60 years should discuss with their healthcare provider the risks and benefits of the vaccine given their travel plans.”

Yellow Fever Frequently Asked Questions

Why would you get the yellow fever vaccine if you were older than aged 60 years and you knew there was a higher risk of severe side effects?

Yellow fever itself is a life threatening disease without a cure and a case fatality rate of up to 50%, and again, YEL-AVD is not common, occurring in about 0.4/100,000 doses.

So you would typically want to get vaccinated if you were traveling to an area where yellow fever was a risk.

“Since January 2018, 10 travel-related cases of yellow fever, including four deaths, have been reported in international travelers returning from Brazil. None of the 10 travelers had received yellow fever vaccination.”

Fatal Yellow Fever in Travelers to Brazil, 2018

In addition to outbreaks, yellow fever is still endemic in forty-seven countries in Africa and Central and South America, leading to 170,000 severe cases and 60,000 deaths in recent years, including some deaths in unvaccinated travelers returning from these areas. Did you read about these deaths in the paper?

Although it is not on the routine immunization schedule, if you are traveling somewhere and yellow fever is a risk, you should get a yellow fever vaccine.

Professor Gore’s death, at age 67, is a tragedy, no matter the cause.

That we are having to talk about it because anti-vaccine folks are using his death to push their idea that vaccines aren’t safe is unconscionable.

More on Yellow Fever Vaccine Deaths

Seven New Year’s Vaccine Resolutions for 2019

If you’re making New Year’s resolutions, here’s one for the top of your list:

  1. I won’t complain about my kids being kept out of school during an outbreak, if I intentionally didn’t vaccinate them.

Yes, apparently that was a thing this past year…

Not surprisingly, parents lost their challenge to get their unvaccinated kids back into their Waldorf school during a chicken pox outbreak.
Not surprisingly, parents lost their challenge to get their unvaccinated kids back into their Waldorf school during a chicken pox outbreak.

It is an important reminder that there are consequences if you choose to not vaccine your kids.

In addition to the risk of getting a vaccine-preventable disease, the risk of getting a vaccine-preventable disease and getting someone else sick, there is the chance that your kids will be quarantined and kept out of daycare or school until the outbreak is over.

Six More New Year’s Vaccine Resolutions for 2019

Need some more?

  1. I will not travel out of the country without getting caught up on my vaccines. Remember, most outbreaks are started when an intentionally unvaccinated person travels out of the country, gets exposed to a vaccine-preventable disease, comes home while they are still in the incubation period and not showing symptoms, and then eventually get sick, exposing others.
  2. I won’t let a small, yet vocal anti-vaccine minority scare me into a poor decision about my child’s vaccines
  3. I will not lie to get a religious vaccine exemption. Is your religion really against vaccinating and protecting your child?
  4. I will avoid anti-vaccine echo chambers when doing my research about vaccines.
  5. I will learn about the cognitive biases that might me keeping me from vaccinating and protecting my kids.
  6. I will not repeat an anti-vaccine point that has already been refuted a thousand times.

Vaccines are safe, effective, and necessary.

This year, resolve to make the right choice and get your kids vaccinated and protected.

More on Seven New Year’s Vaccine Resolutions for 2019

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

The National Vaccine Injury Compensation Program Payouts Prove that Vaccines are Dangerous

Have you heard this argument?

Misinformation about the NVICP, like from this Focus for Health article, likely helps confuse and scare many parents.
Misinformation about the NVICP, like from this Focus for Health article, likely helps confuse and scare many parents.

Apparently, some folks think that because we have a National Vaccine Injury Compensation Program that compensates those who have serious problems after a vaccine, even deaths, then it must mean that vaccines are dangerous.

Do the National Vaccine Injury Compensation Program Payouts Prove that Vaccines are Dangerous?

To most other people, that argument doesn’t hold water.

Why?

Because we know that:

  • the National Vaccine Injury Compensation Program is a no-fault alternative to the traditional legal system for resolving vaccine injury petitions
  • of over 3.1 billion doses of vaccines that were distributed in the United States between 2006 and 2016, there were 3,749 compensated claims through the NVICP
  • almost 80% of all compensated awards by the NVICP come as a “result of a negotiated settlement between the parties in which HHS has not concluded, based upon review of the evidence, that the alleged vaccine(s) caused the alleged injury.”
  • the NVICP settlements are funded by an excise tax on vaccines
  • the NVICP cases are published by the U.S. Court of Federal Claims, so all information is disclosed to the public and no safety concerns are hidden

So what does the National Vaccine Injury Compensation Program (VICP) really prove?

It proves that true vaccine injuries are very rare – about 1 in a million rare.

It proves that while vaccines are not 100% safe, they are very safe.

Certainly safer than the complications of a vaccine-preventable disease.

And it proves that anti-vaccine arguments are very easy to refute

More on the NVICP and Vaccine Safety