Tag: vaccine safety systems

Immunization Advisory Groups

Who makes recommendations regarding immunizations?

Your pediatrician?

The CDC?

Merck?

“The most influential body making vaccine recommendations in the USA is the Advisory Committee on Immunization Practices (ACIP).”

Vaccinology – An Essential Guide

In the United States, those recommendations are made by the Advisory Committee on Immunization Practices (ACIP), a group of medical and public health experts who provide advice and guidance to the Director of the CDC.

Immunization Advisory Groups

Again, ACIP is just for the United States though.

Many countries have their own Immunization Advisory Groups
Many countries have their own Immunization Advisory Groups

In other countries, there is:

Altogether, at least 99 countries have their own National Immunization Technical Advisory Groups!

“Immunization Technical Advisory Groups (ITAGs) are expert advisory committees that provide recommendations to guide a country’s national immunization programs and policies. They consist of independent experts with the technical capacity to evaluate new and existing immunization interventions. The premise of these groups is to facilitate a systematic, transparent process for developing immunization policies by making evidence-based technical recommendations to the national government. Their role is primarily technical and advisory and is intended to bring increased scientific rigour and credibility to the complex process of making immunization policies, free of political or personal interests.”

Bryson et al on A global look at national Immunization Technical Advisory Groups

These National Immunization Technical Advisory Groups help countries to tailor immunization schedules and vaccination programs to local needs, while also considering the vaccine policies of the WHO and other experts.

More on Immunization Advisory Groups

Which Countries Have a Vaccine Injury Compensation Program?

Vaccines are safe, effective, have few risks, and are obviously necessary.

They aren’t perfect though, which is why “the National Vaccine Injury Compensation Program (VICP) may provide financial compensation to individuals who file a petition and are found to have been injured by a VICP-covered vaccine.”

But the NVICP is only in the United States.

Which Countries Have a Vaccine Injury Compensation Program?

What do other countries do?

The United States isn't the only country with a vaccine injury compensation program. We weren't even the first to have such a system.

You will likely be surprised to know that many have their own vaccine injury compensation programs, including:

  1. Germany ( year of introduction – 1961)
  2. France (1963)
  3. Japan (1970)
  4. Switzerland (1970)
  5. Denmark (1972)
  6. Austria (1973)
  7. New Zealand (1974)
  8. Sweden (1978)
  9. UK Vaccine Damage Payments Unit (1979)
  10. Finland (1984)
  11. Government of Québec Vaccine Injury Compensation Program (1985)
  12. United States NVICP (1988)
  13. Taiwan (1988)
  14. Italy (1992)
  15. Korea National Vaccine Injury Compensation Program (1994)
  16. Norway (1995)
  17. Iceland (2001)
  18. Slovenia (2004)
  19. Hungary (2005)

Does this prove that vaccines are dangerous?

“Vaccines are extremely safe and harm is rare. World-wide, more than 30,000 vaccine doses are delivered per second through routine immunization programs, which,in turn, prevent an estimated 2 million to 3 million deaths annually. The occurrence of serious adverse events, such as those that result in death, threaten life, require inpatient hospitalization, or result in significant disability, are rare (eg, <1 adverse event occurs per 10 million doses for tetanus toxoid vaccines, 1-2 adverse events per 1 million doses for inactivated influenza vaccine, and none for hepatitis A).”

Halabi et al on A Global Vaccine Injury Compensation System

Of course not!

Remember, payouts from these programs, compared to the number of doses of vaccines given, are rare.

Should all countries have a compensation program?

“The most important justification, however, is an ethical argument from justice and equity: introduction of a vaccine injury compensation scheme acknowledges the unique situation that routine childhood immunization is a public health measure, given and accepted in good faith, that may occasionally damage the recipient.”

David Isaacs on Should Australia introduce a vaccine injury compensation scheme?

Sure.

People shouldn’t have to fight for compensation for the rare circumstance for when a true vaccine injury does occur.

More on International Vaccine Injury Compensation Programs

What’s the Difference Between the MMR and MMR-II Vaccines?

As most folks know, the original MMR vaccine, which combined the separate measles, mumps, and rubella shots, was licensed way back in 1971.

It included the original rubella vaccine, which was made with a duck embryo derivative of HPV-77 that was attenuated by passing it 77 times in monkey kidney cells.

Wait, what?

HPV?

Before the new conspiracy theories start, no, not that HPV.

It stands for High Passage Virus.

What’s the Difference Between the MMR and MMR-II Vaccines?

And while the vaccine worked, it didn’t work as well and caused more side effects than a RA27/3 rubella vaccine that was already approved in Europe

“Over the next decade, accumulating evidence led to changes in the United States. First, the duck embryo and dog kidney vaccine strains caused significant joint reactions [24–27]. Second, reinfection on exposure to wild rubella virus was demonstrated frequently with all strains except the RA 27/3 vaccine [28–30]. Third, the good safety record of the RA 27/3 vaccine in Europe, plus the majority opinion of scientists, led the US Food and Drug Administration to license RA 27/3. Important pressure for this decision came from Dorothy Horstmann at Yale, who was convinced by her comparative studies of rubella vaccines [31], and by Maurice Hilleman at Merck, who sought a better rubella strain for measles-mumps-rubella (MMR) vaccine.”

Stanley Plotkin on The History of Rubella and Rubella Vaccination Leading to Elimination

So that’s it, they just changed out the rubella component for one that was safer and worked better.

The new and improved MMR-II vaccine was approved by the FDA in 1978.
The new and improved MMR-II vaccine was approved by the FDA in 1978.

And of course, they did the appropriate clinical trials and got FDA approval for this updated vaccine.

The control group didn't get a vaccine during the study.
The control group didn’t get a vaccine during the study.

But did they compare the vaccines against a saline placebo?

“The inclusion of a seropositive control group allowed the rates of reaction to be viewed against the background symptoms unrelated to vaccine administration.”

Polk et al on A controlled comparison of joint reactions among women receiving one of two rubella vaccines.

They actually went a little further, in a double-blind, controlled cohort study comparing it to folks who didn’t receive any vaccine at the time of the study!

Why so many joint issues with the vaccine?

The studies were in adults, who seemed to have more side effects with the vaccine. Still, the side effects, including arthritis, were transient.

What about the idea that it was studied long enough before being approved?

Both the rubella component and the MMR-II vaccine were studied both before and after being approved. In fact, the MMR-II vaccine is probably the most studied vaccine in history!

Believe it or not, they include placebo-controlled trials.

A double-blind, placebo-controlled, cross-over MMR study in twins!

What was the placebo in the Finland twin trial?

“The injections consisted of 0.5 ml of vaccine 2-5 or placebo (the same product including neomycin and phenol-red indicator but without the viral antigens) and were administered subcutaneously by the nurse to the left deltoid or gluteal region.”

Peltola et al on Frequency of true adverse reactions to measles-mumps-rubella vaccine. A double-blind placebo-controlled trial in twins.

If that doesn’t sound like a placebo to you, keep in mind that the MMR vaccine doesn’t contain that many ingredients. Remember, MMR doesn’t contain aluminum or thimerosal. And if the placebo didn’t contain the antigens, then it likely didn’t contain all of the things that went into getting those antigens in the vaccine, such as cell cultures and albumin, etc.

Still, some folks aren’t going to be satisfied unless there is a study with a saline placebo.

“The four other vaccines were commercial products of Merck Sharp & Dohme. The placebo consisted of vaccine diluent.”

Lerman et al on Clinical and Serologic Evaluation of Measles, Mumps, and Rubella (HPV-77: DE-5 and RA 27/3) Virus Vaccines, Singly and in Combination

The vaccine diluent?

What’s that?

It depends on the vaccine, but for MMR-II it’s sterile water.

“Placebo DTP consisted of sterile saline which was dispensed into sterile Tubex syringes.”

Deforest et al on Simultaneous Administration of Measles-Mumps-Rubella Vaccine With Booster Doses of Diphtheria-Tetanus-Pertussis and Poliovirus Vaccines

The MMR vaccine was even tested in placebo controlled trials with other vaccines!

And like other vaccines, the MMR vaccine has been found to be safe, with few risks, and is definitely necessary.

More on the the Difference Between the MMR and MMR-II Vaccines

Are Vaccines Contaminated with Retroviruses?

Would you be concerned to know that the FDA is investigating how to make sure vaccines aren’t contaminated with retroviruses?

“Therefore, to ensure the safety of vaccines, our laboratory is investigating ways to activate latent viruses in cell lines and to detect the activated viruses, as well as other unknown viruses, using new technologies. We will then adapt our findings to detect viruses in the same types of cell substrates that are used to produce vaccines. We are also trying to identify specific biological processes that reflect virus activity.”

Investigating Viruses in Cells Used to Make Vaccines; and Evaluating the Potential Threat Posed by Transmission of Viruses to Humans

Or like most folks, would it reassure you that they are continuing to work to make sure that our vaccines are safe.

Are Vaccines Contaminated with Retroviruses?

Vaccines are not contaminated with infectious retroviruses.

“Vaccines effectively reduce and prevent death and disease from many viral infections. However, vaccine production occasionally has been complicated by inadvertent contamination with adventitious agents that may have originated from cell substrates used to propagate vaccine strains.”

Hussain et al on Lack of Evidence of Endogenous Avian Leukosis Virus and Endogenous Avian Retrovirus Transmission to Measles Mumps Rubella Vaccine Recipients

The issue first came up back in 1995 when it was discovered that MMR vaccines contained reverse transcriptase proteins. Researchers later found endogenous avian leukosis virus (ALV) and endogenous avian retrovirus (EAV) in those vaccines. Fortunately, they were not infectious and did not actually cause infections in any of the folks who got the vaccines.

Why were they there?

“Virtually all vertebrates studied, including humans, carry endogenous retroviral genomes as part of their natural genetic constitution.”

Adventitious Viral Genomes in Vaccines but Not in Vaccinees

The MMR vaccine is grown in chick embryo tissue culture. Partial or complete genomes of these viruses can be present in chicken DNA. In fact, all chickens contain endogenous avian retroviral genome (EAV), and although that means they can release viral particles, they are noninfectious, so can’t make you sick.

Why weren’t they detected when the vaccines were first developed and approved?

The technology wasn’t available at the time.

“The absence of an infectious retrovirus in the MVVE material used in this study and in the CEF supernatant used in the previous study (which contained levels of RT activity similar to those of MVVE, based upon comparison with the positive control AMV RT dilution series) provides confidence regarding the safety of the earlier MV vaccines used in humans. The results of this study further demonstrate the absence of a known public health safety concern related to the presence of RT activity in chick-cell-derived vaccines and support World Health Organization recommendations for the continued use of chick-cell-derived vaccines in humans.”

Shahabuddin et al on No Evidence of Infectious Retroviruses in Measles Virus Vaccines Produced in Chicken Embryo Cell Cultures

And once the technology was available, these retroviruses were thoroughly investigated and found to not be a safety hazard. That’s not surprising though, as no problems were previously detected by our vaccine safety systems.

So why are we still talking about retroviruses in vaccines?

Judy Mikovits is still finding retroviruses wherever she looks for them…
Judy Mikovits is still finding retroviruses wherever she looks for them…

Because anti-vaccine folks need something else to use to scare folks away from vaccinating and protecting their kids

More on Vaccines and Retroviruses