Tag: placebo

Are Vaccines Only Tested for 4 or 5 Days?

Where do some folks get the idea that vaccines are only tested for 4.5 days?

Anti-vax protestors often carry signs that say vaccines are only tested for 4.5 days. Don't believe them.
Anti-vax protestors often carry signs that say vaccines are only tested for 4.5 days. Don’t believe them.

The usual suspects…

Are Vaccines Only Tested for 4 or 5 Days?

But who gave them the idea to put it on their sign?

Again, the usual suspects…

Did the idea that vaccines are only tested for 4.5 days come from JB Handley, Children’s Health Defense Director and Co-Founder of Generation Rescue?
Did the idea that vaccines are only tested for 4.5 days come from JB Handley, Children’s Health Defense Director and Co-Founder of Generation Rescue?

Before we actually look to see if the original clinical trials for the hepatitis B vaccines only “solicited adverse reactions” for four or five days after vaccination, lets see what the safety studies have shown since these vaccines were approved in the 1980s.

These and other studies have shown that the hepatitis B vaccines are safe.

What about the idea that we only know what happens in the first four or five days after the vaccine is given?

Hepatitis B Vaccine Safety Testing

That’s not true. There are plenty of long term studies and safety studies typically collect safety information for weeks and months after a child is vaccinated.

“Open-ended diaries were provided to the parent(s) or guardian of the child before the vaccination program began in which to record any health problems that occurred 1 month before and 1 month following each of the 3 doses of vaccine, whether or not a health professional was consulted.”

De Serres et al on Importance of attributable risk in monitoring adverse events after immunization: hepatitis B vaccination in children.

Still, it is important to note that the further you get from a vaccination, the less likely that an adverse event is actually going to be caused by the vaccine though.

Consider the study by De Serres, Importance of attributable risk in monitoring adverse events after immunization: hepatitis B vaccination in children, in which they looked at the reports of adverse events both before and after vaccination and concluded that “postimmunization incidence systematically overestimates the risk of adverse events.”

Vaccines are tested very carefully, starting with small phase I and phase II trials, before moving to larger and longer lasting phase III trials.
Vaccines are tested very carefully, starting with small phase I and phase II trials, before moving to larger and longer lasting phase III trials.

It is also very important to note that like other vaccines, the hepatitis B vaccine was well tested before it was approved.

Although this was an efficacy trial, it included a double blind, placebo control and the researchers did notice any side effects.
Although this was an efficacy trial, it included a double blind, placebo control and the researchers did notice any side effects.

And many of the studies did include a placebo group.

A lot of folks in the placebo group for the hepatitis B vaccine trials got hepatitis B.
A lot of folks in the placebo group for the hepatitis B vaccine trials got hepatitis B.

Unfortunately, a lot of the folks in the placebo groups ended up getting hepatitis B.

In one study, Hepatitis B vaccine: efficacy in high-risk settings, a two-year study, which included an unvaccinated control group – “The control group was comprised of 31 patients and 24 staff members who had not been in contact with HBV until they entered the units and who did not wish to be vaccinated.”

What happens when you do a vaccinated vs unvaccinated study?
What happens when you do a vaccinated vs unvaccinated study?

Importantly, this study found “no local or general reaction to the immunization. A monthly biological and clinical survey of the vaccinated subjects showed no evidence of complication due to vaccination, especially no sign of auto­immunity.”

So why do we still hear the myth that vaccines are only tested for 4.5 days?

Anti-vax folks need to convince their followers that vaccines aren’t safe.

A careful look at all that went into the development of the hepatitis B vaccines shows that they are.

It also shows that vaccines are very necessary.

More on Hepatitis B Vaccine Safety Testing

More Vaccinated vs Unvaccinated Studies

Anti-vaccine folks continue to call for vaccinated vs unvaccinated studies.

A vaccinated vs unvaccinated study that anti-vaccine folks don't talk about...
A vaccinated vs unvaccinated study that anti-vaccine folks don’t talk about…

Not surprisingly, they ignore all of the studies that have already been done.

More Vaccinated vs Unvaccinated Studies

Listening to these anti-vaccine folks, you would actually think that the only vaccinated vs unvaccinated “study” that has ever been done is the survey about homeschoolers that they always talk about…

That leaves out a lot of other vaccinated vs unvaccinated studies, including:

Do we need even more studies on vaccinated vs unvaccinated children?

We already know that unvaccinated kids get sick more and they have more severe disease. Who is going to approve of or want to do a study that only puts kids at risk to get a vaccine-preventable disease?

Vaccines are safe, with few risks, and they are obviously necessary.

More on Vaccinated vs Unvaccinated Studies

Is the MMR Vaccine Licensing Being Called into Question?

Why do some folks think that the MMR vaccine licensing is being called into question?

Yup. That’s what the usual suspects are trying to make you think.

Is the MMR Vaccine Licensing Being Called into Question?

Taking advantage of the fact that many sites publish all press releases, these folks want you to think that a major news site is following their latest bombshell, which of course is just another dud.

The MMR was licensed in 1971. The ICAN papers are from 1978…

You mean there really isn’t an FDA coverup?

“Clinical studies of 284 triple seronegative children, 11 months to 7 years of age, demonstrated that M-M-R II is highly immunogenic and generally well tolerated.”

MMR II Package Insert

Not only is the package insert very transparent about the studies used to approve the MMR II vaccine they are talking about, since only a minor change was made to the original MMR vaccine, which was approved in 1971, it isn’t surprising that larger trials weren’t required at the time.

So there were earlier, larger trials?

Yup.

But did they use a saline control group?

Nope.

A Vaccinated vs Unvaccinated Study - Stokes et al on Trivalent combined measles-mumps-rubella vaccine. Findings in clinical-laboratory studies.
A Vaccinated vs Unvaccinated Study – Stokes et al on Trivalent combined measles-mumps-rubella vaccine. Findings in clinical-laboratory studies

The control group was actually unvaccinated.

It is also important to keep in mind that this study, and a few other MMR studies, followed much, much larger studies of the individual measles, mumps, and rubella vaccines.

“The large majority of children in the United States have been vaccinated against measles and a sizable portion have been given mumps and rubella vaccines. It is estimated by us based on vaccination distribution that about 41 million children have received measles vaccine, 7 million mumps vaccine, and 21 million rubella vaccine. The combined triple vaccine provides a simple, safe, and effective immunization procedure using a single vaccine dose against three important diseases in children who have not yet been immunized.”

Stokes et al on Trivalent combined measles-mumps-rubella vaccine. Findings in clinical-laboratory studies.

Much larger double-blind, placebo-controlled studies of the individual measles, mumps, and rubella vaccines.

This is why you don’t routinely do vaccinated vs unvaccinated studies anymore. It is unethical to let kids get measles, mumps, rubella or other diseases.

The bottom line is that the measles (1968), mumps (1967), and rubella (1969) vaccines were safe when they were approved by the FDA.

The MMR (1971) was safe when it was approved by the FDA.

And MMR-II (1978) was safe when it was approved by the FDA.

Since then, there have also been studies showing that getting a second dose of MMR-II is safe and effective and that ProQuad, the combination measles, mumps, rubella, and chickenpox vaccine is safe and effective, although it is associated with a small increased risk of febrile seizures if given as a first dose.

There is no FDA coverup. No bombshell.

Just anti-vaccine folks continuing to try and scare you away from vaccinating and protecting your kids.

More on the Licensing of the MMR Vaccine

Is the Meningococcal Vaccine More Dangerous Than Meningococcal Disease?

No one who has ever seen a child with meningococcal disease would ever think that it was even remotely possible that getting a meningococcal vaccine was more dangerous than getting the disease.

“The case-fatality ratio of meningococcal disease is 10% to 15%, even with appropriate antibiotic therapy. The case-fatality ratio of meningococcemia is up to 40%. As many as 20% of survivors have permanent sequelae, such as hearing loss, neurologic damage, or loss of a limb.”

Epidemiology of Vaccine Preventable Diseases (PinkBook)

Of course, that doesn’t stop anti-vaccine folks from spreading misinformation about these vaccines to try and scare parents away from vaccinating and protecting their kids.

Is the Meningococcal Vaccine More Dangerous Than Meningococcal Disease?

We actually vaccinate against meningitis with many different vaccines, including Hib, Prevnar, MMR, and the meningococcal vaccines.

And there are different types of meningococcal vaccines, including those that protect against Neisseria meningitidis serogroups A, C, W, Y and Men B.

Meningococcal vaccines are safe and effective against meningococcemia and meningococcal meningitis, both terrible diseases.
Meningococcal vaccines are safe and effective against meningococcemia and meningococcal meningitis, both terrible diseases.

So routine vaccinations likely prevent up to 500 meningitis deaths each year, just in the United States, including many deaths from Hib meningitis, pneumococcal meningitis, and meningococcal disease.

“During 2005-2011, an estimated 800-1,200 cases of meningococcal disease occurred annually in the United States, representing an incidence of 0.3 cases per 100,000 population.”

Epidemiology of Vaccine Preventable Diseases (PinkBook)

What about the idea that 1 in 100 people will have a serious reaction to the vaccine?

“The most frequently reported adverse events for MenACWY-D include fever (16.8%), headache (16.0%) injection site erythema (14.6%), and dizziness (13.4%). Syncope was reported in 10.0% of reports involving MenACWY-D. Of all reported MenACWY-D events, 6.6% were coded as serious (i.e., resulted in death, life-threatening illness, hospitalization, prolongation of hospitalization, or permanent disability). Serious events included headache, fever, vomiting, and nausea. A total of 24 deaths (0.3%) were reported.”

Epidemiology of Vaccine Preventable Diseases (PinkBook)

The serious events listed above were from the clinical trials for the vaccine and didn’t differ between the vaccine and placebo.

Although meningococcal vaccines can have frequent mild side effects, they very rarely have serious side effects.

Not everything that happens during a clinical trial is related to the vaccine, even though it still gets reported. Another Menactra trial reported no deaths and the serious adverse events that were reported weren’t related to getting vaccinated.

Here is another meningococcal study in which a few of the participants died – one in a car accident and the other a drug overdose.

These deaths were not related to getting vaccinated, but were listed because they occurred during the study.
These deaths were not related to getting vaccinated, but were listed because they occurred during the study.

Unfortunately, vaccines can’t protect you from everything…

It would be especially nice if they could protect us from bad anti-vaccine memes.

More on Meningococcal Vaccine Safety