Tag: vaccine pipeline

Where are the Saline Placebos?

Remember when anti-vaccine folks used to say that there were no double-blind, placebo-controlled randomized clinical trials for vaccines?

What happened once they realized that there actually were?

They moved the goal posts…

Where are the Saline Placebos?

Okay, they said.

So you have done double-blind, placebo-controlled randomized clinical trials when testing vaccines, but what placebo did you use?

Was it a pure saline placebo?

“Placebo Control – A comparator in a vaccine trial that does not include the antigen under study. In studies of monovalent vaccines this may be an inert placebo (e.g. saline solution or the vehicle of the vaccine), or an antigenically different vaccine. In combined vaccines, this may be a control arm in which the component of the vaccine being studied is lacking.”

WHO on the Guidelines on clinical evaluation of vaccines: regulatory expectations

Although no guidelines actually call for using a pure saline placebo, that’s all anti-vaccine folks will accept these days.

Why?

That’s their MO – or method of operation.

When one theory or myth gets squashed – they move to another.

They move the goalposts.

It doesn’t matter that there are often ethical and logistical problems with using pure saline placebos, that’s all they want to hear about it.

That they wouldn’t be satisfied and start vaccinating their kids if all vaccine studies started to use saline placebos should be evident when you consider that many vaccine studies have already used saline placebos!

There are many more vaccine studies that have used saline placebos and like other vaccine studies, have found vaccines to be safe and effective.

But how do you know that they used a real saline placebo and not some kind of saline solution with other stuff in it?

If it isn’t clear to you in the methods section of the study, go to the source – the original clinical trials record and it will be listed there.

What are you going to be worried about now?

More on Saline Placebos

Are You Ready for DNA Vaccines?

Believe it or not, vaccines aren’t a one-size-fits-all kind of a thing.

“There are several different types of vaccines. Each type is designed to teach your immune system how to fight off certain kinds of germs — and the serious diseases they cause.”

Vaccine Types

In addition to live vaccines, like MMR, there are inactivated vaccines, toxoid vaccines, and subunit, recombinant, polysaccharide, and conjugate vaccines.

Are You Ready for DNA Vaccines?

Vaccines made with current technology have helped save millions of lives.

It’s time for some new approaches though, especially as we are seeing the limitations of some of our current vaccines, especially the seasonal flu vaccine.

“DNA vaccines take immunization to a new technological level. These vaccines dispense with both the whole organism and its parts and get right down to the essentials: the microbe’s genetic material. In particular, DNA vaccines use the genes that code for those all-important antigens.”

NIH on Vaccine Types

While a DNA vaccine might sound like something out of the 23rd century, researchers have been studying them since the 1990s.

“Researchers have found that when the genes for a microbe’s antigens are introduced into the body, some cells will take up that DNA. The DNA then instructs those cells to make the antigen molecules. The cells secrete the antigens and display them on their surfaces. In other words, the body’s own cells become vaccine-making factories, creating the antigens necessary to stimulate the immune system.”

NIH on Vaccine Types

Does the idea of being injected with the genes for a microbe’s antigens scare you?

“The original concerns associated with the DNA platform were the potential for genomic integration and development of anti-DNA immune responses. Exhaustive research has found little evidence of integration, and the risk for integration appears to be significantly lower than that associated with naturally occurring mutations”

Ferraro et al on Clinical Applications of DNA Vaccines: Current Progress

What do you think happens when you get the flu?

The flu virus and it’s DNA is taken up by your cells, and those cells then start making more flu proteins.

“This approach offers a number of potential advantages over traditional approaches, including the stimulation of both B- and T-cell responses, improved vaccine stability, the absence of any infectious agent and the relative ease of large-scale manufacture.”

WHO on DNA Vaccines

So where are all of the DNA vaccines?

“However, the results of these early clinical trials were disappointing. The DNA vaccines were safe and well tolerated, but they proved to be poorly immunogenic. The induced antibody titers were very low or nonexistent, CD8+ T-cell responses were sporadic, and CD4+ T-cell responses were of low frequency. However, these studies provided proof of concept that DNA vaccines could safely induce immune responses (albeit low-level responses) in humans.”

Ferraro et al on Clinical Applications of DNA Vaccines: Current Progress

After getting disappointing results in the 1990s, researchers have since moved on to second-generation DNA vaccines, which are being tested for HIV treatment and prevention, Zika, Dengue fever, influenza (DNA vaccine prime), HPV, cancer treatment (metastatic breast, B cell lymphoma, melanoma, prostate, colorectal), chronic hepatitis B treatment, chronic hepatitis C treatment, herpes, and malaria.

There are many completed trials for DNA vaccines.
There are already many completed trials for DNA vaccines.

While many of these DNA vaccines are now in phase I and II trials, unfortunately, that means we are still a long time away from having a DNA vaccine on the immunization schedule.

More on DNA Vaccines

How Are Vaccines Related to News About Food Recalls and Food Poisoning?

Do you ever think about vaccines when you think about food recalls?

How about when you think about food poisoning?

Well, maybe you should, after all, we do have vaccines to prevent hepatitis A infections and typhoid fever, both are which can be spread through contaminated food.

How Are Vaccines Related to News About Food Recalls and Food Poisoning?

That’s not exactly what we were talking about though…

Anti-vaccine folks have a new conspiracy theory about food recalls and food poisoning.
Surprise! Anti-vaccine folks have a new conspiracy theory about food recalls and food poisoning. How often do these types of posts correlate with the truth? What do you guys think? Zero?

That’s right, some folks think that the recent food recalls are correlated to vaccines. They are “creating a market” for a new Salmonella enterica serovar Typhimurium vaccine!

“We evaluated the extent of attenuation and immunogenicity of the ΔlppAB and ΔlppAB ΔmsbB mutants of Salmonella enterica serovar Typhimurium when delivered to mice by the oral route.”

Erova et al on Protective Immunity Elicited by Oral Immunization of Mice with Salmonella enterica Serovar Typhimurium Braun Lipoprotein (Lpp) and Acetyltransferase (MsbB) Mutants

At least they are if mice are monitoring our outbreaks and are in the market for a Salmonella enterica serovar Typhimurium vaccine?

How would that work anyway? No, not mice watching the news and ordering vaccines…

Do they actually think that someone is contaminating our food with Salmonella bacteria so that folks will want these vaccines, when they become available?

Food poisoning is horrible!

Whether it is for Listeria, Salmonella, or E. coli, it likely won’t be very hard to get folks vaccinated, if and when they become available.

More on Propaganda About Vaccines and Food Recalls

Should You Get an Extra Dose of Gardasil9?

Believe it or not, the first human papillomavirus (HPV) vaccine was approved way back in 2006.

HPV Vaccine is Cancer Prevention.

And believe it or not, we are now on our third version of the vaccine, which provides protection against even more strains of HPV.

HPV Vaccine Timeline

So we have gone from:

  • Cervarix – HPV serotypes 16, 18 (2006)
  • Gardasil – HPV serotypes 6, 11, 16, 18 (2006)
  • Gardasil9 – HPV serotypes 6, 11, 16, 18, 31, 33, 45, 52, and 58 (2014)

And with each new vaccine, there comes more protection against anal and genital warts and anal, genital, head and neck, and cervical cancers.

Gardasil9, the only HPV vaccine available in the United States, increases the protection level against cervical cancer from 70 to 90%!

Should You Get an Extra Dose of Gardasil9?

Has your child already finished their HPV vaccine series?

With which HPV vaccine?

To be clear, if they have finished the series, then they are considered to be fully vaccinated and protected.

“Persons who have completed a valid series with any HPV vaccine do not need any additional doses.”

National Cancer Institute on Human Papillomavirus (HPV) Vaccines

Remember, the key, high-risk strains that cause most HPV-associated cancer are HPV-16 and 18, which are present in all of the HPV vaccines.

The extra coverage in Gardasil9 to HPV strains 31, 33, 45, 52, and 58 could prevent an additional 10% of invasive HPV associated cancers or about 3,800 cases each year though, mostly in women.

Should you get any extra doses of Gardasil9 for this extra coverage?

“Administration of a 3-dose regimen of 9vHPV vaccine to adolescent girls and young women 12-26 years of age who are prior qHPV vaccine recipients is highly immunogenic with respect to HPV types 31/33/45/52/58 and generally well tolerated.”

Garland et al on Safety and immunogenicity of a 9-valent HPV vaccine in females 12-26 years of age who previously received the quadrivalent HPV vaccine.

While safe to do and it works, there is no formal recommendation that anyone actually get any extra doses of Gardasil9 at this time.

It is something to consider if you want the extra protection though.

Will we get even more coverage in future HPV vaccines? The future might come in different types of vaccines or even in therapeutic vaccines. There doesn’t seem to be a new version of Gardasil with expanded strain coverage in the immediate pipeline though.

More on Getting an Extra Dose of HPV9