Tag: vaccine pipeline

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

Why Do Some People Think That Vaccines Cause AFM?

So we know that vaccines don’t cause acute flaccid myelitis.

Consider a five-year-old in Maryland who recently came down with symptoms of AFM.

Was he recently vaccinated?

Nope. It had been some time since his four-year-old vaccines. Almost a year. And he had not gotten a flu vaccine yet.

What he did have were worsening symptoms about two weeks after he had seemed to get over a cold, something he has in common with most other kids with AFM.

“To try to pin a tragic yet uncommon neurological condition caused by enteroviruses on vaccines is dangerous and puts more kids at risk.”

Scott Krugman, MD

As with this case, the CDC reports no correlation with vaccines in the cases that they have investigated.

And remember, some of these kids have been unvaccinated!

That makes you wonder why some folks actually think that vaccines are associated with AFM, doesn’t it?

Why Do Some People Think That Vaccines Cause AFM?

That’s right, as you are likely suspecting, the usual suspects are pushing anti-vaccine propaganda and promoting the idea to scare parents away from vaccinating and protecting their kids.

“…there are many other reasons to suspect vaccine-related mechanisms of causation for AFM in the U.S., a primary one being that the scientific literature has documented paralysis as an adverse reaction to vaccination for decades!”

The Non-Polio Illness That “Looks Just Like Polio” by Lyn Redwood, RN, MSN, President, Children’s Health Defense

If any of these kids had recently gotten the oral polio vaccine, then sure, an adverse reaction to the vaccination would be at the top of the list of possible causes. After all, we know that VAPP can occur after OPV, but that vaccine hasn’t been used in the United States since 2000, when we switched to IPV.

Why do these folks think that they have it all figured out?

Vaccines are not causing AFM because of needle puncture wounds or tonsillectomies.
Vaccines are not causing AFM because of needle puncture wounds or tonsillectomies.

The AFM outbreaks happen at the beginning of the school year, when kids are all getting their shots, right?

Nope. They happen during the summer and early fall, peaking in August. And despite what some folks think, most parents don’t wait until the end of summer, just before school starts, to vaccinate their kids. Plus, most kids don’t even need vaccines before the start of the school year. Kids typically only get vaccines before starting kindergarten and middle school.

But the outbreaks do coincide with the when kids get their flu shots, right?

How many kids get flu shots in June and July?

If it was flu shots, the peak would be in October and November, when most kids get their flu shots and we would continue to see cases through December and January.

Many anti-vaccine websites and Facebook groups are pushing the idea that vaccines cause AFM.
Many anti-vaccine websites and Facebook groups are pushing the idea that vaccines cause AFM.

Of course, there is absolutely no evidence that flu vaccines, or any other vaccines, cause AFM.

What about the journal article that Brandy Vaughan posts as evidence?

“By reviewing vaccine-associated inflammatory diseases of the central nervous system, this study describes the current knowledge on whether the safety signal was coincidental, as in the case of multiple sclerosis with several vaccines, or truly reflected a causal link, as in narcolepsy with cataplexy following pandemic H1N1 influenza virus vaccination.”

Vaccine-associated inflammatory diseases of the central nervous system: from signals to causation

Even if you just read the abstract, as many folks do, you get a good idea where they are going with the article. It talks about how the claims of an association between multiple sclerosis and vaccines were proven to be purely coincidental.

Remember, correlation does not imply causation.

With AFM, you don’t even have much correlation to imply causation though!

Most cases occur just before we start giving flu vaccines and they don’t occur every year or in every state.

But doesn’t the article mention myelitis?

“Most of the published associations are based on individual case reports or small series of patients.”

Vaccine-associated inflammatory diseases of the central nervous system: from signals to causation

It does mention myelitis, just like it mentions MS – where an association has been shown to be purely coincidental.

Remember, case reports are not good evidence.

“…there are many other reasons to suspect vaccine-related mechanisms of causation for AFM in the U.S., a primary one being that the scientific literature has documented paralysis as an adverse reaction to vaccination for decades!”

The Non-Polio Illness That “Looks Just Like Polio” by Lyn Redwood, RN, MSN, President, Children’s Health Defense

But isn’t acute flaccid myelitis listed as a possible side affect in the package inserts for our vaccines?

Uh, TRANSVERSE myelitis and ACUTE DISSEMINATED ENCEPHALOmyelitis are not the same as acute flaccid myeltitis.
Uh, TRANSVERSE myelitis and ACUTE DISSEMINATED ENCEPHALOmyelitis are not the same as acute flaccid myelitis.

While it should be clear that AFM isn’t the same as ADEM and TM, it is very important to understand that even when those other conditions are listed in a package insert, it is in the section that is marked “without regard to causality.”

This isn’t evidence that vaccines cause AFM!

But didn’t the BMJ publish a study about Vaccines and the U.S. Mystery of Acute Flaccid Myelitis?

BMJ seems to allow anyone to publish responses to their articles online...
BMJ seems to allow anyone to publish responses to their articles online…

Nope. What they did is let someone publish what is essentially an online letter to the editor. And anti-vaccine folks are spreading it around like it is an actual BMJ study…

Surprised?

You shouldn’t be.

This is how anti-vaccine propaganda works.

Why are vaccine injury lawyers talking about AFM?
Why are vaccine injury lawyers talking about AFM?

It’s no coincidence that anti-vaccine folks are trying so hard to associate the outbreaks of AFM with vaccines. What better way to scare folks and make them think that vaccines are dangerous?

AFM is all that anti-vaccine folks are talking about these days...
AFM is all that anti-vaccine folks are talking about these days…

How are ‘we’ working on a vaccine for AFM if we don’t even know what causes AFM???

But that’s how many anti-vaccine folks think. Everything is a vaccine injury. Everything is a conspiracy.

Don’t believe them. Vaccines are safe and necessary.

More on Anti-Vaccine Propaganda About AFM

 

Do My Kids Need the RSV Vaccine?

While I’m sure that many parents would love to get their kids vaccinated and protected against RSV, unfortunately, we don’t yet have an actual RSV vaccine.

We do have Synagis (palivaizumab) though, a monthly injection that can be given to high risk children during RSV season to help prevent them from getting RSV.

Do My Kids Need Synagis?

Synagis is not a vaccine and doesn’t stimulate your body to make antibodies,  but is instead an injection of RSV antibodies made by recombinant DNA technology. That’s why you need to get an injection each month. The antibodies don’t last much longer.

So why doesn’t everyone get Synagis if RSV can be such a deadly disease?

For one thing, there is the high cost of Synagis injections, but there is also the fact that Synagis is only approved to be given to kids who are at high risk for severe RSV infections.

“Palivizumab prophylaxis has limited effect on RSV hospitalizations on a population basis, no measurable effect on mortality, and a minimal effect on subsequent wheezing.”

AAP on Updated Guidance for Palivizumab Prophylaxis Among Infants and Young Children at Increased Risk of Hospitalization for Respiratory Syncytial Virus Infection

And Synagis doesn’t have as a great an effect on preventing RSV infections as we would like. That’s why we need a real RSV vaccine instead.

When to start Synagis is carefully determined by the start of RSV season.
When to start Synagis is carefully determined by the start of RSV season.

So because it likely doesn’t provide that much help to kids who aren’t at very high risk for severe disease, the latest guidelines recommend that Synagis be given to:

  • pre-term infants born before 29 weeks, 0 days’ gestation and who will be younger than 12 months at the start of the RSV season
  • preterm infants with CLD of prematurity, defined as birth at <32 weeks, 0 days’ gestation and a requirement for >21% oxygen for at least 28 days after birth.
  • certain infants with hemodynamically significant heart disease during their first year of life and might include infants with cyanotic heart defects, infants with acyanotic heart disease who are receiving medication to control congestive heart failure and will require cardiac surgical procedures and infants with moderate to severe pulmonary hypertension, infants with heart lesions that were corrected by surgery, but who continue to require medications for congestive heart failure, and children under age two years who have had a cardiac transplant.
  • certain children in their second year of life if they required at least 28 days of supplemental oxygen after birth and who continue to require medical intervention (supplemental oxygen, chronic corticosteroid, or diuretic therapy)
  • certain infants in their first year of life with pulmonary abnormality or neuromuscular disease that impairs the ability to clear secretions from the upper airways
  • certain children in their second year of life if they will be profoundly immunocompromised during RSV season

Those who qualify get up to five monthly doses, beginning in November, to help make sure they are covered through the peak of RSV season – December to May.

Whether or not your high risk child gets Synagis, you can help to reduce their risk of getting RSV by making sure they are not exposed to tobacco smoke, keep them away from crowds of people, wash hands often, and if possible, keep them out of day care.

And get them all of their other vaccines, including a flu shot once they are six months old.

What do you do if your high risk child was denied Synagis by your insurance plan? If your infant has a qualifying condition, your pediatrician should be able to help you write an appeal to your insurance company stating that getting Synagis is a medical necessity.

More on Synagis and RSV Vaccines

What Is a Hexavalent Vaccine?

Most folks know that we have combination vaccines that help reduce the number of injections that kids have to get at one visit.

You might not think of it as a combination vaccine, but one of the first, DPT, simply combines protection against diphtheria, pertussis, and tetanus into one shot.

Of course, we have come a long way since the days when DPT and MMR were considered combination vaccines.

Wait, why aren’t they considered combination vaccines anymore?

It’s not part of any conspiracy. It’s simply because you can’t get their individual components separately anymore. There is no measles or rubella shots anymore. Just the MMR. There is no tetanus shot.

Combination Vaccines

Not surprisingly, it is now becoming routine for kids to get combination vaccines instead of separate shots.

That’s because while the great majority of us want our kids vaccinated and protected, few enjoy shots and needles.

“The use of licensed combination vaccines is preferred over separate injection of their equivalent component vaccines.”

AAP on Combination Vaccines for Childhood Immunization

Does this mean more vaccines at one visit?

Nope.

“So, at a doctor’s visit, your child may only get two or three shots to protect him from five diseases, instead of five individual shots. Fewer shots may mean less pain for your child and less stress for you.”

CDC on Combination Vaccines

It just means fewer injections.

Combination vaccines combine the vaccines that you are already getting into one injection.

What Is a Hexavalent Vaccine?

And they might get even fewer with the latest hexavalent vaccines (six-in-one).

This is the next step up from our current pentavelent vaccines (five-in-one), like Pediarix (combines DTaP, Hep B, and IPV) and Pentacel (combines DTaP, IPV, and Hib).

The hexavalent vaccines combine protection against diphtheria, tetanus, acellular pertussis, Haemophilus influenzae type B, poliovirus and hepatitis B (DTaP-Hib-IPV-HepB) into one injection.

Sounds good, right?

Although not approved in the United States, hexavalent vaccines, including Infanrix Hexa have been used in many other countries since 2000! Another, Hexavac was withdrawn from the market because of issues with waning hepatitis B antibody titers (kids had levels that were still protective, but were on the low side).

When will get a hexavalent vaccine in the United States?

Obviously, the early problems with Hexavac kept us from getting a hexavalent vaccine, at least before the next generation of vaccines was developed.

Hexavalent vaccines are widely available in most parents of the world.
Hexavalent vaccines are widely available in most parents of the world.

Two new hexavalent vaccines, Vaxelis and Hexyon, have recently been licensed in Europe, after many studies showed that they worked and were safe when given with all of the other vaccines on the schedule, including Prevnar, rotavirus, Men C, and MMRV.

And one of these might soon be coming to the United States.

V419 (Vaxelis), which was developed in collaboration between Merck and Sanofi Pasteur, has been under review by the FDA since 2014 has already received a Complete Response Letter that was “deemed complete and acceptable for review.”

Hopefully that means we will get a hexavalent vaccine soon.

Remember, that could mean just two shots at infant well check ups, but continued protection against eight vaccine-preventable diseases, as they get a hexavalent vaccine, Prevnar and the rotavirus vaccine!

More on the Hexavalent Vaccine

Vaccine Fast Tracking

Like a few other vaccines, Gardasil underwent Fast Track approval by the FDA.

“This is the first vaccine licensed specifically to prevent cervical cancer. Its rapid approval underscores FDA’s commitment to help make safe and effective vaccines available as quickly as possible. Not only have vaccines dramatically reduced the toll of diseases in infants and children, like polio and measles, but they are playing an increasing role protecting and improving the lives of adolescents and adults.”

Jesse Goodman, MD, MPH, Director of FDA’s Center for Biologics Evaluation and Research

But that doesn’t mean that any corners were cut in getting it quickly approved or that the vaccine isn’t safe.

Vaccine Fast Tracking

The Fast Track process can help get new drugs and vaccines approved more quickly by the FDA because they have:

  • more frequent meetings with the FDA to discuss the drug’s development plan and to help ensure the collection of appropriate data needed to support drug approval
  • more frequent written communication from the FDA about such things as the design of the proposed clinical trials and the use of biomarkers
  • eligibility for Accelerated Approval and Priority Review, if relevant criteria are met
  • a Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA.

In very simple terms, it is kind of like having a VIP pass at an amusement park. It gets you a guide and helps you jump to the front of many of the lines, but you still don’t get to operate the rides yourself.

Vaccine fast tracking doesn't mean that a vaccine gets approved too fast.
It is a myth that vaccine fast tracking means that a vaccine gets approved too fast.

Which vaccines have had Fast Track approval?

They include Gardasil, Vaxchora, a cholera vaccine, the MenB vaccines, and FluBlock, the flu vaccine that is made in insect cells.

Others that have Fast Track designation include vaccines for  anthrax (NuThrax anthrax vaccine adsorbed with CPG 7909 adjuvant), chikungunya, Clostridium difficile (Clostridium difficile toxoid vaccine), malaria, RSV, Zika, Ebola, Invasive
Staphylococcus aureus infections in surgical populations, Shigella (Flexyn2a), and Lyme disease. None are approved yet though.

And that all of these vaccines have Fast Track designation is a good reminder that it isn’t a guarantee of approval.

“With Fast Track designation, early and frequent communication between the FDA and the biopharmaceutical company is encouraged throughout the entire drug development and review process to help to quickly resolve any questions or issues that arise, potentially leading to an earlier approval and access by patients.”

Encouraging Vaccine Innovation: Promoting the Development of Vaccines that Minimize the Burden of Infectious Diseases in the 21st Century

It just puts them on a Fast Track to get approved if they meet all of the FDA requirements for safety and efficacy.

The ability to develop and approve new vaccines quickly is also important as we continue to face new emerging disease threats. Faced with a deadly global pandemic, everyone will be glad that we have the ability to Fast Track vaccines and other drugs.

More on Vaccine Fast Tracking