Tag: pertussis

Are Reported Pertussis Cases up by 114% Since 1967?

We know that we are seeing more pertussis cases these days.

Although the last few years have been better, 2012 was an especially bad year, with at least 48,277 cases and tragically, at least 4 deaths.

Are Reported Pertussis Cases up by 114% Since 1967?

How does that compare to the the pre-vaccine era?

Cases are still well below what they were in the pre-vaccine era, before we were routinely using DPT and DTaP vaccines.

Reported cases of pertussis are still down from the prevaccine era and there are far fewer deaths, from 37 deaths in 1967 to 6 in 2015.
Reported cases of pertussis are still down from the prevaccine era and there are far fewer deaths, from 37 deaths in 1967 to 6 in 2015.

What about the idea that pertussis cases are up 114% since 1967?

While that may be true, the first thing you should ask yourself when looking at Lauren Novelli’s little graph, is why did she choose 1967?

Reported Pertussis Cases Are Down Since the Pre-Vaccine Era

We did start using a new vaccine in 1967, but it was the measles vaccine, not the DPT vaccine. Vaccines against diphtheria, pertussis, and tetanus had been available for some time and were used more routinely beginning in the 1950s.

And that explains the drop in pertussis cases from just over 120,000 in 1950 to about 40,000 in 1959.

More importantly, even as pertussis cases are increasing again, we aren’t seeing as many people dying from pertussis.

In 2018, there were 13,439 reported pertussis cases and 10 deaths.
In 2018, there were 13,439 reported pertussis cases and 10 deaths.

Is that because of better hygiene, sanitation, and nutrition?

No.

We had those in most of the United States in the 1950s and 60s. The big change is that even though the current pertussis vaccine might not be perfect, having issues with waning immunity, it can still protect you from severe disease.

Vaccinating against pertussis is far from useless and there is absolutely no evidence of dormant bacteria carriers being triggered into becoming active infections.

This is pure propaganda, but you should expect no less from someone who describes themselves as an intuitive nurse and sells CBD oil.

More on Reported Pertussis Cases

Why is the Tdap Vaccine in Category C?

The Tdap vaccine is routinely recommended for all pregnant women, so why would it be in the FDA Category C?

The FDA has actually removed the pregnancy categories.

We should start by stating that “risk-benefit decisions regarding use of a drug during pregnancy are more complex than the category designations suggest.”

Why is the Tdap Vaccine in Category C?

Anyway, the category designations are no longer being used on new drugs and vaccines.

“In December of 2014, the FDA published the Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling, referred to as the “Pregnancy and Lactation Labeling Rule” (PLLR or final rule). The PLLR removes pregnancy letter categories – A, B, C, D and X. Instead, under the final rule, narrative summaries of the risks of a drug during pregnancy and discussions of the data supporting those summaries are required in labeling to provide more meaningful information for clinicians.”

Guidelines for Vaccinating Pregnant Women

So is it still Category C?

Yes, for now. Few vaccines have converted to the new labeling system yet, which still leaves us with:

  • Pregnancy Category B: Tdap (Boostrix) – Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus during the first trimester (and there is no evidence of risk in later trimesters).
  • Pregnancy Category C: Tdap (Adacel) – Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks OR Animal reproduction studies have not been conducted and there are no adequate and well-controlled studies in humans.

Of course, the Vaccine Safety Datalink has published more than 14 studies “related to pregnancy and vaccination during pregnancy” and has used “data to study the health of children born to women who were vaccinated during pregnancy.”

And many of these studies are about the Tdap vaccine!

“There are no theoretical or proven concerns about the safety of the Tdap vaccine (or other inactivated vaccines like Tdap) during pregnancy. The shot is safe when given to pregnant women.”

Frequently Asked Questions for Pregnant Women Concerning Tdap Vaccination

This will likely be reflected when we get new labels for these vaccines, with wording that makes it clear that Tdap vaccines are safe in pregnancy.

what to know about the tdap vaccines and their category c designation

Tdap vaccines still have a Category C designation simply because their labels haven’t been updated to reflect the latest safety studies.

More on Tdap Vaccines and Category C

Making a Better Pertussis Vaccine

So we know that we need a better pertussis vaccine.

DTaP and Tdap just aren’t doing the job that they should be doing.

Whooping Cough is back, again.
Whooping Cough is back, again.

So when will we get one?

Making a Better Pertussis Vaccine

Since anti-vaccine folks are always talking about the 300 new vaccines in the pipeline, you would think that we would have had several new pertussis vaccines by now…

Unfortunately, we don’t.

What we do have is some good candidates, including:

  • new acellular pertussis vaccines, either with more antigens or an adjuvant
  • a new live attenuated nasal vaccine, BPZE1
  • new whole-cell vaccines with reduced endotoxin contents (so should have fewer side effects that then original whole-cell pertussis vaccine – DTP)

Before you get too excited, keep in mind that none of these vaccines will be available in your pediatrician’s office any time soon. Developing a new vaccine takes a lot of time.

BPZE1 has started phase 2a trials though.

What do we do until we get new pertussis vaccines?

“We should be more vigilant than we have been in the past to recognize and treat pertussis in all age groups so that transmission to young infants is reduced. Most important (although not discussed in this review) is to ensure that all pregnant women receive the Tdap vaccine between 27 and 36 weeks’ gestation with each pregnancy. Also, we should consider routinely administering Tdap vaccine every 3 years to all adolescents and adults who were primed with a DTaP vaccine.”

James D. Cherry on The 112-Year Odyssey of Pertussis and Pertussis Vaccines—Mistakes Made and Implications for the Future

We should keep using the pertussis vaccines we have!

Vaccines work, even when they aren’t as effective as we would like.

More on Making a Better Pertussis Vaccine

About Those Lawsuits That Almost Put Vaccine Manufacturers out of Business

So you likely know that there were a bunch of lawsuits against manufacturers of the DPT vaccine in the early and mid 1980s.

“As the number of lawsuits grew to hundreds during the early 1980s, the pharmaceutical companies making vaccines saw their liability insurance bills soar. Worried not only about multimillion-dollar settlements, but also even the legal costs of defending themselves successfully, several companies simply stopped making vaccine.”

How a Media Scare On Vaccine Started a ‘near-Epidemic’

That’s why the National Vaccine Injury Compensation Act passed in 1986, creating the National Vaccine Injury Compensation Program and the Vaccine Court.

About Those Lawsuits That Almost Put Vaccine Manufacturers out of Business

But did those DPT vaccine lawsuits prove that vaccines aren’t safe?

Is that why vaccine manufacturers needed help to limit their liability?

“The total amount claimed in 1984 DTP vaccine suits ($1.3 billion) is more than 20 times the total value of 1984 sales of DTP vaccine at the market price of $2.80 per dose.”

Hinman on DTP Vaccine Litigation

Of course not!

While the older DPT vaccine did cause more local reactions, pain, and fever than the newer DTaP vaccine that replaced it, all of the serious reactions that triggered the lawsuits were later found to not be caused by the vaccine.

Most of the DPT lawsuits were thought to be frivolous.

That’s not surprising, as the same vaccine lawsuits that were succeeding in driving vaccine manufacturers out of business in the United States were failing in the UK and Canada!

This included the Loveday judgment in Great Britain’s High Court of Justice, Queen’s Bench Division and the Rothwell judgment in the Supreme Court of Ontario, Canada, both decided in 1988, with justices ruling that there was “insufficient evidence to demonstrate that pertussis vaccine can cause permanent brain damage in children.”

Similar cases were succeeding in the US though..

“The number (and dollar value) of suits increased in 1982, a year when broadcast and print media began to devote considerable attention to the alleged hazards associated with the use of pertussis-containing vaccines. Most of the media coverage has emphasized alleged risks of pertussis vaccines and has given relatively little attention to the benefits of their use.”

Hinman on DTP Vaccine Litigation

Most experts knew that most of the lawsuits were frivolous, but they weren’t able to stop the damage that was to come, as:

  • the DPT: Vaccine Roulette special aired on TV
  • Barbara Loe Fisher, believing that her child was damaged by the DPT vaccine, formed the Dissatisfied Parents Together organization and wrote the book DPT: A Shot in the Dark, which later influenced Bob Sears
  • there were temporary shortages of DTP vaccine in 1984, as “two of the three American manufacturers of the product decided to halt or restrict its sales.”

What else happened? I mean besides all of the studies proving the DPT vaccine was safe?

Parents who had been scared by the DPT controversy were ready and primed when Andy Wakefield showed up and told them that they had something new to worry about – the MMR vaccine and autism.

And of course, pertussis is now returning, as more parents are scared to vaccinate their kids and the newer DTaP vaccine isn’t as effective as DPT.

More on Those Lawsuits That Almost Put Vaccine Manufacturers out of Business