For example, while it might sound like there have been a lot of adverse drug reaction reports for the DTaP vaccine, with 179,447 reports in VigiAccess, since those are worldwide reports since 1968, it is likely among many billions of doses of vaccines being given.
Most importantly though, as with VAERS, “The reports in VigiBase result from suspicions of a relationship between a drug and a reaction. No causal relation has been confirmed.”
So how do you put the numbers from VigiBase and VigiAccess in context?
If you consider that reports and safety signals from VigiBase, VigiMatch, VigiRank, and other tools used by the Uppsala Monitoring Centre continue to find that vaccines are safe, then to put the DTaP numbers in context, they help us know that vaccines are being well monitored for safety.
And since we know that these diseases haven’t disappeared, any further context, if you need it, would be that since vaccines are safe and necessary, then you should get yourself and your family vaccinated and protected.
Reagan didn’t do much for vaccines, but it isn’t fair to pin this one on him.
It seems that some folks think that the Department of Health and Human Services hasn’t been complying with federal vaccine safety mandates for 30 years.
Did the US Government Lose a Landmark Vaccine Lawsuit?
While anti-vaccine folks are pushing this lawsuit victory (?) to make folks think that HHS has done absolutely nothing to promote vaccine safety in the last 30 years, that is obviously nonsense.
The lawsuit was actually just about the reporting requirements of paragraph (c) of section 2127 of the National Childhood Vaccine Injury Act of 1986.
It should be clear that the HHS has done plenty to promote vaccine safety though.
Even if no formal reports were filed, the HHS secretary did report to and appear before Congress. Come to think of it, they even sent some reports to Congress.
And the Health and Medicine Division (HMD) division (previously known as the Institute of Medicine (IOM) of the National Academies of Sciences, Engineering, and Medicine has published a number of vaccine safety reviews and reports under commission of HRSA, an agency of HHS.
Where do folks think that all of those IOM vaccine safety reports and reviews come from? Were they sent to Congress?
a Task Force on Safer Childhood Vaccines was established and completed a report, “identifying key issues and enhancing collaboration on behalf of vaccine safety” in 1996. Did someone forget to send it to Congress?
the Salk inactivated polio vaccine (IPV) replaced the oral polio vaccine (OPV) in 1996 because of a small risk of vaccine-associated paralytic poliomyelitis (VAPP), beginning with a sequential IPV-OPV vaccine schedule and then going to an all IPV schedule in 2000
the DTaP vaccine, which is supposed to have fewer side effects than DTP is licensed, and replaces DTP for all required doses by 1997, although DTP is never actually shown to have caused seizures or brain damage
RotaShield, the first rotavirus vaccine is licensed in 1998 but is soon withdrawn from the market in 1999 after it is associated with an increased risk of intussusception, a form of bowel obstruction
a new National Vaccine Plan was established in 2010, with the goal to develop new and improved vaccines, enhance the vaccine safety system, support communications to enhance informed vaccine decision-making, ensure a stable supply of, access to, & better use of recommended vaccines in the U.S., and increase global prevention of death & disease through safe & effective vaccination. Was the plan sent to Congress?
They did settle a lawsuit though, a lawsuit which was then dismissed.
So like the CDC whistleblower movie that didn’t include a whistleblower, anti-vaccine folks think that they have a smoking gun about vaccine safety reports, except that it is very obvious that all kinds of reports about vaccine safety have been done over the years.
Although it does seem like HHS didn’t file the required formal reports and keep to the strict letter of the National Childhood Vaccine Injury Act of 1986, there is abundant evidence that they have actually done all of the work required to make sure that our vaccines are safe.
There was a baboon study with the pertussis vaccine and it found that previously vaccinated baboons could develop asymptomatic carriage of the pertussis bacteria after they were intentionally infected.
Here is where it is important to note that an infection is different than a disease.
The example that many people are familiar with is tuberculosis. It is common to have a TB infection without any signs or symptoms and to not feel sick. The only reason we know that they have TB is because they had a positive TB test.
Unfortunately, about 5 to 10% of these people with TB infections can eventually develop TB disease, with coughing, weight loss, night sweats, fever, and chest pain, etc.
It is kind of the same with the baboons in the study. Twenty-four hours after two previously vaccinated baboons were inoculated with pertussis bacteria in the back of their nose and trachea, an unvaccinated baboon was put in each of their cages.
The vaccinated baboons continued to have pertussis bacteria in their noses, which the researchers had put there, for up to 35 days. And they were able to eventually pass the pertussis bacteria to the unvaccinated baboons in their cages. Vaccinated baboons also became infected or colonized after they were put in a cage with an intentionally infected unvaccinated baboon.
“…animals did not cough and showed no reduction of activity, loss of appetite, or other outward signs of disease.”
Warfel et al on Acellular pertussis vaccines protect against disease but fail to prevent infection and transmission in a nonhuman primate model
The vaccinated baboons were infected, but they never did develop symptoms of pertussis.
What Does The Baboon Study Mean?
One thing that is for sure – the baboon study found that the pertussis vaccines work. Only unvaccinated baboons got sick with pertussis.
Are vaccinated people becoming colonized and then getting others sick?
I guess it is possible, but we are not baboons in a cage with other baboons. How would we spread a respiratory disease, even if we did become colonized with the bacteria, if we don’t have symptoms?
It may explain part of our outbreaks though.
If vaccinated people do commonly become colonized with pertussis bacteria, then they might very well test positive for pertussis even though they don’t have symptomatic pertussis disease. So when they develop a cold or bronchitis and are found to have a positive pertussis test, then couldn’t that test just indicate that they have a pertussis infection and not disease, even though something else is actually causing their symptoms?
That’s kind of what the baboon study found. All of the baboons tested positive, but only the unvaccinated baboons had symptomatic pertussis disease.
“Baboons vaccinated with wP vaccines exhibit a level of protection that is intermediate between convalescent animals and aP-vaccinated animals. They exhibit no outwards signs of disease and are initially colonized to the same high level as aP-vaccinated animals but clear the infection more rapidly.”
Pinto et al on Pertussis disease and transmission and host responses: insights from the baboon model of pertussis.
It is interesting to note that the baboon study also found that baboons who had received whole cell pertussis vaccines also became carriers. They just didn’t stay carriers for as long as the baboons who got the newer acellular pertussis vaccine. But since they were still carriers, if asymptomatic transmission is such a big problem, wouldn’t it have been a big problem back in the day when everyone got whole cell pertussis vaccines?
“The baboon model pioneered by Warfel et al. is without question a game-changer, shedding light on the impact of vaccination on disease and infection. However, the view it affords is clearer with respect to immunity and pathology than with respect to transmission. We point out that the extrapolation of the possibility of transmission from vaccinated baboons in the laboratory to the probability of transmission from vaccinated humans in the population is unwarranted. More work is needed to elucidate the relative transmissibility of infections in vaccinated vs. unvaccinated hosts. The evidence adduced above suggests, however, that vaccination with aP must have a strong effect on transmission as well as disease.”
Matthieu Domenech de Cellès et al on Epidemiological evidence for herd immunity induced by acellular pertussis vaccines
Even the author of the baboon study has said that “We agree that these data should not be directly extrapolated to pertussis transmission in humans. Although baboons are >96% genetically similar to humans, there are likely differences in how the species respond to vaccination and infection. We also agree that aP-vaccinated infected people are likely less efficient at transmitting pertussis compared with unvaccinated infected people, although it is not clear to what extent.”
Others think that asymptomatic carriage of pertussis might behind a lot of our recent outbreaks. Or at least what helps them grow so large.
Still, it is important to remember that unvaccinated folks do play a role in these outbreaks too. In a pertussis outbreak at a Florida preschool, in which most kids were vaccinated, the outbreak was started by a vaccine-exempt toddler.
And we have seen this in many other areas and it has been confirmed by many studies. Whatever else is contributing to pertussis outbreaks, like waning immunity, they are also associated with vaccine refusal.
“Counties with higher exemption rates had higher rates of reported pertussis among exempted and vaccinated children when compared with the low-exemption counties.”
Imdad et al. on Religious exemptions for immunization and risk of pertussis in New York State, 2000-2011.
But what if the DTaP and Tdap vaccines do cause folks to be asymptomatic carriers?
Even if that is true, understand that these vaccines don’t actually infect you, making you a carrier. They just might not prevent you from becoming a carrier if you are exposed to someone else with pertussis. While that might be a good reason to develop a new and better pertussis vaccine, it certainly isn’t a reason to skip or delay your child’s vaccines now.
Remember that even with our current outbreaks, rates of pertussis were much higher in the pre-vaccine era.
What to Know About Vaccines and Asymptomatic Carriers of Pertussis
The role of asymptomatic carriers and pertussis is controversial, but it certainly isn’t a reason to skip or delay your child’s vaccines.
More on the Vaccines and Asymptomatic Carriers of Pertussis
And many of the other vaccines can be given as a combination vaccine, either Pediarix (combines DTaP-IPV-HepB) or Pentacel (combines DTaP-IPV-Hib), to reduce the number of individual shots your baby needs to get even more.
While that still means multiple injections, there are things you can do to minimize the pain during and after the vaccines, from breastfeeding and holding your baby to simply trying to get them distracted.
Your Baby’s Next Vaccines
After their first vaccines at two months, your baby will complete their primary series of vaccines with repeated dosages of the same vaccines at four and six months.
Why do we need to repeat the same vaccines?
Because that’s often what it takes to help us build up an immune response to a vaccine, especially at this age.
These first vaccines prime the immune system, which when followed by a later booster vaccine, provide good protection against each disease.
And the requirement of multiple dosages of a vaccine is a small price to pay to be able to skip the symptoms and risk of more serious consequences that come from getting a natural infection and natural immunity.
Did your baby have a reaction to their first set of vaccines?
While some fever, pain, and fussiness is not unexpected, be sure to tell your health care provider if your baby had a reaction that you think was more severe, like a high fever or non-stop crying for several hours.
Can you expect a reaction to your baby’s second set of shots if they had a reaction to the first? Probably not. Side effects, even those that are serious, rarely happen again, even when the same vaccines are given.
Your Baby’s Vaccines
While you certainly shouldn’t skip or delay any of these vaccines, you should know that:
the routine age for starting these vaccines is at two months, but
if necessary, they can be given as early as when a baby is six weeks old.
the routine interval between dosages of the primary series of these vaccines is two months, but
if necessary (usually as part of a catch-up schedule), these vaccines can be usually be given as soon as four weeks apart, although the third dose in the series of DTaP, IPV, and Hepatitis B vaccines shouldn’t be given any sooner than at age six months.
infants who will be traveling out of the United States should get an early MMR vaccine – as early as six months of age
And if your baby is at least six months old during flu season, then they will also need two doses of the flu shot given one month apart. The minimum age to get a flu shot is six months, and kids get two doses during their first year of getting vaccinated against the flu to help the vaccine work better.
Pertussis has been known since at least the Middle Ages, although the bacteria that causes pertussis, Bordetella pertussis, wasn’t discovered until 1906.
That discovery led to the later development of the first pertussis vaccines, but before then, pertussis was a big killer, with epidemic cycles every 2 to 5 years.
During one of these cycles in the United States, from 1926 to 1930, there were:
909,705 cases, and
Unfortunately, even natural infection doesn’t provide life-long immunity, so adults would get pertussis and give it to susceptible kids, who were most likely to die during these epidemics.
But even in non-epidemic years, a lot of folks got pertussis. The number of reported cases ranged from “just” 161,799 in 1928 to 202,210 in 1926. And during one of the biggest years, 1934, there were 265,269 cases!
Post-Vaccine Era Pertussis Outbreaks
That changed in the vaccine era.
The first pertussis vaccines were developed in the 1930s and became more widely used in the 1940s when it was combined into the whole-cell DTP vaccine.
This was replaced with the acellular DTaP vaccine in 1997, with the Tdap vaccine being added to the vaccine schedule in 2006.
These vaccines helped to greatly reduce how many people got pertussis and how many people died from pertussis:
1940 – 183,866 cases
1950 – 120,718 cases and 1, 118 deaths
1960 – 14,809 cases and 118 deaths
1970 – 4,249 cases and 12 deaths
1980 – 1,730 cases and 11 deaths
1990 – 4,570 cases and 12 deaths
2000 – 7,867 cases and 12 deaths
2010 – 27,550 cases and 26 deaths
They never eradicated pertussis though, and as you can see, recently, pertussis cases have started to rise again.
In 2012, there were 48,277 cases of pertussis in the United States, the most since 1950, when we had 68,687 cases. Unfortunately, with the rise in cases, we are also seeing the tragic consequences of this disease – 20 deaths in 2012, mostly infants under age 3 months.
Pertussis cases remained steady, but high, in 2013 and 2014, at around 30,000 cases in the United States.
In California, pertussis reached epidemic levels. The California Department of Public Health reported at least 11,114 cases in 2014 – the highest numbers of pertussis cases in the state in 70 years!
And as expected with the rise in cases, there were 3 pertussis related deaths in California that year – all infants who had contracted pertussis when they were less than 8 weeks old. Two of the infants became sick in 2013, but the third, a 5-week-old baby, got infected in 2014.
Another baby, only 25 days old died in early 2015, but will be counted as the 2nd death of 2014 since that is when the illness started. About 383 patients, mostly infants who are less than 4 months old, were hospitalized in California that year, including 80 who required intensive care. And according to the California Department of Public Health, about 82% of the cases in infants were born to mothers who did not receive a dose of Tdap during their third trimester of pregnancy.
What’s happened since then?
Pertussis cases are continuing to fall each year! In fact, with about 16,000 cases in the United States, 2017 may have ended with the lowest number of pertussis cases since 2008.
Still, with just 1,830 pertussis cases in California in 2016, there were two deaths – both infants who were younger than 3 months of age when they got sick. And there was at least one death in 2017, with similar rates of disease, although reports are still preliminary.
Why So Many Pertussis Outbreaks?
Ever since a 2010 California pertussis outbreak, in which there were 9,154 cases of pertussis, the most in 63 years, and 10 infants died, many people, especially parents, began wondering why we were seeing more pertussis these days.
Is it because the pertussis vaccines simply don’t work, as the anti-vaccine movement would have you think?
A commentary, Why Do Pertussis Vaccines Fail?, by James Cherry, MD, gave us some answers.
While the title of the article might have you think that all of the blame lies with the pertussis vaccines, that certainly isn’t the case. While there can be vaccine failures with the pertussis vaccines, just like any other vaccine, that doesn’t mean that the vaccine doesn’t work for most children.
One of the problems is that the DTaP vaccine likely isn’t as effective as the older DTP vaccine. So instead of efficacy of 84 to 85%, as was once believed, it is likely closer to just 71 to 78%.
Other issues, including waning immunity, the possibility of an incorrect balance of antigens in the vaccine that could create a blocking effect, and genetic changes in the B. pertussis bacteria, could also possibly lead to increased vaccine failure rates.
So it isn’t that the pertussis vaccines don’t work.
That should be easy to see when you look at the pertussis rates in California, when the highest rates by far were in infants less than 6 months of age (434 per 100,000 people). In contrast, children who were 6 months to 6 years old had a rate of only 62 per 100,000.
And the results of a study that were presented at the 49th annual meeting of the Infectious Diseases Society of America in Boston show just how important the pertussis vaccine is, as:
vaccine effectiveness was 98.1 percent among children who received their 5th dose within the past year
long term effectiveness – children who were five or more years past their last DTaP dose – was about 71 percent
children who had never received any doses of DTaP (unvaccinated children) faced odds of having whooping cough at least eight times higher than children who received all five doses
It is also important to note that the high rates seen in 2010 in California are still well below the rates that were seen in the pre-vaccination era, when the attack rate of pertussis in the United States was as high as 157 per 100,000 people, with about 200,000 cases a year.
What’s the answer?
“The present “resurgence of pertussis” is mainly due to greater awareness and the use of PCR for diagnosis. There are also many other factors which have contributed to the “resurgence.” New vaccines are clearly needed; with our present vaccines (DTaP and adolescent and adult formulated tetanus and diphtheria toxoids and acellular pertussis vaccine (Tdap)), if used correctly, severe pertussis and deaths in infants can be prevented.”
James D. Cherry, MD on The History of Pertussis (Whooping Cough); 1906 – 2015: Facts, Myths, and Misconceptions
It certainly isn’t for more kids to follow non-standard, parent-selected, delayed protection vaccine schedules or to simply skip vaccines all together. Since natural immunity isn’t going to keep newborns and infants from getting pertussis, the ages which are most at risk for life-threatening infections, they can catch pertussis from people around them, including those working on their natural immunity. Natural infections don’t even provide life-long protection against pertussis, as some people believe. That natural immunity wanes fairly quickly too.
The future of pertussis control is more likely going to be in maximizing our current vaccination program, including getting more teens and adults to get the Tdap vaccine, especially when women are pregnant.
That’s the best strategy, at least until new pertussis vaccines are developed. It provides a lot of benefits. According to the CDC, like with the flu vaccine, when you get a pertussis vaccine, in addition to protecting yourself and those people around you, “people who do catch whooping cough after being vaccinated are much less likely to be hospitalized or die from the disease.”
Unfortunately, not everyone has gotten the message. And because of waning immunity, children who aren’t vaccinated against pertussis can’t “hide in the herd” and rely on the rest of us who do vaccinate our children to provide them with protection. Instead, since they are at a higher risk, they get pertussis and get even more people sick.
In one study, Parental refusal of pertussis vaccination is associated with an increased risk of pertussis infection in children, researchers found that “vaccine refusers had a 23-fold increased risk for pertussis when compared with vaccine acceptors, and 11% of pertussis cases in the entire study population were attributed to vaccine refusal.” The highly contagious nature of pertussis then means every primary case is probably going to infect as many as 17 other people. That’s why it makes sense that higher rates of children using vaccine exemptions could be at least one of the factors in these outbreaks.
In fact, several studies, including, Geographic Clustering of Nonmedical Exemptions to School Immunization Requirements and Associations With Geographic Clustering of Pertussis, found that “geographic pockets of vaccine refusal are associated with the risk of pertussis outbreaks in the whole community.”
Many factors are responsible for the rise in pertussis outbreaks in recent years, but it is clear that being unvaccinated and unprotected put you at greatest risk for getting pertussis and passing it on to others.
Fortunately, they can usually be comforted quickly.
Historically, there has been one situation where kids might cry for longer periods of times.
Non-Stop Crying After DTaP Vaccines
The DTP vaccine was known to cause non-stop crying, for 3 hours or more in up to about 1 child out of 1,000.
“Persistent crying following DTaP (as well as other vaccines) has been observed far less frequently than it was following the use of DTP. When it occurred after DTP, it was considered to be an absolute contraindication to further doses of pertussis-containing vaccine. When it occurs following DTaP, it is considered a “precaution” (or warning). If you believe the benefit of the pertussis vaccine exceeds the risk of more crying (which, although unnerving, is otherwise benign), you can administer DTaP.”
Immunization Action Coalition on Ask the Experts about DTP
Although uncommon, it is certainly scary to have a child cry for 3 hours or more after a vaccine.
I guess that’s one good reason we don’t use the DTP vaccine anymore. On the other hand, although the newer DTaP has fewer side effects, it doesn’t work as well as the older DTP vaccine at protecting kids against pertussis.
What Causes Non-Stop Crying After DTaP Vaccines?
Some people have very wrong ideas about what caused this non-stop crying after the DTP vaccine, which is reflected in the nick-names they gave it, such as the “DTP scream,” “cry-encephalitis,” or the “encephalitic cry.”
If your child has had non-stop crying after their DTP vaccine, or DTaP vaccine for that matter, you can be reassured that they didn’t have encephalitis!
Again, although it is scary to have your child crying non-stop for 3 hours or more, this crying is benign and has no long term effects.
Crying non-stop for 3 hours or more after a vaccine can be scary. Fortunately, DTaP crying is not caused by encephalitis or any other terrible thing you might read about. It is a painful local reaction.
Just about any side effect after a vaccine can be scary for parents.
What if your child suddenly became limp, wasn’t responsive, and was pale?
That would be scary for any parent.
What Are Hypotonic-Hyporesponsive Episodes?
But that’s just what can happen when a child has a hypotonic–hyporesponsive episode (HHE).
“A hypotonic-hyporesponsive episode (HHE) is the sudden onset of hypotonia, hyporesponsiveness, and pallor or cyanosis that occurs within 48 hours after childhood immunizations.”
DuVernoy et al on Hypotonic-hyporesponsive episodes reported to the Vaccine Adverse Event Reporting System (VAERS), 1996-1998
These types of episodes were once thought to happen once for every 1,750 DTP vaccines given.
Fortunately, although they certainly do sound scary, the episodes stop on their own and don’t cause any permanent harm.
Hypotonic-hyporesponsive episodes were even removed as table injuries after DTP back in 1995. It is not that HHE can’t occur after DTP, DTaP, or other vaccines, but rather that HHE doesn’t then cause any permanent neurological damage to the child.
And it is rare for kids to have a second episode, so they can continue to get vaccinated. HHE is not a good reason to skip or delay all of your child’s vaccines. While not a contraindication to getting vaccinated, having an episode of HHE “within 48 hours after receiving a previous dose of DTP/DTaP,” is listed as a precaution to getting another dose of DTaP or Tdap though.
“In general, vaccinations should be deferred when a precaution is present. However, a vaccination might be indicated in the presence of a precaution if the benefit of protection from the vaccine outweighs the risk for an adverse reaction.”
CDC on Vaccine Contraindications and Precautions
Also, HHE has become even more rare since we switched to using DTaP, instead of the older DTP vaccine. So being worried about HHE is definitely not a good reason to skip or delay any vaccines.
What to Know About Hypotonic-Hyporesponsive Episodes
Hypotonic-hyporesponsive episodes were more common after the older DTP vaccines, but still didn’t cause any long term problems and aren’t a good reason to skip or delay your child’s vaccines.