Tag: intussusception

Are Fewer Than 1% of Vaccine Injuries Reported to VAERS?

It is a common anti-vaccine argument that fewer than 1% of vaccine injuries are reported to VAERS.

I've found that fewer than 1% of anti-vaccine signs are true...
I’ve found that fewer than 1% of anti-vaccine signs are true…

They even think that they have evidence from Harvard to support their claim!

Are Fewer Than 1% of Vaccine Injuries Reported to VAERS?

Do they?

Are fewer than 1% of vaccine injuries reported to VAERS?

It has long been suspected that reports to VAERS are under-reported, as it is a passive reporting system.

The original claims for under-reporting to VAERS were based on an old study about drug reactions and were not specific to vaccines though.

Is that the Harvard study?

Nope.

“Restructuring at CDC and consequent delays in terms of decision making have made it challenging despite best efforts to move forward with discussions regarding the evaluation of ESP:VAERS performance in a randomized trial and comparison of ESP:VAERS performance to existing VAERS and Vaccine Safety Datalink data. However, Preliminary data were collected and analyzed and this initiative has been presented at a number of national symposia.”

Electronic Support for Public Health–Vaccine Adverse Event Reporting System (ESP:VAERS)

They are talking about a report, Electronic Support for Public Health–Vaccine Adverse Event Reporting System (ESP:VAERS), that was conducted at Harvard Pilgrim Health Care, Inc.

“Preliminary data were collected from June 2006 through October 2009 on 715,000 patients, and 1.4 million doses (of 45 different vaccines) were given to 376,452 individuals. Of these doses, 35,570 possible reactions (2.6 percent of vaccinations) were identified.”

Electronic Support for Public Health–Vaccine Adverse Event Reporting System (ESP:VAERS)

It is very important to note that all the study found is that all possible reactions, including minor reactions, like pain and fever, are not common.

They didn’t actually finish the report to see how commonly those reactions were reported to VAERS.

But we already know that more serious reactions are reported to VAERS much more routinely.

“Sensitivities ranged from 72% for poliomyelitis after the oral poliovirus vaccine to less than 1% for rash and thrombocytopenia after the MMR vaccine.”

Rosenthal et al on The reporting sensitivities of two passive surveillance systems for vaccine adverse events

And there has even been a more recent report, Advanced Clinical Decision Support for Vaccine Adverse Event Detection and Reporting, which also used an ESP-VAERS system, that found great improvements in reporting of adverse events to VAERS.

Even more importantly, even with it’s limitations, VAERS works!

“Despite its limitations, VAERS effectively detected a possible problem soon after introduction of RRV-TV in the United States.”

Lynn R. Zanardi, et al on Intussusception Among Recipients of Rotavirus Vaccine: Reports to the Vaccine Adverse Event Reporting System

Although it would be ideal to have even more reports sent to VAERS, time and again, we have seen that VAERS works.

“On November 23, 2010, the combination of the coding term “febrile convulsion” and the Fluzone(®) TIV product exceeded a predetermined threshold in the VAERS database. By December 10, we confirmed 43 reports of febrile seizure following TIV in children aged 6-23 months. Clinical features of most reports were consistent with typical uncomplicated febrile seizures, and all children recovered. Further epidemiologic assessment of a possible association between TIV and febrile seizures was undertaken in a separate, population-based vaccine safety monitoring system.”

Leroy et al on Febrile seizures after 2010-2011 influenza vaccine in young children, United States: a vaccine safety signal from the vaccine adverse event reporting system.

As we have seen, for VAERS to work, we don’t need all side effects and reactions to be reported.

“VAERS is primarily a safety signal detection and hypothesis generating system. Generally, VAERS data cannot be used to determine if a vaccine caused an adverse event. VAERS data interpreted alone or out of context can lead to erroneous conclusions about cause and effect as well as the risk of adverse events occurring following vaccination.”

Shimabukuro et al on Safety monitoring in the Vaccine Adverse Event Reporting System (VAERS).

Also, VAERS is not the only safety system that we have to make sure that our vaccines are safe.

The other thing that folks should understand? Most reports to VAERS are not actually vaccine injuries

More on the Percentage of Reports to VAERS

How Long Do Side Effects of Immunizations Last?

Immunizations are safe, but they can have some risks and side effects.

Vaccine side effects can be reported to VAERS online or using a downloadable form.
Vaccine adverse events can be reported to VAERS online or using a downloadable form.

Fortunately, most are fairly mild, like pain and fever.

How Long Do Side Effects of Immunizations Last?

And most vaccine side effects go away quickly.

For example, fever and fussiness, two of the most common vaccine reactions, typically only lasts a day or two.

Others can last a little longer, but still usually go away on their own:

  • when kids get a rash after their MMR vaccine, it might last three or four days
  • even when kids get swelling of an entire arm or leg after the DTaP shot is given, it might last for 1–7 days
  • pain at the injection site typically only lasts a few days
  • shoulder injury related to vaccine administration (SIRVA) can last months and sometimes doesn’t go away
  • arthritis after a rubella containing vaccine, which mostly occurs in adults, typically only lasts a few days
  • febrile seizures are usually brief and rarely lead to non-febrile seizures
  • immune thrombocytopenic purpura (ITP) after a measles containing vaccine resolves in two weeks to six months, typically without any treatment
  • intussusception after a rotavirus vaccine resolves with treatment, either an air contrast enema or surgery
  • Guillain-Barré Syndrome after a seasonal flu vaccine, which is very rare, resolves in the majority of people over a period of years

Do any have more long lasting effects?

VAPP or vaccine-associated paralytic polio after the oral polio vaccine might not resolve. Fortunately, it only occurs in about 1 in every 1.27 million children receiving their first dose of OPV. It is even less common after bOPV, which is oral polio vaccine that is now being used. And won’t happen at all once we stop using oral polio vaccines.

Encephalitis or encephalopathy after a pertussis or a measles, mumps, and rubella virus containing vaccine might also lead to long lasting effects.

And some, like anaphylaxis, are life-threatening.

Fortunately, most long-term vaccine studies have shown that immunizations are safe, rarely causing severe reactions, and don’t have many long term side effects.

What to Know About How Long Immunization Side Effects Last

Most vaccine side effects are mild and only last a few days.

More on Immunization Side Effects

Why Did Anti-Vaccine Folks Applaud Rand Paul’s Testimony at the Senate Health Committee Hearing on Vaccines and Outbreaks?

Wait, what?

Why Did Anti-Vaccine Folks Applaud Rand Paul's Testimony at the Senate Health Committee Hearing on Vaccines and Outbreaks?

Anti-vaccine folks actually applauded Rand Paul’s testimony at the Senate Health Committee Hearing on Vaccines and Outbreaks?

Why Did Anti-Vaccine Folks Applaud Rand Paul’s Testimony at the Senate Health Committee Hearing on Vaccines and Outbreaks?

Surprisingly, many of the things he said weren’t anti-vaccine.

I guess they ignored those parts…

  • …given the choice, I do believe that the benefits of most vaccines vastly outweigh the risks.
  • I’m not hear to say don’t vaccinate your kids… if this hearing is for persuasion, I’m all for the persuasion. I vaccinated myself. I vaccinated my kids.
  • For myself and my kids, I believe that the benefits of vaccines greatly outweigh the risks…

So why were they cheering?

Because that’s not all he said…

“Today, instead of persuasion, many governments have taken to mandating a whole host of vaccines, including vaccines for non-lethal diseases.”

Sen Rand Paul

While some vaccine-preventable diseases are more deadly than others, they can all be deadly. From rotavirus and HPV to hepatitis A, these diseases can kill people.

Which vaccine-preventable disease does he think is non-lethal?

“Sometimes these vaccine mandates have run amok. As when the government mandated a rotavirus vaccine that was later recalled because it was causing intestinal blockage in children.”

Sen Rand Paul

That’s an interesting example of “the government” that has run amok…

Which “government” mandated that the original rotavirus vaccine be given to children?

As Senator Paul hopefully understands, the Federal government doesn’t mandate vaccines for anyone. And since it must be given at such a young age, even states don’t actually mandate that the rotavirus vaccine be given to children…

Even today, there are no mandates for the rotavirus vaccine.

If there were, it still wouldn’t mean giving up your Liberty, after all, vaccine mandates don’t mean forced vaccination.

“It is wrong to say that there are no risks to vaccines. Even the government admits that children are sometimes injured by vaccines. Since 1988, over $4 billion has been paid out from the Vaccine Injury Compensation Program. Despite the government admitting to and paying $4 billion for vaccine injuries, no informed consent is used or required when you vaccinate your child. This may be the only medical procedure in today’s medical world where an informed consent is not required. “

Sen Rand Paul

No one says that there are no risks to vaccines. That’s a classic anti-vaccine talking point.

What folks actually say is that vaccines are safe, with few serious risks.

And the $4 billion that Rand Paul and anti-vaccine folks often talk about has been paid out over more than 30 years, during a time that we have given nearly 300 million doses of vaccines each and every year!

But what’s that he said about informed consent?

Why wouldn’t informed consent be given or be required before getting a vaccine?

Of course, parents get informed consent before getting vaccines.

They don’t get informed consent if they decide to skip or delay their child’s vaccines after getting bad information.

“Now proponents of mandatory government vaccination argue that parents who refuse to vaccinate their children risk spreading these diseases to the immunocompromised community. There doesn’t seem to be enough evidence of this happening for it to be recorded as a statistic, but it could happen. But if the fear of this is valid, are we to find that next we will be mandating flu vaccine?”

Sen Rand Paul

Lastly, why didn’t Sen Paul find evidence that intentionally unvaccinated kids are spreading disease to the immunocompromised community?

Maybe he didn’t look…

It happens.

Do we need it to happen more often so that it becomes a large statistic before he and others will advocate that folks get vaccinated to attend school?

Do you understand have a better understand now why anti-vaccine folks were cheering after his testimony?

“If you believe in Liberty, that’s fine, don’t get immunized. But I don’t think that you need to necessarily expose others to disease.”

Sen Bill Cassidy

It should give you a better understanding both of Rand Paul’s ideas and those of the anti-vaccine movement.

More on Rand Paul’s Testimony at the Senate Health Committee Hearing on Vaccines and Outbreaks

Vaccines – Year in Review 2018

Another year has passed and although anti-vaccine folks keep talking about those 300 vaccines in pipeline, there were few new developments in the vaccine world in 2018.

Bob Sears got in trouble with the Medical Board of California over vaccine exemptions.
This happened in 2018.

Well, maybe that’s not entirely true.

Vaccines – Year in Review 2018

So what can we say about 2018 when it comes to vaccines?

Well, we did get some new ones!

  • approved by the FDA in late 2017, a new hepatitis B vaccine for adults, Heplisav-B, the formal recommendation for its use from the ACIP came on February 21, 2018
  • although it was both approved by the FDA and formally recommended by the ACIP in late 2017, Shingrix, the new shingles vaccine, became more widely available in 2018 – well kind of – there have been a lot of shortages due to high demand for the vaccine
  • Vaxelis, a hexavalent vaccine that combines DTaP-IPV-Hib-HepB into one shot was FDA approved on December 21, 2018, but likely won’t be available for a few more years
  • FluMist, the nasal spray flu vaccine, returned

And we lost one… Last year was the first full year that Menomune, an older meningococcal vaccine, was no longer available. It was discontinued because of low demand, as we began to use the newer vaccines, Menactra and Menveo instead.

In other immunization news:

  • a 2017 shortage of yellow fever vaccine continued into 2018
  • a shortage of monovalent pediatric hepatitis B vaccine will continue into 2019 (doesn’t affect combination vaccines with hepatitis B)
  • Gardasil 9 received an expanded recommendation – women and men between the ages of 27 and 45 years can now get vaccinated and protected with this HPV vaccine
  • the hepatitis A vaccine got a lower age recommendation – at least in special situations – “HepA vaccine be administered to infants aged 6–11 months traveling outside the United States when protection against HAV is recommended.”
  • the recommendation to use a third dose of MMR to control outbreaks of mumps was formally approved
  • the WHO updated its recommendations for use of the dengue fever vaccine (Dengvaxia) to makes sure that only dengue-seropositive persons are vaccinated, as they found an increased risk of severe dengue in seronegative people who were vaccinated
  • Of the 163 million to 168 million doses of flu vaccine that will be distributed in the United States for the 2018-2019 season, more than 80% will be thimerosal free.
  • China had an issue with substandard DTaP vaccines made by one company in one part of the country
  • India had an issue with contaminated polio vaccines made by one company in one part of the country – bivalent oral polio vaccines (two strains) still contained all three strains of polio vaccine virus
  • Measles cases and deaths spiked globally because of gaps in vaccination coverage

If you didn’t hear about any of those things in the news, you may have heard about the death of two young children in Samoa after they received an MMR vaccine. That tragedy almost certainly was caused by an error in administering/mixing the vaccines, and not because there was anything wrong with the vaccines themselves.

Need help getting educated about vaccines? Despite continued outbreaks, 2018 was a good year for vaccine advocates and vaccine education.

Several good books about vaccines were published, including:

And in case you missed it, we found out that:

Of course, for most of us, none of this is really news. We know that vaccines are safe, effective, and necessary.

And sadly, Betty Bumpers died. We can honor her legacy by continuing her work and helping to make sure that every child gets vaccinated and protected.

More on Vaccines Year in Review 2018