Improving Vaccine Policy Making: A Dose of Reality – Dorit R Reiss and Paul A Offit

vaccine policy

This post is a preprint of an article to be published in Vaccine entitled “Improving Vaccine Policy Making: A Dose of Reality.” The authors are Dorit Rubinstein Reiss, Ph.D., Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), and Paul A. Offit, MD, Professor of Pediatrics, Division of Infectious Disease, The Children’s Hospital of Philadelphia, The Perelman School at the University of Pennsylvania.

This article’s full citation is:

Reiss DR, Offit PA. Improving Vaccine Policy Making: A Dose of Reality. Vaccine. 2020 February 5. doi: 10.1016/j.vaccine.2020.01.036.

This preprint (see Note 1) is being published here, with permission from Professors Reiss and Offit, as a public service because it is an important part of the discussion on vaccine policy. Continue reading “Improving Vaccine Policy Making: A Dose of Reality – Dorit R Reiss and Paul A Offit”

Gardasil 9 safety – more published evidence supporting the HPV vaccine

Gardasil 9 safety

Two new articles (plus an editorial) published in Pediatrics reinforce the evidence supporting Gardasil 9 safety. I have been writing about the safety of the cancer-preventing HPV vaccines for years, and it’s clear that it’s settled science.

Of course, I’m here to review any new articles about Gardasil 9 safety, because the evidence supporting it has become overwhelming. Nevertheless, HPV vaccine uptake has remained stubbornly low, around 49% in the USA as of 2017. 

Let’s start with a quick review of HPV and HPV vaccines. Continue reading “Gardasil 9 safety – more published evidence supporting the HPV vaccine”

Too many vaccines – debunking another unscientific anti-vaxxer myth

too many vaccines

Each day, I have plans to write about something other than another anti-vaccine myth, like we give our kids too many vaccines. But like Al Pacino said in The Godfather, “just when I thought I was out, they pull me back in.” Now I get pulled into another anti-vaxxer myth.

Unfortunately, my wonderful, well-researched, 15,000-word article about the existence of Sasquatch will have to wait for another day. Yes, it makes me sad. 

Seriously, the “too many vaccines” trope pushed by the anti-vaccine religion is one of the most annoying in the discussions about vaccines. Their bogus claim is that we give children too many vaccines too early in life, and that causes all kinds of harm.

Per usual, the anti-vaccine zealots lack any robust scientific evidence supporting their claims, but you know those people – there’s no trope, myth, or meme that they won’t employ, irrespective of evidence, to push lies about vaccines.

So let’s take a look at this old anti-vaccine myth of too many vaccines in light of a recently published, powerful study that provides more evidence that this particular myth doesn’t hold any water. Continue reading “Too many vaccines – debunking another unscientific anti-vaxxer myth”

Debunking the claim that vaccines kill people using real scientific evidence

Vaccines kill

The anecdotal beliefs from the anti-vaccine religion that vaccines kill babies, children, and adults (warning, the link is from Natural News, one the worst websites for scientific credibility) is frustrating. Dorit Rubinstein Reiss and I have written two articles, about Nick Catone and Colton Berrett, that refute parental claims that vaccines killed their children. Those boys deaths were tragic, but according to the best evidence we have, neither were the result of vaccines.

Deaths attributed to vaccines are often not causally related. It may feel like one event that follows another event is related, which is the post hoc ergo propter hoc fallacy. There may not be any correlation, let alone causality, that would make us accept that vaccines kill.

Those of us who accept the fact that vaccines are very safe, and indeed, not really a risk for causing death, have found no evidence that there has been a single death attributed to vaccines over the past couple of decades. But that’s just examining the high quality scientific and medical literature, which may or may not be 100% inclusive of all post-vaccination mortality.

Now, I’ve always contended that there is no evidence that there has ever been a death attributed to vaccines. I never agreed with the old adage that “science can’t prove a negative,” but I do think that the burden of proof is on those making that claim. Where is the evidence of a link between vaccines and mortality? Sometimes, the absence of evidence can be evidence of absence, Carl Sagan’s claims notwithstanding, especially if we look very carefully for that evidence.

Let’s move on to this pivotal study in our understanding of whether vaccines kill. They don’t.

Continue reading “Debunking the claim that vaccines kill people using real scientific evidence”

Properly evaluating vaccine mortality – let’s not abuse VAERS

vaccine mortality

The public’s concern about adverse events, especially death, immediately or soon after vaccinations is very disruptive to vaccine uptake, leading to increased morbidity and mortality of vaccine-preventable diseases. For example, a 2009 Japanese study that showed 107 deaths following H1N1 influenza A vaccination, assumed a causality between the vaccine and the deaths without any evaluation of background rates of of deaths, which would help indicate whether there was any significance to the death rate or even if its related to the vaccination. Vaccine mortality is one of the most abused terms in discussions about vaccines.

It has been demonstrated that passively reported data, that is, data that isn’t actively investigated by trained researchers, cannot be used to assess causality. In an active investigation, it was found that only 2 of the 107 deaths had an autopsy performed, and most of the others had other underlying diseases and conditions that were causally related to the mortality events. Furthermore, 15 million people were vaccinated with the H1N1 seasonal vaccine, and it would be expected that there would be >8000 deaths during the 20 days after vaccination using a crude mortality rate in Japan. Though it would still be a misuse of statistics,  there really is more evidence that the H1N1 vaccination lowered the background death rate from 8000 to 107 post vaccination. Continue reading “Properly evaluating vaccine mortality – let’s not abuse VAERS”

Inventing your own vaccine schedule? Not a wise idea.

There antivaccination crowd runs the gamut from truly scary deniers who invent all sorts of lies to try to stop vaccines to people who seem to think that the risk of vaccine adverse events somehow surpasses the risk of the disease itself, mostly because they lack the cultural memory of what it was like in the world pre-vaccines. Vaccines are a critical part of the drop in the infant mortality rate by over 90% since the 1930’s, so we have just forgotten.

There is a group of parents that kind of sit in the middle of the so-called “vaccine debate.” They are not necessarily opposed to vaccinations, but they pick and choose which vaccines they give their children, and they have come up with a revised vaccine schedule which has no basis in science. Dr. Sears (there’s four of them in the family, and they all say the same thing) is one of the more notable proponents of the revised vaccination schedule.  In general, the vaccine delayers avoid some vaccines (Hepatitis-B being the most important one), and delay or even eliminate boosters shots.


The current US-based vaccine schedule is established by some pretty bright people. The Advisory Committee of Immunization Practices, a part of the US Centers for Disease Control and Prevention, the world’s leading center for detecting and preventing infectious diseases, is made up of some of the nation’s leading experts on infectious disease, immunology, vaccines, and public health. Their only goal is to determine which vaccines are necessary to protect the lives of citizens of the USA, and then to establish a healthy schedule for those vaccines. They do not pull this data out of thin air, but is based on the best research evidence available to them. As I’ve written before, vaccines prevent over 42,000 deaths every single year.

A recent study found that delaying the MMR vaccine (for measles, mumps and rubella), in the second year of life, doubled the risk of a seizure occurring after the vaccination. Now seizures are not unusual with vaccination, and are a result of the high fever that some children get after vaccination. But seizures are fairly common in children who haven’t been vaccinated recently. It’s always scary to parents, but they are minor, usually cause no long-term damage, including epilepsy.

The researchers, led by Simon Hambidge, MD PhD, of the Institute for Health Research at Kaiser Permanente Colorado, analyzed data from 323,247 children, born between 2004 and 2008, whose records are in the Vaccine Safety Datalink system, a collaborative effort between CDC’s Immunization Safety Office and 9 managed care organizations (MCOs), that monitors immunization safety and address the gaps in scientific knowledge about rare and serious events following immunization

The researchers located records 5,667 children who had experienced a seizure in their first two years of life and did not have a seizure disorder. The researchers then compared the timing of these children’s seizures to the dates they had received various vaccinations and considered whether the vaccines had been received on time or not, per the CDC’s and ACIP’s recommendations

cdc-vaccine-scheduleThe analysis revealed that there was no correlation between receiving any vaccine and experiencing seizures for children during their first year of life. However, those children who received the MMR vaccine between 12 and 15 months old, when it’s recommended, were at about 2.6X higher risk of a seizure than an unvaccinated child. That translates to about one seizure for every 4000 children receiving the vaccine. If parents delayed the MMR vaccine until any time between 16 and 23 months, the risk of a seizure was 6.5X greater than when not being vaccinated. In other words, delaying the vaccine 4-8 months more than doubles the risk of seizures.

In general, febrile or acute seizures are not serious, they just seem scary. Most vaccines, such as  DTaP (the vaccine for diphtheriatetanus and whooping cough) actually show no difference in seizures between vaccinated and unvaccinated children. Seizures occur in about 5 out of 100 children sometime during their lives, with 95% of them not serious or symptomatic of other diseases. In other words, the background risk of seizure might actually be higher than the incidence observed in vaccinated children, just in case a reader wants to head down that path.

Thus, if you’re coming up with your own vaccine schedule, you’re increasing the risk of a minor, but kind of scary, adverse event–a febrile seizure. Why would one do that to gain no other benefit? That’s not clear to me.

Visit the Science-based Vaccine Search Engine.

Key citations:



Why we vaccinate–protect kids from rotavirus induced seizures


H. Fred Clark and Paul Offit, the inventors of RotaTeq, a pentavalent rotavirus vaccine.
H. Fred Clark and Paul Offit, the inventors of RotaTeq, a pentavalent rotavirus vaccine.

Rotavirus is a virus that causes gastroenteritis, an inflammation of the stomach and intestines. Rotavirus causes severe watery diarrhea, often with vomiting, fever, and abdominal pain. In babies and young children, it can lead to dehydration (loss of body fluids). Globally, it causes more than a half a million deaths each year in children younger than 5 years of age. 

Prior to the launch of the rotavirus vaccine (RotaTeq® or Rotarix®) in the United States in 2006, rotavirus was the leading cause of severe diarrhea in infants and young children. Before the vaccine became available, almost all children in the United States were infected with rotavirus before their 5th birthday. Each year, in the US, rotavirus lead to more than 400,000 doctor visits; more than 200,000 emergency room visits; 55,000 to 70,000 hospitalizations; and 20 to 60 deaths in children younger than 5 years of age. After the introduction and widespread use of the vaccine, a Cochrane systematic review concluded that the rotavirus vaccines may prevent up to 96% of severe diarrhea cases arising from rotavirus. Continue reading “Why we vaccinate–protect kids from rotavirus induced seizures”