Tag: ACIP

Does the CDC Determine Medical Exemptions for Vaccines?

California’s new vaccine law has some folks arguing about medical exemptions again.

Yes, the CDC does not determine medical exemptions for vaccines. That's not news.
Yes, the CDC does not determine medical exemptions for vaccines. That’s not news.

Some want very broad guidelines and are confused about how doctors determine who should get a medical exemption.

Does the CDC Determine Medical Exemptions for Vaccines?

Bob Sears even thinks he has a bombshell revelation that clears everything up.

An email from the CDC!

You can be sure that the "medical provider's prerogative" does not include any reason they think up, even those that have no evidence to back them up.
You can be sure that the “medical provider’s prerogative” does not include any reason they think up, even those that have no evidence to back them up.

The thing is, no one has ever said that ACIP contraindications and precautions to vaccination are the one and only factor that should determine whether or not a child should get a medical exemption.

“If a child has a medical exemption to immunization, a physician licensed to practice medicine in New York State must certify that the immunization is detrimental to the child’s health. The medical exemption should specify which immunization is detrimental to the child’s health, provide information as to why the immunization is contraindicated based on current accepted medical practice, and specify the length of time the immunization is medically contraindicated, if known.”

Dear Colleague letter regarding guidelines for use of immunization exemptions

So no one should really be surprised by an email that says the CDC does not determine medical exemptions.

What Qualifies as a Vaccine Medical Exemption?

What are the other big factors, in addition to ACIP contraindications and precautions?

“A medical exemption is allowed when a child has a medical condition that prevents them from receiving a vaccine.”

What is an Exemption and What Does it Mean?

Medical exemptions for vaccines should be based on AAP and ACIP guidelines, current accepted medical practice, and evidence based medicine.

“Medical exemptions are intended to prevent adverse events in children who are at increased risk of adverse events because of underlying conditions. Many of these underlying conditions also place children at increased risk of complications from infectious diseases. Children with valid medical exemptions need to be protected from exposure to vaccine-preventable diseases by insuring high coverage rates among the rest of the population. Granting medical exemptions for invalid medical contraindications may promote unfounded vaccine safety concerns. Although states may wish to allow parents who make decisions based on poor science or perceptions to withhold vaccines from their children, these exemptions should be distinguished from valid medical exemptions.”

Salmon et al on Keeping the M in Medical Exemptions: Protecting Our Most Vulnerable Children

For example, in addition to kids who may have had a severe allergic reaction to a vaccine, there are often children with immune system problems or who have a moderate or severe illness who can’t get one or more vaccines, at least temporarily.

These are among the common conditions that the AAP says should NOT delay vaccination and which are often mistakenly thought to qualify someone for a medical exemption.
These are among the common conditions that the AAP says should NOT delay vaccination and which are often mistakenly thought to qualify someone for a medical exemption.

Medical exemptions for vaccines should not be based on anecdotes or simply because a vaccine-friendly doctor has scared a parent away from vaccinating and protecting their kids.

There are very few family history issues that would make a child have to skip or delay getting a vaccine.
There are very few family history issues that would make a child have to skip or delay getting a vaccine.

They should rarely be done based on family history of reactions or what some people think are vaccine reactions.

This is what a fake medical exemption will get you - a life-threatening disease.
The child’s medical exemption was for “cytotoxic allergies secondary to immunization,” without any evidence that it was necessary. In addition to a fake medical exemption, he got tetanus.

In general, they should rarely be given, as the AAP states in their policy statement, Medical Versus Nonmedical Immunization Exemptions for Child Care and School Attendance, “only a very small proportion of children have medical conditions prohibiting specific immunizations…”

That’s why rates of medical exemptions should be low.

“Between the 2009-2010 and 2016-2017 school years, the national median prevalence of medical exemptions has remained constant, between 0.2% to 0.3%, with state-level ranges showing little heterogeneity over time, never exceeding the range of 0.1% to 1.6% over this period.”

Bednarczyk et al on Current landscape of nonmedical vaccination exemptions in the United States: impact of policy changes

And why you shouldn’t have schools with high rates of medical exemptions or doctors writing a lot of medical exemptions.

More on Vaccine Medical Exemption Guidelines

ACIP June 2019 Update

The Advisory Committee on Immunization Practices (ACIP) holds three meetings each year at the Centers for Disease Control and Prevention (CDC) in Atlanta, Georgia to review scientific data and vote on vaccine recommendations.

Topics at the ACIP June 2019 meeting, held on June 26 and 27, included:

  • 9vHPV Immunogenicity and Safety Trial in Mid-Adult Females
  • Overview of Health Economic Models for HPV Vaccination of Mid-Adults
  • HPV Vaccines Evidence to Recommendations (EtR) Framework
  • HPV Vaccines Work Group Considerations and Proposed Policy Options
  • Considerations for PCV13 use among adults 65 years or older and summary of the Evidence to Recommendations (EtR) Framework Proposed policy options
  • Combination Vaccines – Summary and Relevant Evidence to Recommendation Information
  • Update: Safety Monitoring and Surveillance for Recombinant Zoster Vaccine (RZV)
  • Herpes Zoster Work Group Summary
  • Pertussis Vaccines EtR Framework, Work Group Considerations and Proposed Policy Options
  • Rabies Vaccine
  • 2018-19 U.S. Influenza Activity
  • 2018-19 Influenza Vaccine Effectiveness
  • 2018-19 Influenza Vaccine Safety
  • Influenza Vaccine Proposed Recommendations for 2019-20
  • Proposed Recommendations for Use of Hepatitis A
  • Dengue Epidemiology in the U.S.
  • Dengvaxia Phase III Clinical Trials and Long Term Follow Up
  • Dengue Vaccine Work Group Considerations and Next Steps

If you haven’t been watching the meeting, the slides, videos, and minutes will be available later.

ACIP June 2019 Meeting Votes

And ACIP members voted on a number of issues, including:

Passed.
Passed.
This changes the 2014 ACIP recommendation to give PCV13 to all adults 65 years or older.
A series of votes on DTaP, Hib, IPV, and hepB got Vaxelis, the newly FDA approved hexavalent vaccine, added to the VFC program.

Coming up tomorrow will be votes on flu, hepatitis A, and meningococcal B vaccines.

More on the ACIP June 2019 Meeting

Is the MMR Safe for 6-Month-Old Babies?

Most parents understand that the first dose of the MMR vaccine is routinely given to children when they are 12 to 15 months old, at least in the United States.

In some other countries, the first dose is routinely given as early as 8 to 9-months of age.

And in high-risk situations, the MMR can safely be given to infants as early as age 6-months.

Is the MMR Safe for 6 Month Old Babies?

An early MMR, is that safe?

This type of pure anti-vaccine propaganda is what caused the measles outbreaks in New York in the first place...
This type of pure anti-vaccine propaganda is what caused the measles outbreaks in New York in the first place…

Yes, it is safe.

What about the package insert?

“Local health authorities may recommend measles vaccination of infants between 6 to 12 months of age in outbreak situations. This population may fail to respond to the components of the vaccine. Safety and effectiveness of mumps and rubella vaccine in infants less than 12 months of age have not been established. The younger the infant, the lower the likelihood of seroconversion (see CLINICAL PHARMACOLOGY). Such infants should receive a second dose of M-M-R II between 12 to 15 months of age followed by revaccination at elementary school entry.”

MMR II Package Insert

The package insert says to give infants who get an early dose another dose when they are 12 to 15 months old! It doesn’t say to not protect these babies!

But what about the idea that the safety and effectiveness of MMR hasn’t been proven for infants under 12 months of age?

In general, the package insert is only going to list studies that the manufacturer used to get FDA approval for their vaccine. Since it is an off-label recommendation of the ACIP, they would not include the studies that show that an early MMR is safe and effective.

“In conclusion, this study indicated that the MMR was well tolerated and immunogenic against measles, mumps and rubella with schedule of first dose both at 8 months and 12 months age. Our findings strongly supported that two doses of MMR can be introduced by replacing the first dose of MR in current EPI with MMR at 8 months age and the second dose at 18 months in China.”

He et al on Similar immunogenicity of measles-mumps-rubella (MMR) vaccine administrated at 8 months versus 12 months age in children.

Before 8 months, an early MMR isn’t likely to be as effective as giving it later. That’s because some maternal antibodies might linger in a baby’s system and can interfere with the vaccine working, even after six months. How many antibodies and how much interference?

It’s almost impossible to tell for any one child, but the risk that this maternal protection has begun to wear off and these infants are at risk to develop measles is too great. That’s the reason that they get an early MMR, even though we know it won’t be as effective as a dose given later and we know it will have to be repeated.

Is this early dose safe?

“This review did not identify any major safety concerns. These findings may facilitate discussions about the risks and benefits of vaccinating infants who are potentially exposed to this life-threatening disease.”

Woo et al on Adverse Events After MMR or MMRV Vaccine in Infants Under Nine Months Old

Of course! Although the complications of measles can be serious, even deadly, we aren’t going to recommend something that is even worse.

“Early MMR vaccination is well tolerated, with the lowest AE frequencies found in infants aged 6-8 months. It is a safe intervention for protecting young infants against measles.”

van der Maas et al on Tolerability of Early Measles-Mumps-Rubella Vaccination in Infants Aged 6-14 Months During a Measles Outbreak in The Netherlands in 2013-2014.

So an early MMR is safe, with few risks, and is likely effective at preventing measles.

And by now you know what’s not safe. That’s right, getting measles.

More on Early MMR Vaccines

Is the Japanese Encephalitis Vaccine the Stupidest Vaccine Known to Man?

You probably aren’t surprised to hear that Japanese encephalitis isn’t very common in the United States.

“Travelers who go to Asia are at risk for getting Japanese encephalitis (See map). For most travelers the risk is extremely low but depends on where you are going, the time of year, your planned activities, and the length of the trip. You are at higher risk if you are traveling to rural areas, will be outside frequently, or will be traveling for a long period of time”

Japanese Encephalitis

Fortunately, if you are one of those travelers who will be at risk, a Japanese encephalitis vaccine is available.

Is the Japanese Encephalitis Vaccine the Stupidest Vaccine Known to Man?

So how many people get Japanese encephalitis in the United States?

Del Bigtree thinks that it is stupid to have a vaccine against a disease that kills up to 20,400 in the world each year.
Del Bigtree thinks that it is stupid to have a vaccine against a disease that kills up to 20,400 in the world each year.

Not many, but that doesn’t mean it isn’t important to have a Japanese encephalitis vaccine if you need it, right?

“Now correct me if I’m wrong, but no one seems to be complaining of the fact that we have two vaccines that injured have injury rates adverse events of over 100 people. Nine serious adverse events. When the disease itself has only infected 12 human beings in 24 years.

That means that both of these vaccines are six times more dangerous than the disease itself, yet no one on this panel seems to want to discuss that. I imagine that you all will pass whatever it is the Japanese encephalitis next – the stupidest vaccine known to man.

Remember 12 people infected in America – 4 million people visiting the Asia every single year – 24 years – 12 people been infected, and yet we are having this conversation. It is clear that this is a money making operation for the vaccine maker and has nothing to do with actual safety.”

Del Bigtree at the ACIP Meeting

Del’s rant was in response to the Advisory Committee on Immunization Practices discussing Japanese encephalitis vaccines…

It is clear that he doesn’t understand how any of this works, so let’s correct him, since he did ask.

First things first.

Why does he think that only 12 people have been infected with Japanese encephalitis in the United States?

“In the United States, in 25-year period following licensure of JE vaccine in 1992, 12 travel-associated cases reported (< 1 case per year)”

Review of Japanese encephalitis (JE) and JE Vaccine Work Group plans

That’s actually the data from the ACIP JE Vaccine Work Group…

Japanese encephalitis is more common in Asia, where it is endemic in 24 countries in the WHO South-East Asia and Western Pacific regions.

Still, since it isn’t on the list of National Notifiable Conditions, it is possible that a low number of cases have been reported to the CDC because few of the cases actually get reported.

It is also possible that there are few cases because folks who are high risk now get vaccinated and protected. Rates were higher in the pre-vaccine era.

But there is also the fact that most travelers are not at risk to get Japanese encephalitis, so maybe there really have only been 12 cases.

“However, given the large numbers of travelers to Asia (>5.5 million U.S. travelers entered JE-endemic countries in 2004), the low risk for JE for most travelers to Asia, and the high cost of JE-VC ($400–$500 per 2-dose primary series), providing JE vaccine to all travelers to Asia likely would not be cost-effective. In addition, for some travelers with lower risk itineraries, even a low probability of vaccine-related serious adverse events might be higher than the risk for disease. Therefore, JE vaccine should be targeted to travelers who, on the basis of their planned travel itinerary and activities, are at higher risk for disease.”

Use of Japanese Encephalitis Vaccine in Children: Recommendations of the Advisory Committee on Immunization Practices, 2013

That doesn’t mean that we shouldn’t have these vaccines or that this is all part of a money-making operation, does it?

If it was a “money-making operation,” wouldn’t the ACIP recommend the Japanese encephalitis vaccines for all travelers?

Or to make even more money, wouldn’t they just add it to the routine immunization schedule and recommended it for all children?

“Travelers to JE-endemic countries should be advised of the risks for JE disease and the importance of personal protective measures to reduce the risk for mosquito bites. For some travelers who will be in a higher-risk setting based on season, location, duration, and activities, JE vaccine can further reduce the risk for infection. JE vaccine is recommended for travelers who plan to spend a month or longer in endemic areas during the JE virus transmission season.”

Use of Japanese Encephalitis Vaccine in Children: Recommendations of the Advisory Committee on Immunization Practices, 2013

Instead, they make recommendations, even with the latest updates, that virtually guarantees a very low market for the vaccine.

But if the disease isn’t common, why have a vaccine at all?

“Although symptomatic Japanese encephalitis (JE) is rare, the case-fatality rate among those with encephalitis can be as high as 30%. Permanent neurologic or psychiatric sequelae can occur in 30%–50% of those with encephalitis.”

Japanese encephalitis

Japanese encephalitis is deadly!

There have been at least 5 deaths, including 2 children, among just 12 cases (if Del's stats are right).
There have been at least 5 Japanese encephalitis deaths, including 2 children, among just 12 cases (if Del’s stats are right).

And since the Japanese encephalitis vaccines are safe, with few risks (Del is talking about VAERS reports when he talks about vaccine injury rates), why wouldn’t you get vaccinated and protected if you were going to be at risk?

“No safety concerns to date in post-licensure surveillance.”

Review of Japanese encephalitis (JE) and JE Vaccine Work Group plans

After all, there is nothing stupid about wanting to reduce your risk of getting sick and dying.

More on Japanese Encephalitis