Tag: ACIP

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


Did the FDA Admit That the Government Is Recommending Untested, Unlicensed Vaccines for Pregnant Women?

Have you heard?

There is a new bombshell from anti-vaccine folks!

It turns out, they say, that the FDA has admitted that the government is recommending untested, unlicensed vaccines for pregnant women.

Is that true?

Did the FDA Admit That the Government Is Recommending Untested, Unlicensed Vaccines for Pregnant Women?

Of course not!

Their evidence?

A response to a Freedom of Information Act request for vaccines that don’t exist. That’s right, neither Tdap nor flu vaccines are currently FDA approved for use by pregnant women.

Of course, that doesn’t mean that Tdap and flu vaccines aren’t recommended for use by pregnant women.

Wait, why the difference?

Why are pregnant women being given a vaccine that isn’t formally FDA approved for their use?

Well, vaccine manufacturers have to seek FDA approval for their products. The FDA doesn’t just up and approve new products or give them new indications. And none have ever sought approval in pregnancy.

But that doesn’t keep health experts from making off-label recommendations, such as getting a flu vaccine when you are pregnant.

“In prelicensure evaluations, the safety of administering a booster dose of Tdap to pregnant women was not studied. Because information on use of Tdap in pregnant women was lacking, both manufacturers of Tdap established pregnancy registries to collect information and pregnancy outcomes from pregnant women vaccinated with Tdap. Data on the safety of administering Tdap to pregnant women are now available.”

Updated Recommendations for Use of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine (Tdap) in Pregnant Women and Persons Who Have or Anticipate Having Close Contact with an Infant Aged <12 Months — Advisory Committee on Immunization Practices (ACIP), 2011

As important as FDA approval is a recommendation from the Advisory Committee on Immunization Practices (ACIP). In fact, even after a vaccine gets approved by the FDA, it still has to get a recommendation from the ACIP before it gets on the immunization schedule and is used routinely!

“Flu shots have been given to millions of pregnant women over many years with a good safety record. There is a large body of scientific studies that supports the safety of flu vaccine in pregnant women and their babies.”

Flu Vaccine Safety and Pregnancy

Getting a flu vaccine during pregnancy is a recommendation that has been evolving since 1983. It was known to be safe then, and we are even more confident that it is safe now.

A Tdap shot has been recommended since 2011, although it was first suggested in 2008 that pregnancy was not a contraindication for receiving Tdap.

How do we know these vaccines are safe during pregnancy?

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.”

Despite what Robert F. Kennedy, Jr and his ironically named Children’s Health Defense organization might think, Tdap and flu shots in pregnancy have been well studied and have been found to be safe.

Ignoring all of the above studies, Kennedy highlights a few that he thinks found problems with flu shots in pregnancy, including one that showed “a suggestion of increased ASD risk among children whose mothers received an influenza vaccination in their first trimester,” a suggestion that was not statistically significant and which was not found in the other trimesters. And another that found an increased risk of spontaneous abortion in women who had also received a flu shot in the previous season, a safety signal that has never been seen before and which continues to be investigated.

Not surprisingly, his latest bombshell is landing with as big of a thud as his HHS lawsuit, as have most of his statements these days…

“CHD’s Chairman Robert F. Kennedy, Jr. notes that most flu shots given to pregnant women still contain a mercury-based preservative thimerosal.”

FDA Admits That Government Is Recommending Untested, Unlicensed Vaccines for Pregnant Women

Has Kennedy missed the fact that 80% of flu vaccines are now thimerosal free? It makes you wonder how he defines the word “most?”

“Thimerosal is acknowledged by Proposition 65 in California as a reproductive toxicant and exposure during pregnancy can cause learning and behavioral problems. Tdap contains aluminum, which FDA regulates as a toxin in parenteral nutrition but not in vaccines.”

FDA Admits That Government Is Recommending Untested, Unlicensed Vaccines for Pregnant Women

And what is he concerned about in thimerosal-free flu shots which also don’t contain aluminum? Are those okay in his book?

Mostly, after several flu seasons in which so many people have died, you have to wonder what his goal is here. Does Robert F. Kennedy, Jr. expect folks to skip getting a flu shot when they are pregnant and instead risk getting the flu? Should they skip their Tdap shot and risk their baby dying of whooping cough?

Or should they just stop listening to this type of anti-vaccine propaganda?

More on Did The FDA Admit That The Government Is Recommending Untested, Unlicensed Vaccines For Pregnant Women?

Did Dr. Bob Uncover a CDC Plot to Give Adult Flu Shots to Babies?

Have you heard the news?

Uh, the ACIP can't request a license for a vaccine...
Uh, the ACIP can’t request a license for a vaccine…

Dr. Bob and his new podcasting side kick think that the “CDC wants the FDA to approve adult doses of the flu vaccine for babies, because the normal half-doses approved for babies don’t work well enough.”

Did Dr. Bob Uncover a CDC Plot to Give Adult Flu Shots to Babies?

This is likely going to surprise Dr. Bob, but many infants already get the same dose of flu vaccine as adults.

Both FluLaval and Fluarix are given at the same 0.5ml dose, containing 15 µg of HA per vaccine virus, to infants, older children, and adults.

Fluzone, on the other hand, is still given at a 0.25ml dose, containing 7.5 µg of HA per vaccine virus, to children between the ages of 6 months to three years, and a larger 0.5ml dose to older kids and adults.

Why the differences?

“In a randomized trial comparing immunogenicity and safety of 0.5 mL FluLaval Quadrivalent with 0.25 mL Fluzone Quadrivalent, safety and reactogenicity were similar between the two vaccines.”

Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices—United States, 2018–19 Influenza Season

Because they are just as safe at the lower doses and might actually work better.

Then why did we ever use a lower dose for infants?

That recommendation was based on the older, whole-virus version of the flu shot, which did cause more side effects for infants when given at a full dose. We now use split-virus flu shots that don’t have this problem.

And now, the manufacturer of Fluzone has done a study, and not surprisingly, they have also found that “safety profile of a 0.5 ml (full-dose) is similar to 0.25 ml (half-dose) and may be more immunogenic.”

So they are submitting a BLA to the FDA for the use of the 0.5ml dose of their flu vaccine for infants.

What about the idea of an “adult dose of mercury” for infants?

Over 80% of flu vaccines were thimerosal free this year. You almost have to go out of your way to get your kids a flu vaccine with thimerosal, so no, this won’t mean an “adult dose of mercury” for your infant.

Most importantly though, if you understand how vaccines work, you know that the dose of vaccines for kids and adults is not calibrated by weight or age, so none of this really matters. The immune reaction that helps antibodies travel all through your body starts locally, near where the vaccine was given, so a 20-pound infant and a 200-pound adult can get the same dose of flu shot and both can be protected.

More on Dr. Bob’s CDC Plot to Give Adult Flu Shots to Babies