Tag: ACIP

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

Why Aren’t Vaccines Regulated like Drugs?

Have you ever heard the argument that vaccines aren’t held to the same standards as drugs, food, or other products?

“Vaccines are not held to the same double blind gold standard of clinical testing as other pharmaceutical drugs because they are considered biological products under the Public Health Federal Food, Drug and Cosmetic Act. They meet the same standards as cosmetics.”

20 VACCINE “FACTS” you need to know to make an informed decision

Placebos, liability, testing – these are all arguments that anti-vaccine folks try to use to scare parents into thinking that vaccine development isn’t well regulated and vaccines aren’t held to the same standard as drugs.

Why Aren’t Vaccines Regulated like Drugs?

Would you be surprised to learn that part of their argument is true?

Even after approval by the FDA, a vaccine still has to be reviewed by the ACIP before it is put on the immunization schedule.
Even after approval by the FDA, a vaccine still has to be reviewed by the ACIP before it is put on the immunization schedule.

No, not the part that vaccine development isn’t well regulated!

“Current authority for the regulation of vaccines resides primarily in Section 351 of the Public Health Service Act and specific sections of the Federal Food, Drug and Cosmetic Act.”

Vaccine Product Approval Process

Federal regulations and rules ensure that our vaccines are safe.

  • Public Health Service Act (42 USC 262-63) §351
  • Food, Drug, and Cosmetic Act (21 USC 301-392)
  • Title 21 Code of Federal Regulations (CFR) 600-680 – standards for biological products
  • Title 21 CFR 314 (21 CFR 601.25[d][2], specific to biologicals – ensures adequate and well-controlled clinical trials
  • Title 21 CFR 312 – investigational new drug application (IND)
  • Title 21 CFR 210-211 – good manufacturing practices
  • Title 21 CFR 58 – good laboratory practices
  • Title 21 CFR 56 – institutional review boards
  • Title 21 CFR 50 – protection of human subjects
  • Prescription Drug User Fee Act (PDUFA) of 1992, 2002, and 2007
  • Food and Drug Agency Modernization Act (FDAMA) of 1997
  • Food and Drug Agency Amendments Act (FDAAA) of 2007

I meant the part that vaccines aren’t regulated like drugs.

While both vaccines and prescription drugs are regulated by the FDA, that work occurs within two different centers of the FDA:

  • Center for Biologics Evaluation and Research (CBER) – vaccines
  • Center for Drug Evaluation and Research (CDER) – over-the-counter and prescription drugs

Both centers work to make sure we have safe and effective vaccines and drugs to keep us healthy, even if there are some differences in how they do it.

“Vaccine clinical development follows the same general pathway as for drugs and other biologics.”

Vaccine Product Approval Process

That’s right, vaccines and drugs go through the same types of clinical trials.

After completing the three phases though, vaccine developers must then apply for a Biologics License Application (BLA), which is reviewed by a multidisciplinary FDA reviewer team. This is also when their manufacturing facility gets inspected.

“Following FDA’s review of a license application for a new indication, the sponsor and the FDA may present their findings to FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC). This non-FDA expert committee (scientists, physicians, biostatisticians, and a consumer representative) provides advice to the Agency regarding the safety and efficacy of the vaccine for the proposed indication.”

Vaccine Product Approval Process

Once approved and licensed, the FDA and CDC continue to work to make sure the vaccine is safe, including having some vaccines undergo undergo Phase 4 studies and monitoring for side effects through VAERS and the Vaccine Safety Datalink.

And then, even after approval by the FDA, new vaccines aren’t put on the immunization schedule until a review and approval by the Advisory Committee on Immunization Practices (ACIP).

“Canada, like many other countries, exercises tight regulatory oversight over vaccines because they are usually given to very large numbers of healthy individuals. Vaccines in Canada are subject to the Food and Drugs Act and the Food and Drug Regulations. Vaccines are regulated under a specific set of regulations for a subset of drugs known as biologic drugs.”

The Regulation of Vaccines for Human Use in Canada

It is also important to keep in mind that this process doesn’t just happen in the United States.

Still wondering why vaccines aren’t regulated like drugs?

“Vaccine development differs from drug development in several important ways. First, because vaccines are preventive and are given to healthy individuals – often children – they require very large clinical trials, leading to increased research and development costs. Second, vaccines are biological products that can be very complex to manufacture and are subject to stringent quality control standards, resulting in much higher capital costs. Third, unlike drugs, vaccines have no secondary markets, making it unlikely that manufacturers will generate additional profits beyond the initial target markets. Finally, unlike generic drugs, which only need to demonstrate adherence to a pre-established development process, vaccines are biologicals that require full re-development to demonstrate their equivalence. (World Health Organization, 2014). Each manufacturer is required to invest in the full regulatory approval process for their vaccine products.

Myths and Facts about Vaccine Product Price and Procurement

It’s only because vaccines are more strictly regulated than drugs and other products.

Vaccines are safe and necessary.

More on Vaccine Regulation

Retired Hospital Worker’s Flu Shot Speech at the ACIP Meeting

Did you see the video of the retired hospital worker, an emergency room technician, at the ACIP meeting earlier this year?

A retired emergency room technician gave a speech at an ACIP meeting because she is upset that hospital workers have to get yearly flu shots.
A retired emergency room technician gave a speech at an ACIP meeting because she is upset that hospital workers have to  either get yearly flu shots or wear a face mask.

Although brief, and emotional, she hit a lot of anti-vaccine talking points and managed to somehow talk about adult autistics walking around the mall with diapers and helmets at least four times.

Retired Hospital Worker’s Flu Shot Speech at the ACIP Meeting

Praised by anti-vaccine folks for being “explosive” and a “bombshell,” all the speech really does is reveal how easily influenced some folks are by the modern anti-vaccine movement.

“I don’t come here with any degree.”

The only true and one of the most important things she says comes at the beginning. Although it certainly isn’t a requirement to have a degree to speak your mind, in a room full of scientists and doctors who study health policy and vaccines as their life’s work, she was there to tell them that they were wrong.

“No one believes in the flu shots. My colleagues. I didn’t. Because the efficacy – and I won’t give you data, you created the data. 10% one year. 18% another year. 40% at best. And the FluMist you gave to our children from 2 to 8 years for almost 4 years – it never worked. 3%. Oh well.”

Most people actually understand that flu vaccines are important and many get a flu shot each year. Even more get their kids vaccinated and protected each year.

In most years, the flu vaccine is at about 40 to 50% effective at preventing the flu, but has other benefits, including preventing a severe case of the flu, getting hospitalized, and keeping you from dying with the flu!

Did a drop in flu vaccine coverage help contribute to a rise in flu deaths?
Did a drop in flu vaccine coverage help contribute to a rise in flu deaths?

The idea that “no one believes in flu shots” is silly. It is certainly possible that no one this speaker knows believes in flu shots, as many anti-vaccine folks exist in an echo chamber and only hear and read negative things about vaccines.

Her statements about flu vaccine efficacy are also way off, especially about FluMist, as there was only evidence that it didn’t work well against H1N1 flu strains for a few years.

“And then came your mandates. And then came your recommendations. So you know what, for four years before I retired I put a mask on. 12 hour shifts. It wasn’t easy to breath. But that’s how much I didn’t believe in your efficacy.”

Neither the CDC or ACIP mandate that hospital workers get a yearly flu shot.

It is recommended and it is the ethical thing to do, so that we protect our most vulnerable patients, including those who can’t be vaccinated, but the CDC doesn’t issue mandates.

“But the truth. The public’s truth. My observation – which is the first step in scientific theory – they didn’t believe in your shot.”

Making an observation is actually the first step in the scientific method. But you don’t stop there. Why don’t they believe in flu vaccines? Are they scared about all of the anti-vaccine propaganda that they see and read on the Internet or even from anti-vaccine friends or coworkers?

“This year I retired. I’m grateful for that, because my soul was sick about what I saw go on. That flu shot was crazy. First it was 10%. How can you do data? Which 10 got the shot out of a 100?”

How do they know which 10 got the shot?

Believe it or not, when they tell us about flu vaccine effectiveness, they are not basing that number on each and every person who got a flu vaccine. They do a study, enroll patients, see if they get flu, see if they had a flu vaccine, compare them to other patients, etc. It’s actually very easy to tell which ones got the shot…

“I’m looking around, some of you are my age. And if I’m mistaken, I apologize. But I’m in a generation where I got 7 shots. 26 years later, my daughter got 10. Her son got, maybe 60. My new grandson is expected to get maybe 72, and I just watched you add more.”

Yes, a lot has changed from her generation.

Four generations of vaccines or vaccine misinformation?
Four generations of vaccines or vaccine misinformation?

Our now vaccinated kids don’t die from Hib meningitis, Hib epiglotittis, pneumococcal disease, rotavirus, chicken pox, hepatitis A, hepatitis B, measles, etc., and they don’t get congenital rubella syndrome!

And for the record, her new grandson won’t need 72 shots or more.

They didn’t add any more at that ACIP meeting she gave her speech at either.

“Robert Kennedy, Jr – do you know what he says? His family started Special Olympics – there were no autistic kids. He says, where are the 40 year olds wearing diapers with helmets on at the mall if you misdiagnosed them. If you missed them, because you say it’s not vaccines,  where were the special ed classes for people in my generation – there weren’t any. Because they didn’t exist.”

Special education classes didn’t exist back then, because we didn’t start getting things like that until passage of the Education for All Handicapped Children Act in 1975. Before that, many states actually had laws excluding special needs children from school!

So there weren’t any special ed classes because they weren’t available, not because they weren’t needed.

And as the first school for autistic children, the Sybil Elgar School, was established in 1965, it should be obvious that her comments about autistic adults are not only wrong, they are offensive.

“I don’t care what you say that the autism and vaccines don’t exist – it does. I watched a perfectly healthy beautiful 2-year-old get those shots and become a severe autistic child. And guess what, he will be 40 and walking around the mall with a diaper on and helmet.”

This is everything that is wrong with the modern anti-vaccine movement.

Continuing to push the idea that vaccines are associated with autism and being locked into a deficit model of thinking about autism, so that when you look at your child, all you see is an adult with a “diaper on and helmet,” instead of beautiful autistic 2-year-old.

Ironically, she ended her speech with this quote by William Wilberforce.

“Having heard all of this you may choose to look the other way but you can never again say you did not know.”

William Wilberforce

Nothing she said was true and some of it was actually offensive.

You can’t say you don’t know now.

More on the Retired Hospital Worker’s Flu Shot Speech at the ACIP Meeting

Did the FDA Approve a New HPV Vaccine for Adults?

What do you know about the HPV vaccine?

Hopefully you know that it can prevent cervical cancer and that lots of folks spread misinformation that is intended to confuse and scare you away from getting vaccinated and protected with it and other vaccines.

Did the FDA Approve a New HPV Vaccine for Adults?

News that the approved ages for Gardasil have been expanded will likely add to that confusion for a little while.

The FDA simply approved the expanded use of the existing Gardasil 9 vaccine – not a new vaccine.
The FDA simply approved the expanded use of the existing Gardasil 9 vaccine – not a new vaccine.

The first thing to understand is that the FDA did not approve a new Gardasil vaccine for older adults.

They very simply expanded the age recommendations for who should get the existing Gardasil 9 vaccine, which was approved back in 2014, replacing the original Gardasil vaccine, which was approved in 2006.

“The U.S. Food and Drug Administration today approved a supplemental application for Gardasil 9 (Human Papillomavirus (HPV) 9-valent Vaccine, Recombinant) expanding the approved use of the vaccine to include women and men aged 27 through 45 years.”

Why the new age indication?

“In a study in approximately 3,200 women 27 through 45 years of age, followed for an average of 3.5 years, Gardasil was 88 percent effective in the prevention of a combined endpoint of persistent infection, genital warts, vulvar and vaginal precancerous lesions, cervical precancerous lesions, and cervical cancer related to HPV types covered by the vaccine.”

But isn’t the whole point of giving the HPV vaccine to preteens that you want to get them vaccinated and protected before they are sexually active and exposed to and infected by HPV?

Sure, but if you didn’t, and unless you are sure that you have been exposed to and have been infected by all 9 types of HPV strains that Gardasil 9 protects you against, then the vaccine is still a good idea when you are older.

Except FDA approval doesn’t automatically mean that your insurance company will pay for it.

That usually comes once a vaccine is formally added to the immunization schedule by the ACIP.

“In a 2005 study, 92% of insurance plans reported following Advisory Committee on Immunization Practices recommendations to determine covered vaccines; of those, 60% could extend coverage within 3 months after issuance of recommendations and 13% in 1 month.”

Lindley et al on Financing the Delivery of Vaccines to Children and Adolescents: Challenges to the Current System

And Obamacare still requires insurance plans to provide ACIP-recommended vaccines at no charge.

Will Gardasil 9 be added to the immunization schedule for adults?

The extended age indication for Gardasil 9 will be discussed at the next ACIP meeting.
The extended age indication for Gardasil 9 will be discussed at the next ACIP meeting.

We should know sooner, rather than later. It is on the agenda for the next ACIP meeting on October 25…

More on Gardasil for Older Adults

Flumist Is Not Just a Last Resort

The return of FluMist has hit a slight snag.

Most folks will remember that on February 12, 2017, at a meeting of the Advisory Committee on Immunization Practices (ACIP), members voted to once again recommended FluMist Quadrivalent to prevent the flu. So it will be available for this year’s flu season.

Many parents and pediatricians welcomed the news, as it meant that many kids could avoid getting a shot and could get the nasal spray flu vaccine instead.

Why did flu vaccine rates drop in younger school age kids when Flumist wasn't available?
Why did flu vaccine rates drop in younger school age kids when Flumist wasn’t available?

It was especially good news for those kids who skipped getting a flu vaccine because they didn’t want to get a shot when Flumist wasn’t available.

Flumist as a Last Resort?

So what’s the problem?

“The Academy recommends pediatricians give children inactivated influenza vaccine in the upcoming season and use live attenuated vaccine only as a last resort.”

American Academy of Pediatrics

Members of the AAP Committee on Infectious Diseases (COID) are concerned that FluMist, even after it has been changed to address previous issues, may not work as well as a standard flu shot.

“Influenza is unpredictable from year to year, so we really want to immunize as many kids as we can against the flu with what we think will be the most effective product. That’s why we’re recommending the flu shot this coming season.”

Henry H. Bernstein, D.O., M.H.C.M., FAAP

While many of us were surprised by the “last resort” phrasing from the AAP, maybe we shouldn’t have been.

In addition to being an ex officio member of the AAP Committee on Infectious Diseases (COID), Henry H. Bernstein was one of only two members of the ACIP who voted against bringing FluMist back, going against the opinion of twelve other members who voted in favor of FluMist.

Dr. Henry H. Bernstein is also the “leading voice on AAP’s annual policy statement on preventing flu in children with flu vaccines.”

“The data reviewed showed that receiving the nasal spray vaccine is better than not getting any vaccine at all,” said Flor Munoz, MD, FAAP, member of the AAP Committee on Infectious Diseases. “If you get the nasal spray vaccine, just be aware that, depending on the performance of the new vaccine formulation, there might be a chance you will not be fully protected against H1N1 strains of flu. The efficacy of this new formulation has not yet been determined.”

It is important to note that the AAP is not saying that Flumist won’t work though.

“The effectiveness of this new formulation of LAIV4 has not been confirmed, since A/H1N1 virus has not widely circulated recently.”

AAP influenza immunization recommendations revised for 2018-’19 season

They are basically saying that if the reformulated version of Flumist doesn’t work as it is predicted to work, then your kids might not be protected. They are concerned that we haven’t seen the new version of Flumist work in real world studies against the H1N1 strain of the flu.

Flumist Is Not Just a Last Resort

Fortunately, the AAP has somewhat rephrased their message about Flumist (LAIV4). While they still recommend that the inactivated influenza vaccine (flu shots) be the primary choice for children, they now say that:

“LAIV4 may be offered for children who would not otherwise receive an influenza vaccine (and for whom it is appropriate by age and health status).”

AAP influenza immunization recommendations revised for 2018-’19 season

Importantly though, parents and pediatricians should note that the recommendations of the Advisory Committee on Immunization Practices (ACIP) for the 2018–19 flu season very clearly make no preferential recommendation for the use of any influenza vaccine product over another.

“Following two seasons (2016–17 and 2017–18) during which ACIP recommended that LAIV4 not be used, for the 2018–19 season, vaccination providers may choose to administer any licensed, age-appropriate influenza vaccine (IIV, RIV4, or LAIV4). LAIV4 is an option for those for whom it is appropriate.”

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

And the ACIP and CDC aren’t the only ones who disagree with the AAP’s decision.

“So I think the AAP was wrong, frankly, to say that FluMist should only be used as a last-resort vaccine for influenza. Rather, they should have gone along with what the ACIP said, which was that these vaccines can now be used interchangeably for persons aged 2-49 years.”

Paul Offit, MD on FluMist: Reasonable Vaccine Option or ‘Last Resort’ for the Upcoming Flu Season?

So what should you do?

If it is going to be a battle getting your kids a flu shot and you might you might have even skipped it the last few years because Flumist wasn’t available, then your choice is very clear.

Get vaccinated with Flumist, as long as your child is at least two years old and otherwise meets the requirements.

And don’t feel bad or worried that your decision is leaving your child unprotected. Remember that Flumist is recommended by the ACIP and CDC and has been used continuously in most other countries (under the name Fluenz).

Your next battle might simply be finding Flumist. Because of the AAP’s “last resort” comment, some pediatricians didn’t even bother ordering any doses.

More on the Latest Flumist Recommendations