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 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.
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.
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.
Reagan didn’t do much for vaccines, but it isn’t fair to pin this one on him.
It seems that some folks think that the Department of Health and Human Services hasn’t been complying with federal vaccine safety mandates for 30 years.
Did the US Government Lose a Landmark Vaccine Lawsuit?
While anti-vaccine folks are pushing this lawsuit victory (?) to make folks think that HHS has done absolutely nothing to promote vaccine safety in the last 30 years, that is obviously nonsense.
The lawsuit was actually just about the reporting requirements of paragraph (c) of section 2127 of the National Childhood Vaccine Injury Act of 1986.
It should be clear that the HHS has done plenty to promote vaccine safety though.
Even if no formal reports were filed, the HHS secretary did report to and appear before Congress. Come to think of it, they even sent some reports to Congress.
And the Health and Medicine Division (HMD) division (previously known as the Institute of Medicine (IOM) of the National Academies of Sciences, Engineering, and Medicine has published a number of vaccine safety reviews and reports under commission of HRSA, an agency of HHS.
Where do folks think that all of those IOM vaccine safety reports and reviews come from? Were they sent to Congress?
a Task Force on Safer Childhood Vaccines was established and completed a report, “identifying key issues and enhancing collaboration on behalf of vaccine safety” in 1996. Did someone forget to send it to Congress?
the Salk inactivated polio vaccine (IPV) replaced the oral polio vaccine (OPV) in 1996 because of a small risk of vaccine-associated paralytic poliomyelitis (VAPP), beginning with a sequential IPV-OPV vaccine schedule and then going to an all IPV schedule in 2000
the DTaP vaccine, which is supposed to have fewer side effects than DTP is licensed, and replaces DTP for all required doses by 1997, although DTP is never actually shown to have caused seizures or brain damage
RotaShield, the first rotavirus vaccine is licensed in 1998 but is soon withdrawn from the market in 1999 after it is associated with an increased risk of intussusception, a form of bowel obstruction
a new National Vaccine Plan was established in 2010, with the goal to develop new and improved vaccines, enhance the vaccine safety system, support communications to enhance informed vaccine decision-making, ensure a stable supply of, access to, & better use of recommended vaccines in the U.S., and increase global prevention of death & disease through safe & effective vaccination. Was the plan sent to Congress?
They did settle a lawsuit though, a lawsuit which was then dismissed.
So like the CDC whistleblower movie that didn’t include a whistleblower, anti-vaccine folks think that they have a smoking gun about vaccine safety reports, except that it is very obvious that all kinds of reports about vaccine safety have been done over the years.
Although it does seem like HHS didn’t file the required formal reports and keep to the strict letter of the National Childhood Vaccine Injury Act of 1986, there is abundant evidence that they have actually done all of the work required to make sure that our vaccines are safe.
A lot of folks, even some pediatricians, are still confused about the recommendations for the meningococcal B vaccines.
Remember, two vaccines, Bexsero and Trumenba, are approved to protect against serogroup B meningococcal disease.
The Men B Vaccine for High Risk Kids
There is no confusion about the recommendation that high risk kids should get vaccinated against meningococcal B disease.
“Certain persons aged ≥10 years who are at increased risk for meningococcal disease should receive MenB vaccine.”
ACIP on Use of Serogroup B Meningococcal Vaccines in Persons Aged ≥10 Years at Increased Risk for Serogroup B Meningococcal Disease: Recommendations of the Advisory Committee on Immunization Practices, 2015
Who’s high risk?
In addition to microbiologists who work with the Neisseria meningitidis bacteria, you are considered to be high risk if you are at least 10 years old and:
have a persistent complement component deficiency, including inherited or chronic deficiencies in C3, C5–C9, properdin, factor D, or factor H
have anatomic or functional asplenia, including sickle cell disease, children with congenital asplenia, and children who’s spleen was removed (splenectomy) to prevent complications of other conditions, such as ITP, hereditary spherocytosis, pyruvate kinase deficiency, Gaucher disease, and hypersplenism, etc.
are taking the medication eculizumab (Soliris), which is used to treat two rare blood disorders, atypical hemolytic uremic syndrome (aHUS) and paroxysmal nocturnal hemoglobinuria (PNH)
And, if high risk, you should either get a 3 dose series of Trumenba or a 2 dose series of Bexsero.
Keep in mind that traveling is not usually a risk factor for Men B, but can be for the other meningococcal vaccines.
The Men B Vaccine for Healthy Teens
But what if you aren’t at high risk?
While teens should routinely get vaccinated with other meningococcal vaccines, Menactra or Menveo, that provide protection against serogroups A, C, W, Y, the recommendation for Men B vaccination is more permissive.
“A MenB vaccine series may be administered to adolescents and young adults aged 16–23 years to provide short-term protection against most strains of serogroup B meningococcal disease. The preferred age for MenB vaccination is 16–18 years.”
ACIP on Use of Serogroup B Meningococcal Vaccines in Adolescents and Young Adults: Recommendations of the Advisory Committee on Immunization Practices, 2015
When given to healthy teens who are not at high risk for meningococcal disease, both Bexsero and Trumenba can be given as a two dose series.
A Permissive Recommendation for Men B Vaccines
This permissive recommendation for Men B is what has got folks confused…
“The recommendation is labeled as “Category B,” meaning that individual clinical decision-making is recommended. A Category A recommendation means a vaccine is recommended for everyone in an age-group or risk factor group.”
ACIP endorses individual choice on meningitis B vaccine
So there is a recommendation for older teens to get vaccinated with the Men B vaccines, it just isn’t the clear cut, get the vaccine, kind of recommendation that we are used to. The recommendation instead says that you can get the vaccine if you want to be vaccinated and protected against meningococcal B disease.
And that’s where the confusion comes from, as over 75% of doctors don’t even know what a category B recommendation really means! That’s not surprising though, as the Advisory Committee on Immunization Practices doesn’t often make category B recommendations for vaccines.
Things that factored into the decision for a permissive recommendation seemed to include that:
routine vaccination of all teens would prevent about 15 to 29 cases of Men B and two to five deaths each year, as there are about 50 to 60 cases and five to 10 deaths each year in children and young adults between the ages of 11 and 23 years, and giving it only to kids going to college would only prevent about nine cases and one death each year
there are some concerns about how effective the MenB vaccines might be, but only because vaccine effectiveness “was inferred based on an immunologic marker of protection,” as it is difficult to otherwise test how well the vaccine works because the disease has a low prevalence and there is no data yet about how long the protection will last, as they are new vaccines. Still, from 63 to 88% of people get protective levels of antibodies after getting the MenB vaccines and the protection should last for at least two to four years.
data on safety was limited, but there were no “no concerning patterns of serious adverse events”
the vaccine likely won’t reduce the nasopharyngeal colonization by MenB bacteria, so might not contribute to herd immunity
If you are still confused, you will hopefully be reassured that a combination, pentavalent MenABCW-135Y meningococcal vaccine is in the pipeline and once available, will almost certainly be recommended for all teens, replacing the need to get separate meningococcal vaccines for protection.
Making a Decision About the MenB Vaccines
So do you get your kids the Men B vaccine series?
“Pediatricians are encouraged to discuss the availability of the MenB vaccines with families.”
AAP on Recommendations for Serogroup B Meningococcal Vaccine for Persons 10 Years and Older
The one thing that is very clear is that you should make your decision after talking to your pediatrician about the risks and benefits of getting vaccinated.
Although many people think that there is no recommendation for healthy teens to get a Men B vaccine, that isn’t really true. There just isn’t a recommendation for routine vaccination of all teens.
It is true that the Men B vaccines aren’t required by most colleges, although some are starting to require them, just like they do Menactra or Menveo.
“The treating clinician should discuss the benefits, risks, and costs with patients and their families and then work with them to determine what is in their best interest.”
AAP on Recommendations for Serogroup B Meningococcal Vaccine for Persons 10 Years and Older
What are the benefits? Your child doesn’t get Men B disease, a disease that is often life-threatening.
What are the risks? In addition to extremely rare risks that you can see with any vaccine, like anaphylaxis, there are the risks that the vaccine doesn’t work, as no vaccine is 100% effective, pain from the shot, or that your child is never exposed, so didn’t actually need the shot, since Men B disease is pretty rare.
“The CDC has estimated the risk of anaphylaxis is 1.3 cases/1 million doses following administration of any vaccine. Thus, the vaccine benefit from prevention of death from MenB disease is approximately equal to the risk of anaphylaxis from MenB vaccine administration.”
H. Cody Meissner, MD on MenB vaccines: a remarkable technical accomplishment but uncertain clinical role
Although thinking about it this way, the risk of anaphylaxis vs the benefit of preventing Men B deaths seems to be equal, remember that anaphylaxis is often treatable.
What are the costs? Men B vaccines are expensive, but are covered by insurance and the Vaccines for Children Program. Still, someone is always paying for them.
What other factors come into play? Some teens are getting caught up on their HPV vaccines and are getting a booster dose of the other meningococcal vaccine at around this same time. While they can certainly all be given together, some pediatricians prioritize getting kids vaccinated and protected with Gardasil and Menactra or Menveo, and so don’t focus on the Men B vaccines.
Still, the vaccine is safe and it works, so the question really may come down to – is it necessary? Or is Men B so rare, that it is worth taking a chance and skipping this vaccine.
What to Know About the Recommendations to Get a Men B Vaccine
Talk to your pediatrician and see if your child should get the Men B vaccine series.
More on Understanding the Recommendations to Get a Men B Vaccine
“The CDC is a subsidiary of the pharmaceutical industry. The agency owns more than 20 vaccine patents and purchases and sells $4.1 billion in vaccines annually. Congressman Dave Weldon has pointed out that the primary metric for success across the CDC is how many vaccines the agency sells and how successfully the agency expands its vaccine program—regardless of any negative effects on human health.”
Robert F Kennedy, Jr
Wait, the CDC sells vaccines?
Myths About the CDC Selling Vaccines
The CDC doesn’t sell vaccines. That’s not their mission.
“The Centers for Disease Control and Prevention (CDC) works 24/7 to protect America from health, safety, and security threats, both foreign and in the U.S. Whether diseases start at home or abroad, are chronic or acute, curable or preventable, human error or deliberate attack, CDC fights disease and supports communities to do the same.”
CDC Mission, Role and Pledge
They do buy vaccines. A lot of vaccines.
In 2017, the CDC immunization program spent just over $4.8 billion dollars, including $4.1 billion on the Vaccines for Children program.
“…from March through December 2016, over 13,000 doses of meningococcal conjugate vaccine, purchased using CDC funding, were used to respond to a deadly outbreak of meningitis in Southern California.”
Department Of Health And Human Services Fiscal Year 2018
Did they sell all of those vaccines?
If they did, then they wouldn’t have to request money from Congress each year to buy more vaccines, now would they?
“CDC buys vaccines at a discount and distributes them to grantees—i.e., state health departments and certain local and territorial public health agencies—which in turn distribute them at no charge to those private physicians’ offices and public health clinics registered as VFC providers.”
The VFC Program: At a Glance
Instead, the vaccines that the CDC buys, at big discounts, since they are buying so many, are offered free to those kids who can’t afford vaccines in the Vaccines for Children (VFC) program and through Section 317 grants.
What About the CDC Vaccine Patents?
Is Kennedy right about the CDC vaccine patents?
“In the course of performing our mission, many CDC researchers identify novel technologies which may be of interest to commercial partners. Some of these technologies are available as a biological or other tangible material for licensing, whereas others are protected under patent.”
Office of the Associate Director for Science (OADS)
OK, so the CDC has patents…
Well, not exactly the CDC. The United States of America as represented by the Secretary of the Department of Health and Human Services has patents…
When you think of Kennedy’s claim, do you think that the CDC has the patent on 20 new vaccines? After all, that’s how it sounds, doesn’t it?
“This technology describes a method for inactivating rotavirus. Traditional inactivation strategies use chemicals that reduce antigenicity (by altering rotavirus proteins), leading to less protection against the virus. Conversely, this method preserves and/or maintains the integrity of viral particles, leading to greater protection against rotavirus. This strategy has been validated in mice, piglets and cattle and further clinical studies are underway.”
A Novel Thermal Method to Inactivate Rotavirus for Use in Vaccines
Why patent these technologies?
Because they were discovered by CDC researchers and if their intellectual properly is not patented, then someone else could patent it, use it or sell it, and keep others from using it.
“After a license is negotiated, post-license compliance must be maintained to ensure the scheduled development of the technology, payment of royalties, and compliance to the license agreement. Based on the terms negotiated in the agreement, a percentage of royalties will go to the inventor, while a portion will go to the originating laboratory for that technology. This allows funding to be reinvested into CDC for the development of additional technologies that can meet other public health needs.”
What is the Process of Technology Transfer?
Should it be a surprise that these patents might generate money?
“Certain people are not considered for ACIP membership. For example, people who are directly employed or have an immediate family member directly employed by a vaccine manufacturer, hold a patent on a vaccine or related product, or serve on a Board of Directors of a vaccine manufacturer are excluded from ACIP membership.”
The Advisory Committee on Immunization Practices (ACIP) and the Childhood Immunization Schedule
“Dr Offit did not sit on the FDA committee that approved any rotavirus vaccine and he was not a member of ACIP, as RFK Jr claims, at the time they voted to recommend adding rotavirus vaccine to the immunization schedule.”
The Truth about vaccines 6: rotavirus
Is it a surprise that Kennedy is just trying to scare folks with all of this talk about selling vaccines and vaccine patents?
What to Know About the CDC’s Vaccine Patents
While the CDC does own and license some patents related to vaccines and vaccine technologies, they don’t actually sell any vaccines.