Why My Kid Won’t Be Getting These New Vaccines Anytime Soon
Sep 11, 2015

There’s a part of me that understands why some people are hesitant to get newly approved and recommended vaccines.

“I don’t want my child to be a pharmaceutical guinea pig.”

“The vaccine hasn’t been around long enough.  How can we really know the long-term side effects?”    

“I didn’t have half the vaccines that kids today get and I survived.  Why do we bother to give so many vaccines for diseases that aren’t even all that serious?”

These are the kind of comments I’ve heard in school, at the doctor’s office, on the playground with other parents, or posted as comments on social media. While I understand that people may be hesitant, and sometimes even fearful, of something new, I tend to address my concerns by learning more about whatever it is I’m afraid of.

Since I began contributing to this blog six years ago, I’ve tried to address some of the most popular immunization concerns I’ve heard from other parents.  In sharing what I’ve learned, It is my sincere hope that others will be better able to make informed immunization decisions based on the sound scientific evidence that I include in my posts.

However, the approval of two new vaccines (HPV9 and MenB) have actually caused me much concern and distress lately.

It’s not that I’m worried about the dangers of these new vaccines.  Quite the contrary.  

I’ve sat through enough presentations at immunization conferences and committee meetings to appreciate the extensive amount of data that is collected and analyzed by hundreds of scientists and doctors as a vaccine makes it’s way through the various phases of clinical trials.

I’ve become familiar with the elaborate process that leads to FDA approval, and I’ve witnessed discussions by the Advisory Committee on Immunization Practices (ACIP) when they’ve considered modifications or additions to the recommended vaccine schedule.  By the time a new vaccine is ever recommended for my child, the vaccine has already been administered to thousands of people in clinical trials and the vaccine’s efficacy and potential adverse effects have already been well documented.  In fact, many vaccines, are already being used in foreign countries for years prior to being approved here in the U.S.  This provides a considerable amount of safety and efficacy data for us to analyze prior to being licensed by the FDA and being recommended by the ACIP.

With all the available data that is scrutinized by so many experts, I’m not concerned at all about the vaccine’s safety.  What I am concerned about is how long it takes for the public to finally have access to these new vaccines after FDA approval and ACIP recommendation.

In the case of these two new vaccines (HPV9 and MenB) my personal experience has been far from ideal.  It’s been at least three months since the new ACIP recommendations and yet I’m still unable to locate a single dose of either vaccine within a 50 mile radius of my home.  To make matters worse, I’m hearing reports from parents who are getting inaccurate information about the availability of these vaccines.

HPV9: The 9-valent HPV Vaccine

HPV9 has been a highly anticipated vaccine, especially for me as a parent of five daughters.  This vaccine is an improvement over previously approved HPV vaccines because it offers protection against nine strains of HPV, as opposed to just two strains in HPV2 or four strains in HPV4.

The current bivalent (HPV2) and quadrivalent (HPV4) vaccines both protect against HPV types 16 and 18, which account for about 70% of all cases of cervical cancer.  The quadrivalent adds protection against serotypes 6 and 11, which account for about 90% of cases of anal and genital warts.

In contrast, the newly approved 9-valent vaccine will protect against 16, 18, 6 and 11, as well as five additional HPV types (31, 33, 45, 52 and 58) which currently account for about 4,000 cases of HPV related cancer in the U.S. each year.  It’s expected that the new HPV9 vaccine will therefore prevent an additional 15-20% of cervical cancers, and an additional 5-20% of other cancers when compared to HPV2 or HPV4. 

To my frustration, the ACIP’s latest recommendation did not express a preference for HPV9 vs. HPV2 or HPV4.   However, there is no doubt that I prefer that my child receive the vaccine that offers the greatest protection and I’ve even delayed administration in hopes of getting HPV9.  Some of my friends, who are also familiar with the FDA’s approval of the HPV9 vaccine, have also been asking their providers and insurance companies about the vaccine’s availability and coverage.

Unfortunately, the amount of misinformation they’ve been receiving is disturbing and frustrating.

One Parent’s Personal Experience Trying to Get HPV9 For Her Daughter:

When asked specifically about HPV9, one clinic told my friend (who lives in another state) that although they have the vaccine it’s likely her insurance wouldn’t cover it.  Her next step was to call the insurance company directly, who proceeded to confuse the situation greatly.  They stated that they will only cover HPV16 and that it is only available to high-risk patients who are 30 years of age and older.  This is grossly inaccurate since none of the available HPV vaccines are approved or recommend for patients over 26 years of age.  There is also no HPV16 vaccine.  Rather, 16 is a specific HPV genotype.

The health plan representative was clearly misinformed but how would the average parent know this?  After asking to speak with a supervisor, my friend was told that they were mistaken and HPV9 was covered, but HPV16 and HPV18 were only covered for age 30 and up.  While it was good to hear that her insurance covered HPV9, it is shocking that even the supervisor was passing along inaccurate misinformation by suggesting there are vaccines known as HPV16 and HPV18. To make matters worse, after all the effort this parent took to locate a facility that could administer HPV9, and to ensure it was covered under her insurance policy, in the end her child was wrongly administered a quadrivalent vaccine as opposed to the 9-valent she requested.

To be fair, there are plenty of providers who are well-educated about the latest immunization recommendations.  I also know of friends in various parts of the country who’ve had no problems locating the HPV9 vaccine and having it successfully administered to their children.  However, conversations like the one above highlight the fact that we still have much work to do.  It is not just enough to educate the parents, but we must also ensuring providers and insurance companies are well versed on the specifics of new vaccines as well.  

Since, the majority of parents don’t realize that there are differences in the protection offered from the various HPV vaccines, they’re probably not inclined to specifically ask for HPV9, which means their child may receive a vaccine that doesn’t offer as much protection as we can now offer. This seems rather counterintuitive.  The reason HPV9 was developed in the first place is because it is an improvement in the amount of protection we can provide and the ultimate reduction of disease.  So, why are we not doing all we can to make it a strong recommendation that is carried out and supported by all providers and insurance companies?

MenB: The Serogroup B Meningococcal Vaccine

The other new vaccine I’ve been anxious for my children to receive (especially my college daughter), is the new meningococcal vaccine series that protects against serogroup B.   Two meningococcal B vaccines were approved by the FDA recently to include Pfizer’s Trumenba in October of 2014, and Novartis’s Bexsero in January 2015. Prior to the FDA’s approval of these MenB vaccines, the CDC’s vaccine schedule only recommended the use of a quadrivalent meningococcal vaccine that protects against serotypes A, C, W and Y, but does not offer any protection against the B serotype.  Children typically receive the quadrivalent meningococcal vaccine between the ages of 11-12, with a booster dose at age 16, that is often a requirement to attend many schools and colleges.

Following the FDA’s approval of this new MenB vaccine, the ACIP was asked to consider an appropriate recommendation.  Unlike HPV9, the MenB vaccine offers protection from another strain of meningococcal disease, but does not replace the previous meningococcal vaccine.  Therefore, it needs to be administered in addition to the quadrivalent meningococcal vaccine that is already on the recommended schedule.  Following outbreaks, amputations and deaths that occurred on several different college campuses last year as a result of serogroup B meningococcal disease, the ACIP found itself under a great deal of pressure to recommend this new MenB vaccine.

However, after much discussion and deliberation, the committee stopped short of a Category A recommendation for routine use of serogroup B meningococcal vaccine, and instead opted to leave the decision to doctors and their patients with what is known as a Category B or “permissive recommendation”.

The approved ACIP recommendation states,

“A serogroup B meningococcal (MenB) vaccine series may be administered to adolescents and young adults 16 through 23 years of age to provide short term protection against most strains of serogroup B meningococcal disease. The preferred age for MenB vaccination is 16 through 18 years of age.”  

Many are concerned that a permissive recommendation, as opposed to a routine recommendation, may be confusing for parents and providers.  Absent of a strong ACIP recommendation, providers may not even recommend MenB vaccine as an option for parents and college students to consider.  And parents, who are getting their child the routine quadrivalent meningococcal vaccine, may mistakenly believe they are doing all they can to prevent meningococcal disease in their children, without ever knowing of the availability of the MenB vaccine to cover a strain of the disease that is not covered in the other vaccine.

In the case of MenB, proactive parents are often encountering misleading information from providers and insurance companies. 

One Parent’s Personal Experience Trying to Get MenB For Her College-Bound Son: 

One friend explained that when she called her provider to inquire about the MenB vaccine, she was told that they were still evaluating the effectiveness of the vaccine to see if it would be covered by insurance.  Huh?

Then she called her health department who claimed that the vaccine had not yet been approved by the FDA.  Again, blatant misinformation.

Fortunately, the University where her son will be attending was able to offer the vaccine and provide accurate and timely information.

It is expected that the ACIP will revisit the MenB recommendation in the future, as they continue to acquire more data.  But until then, there is work to be done to ensure providers, insurance companies and parents get the facts.

When you consider that we now have two new FDA-approved vaccines we can look back at the past year and appreciate the progress.  However, as a parent and immunization blogger, it’s frustrating to hear stories from friends and colleagues that illustrate how much misinformation is being shared.  Unfortunately this means that our children are still vulnerable to diseases we have the ability to prevent. 

Share Your Story

If you have a story you would like to share regarding challenges you have faced in getting either of these two vaccines, please elaborate in the comments below or send us an email at info@shotofprevention.com.  We are interested in hearing personal stories that involve concerns pertaining to access, availability and misinformation so that we can address these issues with specific insurance agencies, health partners and local health departments to help reduce the amount of misinformation that people are receiving.

By working together, we can help bring about the changes we need to protect our children and our communities with the latest vaccines we have available.  

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