A new powerful meningococcal vaccine that trains the immune system to attack the bacteria that can lead to deadly meningitis has now been approved by the FDA for 1-9-year-old children. This is not going to warm the hearts of the anti-vaxxers who think that there are too many vaccines.
Let’s take a look at this vaccine and the disease it prevents, just so parents know that they can protect their children.
Meningococcal infections are caused by the bacterium Neisseria meningitidis (also termed meningococcus). The majority of invasive meningococcal disease cases worldwide can be attributed to six Neisseria meningitidis serogroups (distinct variations of the bacterial called A, B, C, W, X, and Y).
About 1 in 10 individuals have Neisseria meningitidis bacteria in their nasal passages or throat without any signs or symptoms of the disease. These people are called “carriers.” However, for unknown reasons, the bacteria may invade the body and cause meningococcal disease.
According to epidemiological research, serogroups A, B, C, W, and Y account for 90% of all invasive meningococcal disease (IMD)1, with MenB (shorthand for Neisseria meningitidis serogroup B) accounting for the majority of disease in adolescents and young adults in the U.S. and Europe. As of 2016, the burden of MenB is highest in adolescents/young adults (32%).
Meningococcal infections can lead to two diseases – meningococcal meningitis and meningococcal septicemia (also called meningococcemia). Meningitis initially produces general symptoms like fatigue, fever, and headache and can rapidly progress to neck stiffness, coma, and death in 10-15% of cases. Symptoms of meningitis are a medical emergency, and a child or adult should head to the hospital quickly because the time frame between the disease’s onset and serious consequences is short.
According to research, there are approximately 2,600 cases of bacterial meningitis per year in the United States, and on average 333,000 cases in developing countries (See Note 1).
Meningococcemia receives much less public attention than meningitis, but it has been linked to infant deaths. Meningococcemia typically causes a purpuric rash, that does not lose its color when pressed with glass and does not have the symptoms of meningitis mentioned above. Unfortunately, many people ignore the rash without understanding its significance. Meningococcemia carries an approximate 50% mortality rate within a few hours from the initial onset of the disease. I hope this scares every single reader of this article.
According to the CDC, to confirm a meningococcal infection, a physician must do a painful and uncomfortable lumbar puncture to remove cerebrospinal fluid to test. Even without the lumbar puncture, a doctor may begin antibiotic therapy almost immediately if they suspect the disease. And depending on how serious the infection is, patients may require other procedures such as:
- Breathing support
- Medications to treat low blood pressure
- Wound care for parts of the body with damaged skin
But lucky for us, we have a preventative vaccine, so that children won’t have to have a lumbar puncture, serious medical intervention, and potential death.
The meningococcal vaccine is the most effective way to protect against this aggressive disease. Not homeopathy. Not black salve. Not eating a better diet. Just a vaccine.
Trumenba was the first MenB vaccine approved in the U.S. in 2014 for people over 10 years of age. The other FDA-approved MenB vaccine for this age group is Bexsero. There are also vaccines for other serogroups of Neisseria meningitidis (A, C, W, and Y), but we’re focusing on MenB for the purposes of this article.
As required by the FDA, Pfizer, the manufacturer of the Trumenba, needed to successfully complete Phase 2 studies that assessed the safety and effectiveness of the vaccine in children, ages 1-9. These data were used to support a request to the FDA for Breakthrough Therapy designation which allows the agency to expedite a thorough review of the vaccine because of highly successful Phase 2 results. On 23 April 2018, Pfizer received notification from the FDA that it approved the Breakthrough Therapy review, and the vaccine can be indicated for use with 1-9-year-old children (see Note 2).
In addition, there is an active clinical study to confirm the effectiveness of the two-dose vaccination schedule, which means that instead of three vaccinations for MenB, it will be reduced to two.
Finally, this doesn’t mean it will be a part of the vaccine schedule at this time. The CDC’s Advisory Committee on Immunization Practices (ACIP) will review the data and published research on the vaccine. If it feels that the benefits of Trumenba far outweigh the risks (definitely), then ACIP will make a recommendation to the CDC to include the MenB meningococcal vaccine for children between one and nine years old.
This isn’t an article about a new meningococcal vaccine. It’s an article about an old (well, from 2014) vaccine that prevents a serious and deadly disease, meningococcal infections. And now we can prevent the disease in our young children, keeping them safe from harm and death.
I know that this is hard to accept from the pseudoscience-believing crowds in the anti-vaccine religion, but vaccines save lives. And Trumenba, the serogroup B meningococcal vaccine, saves children from a deadly, painful disease.
- I can hear it now – the anti-vaccine crowd will be screaming that “ONLY 2600 PEOPLE GET THE DISEASE. THE VACCINE IS WORTHLESS.”
- Yes, I’m taking this from a press release from Pfizer. The FDA may not post its approval letter for a week or two. In addition, the FDA will take a few weeks to approve an updated package insert which will confirm that the vaccine can be used in 1-9-year-old children.
- Harrison LH. Epidemiological profile of meningococcal disease in the United States. Clin Infect Dis. 2010 Mar 1;50 Suppl 2:S37-44. doi: 10.1086/648963. Review. PubMed PMID: 20144015; PubMed Central PMCID: PMC2820831.
- Riedo FX, Plikaytis BD, Broome CV. Epidemiology and prevention of meningococcal disease. Pediatr Infect Dis J. 1995 Aug;14(8):643-57. Review. PubMed PMID: 8532420.
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