Archive | October, 2014

A Big Step Forward and What Happens Next

30 Oct

In October 2000, the Centers for Disease Control and Prevention (CDC)’s Advisory Committee on Immunization Practices (ACIP) recommended that college students be informed that they were at higher risk for meningococcal disease and told there was a vaccine. It was the right thing to do—to protect our children.

In 2005, a new meningococcal vaccine became available and ACIP recommended it. It protected our adolescents and teens against serogroups A, C, W and Y. Again, it was the right thing to do.

Later, ACIP recommended a booster dose to ensure our kids stayed protected. It was the right thing to do.

But we aren’t done protecting our teens. I have heard over and over from parents whose children have suffered from serogroup B meningococcal disease, “I thought they were protected against meningitis,” they say. They believed their kids had the broadest possible protection.

I was thrilled yesterday (October 29) when the U.S. Food and Drug Administration (FDA) announced the approval of the first vaccine in the United States to prevent serogroup B meningococcal disease. I am hopeful that a second serogroup B vaccine, currently in priority review with the FDA, will also be approved soon. We now have the tools to protect our kids against five serogroups of meningococcal disease.  This includes all the serogroups that cause disease in the U.S.

Now that a vaccine is approved, we need to do the right thing again and routinely recommend serogroup B vaccination for adolescents and teens. We need to protect our children. It is what parents do. It is what society should do.

In the meantime, we know many people have questions about this new vaccine and what it means for their families. We hope this FAQ will help provide some answers:

1. How is this vaccine different from the meningococcal vaccines currently recommended by the CDC? If my children have already been vaccinated do they need to get this new vaccine?

Before now, vaccines licensed in the U.S. helped protect against four major strains of the disease: A, C, W and Y. Those vaccines do not prevent serogroup B meningococcal disease, which accounts for about one-third of U.S. cases. (To learn more about serogroup B meningococcal disease, please visit our website.)

To help protect against all serogroups, teens will need to receive:

  • Vaccination against serogroups A, C, W and Y. Recommended by the CDC for routine vaccination at age 11-12 with a booster dose at age 16.
  • Vaccination against serogroup B (the newly approved vaccine is a three-dose series, the vaccine still in review by the FDA will likely require two doses). The ACIP has not yet issued a recommendation for serogroup B meningococcal vaccination (see question five), however, now is a good time to start a conversation with a healthcare provider about it.

2. When will the vaccine be available? How do I get it?

The manufacturer is working to bring the vaccine to the U.S. but it may take two to three weeks for supply to become available. NMA encourages parents to start a conversation with your child’s healthcare provider about having them vaccinated against serogroup B.

3. Why wasn’t there a vaccine against serogroup B meningococcal disease before now?

Vaccines to protect against serogroup B meningococcal disease were challenging to develop because serogroup B behaves differently than other serogroups. Scientists overcame these challenges and two vaccines were developed. Because of recent serogroup B outbreaks and the devastating effects of meningococcal disease, the FDA granted both vaccines breakthrough therapy status, allowing for an accelerated review process. We expect the second serogroup B vaccine to be licensed soon.

For a great overview of the vaccine development, testing and regulation process visit the History of Vaccines website.

4. Why was the vaccine only licensed for individuals age 10-25?

The age group is based on the clinical trial data submitted by the vaccine manufacturer to the FDA.

5. What is the difference between licensure/approval and recommendation?

The FDA decides whether to approve use, known as licensure, after reviewing clinical data submitted by vaccine manufacturers. Once a vaccine is approved, the CDC’s ACIP, a group of medical and public health experts, makes recommendations on whether and how the vaccine should be used in the U.S. Once these recommendations are accepted by the Director of the CDC and published, they become part of the official immunization schedule.

To learn more about the ACIP and the recommendation process, click here.

6. What can I do to help protect children, teens and young adults from meningococcal disease?

Vaccination offers the best protection against meningococcal disease:

  • Make sure all tweens/teens get vaccinated against serogroups A, C, W and Y at age 11-12 and go back for a booster at age 16. Recent data showed that less than 30% of teens who had received the initial dose also received the recommended booster. We need to do better.
  • Now that there is an approved vaccine for serogroup B, we encourage you to tell your healthcare provider that you want it.

Even if you/your family members have been vaccinated against meningococcal disease you should learn the symptoms so you can watch for it in yourself or in others. We also have resources you can share to help educate friends, family or patients.

Finally, you can follow NMA on Facebook and Twitter where we will let you know when there are opportunities to help raise awareness of this disease and advocate for its prevention.