The Philadelphia Department of Public Health is issuing recommendations on when healthcare providers should recommend and administer the meningococcal serogroup B (MenB) vaccine to patients. In October 2014 and January 2015, the FDA licensed two MenB vaccines for people age 10 to 25 years.

Guidelines on when to recommend the MenB vaccine, and answers to common questions, are below.

Recommend MenB vaccine to people over age 10 if they’re at increased risk

For patients at higher risk, the Advisory Committee on Immunization Practices (ACIP) recommendation for MenB is a Category A recommendation: routinely recommend this to people with conditions that increase the risk of meningococcal disease.

Certain conditions affect a person’s ability to mount an effective immune respose against meningococcal disease. Give MenB vaccine to patients who:

• Have complement deficiency
• Have functional or anatomic asplenia (including patients with a history of sickle cell disease)
• Take eculizumab (Solaris), an immunosuppressive medication that supresses complement

Also give MenB vaccine to people who are part of a MenB outbreak – for example, to students at a high school or university with an active MenB outbreak. Make this determination in consultation with the Health Department.

Individual clinical decision: give MenB to people age 16 to 23

For most patients, the ACIP recommendation for the MenB vaccine is a Category B recommendation: the vaccine may be given to patients age 16 to 23 – preferably between 16 and 18 – to provide short-term protection from most strains of serogroup B meningococcal disease.

Meningococcal infections are fairly rare, with fewer than 500 reported cases per year in the United States and 50 to 60 cases due to serogroup B among adolescents and young adults. The highest rates of infection are among adolescents, especially older adolescents, even those who do not attend college or live in a dormitory. Giving the vaccine to people age 16 to 18 will protect them when they are at the highest risk of infection.

MenB questions and answers

How are MenB vaccines different from the other meningococcal vaccine that we give to adolescents?

There are now two types of meningococcal vaccine:

• MCV4 (quadrivalent meningococcal conjugate vaccine) protects against 4 different meningococcal serogroups: A, C, W, and Y. It is routinely recommended for all 11-12 year olds with a booster dose at 16 years.
• MenB vaccines only protect against serogroup B.

There is no single vaccine that protects against all of these types (A, B, C, W, and Y) at the same time.

Can MenB be given simultaneously with MCV4?

Yes, MenB and MCV4 can be administered at the same visit but if possible, in different arms. Since the MCV4 booster and Men B are recommended for the same age range, simultaneous administration may happen.

How many doses of the MeB vaccine do I need to give?

The 2 different MenB vaccines have different dosing schedules:

• Bexsero: give in 2 doses (0 and >1 month after the first dose), regardless of risk status
• Trumenba: give in 2 doses (0 and 6 months after the first dose) for healthy adolescents. Give in 3 doses (0, 1-2 months, and 6 months after the first dose) to adolescents with high risk conditions or during a MenB outbreak

Does it matter which MenB vaccine I offer?

You can use either one of the MenB vaccines – the CDC does not have a preference for either product. However, the two MenB vaccines are not interchangeable: you should use the same MenB vaccine for all doses in the series.

If your patient has HIV, the CDC recommends the 3-dose Trumenba series, though the 2-dose Bexsero may also be used.

Why is there a Category B recommendation for MenB vaccines?

The ACIP bases their recommendation on tow main factors:

1. An overall low prevalence of meningococcal disease. The ACIP considered the number of potential cases prevented with different recommendation strategies. Targeting older adolescents, young adults, and individuals with high risk conditions would prevent the most cases for the number of individuals vaccinated.
2. The ACIP is awaiting more data on duration of protection and vaccine effectiveness. Right now we know that vaccination increases antibodies against meningococcal B which is used as a measure of protection rather than reduction in clinical disease. The low prevalence of disease makes it difficult to measure the impact of actual infection. We also do not know how long protection will last. Based on current data, antibody levels are still elevated at about 3 years. This is why the vaccine is recommended for short term protection, targeting older adolescents.

Should I recommend it to teens going off to college?

MenB has been associated with recent outbreaks, many of which have been on college campuses. Therefore, some colleges may recommend or require both MCV4 and MenB vaccination.

Age 16 to 23 is the highest age-related risk period for any older adolescent and young adult, even if they are not attending college. The risk of exposure to meningococcus is associated with many behaviors that any adolescent and young adult may engage in, such as intimate kissing, tobacco exposure, large social gathering, and living in a dormitory. This is why MenB vaccine should be preferentially administered to people age 16 to 18.

Am I required to keep it on hand and offer it like the rest of the vaccines on the schedule?

No, there is no requirement to have MenB in stock because of the recommendation to offer vaccination for certain high risk conditions or at your discretion.

However, having MenB vaccine in stock will help ensure that you can provide MenB vaccination for your patients whom you do want to vaccinate and avoid missed opportunities. It is also important to have MenB available if you have patients with any high risk conditions for whom MenB vaccines should be given.

Am I in trouble if I don’t offer it?

Because MenB has a Category B recommendation, there are no penalties if you choose not to offer the vaccine. However, you may be asked about MenB during your regular VFC program audit visit so that we can help answer any questions that you may have.

Will private insurers pay for it?

Health plans are required to cover new vaccine recommendations without cost sharing within one year of the publication of the new recommendation. MenB recommendations were published in October 2015.

I’m just not sure how to proceed with this Category B recommendation.

This is a new vaccine that can help prevent meningococcal disease due to serogroup B for the age group at highest risk of infection. We do not see a lot of meningococcal disease but when we do, there can be significant morbidity and mortality that is difficult to predict. A higher proportion of the disease we do see is due to serogroup B which, until now, we have not been able to prevent through vaccination. When your patients come to clinic for their MCV4 booster, the MenB vaccine can be offered as an option to all 16-18 year old patients. Parents or teens may also request MenB.

The only way to see any of the potential benefits of vaccination is to provide the vaccine.

The Philadelphia Department of Public Health has updated storage and handling guidelines for the Vaccines for Children (VFC) and Vaccines for Adults At Risk (VFAAR) programs. This update includes:

1. New policies
2. New forms
3. New tools
4. Contact us

These new guidelines help ensure that the cold chain is preserved and vaccines are protected.

New policies
These policies ensure that each dose of vaccine administered to patients is viable and effective. Please share this information with all staff who work with VFC and VFAAR vaccines.

Using Digital Data Loggers: Monitor all VFC/VFAAR vaccine with a certified, calibrated digital data logger (DDL) during:

• Routine onsite vaccine storage
• Vaccine transport
• Mass vaccination clinics

PDPH will store back-up DDLs at our offices. You may need a back-up thermometer to:

• Defrost units
• Monitor new units
• Identify issues with your primary DDL

If you need a back-up thermometer, contact TempCheck at 215-685-6777.

Recording vaccine temperature:Continue to use paper temperature logs to check and record vaccine storage unit temperatures twice a day. Record the min and max temperatures at the start of each clinic day.

We will review paper temperature logs at our yearly compliance visits, or during unannounced storage and handling visits. Keep copies of both paper and digital temperature logs on file for at least 3 years.

Storing vaccine: To protect the viability of vaccine, it’s important to store vaccines at acceptable temperatures in appropriate storage units.

Dormitory-style (or bar-style) units – refrigerators with one exterior door and an evaporator plate (cooling coil) for freezing – are not reliable enough to safely store VFC/VFAAR vaccine.

Freezers that are part of a household combination refrigerator/freezer unit are also not acceptable for storing VFC/VFAAR vaccine. For vaccines that must be stored in a freezer, you must use a standalone freezer unit.

Never use dorm-style units or household freezers – even to temporarily store vaccine while your’e defrosting your main units.

New forms

Updated forms are designed to help you maintain the cold-chain at your site. Please download and review the updated documents and fill out the necessary forms. Download them here.

• Paper temperature logs: use the new log with your certified, calibrated DDLs. Please review the instructions to make sure you’re documenting temperatures correctly.
• Vaccine management plan: this ensures that you can protect the viability of VFC/VFAAR vaccine. Keep this near the vaccine storage units.
• Emergency vaccine management plan: Keep this near your vaccine storage units. Fax page 1 to VFC/VFAAR, and whenever you make updates.
• Out-of-range Temperature Response Form: use this to document when vaccines are exposed to out-of-range temperatures, determine if you can still use the vaccines, and report your findings.

New tool: Clinic Tools, a new feature coming to PhilaVax

We have a new tool in PhilaVax: Clinic Tools, which makes it easier for you to meet program requirements.

Over the next few months, we will contact Vaccine Coordinators to conduct Clinic Tools trainings – after which your site can use Clinic Tools to:

• Submit temperature logs online
• Keep up-to-date clinic information like phone numbers, address, staff information, and delivery hours

Contact us if you need assistance

We know that changes can be confusing, so don’t hesitate to be in touch if you have questions about what to do.

Questions about storage and handling, out of range temperatures, or the DDLs? Contact Adam Howsare and Alexis Bridges at 215-685-6777 or TempCheck@phila.gov.