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Vaxelis (DTaP-IPV-Hib-HepB), a Hexavalent Vaccine, is Now Available for VFC

Vaxelis (DTaP-IPV-Hib-HepB), a Hexavalent Vaccine, is Now Available for VFC

To download a PDF version of this notice, click here!

Vaxelis is now available for providers enrolled in the Vaccines for Children (VFC) program. This advisory includes an overview of important information about Vaxelis.

Vaxelis is a hexavalent combined diphtheria and tetanus toxoids and acellular pertussis (DTaP) adsorbed, inactivated poliovirus (IPV), Haemophilus influenzae type b (Hib, PRP-OMP), and hepatitis B (HepB) (recombinant) vaccine. In 2018, FDA licensed Vaxelis for use in children age 6 weeks through 4 years: it is indicated as a 3-dose series for infants at ages 2, 4, and 6 months. ACIP voted to add Vaxelis to the Vaccines for Children (VFC) Program in 2019. Vaxelis became commercially available in the United States in 2021.

Recommendations For Use

Eligible Groups for Receipt of VFC Supplies of Vaxelis

VFC supplies of Vaxelis may be given to VFC-eligible children from 6 weeks through 4 years of age (prior to the 5th birthday).

Licensed Dosing Schedule

Vaxelis is indicated for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae type b. Vaxelis is approved for use as a 3-dose series in children from 6 weeks through 4 years of age (prior to the 5th birthday). Vaxelis is indicated for use in infants at ages 2, 4, and 6 months.

Recommended minimum ages for administration of Vaxelis (DTaP-IPV-Hib-HepB) vaccine and intervals between doses — United States, 2020*

Age/Interval
Minimum age for any dose 6 weeks
Minimum interval between doses 1 and 2 4 weeks
Minimum age for dose 2 10 weeks
Minimum interval between doses 2 and 3 4 weeks
Minimum age for dose 3 24 weeks†
Maximum age for any dose 4 years, 364 days (do not administer on or after the fifth birthday)

† If the third dose of DTaP-IPV-Hib-HepB is given before age 24 weeks, an additional dose of hepatitis B vaccine should be given at
age ≥24 weeks to complete the hepatitis B series.

*DTaP-IPV-Hib-HepB can be used for children aged <5 years requiring a catch-up schedule. However, vaccine doses should not be
administered at intervals less than the minimum intervals indicated in this table.

For guidance on transitioning to Vaxelis and how it fits into the immunization schedule, visit: https://www.vaxelistransition.com.

The Advisory Committee on Immunization Practices (ACIP) recommends that whenever feasible, the same manufacturer’s brand should be used to complete the series. However, if the previous brand is unavailable or unknown, any brand may be used to complete the series. Do not defer immunization solely to wait for a specific brand to be available.

Storage

Vaxelis should be stored at 2º to 8ºC (36º to 46ºF). Do not freeze. Product which has been exposed to freezing should not be used. Do not use after the expiration date shown on the label.

How Vaxelis is supplied

Vaxelis is supplied in a single-dose vial in packages of 10 vials (NDC no. 49281-0590-05). The dosage for Vaxelis is 0.5 mL. Vaxelis does not contain a preservative. The vial stopper, syringe plunger stopper, and syringe tip cap are not made with natural rubber latex.

Administration

Just before use, shake the vial or syringe until a uniform, white, cloudy suspension results.

Inspect the vial or syringe for particulate matter and discoloration prior to administration. If either of these conditions exist, the product should not be administered.

Administer a single 0.5 mL dose of Vaxelis intramuscularly. In infants younger than 1 year, the anterolateral aspect of the thigh is the preferred site of injection. The vaccine should not be injected into the gluteal area.

Vaxelis should not be combined through reconstitution or mixed with any other vaccine. Discard unused portion. Vaxelis is for intramuscular use only.

Precautions and Contraindications

Do not administer Vaxelis to anyone with a history of severe allergic reaction to a previous dose of Vaxelis, any ingredient of Vaxelis, or any other diphtheria toxoid, tetanus toxoid, pertussis containing vaccine, inactivated poliovirus vaccine, hepatitis B vaccine, or Hib vaccine.

Do not administer Vaxelis to anyone with a history of encephalopathy within 7 days of a pertussis containing vaccine with no other identifiable cause.

Do not administer Vaxelis to anyone with a history of progressive neurologic disorder until a treatment regimen has been established and the condition has stabilized.

Ordering and Billing

Vaxelis is available for ordering through the PhilaVax IIS as of today, June 8, 2021. Please contact Jillian Brown (Jillian.Brown@phila.gov) to begin the process of transitioning to Vaxelis at your site. Please note, your practice must choose a single type of combination vaccine to use as part of the primary series. We recommend that sites that are part of a system or are affiliated use the same vaccine presentations across sites to ensure continuity of care and help prevent administration errors.

  • CVX code: 146
  • CPT code: 90697

Resources

Vaccine Information Statements (VIS):

CDC Morbidity and Mortality Weekly Report (MMWR): https://www.cdc.gov/mmwr/volumes/69/wr/pdfs/mm6905a5-H.pdf.

For guidance on transitioning to Vaxelis and how it fits into the immunization schedule, visit: https://www.vaxelistransition.com.

Product insert for Vaxelis includes additional vaccine information, found at: https://www.merck.com/product/usa/pi_circulars/v/vaxelis/vaxelis_pi.pdf.

Additional information on vaccines and vaccine preventable diseases can be found at: http://www.cdc.gov/vaccines/

Make Your Provider Page Public with VaccineFinder!

Make Your Provider Page Public with VaccineFinder!

Dear Immunization Partner,

The Philadelphia Department of Public Health (PDPH) and the CDC are requesting that you make your provider page in VaccineFinder public. VaccineFinder is the portal that you’re using to log your COVID-19 vaccine inventory every 24 hours and can be found here: https://covid.locating.health/

Making your provider page public will allow fellow Philadelphians to search for vaccine clinics near them and therefore make it easier for them to be vaccinated. Your public-facing page will not display inventory information (i.e., number of doses on hand). PDPH has created a training video, linked below, to help you complete this process if you need:

Click here to watch the VaccineFinder Training Video

Please include any information regarding registrations for vaccinations, including a phone number or scheduling link, if possible, on your display page so that members of the public can more easily schedule appointments. As distribution and eligibility expands, it is important to promote vaccine opportunities that are currently available. If your site has the capacity to accept walk-ins, please also include this information on your VaccineFinder page as we hope to continue improving accessibility to vaccinations across the city.

We understand that making your VaccineFinder page public, posting your registration information, and allowing walk-in appointments may raise concerns. If you or your site are concerned, feel free to reach out to a contact at PDPH or email vaccines@phila.gov and they will connect you with a PDPH staff member to help you address your concerns.

Thank you for all the hard work you are doing to vaccinate Philadelphians!

Recommendations for the Meningococcal Serogroup B Vaccine

Recommendations for the Meningococcal Serogroup B Vaccine

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.