Vaxelis
Vaxelis is a vaccine that protects your child from six infections. It helps prevent infection from diphtheria, tetanus, and pertussis (whooping cough), or collectively known as DTaP. Vaxelis also protects against poliomyelitis (polio), Haemophilus influenzae type b (Hib), and hepatitis B. This vaccine is a 3-dose series, typically given to children starting at 2 months of age, but can be started as early as 6 weeks of age. Vaxelis was approved by the FDA in 2018. It's a combination vaccine option that's included in the CDC's recommendations. Vaxelis side effects include pain at the injection site and sleepiness.
What is Vaxelis?
What is Vaxelis used for?
Prevention of:
Diphtheria
Tetanus
Pertussis (whooping cough)
Poliovirus (or polio)
Haemophilus influenzae type b (Hib)
Hepatitis B
How Vaxelis works
Vaxelis is an inactivated vaccine that protects your child from infections caused by certain bacteria and viruses. The vaccine is made with inactive versions of these bacteria and viruses.
When the vaccine is given, your child's immune system gets introduced to the inactive forms of the germs. The body then makes antibodies that can recognize and attack these bacteria or viruses.
If your child gets infected with one of these germs in the future, the body can make antibodies against them quickly to protect your child from getting ill or seriously sick.
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What are the side effects of Vaxelis?
Common Side Effects
- Feeling irritable (up to 62%)
- Sleepiness (up to 56%)
- Pain at the injection site (up to 53%)
- Crying (up to 52%)
- Redness at the injection site (up to 32%)
- Fever (up to 29%)
- Feeling less hungry (up to 29%)
- Swelling at the injection site (up to 23%)
- Vomiting (up to 13%)
Other Side Effects
- Rash
- Swelling of the limb
Serious Side Effects
- Serious allergic reactions: hives, rash, itching, nausea, flushing, dizziness, trouble breathing, chest pain
Source: DailyMed
The following side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
Pros and cons of Vaxelis
Pros
Works well to prevent DTaP, polio, Hib, and hepatitis B
Convenient combination of 4 vaccines in a single shot
Can be given with other vaccines
Cons
Not for use in adults or children 5 years or older
Must be given as an injection by a healthcare professional at a provider’s office, clinic, or pharmacy
Need to get additional doses of DTaP, polio, and Hib vaccine to be completely vaccinated against these infections
Pharmacist tips for Vaxelis
Make sure to keep a record of all your child's immunizations and show it to the provider or pharmacist before your child gets any vaccine, including Vaxelis. The providers can make sure your child is getting all the recommended vaccines on schedule.
Let the provider know if your child is sick on the day that the Vaxelis vaccine dose is scheduled for. The provider can tell you whether you need to reschedule the appointment based on your child's symptoms. Your child might still be able to get their Vaxelis dose if it's a mild illness, such as a cold or low-grade fever. But if your child feels moderately to severely sick, the provider will probably reschedule the appointment so that your child can recover before getting Vaxelis.
Some children might feel sore or they might develop redness at the injection site after they get Vaxelis. This is a common reaction that typically goes away within a few days. You can put a cool, damp cloth on that area to lessen the redness, pain, or swelling.
Your child might develop a fever as a side effect after they get Vaxelis. You can try to lower their fever by giving your child a lukewarm sponge bath. Ask a provider whether it's appropriate for you to give your child fever-lowering medications, such as acetaminophen (Tylenol).
If your child experiences a severe reaction to Vaxelis, you or your child's provider can report it to the vaccine adverse event reporting system (VAERS) or by calling 1-800-822-7967.
Read the vaccine information statement for DTaP, polio, Hib, and hepatitis B for more information.
Frequently asked questions about Vaxelis
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What are the risks and warnings for Vaxelis?
Vaxelis can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Allergic reactions
Risk factors: Allergic reaction to other vaccines
As with any vaccine, there's a rare chance that your child might have a severe allergic reaction (e.g., anaphylaxis) to Vaxelis. Your child's provider might ask you and your child to stay at the pharmacy or clinic for a short period of time after getting vaccinated. This makes sure your child can get proper care if a serious allergic reaction happens during this time. Sometimes, allergic reactions can happen after you've already left the clinic. Get medical help right away if you notice symptoms of a severe allergic reaction, such as fainting, swelling of the face, closing of the throat, difficulty breathing, hives, shaking, or vomiting.
Additionally, let the provider know if your child has previously gotten a vaccine for pertussis (whooping cough), including Vaxelis, and has had fever, has collapsed, has had continuous crying lasting for at least 3 hours, or has had seizures within 2 to 3 days of getting the vaccine. Your child might not be able to get vaccinated with Vaxelis.
Lower response to Vaxelis in children with a weakened immune system
Risk factors: Medical conditions that weaken the immune system | Taking medications that lower your immune system
Vaxelis might not work as well in children with a weakened immune system. This can raise the risk for diphtheria, tetanus, whooping cough, polio, Hib, and hepatitis B even after your child has gotten vaccinated against these infections. Make sure your child's provider knows about any medical conditions your child has or any medications your child takes that can weaken their immune system. Talk to your child's provider if you have any concerns about how well Vaxelis might work to protect your child from infection.
Breathing issues (apnea) in premature babies
Risk factors: Premature birth
Some babies who were born prematurely had breathing problems after they got vaccines that were injected into the muscle. Be sure to talk to your child's provider about the benefits and risks of Vaxelis (a vaccine that's injected into the muscle) if your baby was born prematurely. The provider will discuss whether Vaxelis is right for your child.
Guillain-Barré syndrome (GBS) and nerve problems
Although very rare, some people have reported getting Guillain-Barré syndrome (GBS) after they've received a vaccine for tetanus. GBS is a rare condition that causes muscle weakness and paralysis. Let your child's provider know if your child has previously experienced these symptoms within 6 weeks of receiving a tetanus toxoid-containing vaccine. If so, your child is at higher risk for developing GBS after Vaxelis. Your child's provider can talk with you about the benefits and risks of Vaxelis in this situation.
Additionally, vaccines that contain tetanus toxoid (like Vaxelis) might raise the risk for a nerve problem called brachial neuritis. This condition causes pain and muscle weakness. Contact a provider if your child's shoulder, arm, or hand seems to be limp after getting the vaccine.
Vaxelis dosage forms
Typical dosing for Vaxelis
Vaxelis is typically given as a 3-dose series at 2, 4, and 6 months of age. In some situations, the first dose can be given as early as 6 weeks of age. Vaxelis is given as an injection into the muscle (the thigh muscle for babies up to 1 year of age).
How much does Vaxelis cost?
Vaxelis contraindications
Severe allergy to any DTaP-, polio-, Hib-, or hepatitis B-containing vaccine
History of brain problems within 7 days of getting a previous dose of a pertussis-containing vaccine. These brain problems include having seizures for a long time, not being able to respond normally, or being in a coma.
History of progressive neurologic disorder (e.g., seizures called infantile spasms, uncontrolled seizures) that isn't stabilized.
What are alternatives to Vaxelis?
Prevention of:
Diphtheria
Tetanus
Pertussis (whooping cough)
Poliovirus (or polio)
Haemophilus influenzae type b (Hib)
Hepatitis B
Diphtheria
Tetanus
Pertussis (whooping cough)
Hepatitis B
Poliovirus
Diphtheria
Tetanus
Pertussis (whooping cough)
Poliovirus
Haemophilus influenzae type b (Hib)
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References
Best studies we foundAl Khalili, Y., et al. (2024). Brachial neuritis. StatPearls.
Centers for Disease Control and Prevention. (2021). About Hib Vaccines.
Centers for Disease Control and Prevention. (2019). Before, during, and after shots.
Centers for Disease Control and Prevention. (2019). Combination vaccines.
Centers for Disease Control and Prevention. (2020). Possible side effects from vaccines.
Centers for Disease Control and Prevention. (2021). DTaP (diphtheria, tetanus, pertussis) VIS.
Centers for Disease Control and Prevention. (2021). Haemophilus influenzae type b (Hib) VIS.
Centers for Disease Control and Prevention. (2021). Polio vaccine: What you need to know.
Centers for Disease Control and Prevention. (2021). Vaccines when your child is sick.
Centers for Disease Control and Prevention. (2022). Diphtheria, tetanus, and whooping cough vaccination.
Centers for Disease Control and Prevention. (2022). Diphtheria.
Centers for Disease Control and Prevention. (2022). Haemophilus influenzae disease (including hib).
Centers for Disease Control and Prevention. (2022). Keeping track of records.
Centers for Disease Control and Prevention. (2022). Pertussis (whooping cough).
Centers for Disease Control and Prevention. (2022). Tetanus.
Centers for Disease Control and Prevention. (2023). Child and adolescent immunization schedule by age.
Centers for Disease Control and Prevention. (2023). Child and adolescent immunization schedule by medical indication.
Centers for Disease Control and Prevention. (2023). Hepatitis B VIS (interim).
Centers for Disease Control and Prevention. (2023). Vaccines for Children Program (VFC) information for parents.
Centers for Disease Control and Prevention. (2024). ACIP recommendations.
Merck & Co., Inc. (2018). FDA approves Vaxelis™, Merck and Sanofi’s pediatric hexavalent combination vaccine.
MSP Vaccine Company. (2022). Vaxelis- diphtheria and tetanus toxoids and acellular pertussis, inactivated poliovirus, haemophilus b conjugate and hepatitis b vaccine injection, suspension [package insert]. DailyMed.
MSP Vaccine Company. (2023). Vaxelis requires 2 to 3 fewer shots in the infant vaccination series compared to pentavalent vaccines (+ hep B or Hib vaccine).
National Institute of Neurological Disorders and Stroke. (2023). Infantile spasms.
Vigo, A., et al. (2017). Hypotonic-hyporesponsive episodes after administration of hexavalent DTP-based combination vaccine: A description of 12 cases. Human Vaccines & Immunotherapeutics.
World Health Organization. (2020). How do vaccines work?
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