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.
Prevention of:
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.
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Note: These side effects were reported in clinical trials with children up to 6 months old who received Prevnar 13 and RotaTeq at the same time as Vaxelis.
Contact your healthcare provider immediately if you experience any of the following.
Side effects that you should report to your care team as soon as possible:
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
Vaxelis is a vaccine that protects against infection from six different germs at the same time. It contains vaccines for diphtheria, tetanus, pertussis or whooping cough, polio, Hib, and hepatitis B. It's important to get vaccinations against these infections because they can cause severe complications, including death. If your child needs to complete the DTaP, polio, Hib, and hepatitis B series, Vaxelis is a good option since it's a combination vaccine, which means fewer shots and less pain for your child.
Vaxelis was approved by the FDA in 2018.
The CDC's Advisory Committee on Immunization Practices (ACIP) recommends routine vaccination against DTaP, polio, Hib, and hepatitis B for all children in the United States. Vaxelis is a combination vaccine specifically for children who need vaccination against DTaP, polio, Hib, and hepatitis B. Ask your child's provider or pharmacist to see whether Vaxelis is right for your child.
No, Vaxelis and Pentacel aren't the same. Both Vaxelis and Pentacel offer protection against DTaP, poliovirus, and Hib. But Vaxelis also includes a hepatitis B vaccine. This means that if your child gets Vaxelis, they'll get fewer injections at the provider's office (during their 2-, 4-, and 6-month visits) than they would if they were to receive Pentacel.
If your child has gotten all 3 doses of Vaxelis by the time they're 6 months old, it doesn't mean that they've completed their vaccinations for DTaP, polio, Hib, and hepatitis B. Assuming that your child got the first dose of the hepatitis B vaccine at birth, your child is considered done with the hepatitis B and poliovirus vaccinations. But your child will still need to get 2 more shots to complete DTaP and 1 more shot to complete Hib. The dosing schedule for your child's routine vaccinations can be very confusing. So please ask your child's provider if you have any questions about your child's vaccination schedule and when they'll need to get their next shots.
Vaxelis is given as an injection by a healthcare provider. It's not a vaccine that you can give to your child at home. Your child can get Vaxelis at their provider's office or local pharmacy, but it also might be available at certain community sites (e.g., health clinics, schools, workplaces). Children who qualify can get Vaxelis at no cost at certain clinics that are enrolled in the Vaccines For Children Program.
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.
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.
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.
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.
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 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).
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Vaxelis will not be safe for you to take.