Safety Info | What is IPD? | PREVNAR 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein])

Invasive pneumococcal disease is as scary as it sounds.

Completing all 4 doses of PREVNAR 13® can help protect your baby.

Learn more

Invasive PNEUMOCOCCAL DISEASE

Invasive pneumococcal disease can put your child’s life at risk.

If invasive pneumococcal disease (IPD) sounds scary, that’s because it is. It’s a group of illnesses caused by bacteria called pneumococcus bacteria. It can spread through the air with a cough. The bacteria can enter your child’s body through the mouth, throat, or eyes, and may invade parts of the body that are normally free from infection.

Two types of invasive pneumococcal disease are:
  • Pneumococcal meningitis occurs when the bacteria invade the tissues and fluids surrounding the brain and spinal cord.
  • Pneumococcal bacteremia occurs when the bacteria invade the bloodstream and cause a serious and potentially fatal infection.

Invasive pneumococcal disease can include meningitis that may lead to brain damage or even death.

About 1 in 15 children under the age of 5 who get pneumococcal meningitis die. Others may experience hearing loss or brain damage.

Invasive pneumococcal disease can spread through a cough. And babies under 2 are at higher risk.

Among children, babies under 2 years old are at highest risk, and they can be infected almost anywhere they are. Pneumococcal bacteria are spread by close contact through coughing or even breathing. And if your little one is in daycare, the risk of being infected may be more than twice as high.

 

*

Includes invasive disease caused by Haemophilus influenzae nonserotype b and unknown serotype.

Based on 2013 passive surveillance or notifiable disease cases among children <5 years of age reported to the Centers for Disease Control and Prevention (CDC). Policies for reporting notifiable disease cases can vary by disease or reporting jurisdiction.

 

How PREVNAR 13® helps protect against invasive pneumococcal disease.

The good news is that the PREVNAR 13® vaccine (called PCV13 on your baby’s immunization record) reduces the risk by helping protect against 13 of the most common strains of pneumococcal germs. Like all vaccines, it works with the body’s natural defenses to help develop immunity to disease. Learn more about how vaccines can help prevent disease from the Centers for Disease Control and Prevention (CDC).*

Vaccines can help protect babies.

Your body shielded your baby in the womb; vaccines help shield your baby by preventing disease.

In fact, vaccines have helped make widespread epidemics — smallpox, polio, diphtheria, measles, rubella, and mumps — feel like a distant memory. But these childhood diseases will only remain in control if most children are vaccinated. Should an outbreak happen, babies who haven’t received all their immunization shots could be at higher risk of developing a disease that could lead to hospitalization, disability, or even death.

Vaccines help prevent disease while antibiotics are usually only given to children after they become ill. This is especially concerning for invasive pneumococcal disease, since its germs have often developed a resistance to certain antibiotics.

Currently, the Centers for Disease Control and Prevention (CDC) recommends that children get vaccinated against 14 diseases by the age of 2. Visit the CDC to check what immunizations your child needs* or to learn more about how vaccines can help prevent disease.*

“Vaccinating your children is as important as buckling them into their car seat.”

- Denia Varrasso, MD 
 

 

 

PREVNAR 13®

Help protect your baby against invasive pneumococcal disease (IPD) with the PREVNAR 13® vaccine.

PREVNAR 13® (usually called PCV13, PCV, Pneumococcal conjugate or Pneumococcal on your baby’s immunization record) is given to babies, starting at 2 months, and ending at or soon after their 1st birthday, at 2, 4, 6, and 12-15 months of age, to protect against 13 common strains of pneumococcal bacteria. PREVNAR 13® is not 100% effective. Like other vaccines, PREVNAR 13® works with the body’s natural defenses to help develop immunity to disease. Like some vaccines, it’s administered in 4 doses. Babies should get all 4 doses to help give their developing immune system the defenses it needs to help protect against IPD.

4 doses to help protect - every dose counts.

The Centers for Disease Control and Prevention (CDC) recommends that your baby receive all 4 doses of PREVNAR 13® at 2, 4, 6, and 12-15 months of age. Sticking to this schedule and getting all 4 doses is important. After the 4th dose, your baby’s immunity will be higher than it was after the 3rd dose. If your baby receives fewer than 4 doses, his or her immune response may be lower during a time of greater risk.
Has my baby been vaccinated?

Here are the 4 most common ways the PREVNAR 13® vaccine appears on your baby’s vaccination record:

  • PCV13
  • PCV
  • Pneumococcal conjugate
  • Pneumococcal

 

Getting every recommended dose of PREVNAR 13® on time provides your baby with the optimal protection. Stick to the CDC-recommended dosing schedule — vaccinate your baby at 2, 4, 6, and 12-15 months of age — to ensure your baby’s defense against invasive pneumococcal disease is the strongest it can be.

 

 

Most common side effects.

Having concerns about side effects is only natural. Here are the common ones that some children have experienced with PREVNAR 13®.

  • In children 6 weeks through 17 years, the most common side effects were tenderness, redness, or swelling at the injection site, irritability, decreased appetite, decreased or increased sleep, and fever.
  • The most commonly reported serious adverse events in infants and toddlers were bronchiolitis (inflammation of the lungs) (0.9%), gastroenteritis (inflammation of the stomach and small intestine) (0.9%), and pneumonia (0.9%).

Talk to your healthcare provider about the potential risks and benefits of receiving the PREVNAR 13® vaccine.

Please see additional side effects and Important Safety Information.

Talk to your healthcare provider about the PREVNAR 13® vaccine today.

 

Insurance Coverage

PREVNAR 13® MAY BE AVAILABLE AT NO COST.

CDC-recommended vaccines for your child, like PREVNAR 13®, are considered a preventative service and may be available at no charge. The Affordable Care Act (ACA)* requires new health insurance plans after 2010 to cover preventative services without charging a deductible, copayment, or coinsurance when provided by an in-network provider.

However, if you have no insurance or are eligible for Medicaid, the Vaccines for Children (VFC) program* can help. The Vaccines for Children (VFC) program is a federally funded program that provides vaccines at no cost to children who might not otherwise be vaccinated because of inability to pay. While there is no charge for the vaccines, there may be other costs.

4 DOSES OF PROTECTION

4 doses of PREVNAR 13®, given on schedule, offer protection from invasive pneumococcal disease (IPD).

Invasive pneumococcal disease can include meningitis that may lead to brain damage or even death. PREVNAR 13® can help protect children against IPD.

Once is not enough. Help strengthen your baby’s immune response system with all 4 doses of PREVNAR 13® (PCV or PCV13).

Sticking to this schedule and getting all 4 doses is important. After the 4th dose, your baby’s immunity will be higher than it is after the 3rd dose. If your child receives fewer than 4 doses, his or her immune response may be lower during a time of greater risk.

Vaccinate on time. Follow the CDC-recommended immunization schedule.

The recommended schedule is designed to protect your baby by providing immunity early in life, before they are exposed to life-threatening diseases. Because of routine immunization, the rates of vaccine-preventable diseases (and the risks they posed to the lives of young children) have been dramatically reduced in the United States and in many other parts of the world.

 

 

 

§ As recommended by the CDC Advisory Committee on Immunization Practices (ACIP) and the American Academy of Pediatrics (AAP).
† The recommended time between doses is 4-8 weeks apart.
‡ The 4th dose should be given when your child is 12-15 months of age and at least 2 months after the 3rd dose.
* May be given as early as 6 weeks of age.

 

Regular appointments help keep your baby’s health on track.

To be sure that you and your healthcare provider have done what you can to help protect your child, be sure to keep all of your wellness appointments. The American Academy of Pediatrics recommends that you take your baby in for at least 9 checkups during his or her first 2 years.

Well-child visits are key opportunities to discuss the health and development of your baby, as well as ensure your baby’s vaccination schedule is up to date. Even when your baby’s health seems to be fine, regular checkups during the first 2 years can help ensure your baby receives the recommended preventative care.

  • In a study published by the American Journal of Managed Care, children under the age of 5 who missed more than half the recommended well-child visits had up to twice the risk of being hospitalized as children who attended 75% or more.

Check your baby's vaccination schedule to see if they've received all of the recommended doses. Should you find it is not up to date, talk to your healthcare provider right away.

Tips to help your little one feel more comfortable with their shots.

  • Distract and comfort your baby by cuddling, singing, or talking softly.
  • Smile and make eye contact to reassure your baby that everything’s OK.
  • Have your baby hold a favorite toy or blanket.
  • Ask if you can hold your baby on your lap, then gently rub his or her back during the vaccination.

COMMON QUESTIONS

When it comes to protecting your child from invasive pneumococcal disease (IPD), every dose of PREVNAR 13® is important. So is every question.

Why are vaccines important?

Thanks to vaccines, widespread epidemics of illnesses such as smallpox, polio, diphtheria, measles, rubella, and mumps — devastating childhood disease that were once serious threats to little ones in this country — are mostly a thing of the past. But deadly diseases do still exist. Vaccines are one of the best ways to keep your baby healthy and help prevent diseases that have been under control for years from becoming epidemics.

Children under 2 are at a higher risk for getting certain vaccine-preventable diseases because their immune systems aren’t fully developed. By vaccinating them, you can help protect them from getting sick. But for vaccines to continue to help protect children, children have to be vaccinated. As a parent, that’s where you come in.

Learn more about the importance of vaccines.*

I’ve never heard of invasive pneumococcal disease. Should I be concerned?

Yes. The bacteria that can cause invasive pneumococcal disease can spread through a cough or direct contact with the bacteria when they are on toys or objects. IPD can include meningitis, which may lead to brain damage or even death.

IPD is still occurring in infants and young children in the United States. In March 2010, the CDC reinforced the need for vaccination against invasive pneumococcal diseases, based on reports of these diseases in children younger than 5 years of age. Learn more.

How does invasive pneumococcal disease spread?

Invasive pneumococcal disease can spread through the air by a cough. While anyone can be susceptible, the risk of being infected is almost two and a half times higher for children who attend daycare centers.

How can I protect my baby against invasive pneumococcal disease?

While invasive pneumococcal diseases can be very serious in babies and young children, PREVNAR 13® can reduce this risk.

Doctors at the American Academy of Pediatrics (AAP) and the Centers for Disease Control and Prevention (CDC) and its Advisory Committee on Immunization Practices (ACIP) division recommend PREVNAR 13® for children 6 weeks through 5 years of age. Learn more.

How do I know if my baby has been vaccinated with PREVNAR 13®?

Take a look at your baby’s immunization record. PCV13, PCV, Pneumococcal conjugate, and Pneumococcal are the four most common ways the PREVNAR 13® vaccine may appear on your baby’s immunization record. Check with your healthcare provider to make sure your baby’s shots are up to date. Learn more.

What is PREVNAR 13®?

PREVNAR 13® is a vaccine approved for children 6 weeks through 17 years of age for the prevention of invasive disease caused by 13 strains of Streptococcus pneumoniae. It is also approved for children 6 weeks through 5 years for the prevention of otitis media (ear infection) caused by 7 of the 13 strains. PREVNAR 13® is not 100% effective and will only help protect against the 13 strains included in the vaccine. Learn more.

Why does my baby need all 4 doses of PREVNAR 13®?

If your child receives fewer than 4 doses, his or her immune response may be lower during a time of greater risk. And if you delay a dose, your baby’s immune system may have a lower response during this time.

Pediatricians and medical experts, including the CDC, recommend that PREVNAR 13® should be given as a complete 4-dose series at 2, 4, 6, and 12-15 months of age to help protect your baby against invasive pneumococcal diseases caused by the 13 strains covered by the vaccine during your baby’s period of greater risk. Skipping or delaying vaccines can put your baby at risk. Learn more.

I'm concerned about my baby's vaccination schedule. Why so many vaccines?

The purpose of the immunization schedule recommended by the Centers for Disease Control and Prevention (CDC) and the American Academy of Pediatrics (AAP) is to help build immunity. This schedule is based on when a vaccine will work best to boost your baby’s immune system. Young infants have an enormous capacity to respond to multiple vaccines, as well as to the many other challenges present in the environment. Not only will the vaccines not overwhelm your baby’s system, they’ll actually help strengthen it. According to the AAP, each vaccine dose is scheduled for the age that is considered optimal for producing the best immune system response, balanced with the need to provide protection at the earliest possible age.

I’m concerned about paying for PREVNAR 13®. Is it covered by my baby’s health insurance plan?

CDC-recommended vaccines for your child, such as PREVNAR 13® , are considered a preventative service and may be available at no charge. The Affordable Care Act (ACA)* requires new health insurance plans after 2010 to cover preventive services without charging a deductible, copayment or coinsurance when provided by an in-network provider. But if you have no insurance, or are eligible for Medicaid, you still have options to receive all 4 doses of the PREVNAR 13® vaccine for free.

What if we do not have insurance or are not eligible for Medicaid? Are there programs that can help?

Yes. The Vaccines for Children Program (VFC)* can help. The Vaccines for Children (VFC) program is a federally funded program that provides vaccines at no cost to children who might not otherwise be vaccinated because of inability to pay. While there is no charge for the vaccines, there may be other costs.

Can my child get invasive pneumococcal disease from the vaccine itself?

No. PREVNAR 13® is an inactivated (killed) vaccine. This means that PREVNAR 13® will not cause IPD in your baby since it contains only parts of the bacteria’s (pneumococcus) coating.

Can getting too many vaccines weaken a baby’s immune system?

No. Young infants have an enormous capacity to respond to multiple vaccines, as well as to the many other challenges present in the environment. If anything, vaccines can help prevent the immune system from being weakened by various types of infections.

What if my child missed a dose of PREVNAR 13®?

Check with your healthcare provider.