What Type Of Vaccine Is Prevnar

Who Should Get Vaccinated Against It

Three vaccines are now available to help prevent pneumococcal disease. Before the FDA approval of Prevnar 20, the Centers for Disease Control and Prevention recommended the use of two other pneumococcal vaccines and . You can read more about them here.

The CDC recommends pneumococcal vaccination for all children under 2 years old and all adults at least 65 years old. Although pneumococcal disease can affect people of all ages, younger children and older adults are most at risk.

Depending on vaccination history and the presence of certain medical conditions, other people may also need to receive pneumococcal vaccinations. If you arent sure of your pneumococcal vaccination history, speak to your healthcare provider.

Summary Of Information Contained In This Naci Statement

The following highlights key information for immunization providers. Please refer to the remainder of the Statement for details.

1. What

Streptococcus pneumoniae is a bacterium that can cause many types of diseases including invasive pneumococcal disease , and community-acquired pneumonia .

For the prevention of diseases caused by S. pneumoniae in adults, two types of vaccines are available in Canada: pneumococcal 23-valent polysaccharide vaccine containing 23 pneumococcal serotypes and pneumococcal 13-valent conjugate vaccine containing 13 pneumococcal serotypes.

NACI has been tasked with providing a recommendation from a public health perspective on the use of pneumococcal vaccines in adults who are 65 years of age and older, following the implementation of routine childhood pneumococcal vaccine programs in Canada.

• Immunization and vaccines

2. Who

Information in this statement is intended for provinces and territories making decisions for publicly funded, routine, immunization programs for adults who are 65 years of age and older without risk factors increasing their risk of IPD. These recommendations supplement the recent NACI recommendations on this topic that were issued for individual-level decision making in 2016.

3. How

4. Why

Patients In Health Care Institutions

Residents of long-term care facilities should receive Pneu-P-23 vaccine. Refer to Recommendations for Use for information about pneumococcal vaccination of individuals at increased risk of IPD. Refer to Immunization of Patients in Health Care Institutions in Part 3 for additional information about vaccination of patients in health care institutions.

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Where Can I Find These Vaccines

Your doctors office is usually the best place to receive recommended vaccines for you or your child.

PCV13 is part of the routine childhood immunization schedule. Therefore, it is regularly available for children at:

• Pediatric and family practice offices
• Community health clinics

If your doctor does not have pneumococcal vaccines for adults, ask for a referral.

Pneumococcal vaccines may also be available for adults at:

• Pharmacies
• Health departments
• Other community locations, such as schools and religious centers

Federally funded health centers can also provide services if you do not have a regular source of health care. Locate one near youexternal icon. You can also contact your state health department to learn more about where to get pneumococcal vaccines in your community.

When receiving any vaccine, ask the provider to record the vaccine in the state or local registry, if available. This helps doctors at future encounters know what vaccines you or your child have already received.

Path To Improved Health

Pneumococcal vaccines can protect you against getting pneumonia, which is contagious and spreads from close, person-to-person contact. Pneumonia is an infection of the lungs and can lead to many symptoms, including:

• cough
• chest pains
• bringing up mucus when you cough

For seniors, pneumonia can be very serious and life-threatening. This is especially true if you have a chronic condition, such as diabetes or COPD. Pneumonia can also develop after youve had a case of the flu or a respiratory virus such as COVID-19. It is extremely important to stay current on flu shots each year in addition to your pneumococcal vaccines.

While PPSV23 and PCV13 do not protect against all types of pneumonia, they can make it less likely that you will experience severe and possibly life-threatening complications from the illness.

The American Academy of Family Physicians recommends that seniors who have not had either pneumococcal vaccine should get a dose of PCV13 first, and then a dose of PPSV23 6-12 months later. The vaccines cannot be given at the same time. If you have recently had a dose of PPSV23, your doctor will wait at least one year to give you PCV13.

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Before There Was A Vaccine Pneumococcal Infections Caused Many Problems Each Year In The United States In Children Younger Than 5 Including:

• more than 700 cases of meningitis,
• about 13,000 blood infections,
• about 5 million ear infections, and
• about 200 deaths.

Since the vaccine became available, severe pneumococcal disease in these children has fallen by 88%.

About 18,000 older adults die of pneumococcal disease each year in the United States.

Treatment of pneumococcal infections with penicillin and other drugs is not as effective as it used to be, because some strains are resistant to these drugs. This makes prevention through vaccination even more important.

A Look At Each Vaccine: Pneumococcal Vaccine

Much like Haemophilus influenzae type b , pneumococcal bacteria affect the most defenseless of the population . The diseases caused by pneumococcus include meningitis , bloodstream infections and pneumonia . The pneumococcal vaccine was first introduced for use in all infants in the United States in 2000. Before the vaccine, every year pneumococcus caused about 700 cases of meningitis, 17,000 cases of bloodstream infections, 200 deaths and 5 million ear infections in children.

Infants and young children are at greatest risk of serious infection because they are unable to develop immunity to the sugar that coats the bacteria, something that older children can do when they are more than 2 years of age.

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Types And Composition Of Pneumococcal Vaccines

The FDA licensed 1 conjugate and 1 polysaccharide vaccine for protection against pneumococcal disease.

Pneumococcal Conjugate Vaccine

Pneumococcal conjugate vaccine includes purified capsular polysaccharide of 13 serotypes of Streptococcus pneumoniae conjugated to a nontoxic variant of diphtheria toxin known as CRM197. A 0.5-milliliter PCV13 dose contains approximately 2.2 micrograms of polysaccharide from each of 12 serotypes and approximately 4.4 µg of polysaccharide from serotype 6B the total concentration of CRM197 is approximately 34 g. The vaccine contains 0.02% polysorbate 80, 0.125 milligrams of aluminum as aluminum phosphate adjuvant, and 5 mL of succinate buffer. The vaccine does not contain thimerosal preservative.

Pneumococcal Polysaccharide Vaccine

Pneumococcal polysaccharide vaccine includes purified preparations of pneumococcal capsular polysaccharide. PPSV23 contains polysaccharide antigen from 23 types of pneumococcal bacteria. It contains 25 µg of each antigen per dose and contains 0.25% phenol as a preservative.

• Conjugate: A type of vaccine that joins a protein to an antigen in order to improve the protection the vaccine provides
• Polysaccharide: A type of vaccine that is composed of long chains of sugar molecules that resemble the surface of certain types of bacteria in order to help the immune system mount a response

Problems Reported Following Pcv13 Varied By Age And Dose In The Series The Most Common Problems Reported Among Children Were:

• About half became drowsy after the shot, had a temporary loss of appetite, or had redness or tenderness where the shot was given.
• About 1 out of 3 had swelling where the shot was given.
• About 1 out of 3 had a mild fever, and about 1 in 20 had a higher fever .
• Up to about 8 out of 10 became fussy or irritable.

Adults have reported pain, redness, and swelling where the shot was given also mild fever, fatigue, headache, chills, or muscle pain.

Young children who get PCV13 along with inactivated flu vaccine at the same time may be at increased risk for seizures caused by fever. Ask your doctor for more information.

Problems that could happen after any injected vaccine:

• People sometimes faint after a medical procedure, including vaccination. Sitting or lying down for about 15 minutes can help prevent fainting, and injuries caused by a fall. Tell your doctor if you feel dizzy, or have vision changes or ringing in the ears.
• Some older children and adults get severe pain in the shoulder and have difficulty moving the arm where a shot was given. This happens very rarely.
• Any medication can cause a severe allergic reaction. Such reactions from a vaccine are very rare, estimated at about 1 in a million doses, and would happen within a few minutes to a few hours after the vaccination.

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When Will Prevnar 20 Be Available

We dont know yet when Prevnar 20 will be available since a specific timeline hasnt been announced yet.

Healthcare providers reference the CDCs updated immunizations schedules complex diagrams that show when and how vaccines should be administered to help make sure appropriate vaccines are administered. Prevnar 20 is not yet incorporated into these schedules, so its difficult for healthcare providers to know who specifically should receive the vaccine at this time.

However, its likely that ACIP will recommend the vaccines use and add it to the immunization schedule after they meet in October 2021.

Who Shouldnt Get Prevnar 20

People who have had a severe allergic reaction in the past to any of the vaccines ingredients including diphtheria protein should not receive Prevnar 20. People who are 17 years or younger also shouldnt receive this vaccine.

At this time, the FDA didnt place any other restrictions on who can receive Prevnar 20. If youre unsure if you should receive this vaccine, your healthcare provider can give you more information.

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Effectiveness Of The Pneumococcal Vaccine

Children respond very well to the pneumococcal vaccine.

The introduction of this vaccine into the NHS childhood vaccination schedule has resulted in a large reduction in pneumococcal disease.

The pneumococcal vaccine given to older children and adults is thought to be around 50 to 70% effective at preventing pneumococcal disease.

Both types of pneumococcal vaccine are inactivated or “killed” vaccines and do not contain any live organisms. They cannot cause the infections they protect against.

How Effective Is Each Vaccine

Vaccines help protect against disease, but no vaccine is 100% effective.

Studies show that at least one dose of Prevnar 13 protects 80% of babies from serious pneumococcal infections, 75% of adults age 65 and older from invasive pneumococcal disease , and 45% of adults age 65 and older from pneumococcal pneumonia.

Studies show that one dose of Pneumovax 23 protects 50% to 85% of healthy adults against invasive pneumococcal disease.

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Important Safety Information & Indications For Prevnar 13

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IMPORTANT SAFETY INFORMATION

• Prevnar 13® should not be given to anyone with a history of severe allergic reaction to any component of Prevnar 13® or any diphtheria toxoidcontaining vaccine
• Adults with weakened immune systems may have a reduced immune response
• In adults, the most common side effects were pain, redness, and swelling at the injection site, limitation of arm movement, fatigue, headache, muscle pain, joint pain, decreased appetite, vomiting, fever, chills, and rash
• Ask your healthcare provider about the risks and benefits of Prevnar 13®. Only a healthcare provider can decide if Prevnar 13® is right for you

Patients should always ask their doctors for medical advice about adverse events. You are encouraged to report negative side effects of vaccines to the US Food and Drug Administration and the Centers for Disease Control and Prevention . Visit or call 1-800-822-7967.

Please see full Prescribing Information.

Frequently Asked Questions About Pneumococcal Pneumonia And The Prevnar 13 Vaccine

Pneumococcal pneumonia is a potentially serious disease caused by Streptococcus pneumoniae, a common bacteria. Many people dismiss pneumonia as an illness that only the elderly or sick people get in the hospital. Thats not always true. Pneumococcal pneumonia can strike anywhere, anytime. Even if youre as young as 65 and take good care of yourself, you still may be at increased risk.

Pneumococcal pneumonia is not a cold or the flu. It is a bacterial lung disease, while the flu and cold are caused by viruses. Symptoms can come on quickly and can include cough, fatigue, high fever, shaking chills, and chest pain with difficulty breathing.

Streptococcus pneumoniae

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How Does It Compare To Other Pneumococcal Vaccines

Like Prevnar 20, Prevnar 13 is a conjugate vaccine that works in a similar way to protect you against pneumococcal disease. Pneumovax 23, on the other hand, is a polyvalent vaccine that works by producing antibodies against pneumococcal bacteria.

No vaccine is 100% effective at preventing disease, but all three pneumococcal vaccines Prevnar 13, Prevnar 20, and Pneumovax 23 are considered safe and effective for helping protect against pneumococcal disease. And this latest FDA approval demonstrates ongoing pneumococcal vaccine development, with more candidates currently in the pipeline.

Lets review some key differences between the vaccines.

Medical Conditions Resulting In High Risk Of Ipd

Table 1: Medical Conditions Resulting in High risk of IPD

Non-immunocompromising conditions

IPD is more common in the winter and spring in temperate climates.

Spectrum of clinical illness

Although asymptomatic upper respiratory tract colonization is common, infection with S. pneumoniae may result in severe disease. IPD is a severe form of infection that occurs when S. pneumoniae invades normally sterile sites, such as the bloodstream or central nervous system. Bacteremia and meningitis are the most common manifestations of IPD in children 2 years of age and younger. Bacteremic pneumococcal pneumonia is the most common presentation among adults and is a common complication following influenza. The case fatality rate of bacteremic pneumococcal pneumonia is 5% to 7% and is higher among elderly persons. Bacterial spread within the respiratory tract may result in AOM, sinusitis or recurrent bronchitis.

Disease distribution

Worldwide, pneumococcal disease is a major cause of morbidity and mortality. The World Health Organization estimates that almost 500,000 deaths among children aged less than 5 years are attributable to pneumococcal disease each year. In Canada, IPD is most common among the very young and adults over 65 years of age.

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Most Medicare Advantage Plans And Part D Plans Cover Prescription Drugs

Medicare Advantage plans that offer prescription drug coverage are called Medicare Advantage Prescription Drug Plans . Most Medicare Advantage beneficiaries are enrolled in MA-PDs.1

Medicare Part D prescription drug plans also cover retail prescription drugs.

You can compare Part D prescription drug plans available where you live and enroll in a Medicare prescription drug plan online when you visit MyRxPlans.com.

Medicare prescription drugs plans each have their own formulary, or drug list, that details what prescription drugs are covered by the plan and how they are covered.

Some Medicare Advantage plans also include benefits such as routine dental, hearing and vision coverage.

A licensed insurance agent can help you learn more about Medicare Advantage plans that are available where you live, including the benefits they offer. $0 premium plans may be available in your area.

• Medicare Enrollment Guide

1 Jacobson, Gretchen et al. A Dozen Facts About Medicare Advantage. . Kaiser Family Foundation. Retrieved from www.kff.org/medicare/issue-brief/a-dozen-facts-about-medicare-advantage.

MedicareAdvantage.com is a website owned and operated by TZ Insurance Solutions LLC. TZ Insurance Solutions LLC and TruBridge, Inc. represent Medicare Advantage Organizations and Prescription Drug Plans having Medicare contracts enrollment in any plan depends upon contract renewal.

Medicare has neither reviewed nor endorsed this information.

What Are The Side Effects Of The Pneumococcal Vaccine

After receiving the pneumococcal vaccine, children commonly will have pain or swelling where the shot is given and occasionally low-grade fever. About 1 of every 100 children will develop a high fever.

Side effects from the polysaccharide version used in adults include tenderness and redness at the injection site, and about 1 of every 100 people will get a fever and experience muscle aches.

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What Other Drugs Will Affect Prevnar 13

Before receiving Prevnar 13, tell the doctor about all other vaccines you or your child have recently received.

Also tell the doctor if you or your child have recently received drugs or treatments that can weaken the immune system, including:

• an oral, nasal, inhaled, or injectable steroid medicine

• chemotherapy or radiation

• medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders, such as azathioprine , etanercept , leflunomide , and others or

• medicines to treat or prevent organ transplant rejection, such as basiliximab , cyclosporine , muromonab CD3 , mycophenolate mofetil , sirolimus , or tacrolimus .

If you are using any of these medications, you may not be able to receive the vaccine, or may need to wait until the other treatments are finished.

There may be other drugs that can interact with Prevnar 13. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Talk To Your Healthcare Provider About The Prevnar 13 Vaccine Today

Making the decision to vaccinate your baby against invasive pneumococcal disease is the first step to protecting them. And your healthcare provider is your best resource for answering any questions or concerns you might have. To help you get a dialogue started, watch a video of a discussion between a mom and her doctor. Also, thereâs a Doctor Discussion Guide that you can download and bring to your visit.

Making the decision to vaccinate your baby against invasive pneumococcal disease is the first step to protecting them. And your healthcare provider is your best resource for answering any questions or concerns you might have. To help you get a dialogue started, watch a video of a discussion between a mom and her doctor. Also, thereâs a Doctor Discussion Guide that you can download and bring to your visit.

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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 * 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.

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

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

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