Friday, September 22, 2023

Is Prevnar 13 A Live Virus Vaccine

Medical Conditions Resulting In High Risk Of Ipd

Measles diagnoses spark fears the virus has evolved to overcome vaccines

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.

Vaccines For Children Program

The Vaccines for Children Program provides vaccines to children whose parents or guardians may not be able to afford them. A child is eligible if they are younger than 19 years old and meets one of the following requirements:

  • Medicaid-eligible
  • American Indian or Alaska Native
  • Underinsured

If your child is VFC-eligible, ask if your doctor is a VFC provider. For help in finding a VFC provider near you, contact your state or local health departments VFC Program Coordinator or call CDC at 1-800-CDC-INFO .

Spacing Of Multiple Doses Of The Same Antigen

Vaccination providers should adhere to recommended vaccination schedules . Administration at recommended ages and in accordance with recommended intervals between doses of multidose antigens provides optimal protection.

Administration of doses of a multidose vaccine using intervals that are shorter than recommended might be necessary in certain circumstances, such as impending international travel or when a person is behind schedule on vaccinations but needs rapid protection. In these situations, an accelerated schedule can be implemented using intervals between doses that are shorter than intervals recommended for routine vaccination . The accelerated or minimum intervals and ages for scheduling catch-up vaccinations. Vaccine doses should not be administered at intervals less than these minimum intervals or at an age that is younger than the minimum age.*

Certain vaccines produce increased rates of local or systemic reactions in certain recipients when administered more frequently than recommended . Careful record keeping, maintenance of patient histories, use of immunization information systems , and adherence to recommended schedules can decrease the incidence of such reactions without adversely affecting immunity.

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Extra Doses Of Vaccine Antigens

Administering extra antigens contained in a combination vaccine should be avoided in most situations . Using combination vaccines containing certain antigens not indicated at the time of administration to a patient might be justified when 1) the extra antigen is not contraindicated, 2) products that contain only the needed antigens are not readily available, and 3) potential benefits to the patient outweigh the potential risk for adverse events associated with the extra antigens. An extra dose of many live-virus vaccines and Hib or hepatitis B vaccine has not been found to be harmful . However, the risk for an adverse event might increase when extra doses are administered at an earlier time than the recommended interval for certain vaccines .

A vaccination provider might not have vaccines available that contain only the antigens needed as indicated by a childs vaccination history. Alternatively, although the indicated vaccines might be available, the provider might prefer to use a combination vaccine to reduce the required number of injections. In such cases, the benefits and risks of administering the combination vaccine with an unneeded antigen should be carefully considered and discussed with the patient or parent.

Apnea In Premature Infants


Apnea following intramuscular vaccination has been observed in some infants born prematurely. Decisions about when to administer an intramuscular vaccine, including Prevnar 13, to infants born prematurely should be based on consideration of the individual infant’s medical status and the potential benefits and possible risks of vaccination.

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Evidence Supporting Addition To Routine Vaccination Schedules

After introduction of the pneumococcal conjugate vaccine in 2000, several studies described a decrease in invasive pneumococcal disease in the United States. One year after its introduction, a group of investigators found a 69% drop in the rate of invasive disease in those of less than two years of age. By 2004, all-cause pneumonia admission rates had declined by 39% and rates of hospitalizations for pneumococcal meningitis decreased by 66% in children younger than 2.

Rates of invasive pneumococcal disease among adults have also declined since the introduction of the vaccine.

Before Taking This Medicine

You should not receive Prevnar 13 if you ever had a severe allergic reaction to a pneumococcal or diphtheria toxoid vaccine.

Tell the vaccination provider if you or the child has:

  • a bleeding or blood clotting disorder such as hemophilia or easy bruising or

  • a weak immune system .

Before your child receives Prevnar 13, tell your doctor if the child was born prematurely.

You can still receive a vaccine if you have a minor cold. In the case of a more severe illness with a fever or any type of infection, wait until you get better before receiving Prevnar 13.

Tell the vaccination provider if you are pregnant or breastfeeding.

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More Information About The Vaccine

The PCV is a conjugate vaccine . Sugars are taken from the capsule around the pneumococcal bacteria and joined to a non-toxic diphtheria protein called CRM197. The protein helps to stimulate the immune system in a broader way to respond well to the vaccine. This gives a better immune response in individuals of all ages.

In recent years, there have been several changes to the pneumococcal vaccination schedule in the UK:

  • 2002: a pneumococcal conjugate vaccine protecting against 7 types of pnemococcal bacteria was recommended forimmunisation of babies and children in at-risk groups under the age of two years
  • 2003: pneumococcal polysaccharide immunisation was recommended for all people aged 65 and over
  • 2004: PCV7 was extended to at-risk babies and children under five years of age
  • 2006: PCV7 was added to the routine childhood immunisation programme
  • 2010: a pneumococcal conjugate vaccine protecting against 13 types of pnemococcal bacteria replaced PCV7.

Children 6 Weeks Through 5 Years Of Age

Your Best Shot Pneumococcal Vaccines

In children 6 weeks through 5 years of age , Prevnar 13® is indicated for:

  • active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
  • active immunization for the prevention of otitis media caused by S. pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. No otitis media efficacy data are available for serotypes 1, 3, 5, 6A, 7F, and 19A.

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Clinical Trials Experience With Prevnar 13 In Adults 18 Years Of Age

The safety of Prevnar 13 was assessed in 7 clinical studies 612 conducted in the US and Europe which included 91,593 adults ranging in age from 18 through 101 years.

The 48,806 Prevnar 13 recipients included 899 adults who were aged 18 through 49 years, 2,616 adults who were aged 50 through 64 years, 45,291 adults aged 65 years and older. Of the 48,806 Prevnar 13 recipients, 46,890 adults had not previously received Pneumovax® 23 and 1,916 adults were previously vaccinated with PPSV23 at least 3 years prior to enrollment.

Safety and Immunogenicity Studies

Safety and immunogenicity of Prevnar 13 is supported by 6 clinical studies. Study 66 evaluated the safety and immunogenicity of Prevnar 13 in adults 18 through 64 years of age who had not received a previous dose of pneumococcal vaccine. Adults 18 through 59 years of age received a single dose of Prevnar 13, and adults 60 through 64 years of age received a single dose of Prevnar 13 or PPSV23.

Study 7 was randomized and compared the safety and immunogenicity of Prevnar 13 with PPSV23 as a single dose in adults 70 years vaccinated with PPSV23 .7 Study 8 was randomized and evaluated the safety and immunogenicity of Prevnar 13 and PPSV23 in different sequential order in PPSV23 naive adults aged 60 through 64 years8.

Efficacy Study

Serious Adverse Events in Adult Clinical Studies

Safety and Immunogenicity Studies

Efficacy Study

Solicited Adverse Reactions in Adult Clinical Studies

16.5 9.7

What Is Prevnar 13

Prevnar 13 is used to help prevent disease caused by pneumococcal bacteria. This vaccine contains 13 different types of pneumococcal bacteria.

Pneumococcal disease is a serious infection caused by a bacteria. Pneumococcal bacteria can infect the sinuses and inner ear. It can also infect the lungs, blood, and brain, and these conditions can be fatal.

Prevnar 13 works by exposing you to a small amount of the bacteria or a protein from the bacteria, which causes the body to develop immunity to the disease. Prevnar 13 will not treat an active infection that has already developed in the body.

Pneumococcal 13-valent vaccine is for use in adults and children at least 6 weeks old.

Prevnar 13 helps your body develop immunity to the disease, but will not treat an active infection you already have.

Like any vaccine, Prevnar 13 may not provide protection from disease in every person.

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When To Get The Vaccine

Thereâs no such thing as pneumonia season, like flu season. If you and your doctor decide that you need to have a pneumonia vaccine, you can get it done at any time of the year. If itâs flu season, you can even get a pneumonia vaccine at the same time that you get a flu vaccine, as long as you receive each shot in a different arm.

What If There Is A Serious Reaction

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An allergic reaction could occur after the vaccinated person leaves the clinic. If you see signs of a severe allergic reaction , call 9-1-1 and get the person to the nearest hospital.

For other signs that concern you, call your health care provider.

Adverse reactions should be reported to the Vaccine Adverse Event Reporting System . Your health care provider will usually file this report, or you can do it yourself. Visit the VAERS website at or call . VAERS is only for reporting reactions, and VAERS staff does not give medical advice.

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How Much Do Pneumovax 23 And Prevnar 13 Cost

Pneumovax 23 and Prevnar 13 can be quite expensive without insurance. One dose of Pneumovax 23 currently costs around $135 cash price, while one dose of Prevnar 13 costs around $250 cash price. With a GoodRx coupon, you might be able to reduce your cost for these to around $90 and $195, respectively. Read here for information on how to use a GoodRx coupon for vaccines.

All health insurance marketplace plans under the Affordable Care Act, and most other private insurance plans, must cover pneumococcal vaccines without charging a copayment or coinsurance when an in-network provider administers the vaccine even if you have not met a yearly deductible. Medicare does not cover either vaccine.

Remember: The recommendations for who should get a pneumonia vaccination are based on risk factors and age, so be sure to talk to your doctor if you think you might need one. You should be able to receive both Pneumovax 23 and Prevnar 13 at your local pharmacy. Depending on which state you live in, these vaccines may not require a prescription. Be sure to reach out to your pharmacist for more information. The CDC has more information about these vaccinations here.

Besides Pneumonia Pneumococcal Bacteria Can Also Cause:

  • Ear infections
  • Meningitis
  • Bacteremia

Anyone can get pneumococcal disease, but children under 2 years of age, people with certain medical conditions, adults 65 years and older, and cigarette smokers are at the highest risk.

Most pneumococcal infections are mild. However, some can result in long-term problems, such as brain damage or hearing loss. Meningitis, bacteremia, and pneumonia caused by pneumococcal disease can be fatal.

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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.

Tips To Help Your Little One Feel More Comfortable With Their Shots

PCV13 for Immunocompromised Adults
  • Distract and comfort your baby by cuddling, singing, or talking softly.
  • Smile and make eye contact to reassure your baby that everythingâs 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.

When it comes to protecting your child from invasive pneumococcal disease , 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 â devastating childhood disease that were once serious threats to little ones in this country â 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 arenât 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, thatâs where you come in.

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

How does invasive pneumococcal disease spread?

How can I protect my baby against invasive pneumococcal disease?

What is PREVNAR 13®?

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Pneumonia Vaccine May Affect Course Of Covid

Kaiser Permanente research finds older adults vaccinated with pneumococcal conjugate vaccine received some protection against COVID-19.


PASADENA, Calif. A Kaiser Permanente study showed that one type of pneumonia vaccine, the PCV13 vaccine, may affect the course of COVID-19 for some older adult patients. The study was published in The Journal of Infectious Diseases.

Kaiser Permanente members who received the PCV13 vaccine appeared to be diagnosed with COVID-19 less often, and when they were, they seemed to have less severe outcomes, overall, said the senior author, Sara Y. Tartof, PhD, MPH, a scientist with the Kaiser Permanente Southern California Department of Research & Evaluation. One of the most interesting aspects of our findings was that the patients who received PCV13 received some protection against COVID-19, while those who received PPSV23, another pneumococcal vaccine, did not.

When the virus that causes COVID-19 infects a new person, it encounters a diverse array of viral and bacterial species that naturally reside in the human upper airway. One of these species is a bacterium called Streptococcus pneumoniae, or pneumococcus, which is commonly carried by children as well as adults. While typically harmless, this bacterium is well known for causing pneumonia and other diseases, often in interaction with viruses.

Among adults ages 65 years old and older, those who received the pneumonia vaccine PCV13 had:

Persons With Inadequate Immunization Records

Children and adults lacking adequate documentation of immunization should be considered unimmunized and should be started on an immunization schedule appropriate for their age and risk factors. Pneumococcal vaccines may be given, regardless of possible previous receipt of the vaccines, as adverse events associated with repeated immunization have not been demonstrated. Refer to Immunization of Persons with Inadequate Immunization Records in Part 3 for additional information about vaccination of people with inadequate immunization records.

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Problems That Could Happen After Getting 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 or your child:
  • Feel dizzy
  • Have vision changes
  • Have ringing in the ears
  • Some people get severe pain in the shoulder and have difficulty moving the arm where the doctor gave the shot. This happens very rarely.
  • Any medicine can cause a severe allergic reaction. Such reactions from a vaccine are very rare, estimated at about 1 in a million shots. These types of reactions would happen within a few minutes to a few hours after the vaccination.
  • As with any medicine, there is a very remote chance of a vaccine causing a serious injury or death.
  • Select Safety Information For Pneumovax 23

    Pneumococcal (PCV13 â Prevnar 13)

    Do not administer PNEUMOVAX®23 to individuals with a history of a hypersensitivity reaction to any component of the vaccine.

    Defer vaccination with PNEUMOVAX 23 in persons with moderate or severe acute illness.

    Use caution and appropriate care in administering PNEUMOVAX 23 to individuals with severely compromised cardiovascular and/or pulmonary function in whom a systemic reaction would pose a significant risk.

    Available human data from clinical trials of PNEUMOVAX 23 in pregnancy have not established the presence or absence of a vaccine-associated risk.

    Since elderly individuals may not tolerate medical interventions as well as younger individuals, a higher frequency and/or a greater severity of reactions in some older individuals cannot be ruled out.

    Persons who are immunocompromised, including persons receiving immunosuppressive therapy, may have a diminished immune response to PNEUMOVAX 23.

    PNEUMOVAX 23 may not be effective in preventing pneumococcal meningitis in patients who have chronic cerebrospinal fluid leakage resulting from congenital lesions, skull fractures, or neurosurgical procedures.

    For subjects aged 65 years or older in a clinical study, systemic adverse reactions which were determined by the investigator to be vaccine-related were higher following revaccination than following initial vaccination.

    Vaccination with PNEUMOVAX 23 may not offer 100% protection from pneumococcal infection.

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