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Pneumococcal Vaccines

Nearly one million Americans get pneumococcal disease each year and roughly 67,000 die from it. Pneumonia (lung infection) is the most common disease caused by pneumococcal bacteria, accounting for more than 400,000 hospitalizations in the U.S. annually. According to the U.S. Food and Drug Administration (FDA), three pneumococcal vaccines are currently licensed for use in the U.S.: Prevnar, Prevnar 13 and Pneumovax 23.

*Please seek the advice of a medical professional before discontinuing the use of this vaccine.

Anyone can get pneumococcal disease. Pneumococcal bacteria are spread from person-to-person through saliva, mucus or other respiratory secretions. In addition to pneumonia, the bacteria can cause bacteremia, a blood infection, and meningitis, an infection of the covering of the brain and spinal cord. Less severe illnesses caused by pneumococcal disease include ear and sinus infections.

Some people are at greater risk for pneumococcal disease than others because of age or certain medical conditions, according to the Centers for Disease Control and Prevention (CDC).

“Pneumococcal disease is common in young children, but older adults are at greatest risk of serious pneumococcal infections and even death,” according to the agency. “CDC recommends vaccination with the pneumococcal conjugate vaccine for all babies and children younger than 2 years old, all adults 65 years or older, and people 2 years through 64 years old who are at increased risk for pneumococcal disease due to certain medical conditions.”

Those at Risk for Pneumococcal Disease

Children

  • All children younger than 2 years old
  • Children in group child care
  • Children who have certain illnesses (sickle cell disease, HIV infection, or chronic heart or lung conditions)
  • Children with cochlear implants or cerebrospinal fluid (CSF) leaks (escape of the fluid that surrounds the brain and spinal cord)
  • Some Native American, Alaska Native and African American children

Adults

  • All adults 65 years or older
  • Adults (19-64 years )with chronic illnesses (organ disease; asthma; diabetes or alcoholism)
  • Adults (19-64 years ) with conditions that weaken the immune system
  • Adults (19-64 years ) with cochlear implants or cerebrospinal fluid (CSF) leaks
  • Adults (19-64 years) who smoke cigarettes

Anyone who has had a severe allergic reaction to a previous dose of these vaccines or to any component of the vaccines should not get them. Any vaccine, including a pneumococcal vaccine, can cause a severe allergic reaction, and there is a slight chance of a vaccine causing a serious injury or death. The CDC advises women who need the vaccine to get it before becoming pregnant. People who are moderately or severely ill at the time of a scheduled vaccine should probably wait until they recover to get it. However, it may be OK to receive a vaccine if a person has a mild illness, such as a cold, according to the CDC.

Types of Pneumococcal Vaccines

The FDA has approved two types of pneumococcal vaccines: pneumococcal conjugate vaccine (PCV) and pneumococcal polysaccharide vaccine (PPSV).  A conjugate vaccine joins a protein to part of the bacteria to improve the protection the vaccine provides; a polysaccharide vaccine is made of long chains of sugar molecules. These vaccines differ in that young children do not respond consistently to polysaccharide antigens, and repeat doses of polysaccharide vaccines usually do not cause a booster response.

Prevnar 13 (PCV13) is the pneumococcal conjugate vaccine currently used in routine vaccination in the U.S. It replaced Prevnar 7 (PVC7) in 2010. Pneumovax 23 (PPSV23) is the only pneumococcal polysaccharide vaccine licensed in the U.S.

Child Getting a Shot in the Arm
The CDC recommends infants receive four doses of PCV

The CDC recommends all infants younger than 24 months receive four doses of PCV—the first dose at 2 months, the next two shots at 4 months and 6 months, and a final booster shot at 12 to 15 months. A child who does not get the shots at these times should still be vaccinated. The child’s age will determine the number of doses and time between doses. Children ages 2 through 4 years who are healthy and did not finish the four doses should get one dose of the vaccine.

For most adults who have not received any pneumococcal vaccines (or those with unknown vaccination history), the CDC recommends one dose of PCV13 first, followed at least one year later by one dose of a PPSV23. PCV13 and PPSV23 should not be given during the same doctor’s office visit. When both are indicated, a person should receive PCV13 before PPSV23 whenever possible.

If an adult has already had a dose of PPSV23 but no dose of PCV13, he or she should get a dose of PCV13 at least one year after receiving the most recent PPSV23 dose. If a person has already gotten a dose of PCV13 at a younger age, another dose is not recommended. Vaccine timing for adults with certain medical conditions varies. The patient’s doctor will be able to advise them.

Prevnar 7 and Prevnar 13 (PCV13)

The first pneumococcal conjugate vaccine, Prevnar 7, gained U.S. approval in 2000. Pharmaceutical giant Pfizer manufactured Prevnar 7, and in 2010, the FDA approved Pfizer’s Prevnar 13, which replaced Prevnar 7 in routine vaccination.

Soon after Prevnar 7 hit the market, the CDC conducted a study and found that the vaccine protected 96 percent of healthy children against pneumococcal disease caused by the seven strains in the vaccine. Furthermore, 81 percent of children with medical conditions that put them at increased risk of pneumococcal disease were protected after receiving at least one dose of Prevnar 7. The vaccine was also very successful at preventing certain pneumococcal diseases that are resistant to antibiotics used to treat bacterial infections.

Prevnar 7 protected more than 90 percent of babies from certain pneumococcal disease caused by the strains included in the vaccine.

After routine use of Prevnar 7 began for children in the U.S., the country saw large drops in rates of pneumococcal disease that the vaccine is intended to prevent. In a study including 37,000 babies in California, Prevnar 7 protected more than 90 percent of babies from certain pneumococcal disease caused by the strains included in the vaccine. The children who got the vaccine also had fewer ear infections and fewer ear tubes placed. Prevnar 7 also proved to prevent pneumonia in children.

However, Prevnar 7 only protected against pneumococcal disease caused by seven strains, and rates of certain pneumococcal disease not included in Prevnar 7 protection increased. The main strains causing the increases after Prevnar 7 are covered by Prevnar 13, which helps protect against the 13 types of pneumococcal bacteria that are the most common causes of serious infections in children and adults. It was also shown to help prevent some ear infections. Since Prevnar 13 replaced Prevnar 7 for routine use among children, rates of disease caused by these strains have declined.

Pneumococcal Bacteria Up Close
Microscopic view of a Pneumococcal bacteria

The CDC estimates that more than 30,000 cases of invasive pneumococcal disease and 3,000 deaths were prevented in the first three years of using Prevnar 13. Studies show that at least one dose of Prevnar 13 protects at least 80 percent of babies and 75 percent of adults 65 years or older against certain pneumococcal disease. Studies also showed it protects 45 percent of adults 65 years or older against pneumococcal pneumonia.

Like any vaccine, Prevnar 7 and Prevnar 13 can cause side effects.

Side effects of Prevnar and Prevnar 13 include:

  • Redness
  • Welling
  • Fever
  • Pain or tenderness where the shot was given
  • loss of appetite
  • Irritability
  • Tiredness
  • Headache and chills

These are some reported reactions to pneumococcal conjugate vaccination. Young children who get a pneumococcal conjugate vaccine at the same time as an inactivated flu vaccine may be a greater risk for seizures caused by fever.

People with compromised immune systems, including people with splenic dysfunction, HIV infection and cancer, may respond differently to Prevnar 13. Some infants born prematurely have suffered from apnea — or temporary stops in breathing, especially during sleeping —after receiving vaccines in the muscle. Consider an infant’s medical status and the potential benefits and possible risks of vaccination before deciding whether to give him or her Prevnar 13.

Pneumovax 23 (PPSV23)

Studies show that one dose of Pneumovax23 protects 50 to 85 percent of healthy adults against invasive pneumococcal disease. The FDA approved Pneumovax 23 in 1983 for use in adults 50 years of age or older and people 2 years of age and older who are at increased risk of pneumococcal disease. Children younger than 2 years old should not get Pneumovax 23.

Manufactured by Merck & Co. Inc., the vaccine protects against 23 types of pneumococcal bacteria. It is given in a single 0.5 mL dose as a shot in either the muscle or the fatty tissue of the arm or leg. Because it is made of long chains of sugar molecules, Pneumovax 23 is a pneumococcal polysaccharide vaccine. This type of vaccine is made to look like the surface of certain bacteria in order to help the body build protection against that germ.

The prescribing information includes several warnings about use of Pneumovax 23. People who are immunocompromised, including people receiving immunosuppressive therapy, may have a reduced immune response to the vaccine. Pneumovax 23 may not prevent pneumococcal meningitis in people who have chronic cerebrospinal fluid (CSF) leakage resulting from congenital lesions, skull fractures or neurosurgical procedures. In addition, health care professionals should use caution when giving the vaccine to people with severely compromised cardiovascular and/or pulmonary function.

Pneumovax 23 Fact

Pneumovax 23 may not prevent pneumococcal meningitis in people who have CSF leakage resulting from congenital lesions, skull fractures or neurosurgical procedures.

Pregnant women should only get Pneumovax 23 if it is clearly needed. It’s unknown whether the vaccine can cause fetal harm when given to expectant mothers or whether it can affect reproductive capacity. No animal reproductive studies have been performed with Pneumovax 23. Nursing women should also be cautious as it is unknown whether this vaccine is excreted in human milk.

Receiving Pneumovax 23 at the same time as the shingles vaccine Zostavax has been shown to reduce the immune response to Zostavax, so the FDA recommends considering getting these vaccines at least four weeks apart. The FDA warns that Pneumovax 23 does not replace the need for penicillin (or other antibiotic) prophylaxis against pneumococcal infection, so patients who require penicillin (or other antibiotic) prophylaxis against pneumococcal infection should not discontinue prophylaxis after getting Pneumovax 23. Clinical trials of Pneumovax 23 revealed the most commonly reported adverse reactions.

According to the vaccine package insert:

  • 60% of vaccinated subjects reported injection-site pain, soreness or tenderness
  • 20% of vaccinated subjects reported injection-site swelling or hardening
  • 18% of vaccinated subjects reported headache
  • 16% of vaccinated subjects reported injection-site redness
  • 13% of vaccinated subjects reported physical weakness, lack of energy and fatigue
  • 12% of vaccinated subjects reported muscle pain

If these problems occur after Pneumovax23 vaccination, they usually subside within about two days.

Shoulder Injury, Fainting and Pneumococcal Vaccines

The FDA and CDC warn that shoulder injury and fainting can occur after vaccination. These injuries are covered by the National Vaccine Injury Compensation Program (VICP), a federal program that provides financial compensation to people who are found to be injured by certain vaccines, including pneumococcal conjugate vaccines. To date, the program has awarded more than $3.6 billion to people who have filed vaccine injury and death claims.

After vaccination, some people get severe pain in the shoulder and have difficulty moving the arm where a shot was given. If the first symptom of shoulder injury occurs within 48 hours of administration of a pneumococcal conjugate vaccine and meets the VICP definition, it is presumed that the vaccine caused the injury (unless another cause is proven), and the injured person may receive compensation.

Vaccination & vasovagal syncope

Some vaccinated people suffer from vasovagal syncope (a sudden drop in heart rate and blood pressure that leads to fainting) and are entitled to compensation.

Similarly, some vaccinated people suffer from vasovagal syncope, a sudden drop in heart rate and blood pressure that leads to fainting. If a person experiences vasovagal syncope within one hour of receiving a pneumococcal conjugate vaccine, he or she may be eligible for compensation.

People who faint or suffer from shoulder injury after pneumococcal vaccination may choose to hire an attorney to help file a petition because it is a legal process. Even in instances in which a person files a petition with VICP and is not found to have been injured by a vaccine, he or she may receive compensation through a settlement.

Author

Emily is a former journalist with experience in health care writing. She graduated from the University of Florida with a bachelor’s degree in journalism.

View Sources
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  2. CDC.gov. (2015, June 10). Fast Facts. Retrieved from https://www.cdc.gov/pneumococcal/about/facts.html
  3. CDC.gov. (2016, November 22). Pneumococcal Vaccination: What Everyone Should Know. Retrieved from https://www.cdc.gov/vaccines/vpd/pneumo/public/index.html
  4. FDA.gov. Highlights of Prescribing Information. (n.d.). Retrieved from https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM257088.pdf
  5. FDA.gov. (2016). Highlights of Prescribing Information. Retrieved from https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM201669.pdf
  6. FDA.gov. (2008, October). Pneumococcal 7-valent Conjugate Vaccine. Retrieved from https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM137038.pdf
  7. U.S. Department of Health and Human Services. (2017, March 21). Vaccine Injury Table. Retrieved from https://www.hrsa.gov/vaccinecompensation/vaccineinjurytable.pdf
  8. CDC.gov. (2015, November 30). Pneumococcal Vaccine Timing for Adults. Retrieved from https://www.cdc.gov/vaccines/vpd/pneumo/downloads/pneumo-vaccine-timing.pdf
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