Prevnar 13

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Prevnar 13, there are no specific foods that you must exclude from your diet when receiving this medication. 

Prevnar 13 is given by a healthcare provider as a shot into the thigh or upper arm. 

The preferred sites for injection are the thigh in infants and the muscle of the upper arm in toddlers, children and adults. 

Prevnar 13 is given by a healthcare provider as a single 0.5-mL dose injected into the muscle of the thigh or upper arm. 

• For children 7 months through 5 years of age who have not received Prevnar or Prevnar 13, the catch-up schedule depends on their age.
  • ​7-11 months of age: 3 doses with the first 2 doses at least 4 weeks apart and the third dose after the one-year birthday, separated from the second dose by at least 2 months.
  • 12-23 months of age: 2 doses at least 2 months apart.
  • 24 months through 5 years of age (prior to the 6th birthday): 1 dose
• Children 15 months through 5 years of age who are considered completely immunized with Prevnar may receive one dose of Prevnar 13 to elicit immune responses to the 6 additional serotypes. This catch-up (supplemental) dose of Prevnar 13 should be administered with an interval of at least 8 weeks after the final dose of Prevnar. 
• In children 6 years through 17 years of age, Prevnar 13 is administered as single dose. If Prevnar was previously administered, then at least 8 weeks should elapse before receiving Prevnar 13.

Adults 50 years and older:

• Prevnar 13 is administered as a single dose.

This vaccine is injected into a muscle. You will receive this injection in a doctor's office or clinic setting.

For children, the pneumococcal 13-valent vaccine is given in a series of shots. The first shot is usually given when the child is 2 months old. The booster shots are then given at 4 months, 6 months, and 12 to 15 months of age. Adults usually receive only one dose of the vaccine.

The first injection should be given no earlier than 6 weeks of age. Allow at least 2 months to pass between injections.

If your child is older than 6 months, he or she can still receive this vaccine on the following schedule:

• Age 7-11 months: two injections at least 4 weeks apart, followed by a third injection after the child turns 1 year (at least 2 months after the second injection);

• Age 12-23 months: two injections at least 2 months apart;

• Age 24 months to 5 years (before the 6th birthday): one injection.

The timing of this vaccination is very important for it to be effective. Your child's individual booster schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by the health department of the state you live in.

Your doctor may recommend treating fever and pain with an aspirin-free pain reliever such as acetaminophen (Tylenol) or ibuprofen (Motrin, Advil, and others) when the shot is given and for the next 24 hours. Follow the label directions or your doctor's instructions about how much of this medicine to give your child.

It is especially important to prevent fever from occurring in a child who has a seizure disorder such as epilepsy.

Be sure to keep your child on a regular schedule for other immunizations such as diphtheria, tetanus, pertussis (whooping cough), hepatitis, and varicella (chicken pox). Your doctor or state health department can provide you with a recommended immunization schedule.

An overdose of this vaccine is unlikely to occur.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

• Fever

• Chest pain
• chills
• coughing
• difficult or labored breathing
• difficulty with swallowing
• fast heartbeat
• noisy breathing
• seizures
• skin itching, rash, or redness
• sneezing
• sore throat
• swelling of the face, throat, or tongue
• tightness in the chest

• Bladder pain
• blistering, peeling, or loosening of the skin
• bloody or cloudy urine
• bluish lips or skin
• body aches or pain
• choking
• confusion
• decreased urine output
• diarrhea
• difficult, burning, or painful urination
• dilated neck veins
• ear congestion
• extreme fatigue
• fainting
• frequent urge to urinate
• general feeling of discomfort or illness
• headache
• hives or itching
• irregular breathing
• irregular heartbeat
• joint or muscle pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• lightheadedness
• loss of appetite
• loss of voice
• lower back or side pain
• muscle aches and pains
• nasal congestion
• nausea
• not breathing
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid, shallow breathing
• red, irritated eyes
• runny nose
• shivering
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• sweating
• swelling of the face, fingers, feet, or lower legs
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• trouble sleeping
• unusual tiredness or weakness
• vomiting
• weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Decreased appetite
• decreased sleep
• irritability
• red streaks on the skin
• swelling, tenderness, or pain at the injection site

• Abdominal or stomach pain
• crying
• weakness
• welts

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, rash, redness, scarring, soreness, stinging, tingling, ulceration, or warmth at the injection site
• burning, dry, or itching eyes
• eye discharge or excessive tearing
• pain
• stomach cramps
• tenderness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

• It is used to prevent infections caused by Streptococcus pneumoniae.

• If you need to store Prevnar 13 at home, talk with your doctor, nurse, or pharmacist about how to store it.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• This information should not be used to decide whether or not to take Prevnar 13 or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Prevnar 13. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

A serum anti-capsular polysaccharide antibody concentration of 0.35 µg/mL measured one month after the third dose as a single antibody reference concentration was used to estimate the effectiveness of Prevnar 13 against IPD. The assay used for this determination is a standardized ELISA involving pre-absorption of the test sera with pneumococcal C‑polysaccharide and serotype 22F polysaccharide to reduce non-specific background reactivity. The single antibody reference value was based on pooled efficacy estimates from three placebo-controlled IPD efficacy trials with either Prevnar or the investigational 9-valent CRM197 conjugate pneumococcal polysaccharide vaccine. This reference concentration is only applicable on a population basis and cannot be used to predict protection against IPD on an individual basis. Functional antibodies elicited by the vaccine (as measured by opsonophagocytic assay [OPA]) were also evaluated.

Mechanism of Action

B-cells produce antibodies in response to antigenic stimulation via T‑dependent and T‑independent mechanisms. Prevnar 13, comprised of polysaccharides conjugated to a carrier protein, elicits a T-cell dependent immune response. Protein carrier-specific T-cells provide the signals needed for maturation of the B-cell response and generation of B-cell memory. This type of response induces immune memory and elicits booster responses on re-exposure in infants and young children to pneumococcal polysaccharides.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Prevnar 13 has not been evaluated for any carcinogenic or mutagenic potential, or impairment of fertility.

Prevnar 13 vaccine is used to prevent infection caused by pneumococcal bacteria. Prevnar 13 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.

Prevnar 13 is for use in children from 6 weeks to 5 years old, and in adults who are 50 and older.

Update: Pfizer Receives FDA Approval for Prevnar 13 in Adults Age 18 Through 49 July 12, 2016

Becoming infected with pneumococcal disease (such as pneumonia or meningitis) is much more dangerous to your health than receiving Prevnar 13. However, like any medicine, Prevnar 13 can cause side effects but the risk of serious side effects is extremely low.

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

Contact your doctor if your child will miss a booster dose or gets behind schedule. The next dose should be given as soon as possible. There is no need to start over.

Be sure your child receives all recommended doses of Prevnar 13. If your child does not receive the full series of vaccines, he or she may not be fully protected against the disease.

An overdose of Prevnar 13 is unlikely to occur.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.