Capvaxive

Pronunciation: cap-vacks-iv
Generic name: pneumococcal 21-valent conjugate vaccine
Dosage form: intramuscular injection

Medically reviewed by Carmen Pope, BPharm. Last updated on Jun 19, 2024.

What is Capvaxive?

Capvaxive (pneumococcal 21-valent conjugate vaccine) is a single-dose vaccine that may be used to protect people aged 18 years and older against invasive pneumococcal disease and pneumonia caused by the following Streptococcus pneumoniae serotypes:

Invasive disease: S. pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B
Pneumonia: S. pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B.

The indication for the prevention of pneumonia caused by the listed S. pneumoniae serotypes is approved under the accelerated approval designation based on immune responses. Continued approval for this indication may be contingent upon continued benefits being reported in further clinical trials.

Capvaxive works by inducing opsonophagocytic killing (the engulfment, by macrophages and other phagocytic cells like neutrophils) of bacteria. Capvaxive induces opsonophagocytic activity (OPA) against 22 S. pneumoniae serotypes (serotype 15B has a similar molecular structure to serotype 15C) using opsonization (an immune process where opsonins, such as antibodies, are used to tag foreign pathogens for elimination by phagocytes) to target the specific S. pneumoniae serotypes. Capvaxive protects against 8 serotypes not covered by other pneumococcal shots.

Pneumococcal disease is an infection caused by a bacteria called S. pneumoniae. There are more than 100 different serotypes of pneumococcal bacteria, and certain serotypes put more people at risk for invasive pneumococcal illnesses, such as bacteremia, bacteremic pneumonia, and meningitis, as well as non-invasive pneumonia.

Capvaxive was FDA approved on June 17, 2024.

Capvaxive side effects

Common side effects of Capvaxive reported in people 18 through 49 years of age include:

injection-site pain (73.1%)
fatigue (36.0%)
headache (27.5%)
myalgia (16.4%)
injection-site erythema (13.8%)
injection-site swelling (13.3%).

Common side effects of Capvaxive reported in people 50 years of age and older include:

injection-site pain (41.2%)
fatigue (19.7%)
headache (11.0%).

Keep track of all side effects you have. If you ever need another pneumococcal vaccine, you will need to tell the vaccination provider if the previous shot caused any side effects.

Becoming infected with pneumococcal disease is much more dangerous to your health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is low.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to Merck Sharp & Dohme LLC at 1-877-888-4231 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.

Warnings

You should not receive this vaccine if you ever had a severe allergic reaction to a pneumococcal or diphtheria toxoid vaccine or to any ingredient in Capvaxive.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Before taking this medicine

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

Tell the vaccination provider if you have:

a weak immune system (caused by disease or by using certain medicines) or
if you are receiving radiation or chemotherapy.

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 this vaccine.

Tell the vaccination provider if you are pregnant or breastfeeding.

How is Capvaxive administered?

This vaccine is given as an injection (shot) into a muscle, usually the deltoid muscle of the upper arm.

Only 1 shot is needed.

Usual Adult Dose of Capvaxive for Pneumococcal Disease Prophylaxis:

0.5 mL IM once as a single dose

What happens if I miss a dose?

Capvaxive is used as a single dose and does not have a booster schedule.

What happens if I overdose?

An overdose of this vaccine is unlikely to occur.

What should I avoid after receiving Capvaxive?

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

What other drugs will affect Capvaxive?

Tell the vaccination provider if you have recently received drugs or treatments that can weaken the immune system, including:

steroid medicine
medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders or
medicines to treat or prevent organ transplant rejection.

This list is not complete. Other drugs may affect Capvaxive, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.