PREVNAR 20 Dosage & Rx Info | Uses, Side Effects

Prevnar 20 Generic Name & Formulations

Legal Class

General Description

Pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein); contains a total of 46.2mcg saccharides per 0.5mL; susp for IM inj; contains aluminum.

Pharmacological Class

PCV.

How Supplied

Prefilled syringes—1, 10

Storage

After shipping, Prevnar 20 may arrive at temperatures between 2 ºC to 25 ºC (36 ºF to 77 ºF).

Upon receipt, store refrigerated at 2 ºC to 8 ºC (36 ºF to 46 ºF). Do not freeze.

Store syringes horizontally to minimize resuspension time.

Manufacturer

Pfizer Inc.

Generic Availability

Mechanism of Action

Prevnar 20, comprised of pneumococcal polysaccharides conjugated to a carrier protein (CRM₁₉₇), provides protection against pneumococcal disease by opsonophagocytic killing of S. pneumoniae.

Prevnar 20 Indications

Indications

Active immunization of individuals 6 weeks of age and older against invasive disease caused by S. pneumoniae due to serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F; and against otitis media due to serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F in individuals 6 weeks through 5 years of age. Active immunization for the prevention of pneumonia and invasive disease caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in adults.

Prevnar 20 Dosage and Administration

Adult

Give by IM inj. ≥18yrs: 1 dose (0.5mL).

Children

Give each dose (0.5mL) by IM inj into the anterolateral thigh for infants or the deltoid muscle for toddlers and children. May pretreat with antipyretic. <6wks: not established. ≥6wks: 4 doses usually given at 2, 4, 6, and 12–15mos of age (may start at 6wks of age: give first 3 doses 4–8wks apart, and 4th dose at least 2mos after 3rd dose). Previously unvaccinated older infants and children: 7–11mos: 3 doses (2nd dose at least 4wks after 1st dose, 3rd dose after 1st birthday and at least 2mos after 2nd dose); 12–23mos: 2 doses at least 2mos apart; ≥24mos: 1 dose. 15mos–17yrs: 1 dose; if previously vaccinated with ≥1 dose of a lower valency pneumococcal conjugate vaccine, then at least 8wks should elapse before receiving Prevnar 20.

Administration

For intramuscular injection only. Prevnar 20 is administered as a single dose.

Administer as soon as possible after being removed from refrigeration. Prevnar 20 can be administered provided total time out of refrigeration does not exceed 96 hours.

Cumulative multiple excursions between 0 °C and 2 °C are also permitted as long as the total time between 0 °C and 2 °C does not exceed 72 hours. These are not, however, recommendations for storage.

Do not mix with other vaccines/products in the same syringe.

Prevnar 20 Contraindications

Contraindications

Allergies to any diphtheria toxoid-containing vaccine.

Prevnar 20 Boxed Warnings

Not Applicable

Prevnar 20 Warnings/Precautions

Warnings/Precautions

Have epinephrine inj available. Immunocompromised. Premature infants. Pregnancy. Nursing mothers.

Pregnancy Considerations

Available data on Prevnar 20 administered to pregnant women are insufficient to inform vaccine-associated risk in pregnancy.

Nursing Mother Considerations

It is not known whether Prevnar 20 is excreted in human milk. The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for Prevnar 20 and any potential adverse effects on the breastfed child.

Pediatric Considerations

Safety and effectiveness of Prevnar 20 in individuals younger than 18 years of age have not been established.

Geriatric Considerations

Compared with individuals under the age of 65, Prevnar 20 recipients 70-79 years old and those 80 years and older had lower immune responses for all pneumococcal serotypes.

Prevnar 20 Pharmacokinetics

See Literature

Prevnar 20 Interactions

Interactions

Immunosuppressants (eg, radiation, chemotherapy, high-dose steroids): may get suboptimal response. Antibody responses may be diminished if Pneumovax 23 was received 1 to 5 years prior to Prevnar 20.

Prevnar 20 Adverse Reactions

Adverse Reactions

Inj site reactions (eg, pain, swelling), muscle pain, fatigue, headache, arthralgia.

Prevnar 20 Clinical Trials

Clinical Trials

The approval of Prevnar 20 was based on evidence from several clinical trials including three phase 3 studies involving more than 6000 adult participants. In an active-controlled, double-blind noninferiority trial (ClinicalTrials.gov Identifier: NCT03760146), 3880 pneumococcal vaccine-naïve adults were enrolled into 1 of 3 cohorts based on their age and were randomly assigned to receive either Prevnar 20 or control.

The trial was designed to compare immune responses in patients 60 years of age and older after Prevnar 20 administration to responses in a control group receiving 13-valent pneumococcal conjugate vaccine (Prevnar 13) followed 1 month later with 23-valent polysaccharide vaccine (PPSV23). The immune responses to Prevnar 20 in patients aged 18 to 59 years were also assessed, along with the safety profile of Prevnar 20 in all patients.

Results showed that the primary immunogenicity objectives of noninferiority for the 20 serotypes in Prevnar 20 in patients aged 60 years and older at 1 month after vaccination were met for all serotypes in common with Prevnar 13, and 6 of the 7 additional serotypes when compared with PPSV23; 1 of the new 7 serotypes missed noninferiority by a small margin.

When measured 1 month after vaccination, Prevnar 20 also elicited serotype-specific immune responses to each of the 20 vaccine serotypes in both of the younger age groups (18-49 years and 50-59 years) that were within 2-fold of the corresponding serotype-specific responses in adults 60 to 64 years of age.

Immunogenicity of Prevnar 20 in Adults Previously Vaccinated With Pneumococcal Vaccine

Randomized, open-label trial evaluated immune responses to Prevnar 20 in adults 65 years and older previously vaccinated with PPSV23 (≥1 to ≤5 years prior to enrollment), previously vaccinated with Prevnar 13 (≥6 months prior to enrollment), or previously vaccinated with Prevnar 13 followed by PPSV23 (with PPSV23 vaccination ≥1 year prior to enrollment).
Immune responses in participants who received PPSV23 1 to 5 years prior to Prevnar 20 were diminished compared with immune responses in participants who received Prevnar 13 at least 6 months previously and compared with immune responses in participants who received Prevnar 13 followed by PPSV23, with the last PPSV23 dose given at least 1 year prior to Prevnar 20.

Concomitant Vaccine Administration

Double-blind study conducted in adults 65 years of age and older who had no history of prior pneumococcal vaccination or who had previously received PPSV23 and/or Prevnar 13 at least 6 months prior to enrollment.
Study participants were randomly assigned to receive Prevnar 20 concomitantly with Fluad Quadrivalent followed approximately 1 month later by placebo or Fluad Quadrivalent concomitantly with placebo followed approximately 1 month later by Prevnar 20.
The noninferiority criteria for the comparisons of OPA GMTs were met for all 20 pneumococcal serotypes in Prevnar 20.
The noninferiority criteria for the comparisons of HAI GMTs were also met for all 4 influenza vaccine strains.

Prevnar 20

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