PNEUMOVAX 23 SIDE EFFECTS

Last updated on MDtodate: 10/10/2022

SIDE EFFECTS

The most common adverse reactions, reported in > 10% of subjects vaccinated with PNEUMOVAX 23 in clinical trials were: injection-site pain/soreness/tenderness (60.0%), injection-site swelling/induration (20.3%), headache (17.6%), injection-site erythema (16.4%), asthenia/fatigue (13.2%), and myalgia (11.9%).

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in practice.

In a randomized, double-blind, placebo-controlled crossover clinical trial, subjects were enrolled in four different cohorts defined by age (50-64 years of age and ≥ 65 years of age) and vaccination status (no pneumococcal vaccination or receipt of a pneumococcal polysaccharide vaccine 3-5 years prior to the study). Subjects in each cohort were randomized to receive intramuscular injections of PNEUMOVAX 23 followed by placebo (saline containing 0.25% phenol), or placebo followed by PNEUMOVAX 23, at 30-day (±7 days) intervals. The safety of an initial vaccination (first dose) was compared to revaccination (second dose) with PNEUMOVAX 23 for 14 days following each vaccination.

All 1008 subjects (average age, 67 years; 49% male and 51% female; 91% Caucasian, 4.7% African-American, 3.5% Hispanic, and 0.8% Other) received placebo injections.

Initial vaccination was evaluated in a total of 444 subjects (average age 65 years; 32% male and 68% female; 93% Caucasian, 3.2% African-American, 3.4% Hispanic, and 1.1% Other).

Revaccination was evaluated in 564 subjects (average age 69 years; 53% male and 47% female; 90% Caucasian, 3.5% Hispanic, 6.0% African-American, and 0.5% Other).

Serious Adverse Experiences

In this study, 10 subjects had serious adverse experiences within 14 days of vaccination: 6 who received PNEUMOVAX 23 and 4 who received placebo. Serious adverse experiences within 14 days after PNEUMOVAX 23 included angina pectoris, heart failure, chest pain, ulcerative colitis, depression, and headache/tremor/stiffness/sweating. Serious adverse experiences within 14 days after placebo included myocardial infarction complicated with heart failure, alcohol intoxication, angina pectoris, and edema/urinary retention/heart failure/diabetes.

Five subjects reported serious adverse experiences that occurred outside the 14-day follow-up window: 3 who received PNEUMOVAX 23 and 2 who received placebo. Serious adverse experiences after PNEUMOVAX 23 included cerebrovascular accident, lumbar radiculopathy, and pancreatitis/myocardial infarction resulting in death. Serious adverse experiences after placebo included heart failure and motor vehicle accident resulting in death.4

Solicited and Unsolicited Reactions

Table 1 presents the adverse event rates for all solicited and unsolicited reactions reported in ≥ 1% in any group in this study, without regard to causality.

The most common local adverse reactions reported at the injection site after initial vaccination with PNEUMOVAX 23 were pain/tenderness/soreness (60.0%), swelling/induration (20.3%), and erythema (16.4%). The most common systemic adverse experiences were headache (17.6%), asthenia/fatigue (13.2%), and myalgia (11.9%).

The most common local adverse reactions reported at the injection site after revaccination with PNEUMOVAX 23 were pain/soreness/tenderness (77.2%), swelling (39.8%), and erythema (34.5%). The most common systemic adverse reactions with revaccination were headache (18.1%), asthenia/fatigue (17.9%), and myalgia (17.3%). All of these adverse reactions were reported at a rate lower than 10% after receiving a placebo injection.

Table 1: Incidence of Injection-Site and Systemic Complaints in Adults ≥ 50 Years of Age Receiving Their First (Initial) or Second (Revaccination) Dose of PNEUMOVAX 23 (Pneumococcal Polysaccharide Vaccine, 23 Valent) or Placebo Occurring at ≥ 1% in Any Group

	PNEUMOVAX 23 Initial Vaccination N=444	PNEUMOVAX 23 Revaccination* N=564	Placebo Injection† N=1008
Number Followed for Safety	438	548	984*
	AE Rate	AE Rate	AE Rate
Injection-Site Complaints
Solicited Events
Pain/Soreness/ Tenderness	60.0%	77.2%	7.7%
Swelling/ Induration	20.3%	39.8%	2.8%
Erythema	16.4%	34.5%	3.3%
Unsolicited Events
Ecchymosis	0%	1.1%	0.3%
Pruritus	0.2%	1.6%	0.0%
Systemic Complaints
Solicited Events
Asthenia/Fatigue	13.2%	17.9%	6.7%
Chills	2.7%	7.8%	1.8%
Myalgia	11.9%	17.3%	3.3%
Headache	17.6%	18.1%	8.9%
Unsolicited Events
Fever§	1.4%	2.0%	0.7%
Diarrhea	1.1%	0.7%	0.5%
Dyspepsia	1.1%	1.1%	0.9%
Nausea	1.8%	1.8%	0.9%
Back Pain	0.9%	0.9%	1.0%
Neck Pain	0.7%	1.5%	0.2%
Upper Respiratory Infection	1.8%	2.6%	1.8%
Pharyngitis	1.1%	0.4%	1.3%
*Subjects receiving their second dose of pneumococcal polysaccharide vaccine as PNEUMOVAX 23 approximately 3-5 years after their first dose. †Subjects receiving placebo injection from this study combined over periods. ‡The number of subjects receiving placebo followed for injection-site complaints. The corresponding number of subjects followed for systemic complaints was 981.5 §Fever events include subjects who felt feverish in addition to subjects with elevated temperature.

 

In this clinical study an increased rate of local reactions was observed with revaccination at 3-5 years following initial vaccination.

For subjects aged 65 years or older, injection-site adverse reaction rate was higher following revaccination (79.3%) than following initial vaccination (52.9%). The proportion of subjects reporting injection site discomfort that interfered with or prevented usual activity or injection site induration ≥ 4 inches was higher following revaccination (30.6%) than following initial vaccination (10.4%). Injection site reactions typically resolved by 5 days following vaccination.

For subjects aged 50-64 years, the injection-site adverse reaction rate for revaccinees and initial vaccinees was similar (79.6% and 72.8% respectively).

The rate of systemic adverse reactions was similar among both initial vaccinees and revaccinees within each age group. The rate of vaccine-related systemic adverse reactions was higher following revaccination (33.1%) than following initial vaccination (21.7%) in subjects 65 years of age or older, and was similar following revaccination (37.5%) and initial vaccination (35.5%) in subjects 50-64 years of age. The most common systemic adverse reactions reported after PNEUMOVAX 23 were as follows: asthenia/fatigue, myalgia and headache.

Regardless of age, the observed increase in post vaccination use of analgesics ( ≤ 13% in the revaccinees and ≤ 4% in the initial vaccinees) returned to baseline by day 5.

Post-Marketing Experience

The following list of adverse reactions includes those identified during post approval use of PNEUMOVAX 23. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or their causal relationship to product exposure.

General Disorders And Administration Site Conditions

Cellulitis Malaise
Fever ( > 102°F)
Warmth at the injection site
Decreased limb mobility
Peripheral edema in the injected extremity

Digestive System

Nausea
Vomiting

Hematologic/Lymphatic

Lymphadenitis
Lymphadenopathy
Thrombocytopenia in patients with stabilized idiopathic thrombocytopenic purpura³
Hemolytic anemia in patients who have had other hematologic disorders
Leukocytosis

Hypersensitivity Reactions Including

Anaphylactoid reactions
Serum Sickness
Angioneurotic edema

Musculoskeletal System

Arthralgia
Arthritis

Nervous System

Paresthesia
Radiculoneuropathy
Guillain-Barré syndrome
Febrile convulsion

Skin

Rash
Urticaria
Cellulitis-like reactions
Erythema multiforme

Investigations

Increased serum C-reactive protein