Prevnar Side Effects

Please note - some side effects for Prevnar may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Prevnar - for the Consumer

Prevnar

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Prevnar:

Decreased appetite; diarrhea; fever; redness, soreness, a lump, pain, or tenderness at the injection site.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

Prevnar Side Effects - for the Professional

Prevnar

Pre-Licensure Clinical Trial Experience

The majority of the safety experience with Prevnar® comes from the NCKP Efficacy Trial in which 17,066 infants received 55,352 doses of Prevnar®, along with other routine childhood vaccines through April 1998. The number of Prevnar® recipients in the safety analysis differs from the number included in the efficacy analysis due to the different lengths of follow-up for these study endpoints. Safety was monitored in this study using several modalities. Local reactions and systemic events occurring within 48 hours of each dose of vaccine were ascertained by scripted telephone interview on a randomly selected subset of approximately 3,000 children in each vaccine group. The rate of relatively rare events requiring medical attention was evaluated across all doses in all study participants using automated databases. Specifically, rates of hospitalizations within 3, 14, 30, and 60 days of immunization, and of emergency room visits within 3, 14, and 30 days of immunization were assessed and compared between vaccine groups for each diagnosis. Seizures within 3 and 30 days of immunization were ascertained across multiple settings (hospitalizations, emergency room or clinic visits, telephone interviews). Deaths and SIDS were ascertained through April 1999. Hospitalizations due to diabetes, autoimmune disorders, and blood disorders were ascertained through August 1999.

In Table 6 the rate of local reactions at the Prevnar® injection site is compared at each dose to the DTaP injection site in the same children.

Table 7 presents the rates of local reactions in previously unvaccinated older infants and children.

Table 8 presents the rate of systemic events observed in the efficacy study when Prevnar® was administered concomitantly with DTaP.

Table 9 presents results from a second study (Manufacturing Bridging Study) conducted at Northern California and Denver Kaiser sites, in which children were randomized to receive one of three lots of Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein), Prevnar®, with concomitant vaccines including DTaP, or the same concomitant vaccines alone. Information was ascertained by scripted telephone interview, as described above.

Fever (≥38.0°C) within 48 hours of a vaccine dose was reported by a greater proportion of subjects who received Prevnar®, compared to control (investigational meningococcal group C conjugate vaccine [MnCC]), after each dose when administered concurrently with DTP-HbOC or DTaP in the efficacy study. In the Manufacturing Bridging Study, fever within 48-72 hours was also reported more commonly after each dose compared to infants in the control group who received only recommended vaccines. When administered concurrently with DTaP in either study, fever rates among Prevnar® recipients ranged from 15% to 34%, and were greatest after the 2nd dose.

Table 10 presents the frequencies of systemic reactions in previously unvaccinated older infants and children.

Of the 17,066 subjects who received at least one dose of Prevnar® in the efficacy trial, there were 24 hospitalizations (for 29 diagnoses) within 3 days of a dose from October 1995 through April 1998. Diagnoses were as follows: bronchiolitis (5); congenital anomaly (4); elective procedure, UTI (3 each); acute gastroenteritis, asthma, pneumonia (2 each); aspiration, breath holding, influenza, inguinal hernia repair, otitis media, febrile seizure, viral syndrome, well child/reassurance (1 each). There were 162 visits to the emergency room (for 182 diagnoses) within 3 days of a dose from October 1995 through April 1998. Diagnoses were as follows: febrile illness (20); acute gastroenteritis (19); trauma, URI (16 each); otitis media (15); well child (13); irritable child, viral syndrome (10 each); rash (8); croup, pneumonia (6 each); poisoning/ingestion (5); asthma, bronchiolitis (4 each); febrile seizure, UTI (3 each); thrush, wheezing, breath holding, choking, conjunctivitis, inguinal hernia repair, pharyngitis (2 each); colic, colitis, congestive heart failure, elective procedure, hives, influenza, ingrown toenail, local swelling, roseola, sepsis (1 each).20,21

In the large-scale efficacy study, urticaria-like rash was reported in 0.4%-1.4% of children within 48 hours following immunization with Prevnar® administered concurrently with other routine childhood vaccines. Urticaria-like rash was reported in 1.3%-6% of children in the period from 3 to 14 days following immunization, and was most often reported following the fourth dose when it was administered concurrently with MMR vaccine. Based on limited data, it appears that children with urticaria-like rash after a dose of Prevnar® may be more likely to report urticaria-like rash following a subsequent dose of Prevnar®.

One case of a hypotonic-hyporesponsive episode (HHE) was reported in the efficacy study following Prevnar® and concurrent DTP vaccines in the study period from October 1995 through April 1998. Two additional cases of HHE were reported in four other studies and these also occurred in children who received Prevnar® concurrently with DTP vaccine.27,30

In the Kaiser efficacy study in which 17,066 children received a total of 55,352 doses of Prevnar® and 17,080 children received a total of 55,387 doses of the control vaccine (investigational meningococcal group C conjugate vaccine [MnCC]), seizures were reported in 8 Prevnar® recipients and 4 control vaccine recipients within 3 days of immunization from October 1995 through April 1998. Of the 8 Prevnar® recipients, 7 received concomitant DTP-containing vaccines and one received DTaP. Of the 4 control vaccine recipients, 3 received concomitant DTP-containing vaccines and one received DTaP.20,21 In the other 4 studies combined, in which 1,102 children were immunized with 3,347 doses of Prevnar® and 408 children were immunized with 1,310 doses of control vaccine (either investigational meningococcal group C conjugate vaccine [MnCC] or concurrent vaccines), there was one seizure event reported within 3 days of immunization.28 This subject received Prevnar® concurrent with DTaP vaccine.

Twelve deaths (5 SIDS and 7 with clear alternative cause) occurred among subjects receiving Prevnar®, of which 11 (4 SIDS and 7 with clear alternative cause) occurred in the Kaiser efficacy study from October 1995 until April 20, 1999. In comparison, 21 deaths (8 SIDS, 12 with clear alternative cause and one SIDS-like death in an older child), occurred in the control vaccine group during the same time period in the efficacy study.20,21,25 The number of SIDS deaths in the efficacy study from October 1995 until April 20, 1999 was similar to or lower than the age and season-adjusted expected rate from the California State data from 1995-1997 and are presented in Table 11.

In a review of all hospitalizations that occurred between October 1995 and August 1999 in the efficacy study for the specific diagnoses of aplastic anemia, autoimmune disease, autoimmune hemolytic anemia, diabetes mellitus, neutropenia, and thrombocytopenia, the numbers of such cases were equal to or less than the expected numbers based on the 1995 Kaiser Vaccine Safety Data Link (VSD) data set.

Overall, the safety of Prevnar® was evaluated in a total of five clinical studies in the US in which 18,168 infants and children received a total of 58,699 doses of vaccine at 2, 4, 6, and 12-15 months of age. In addition, the safety of Prevnar® was evaluated in 831 Finnish infants using the same schedule, and the overall safety profile was similar to that in US infants. The safety of Prevnar® was also evaluated in 560 children from 4 ancillary studies in the US who started immunization at 7 months to 9 years of age. Tables 12 and 13 summarize systemic reactogenicity data within 2 or 3 days across 4,748 subjects in US studies (3,848 infant doses and 997 toddler doses) for whom these data were collected and according to the pertussis vaccine administered concurrently.

With vaccines in general, including Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein), Prevnar®, it is not uncommon for patients to note within 48 to 72 hours at or around the injection site the following minor reactions: edema; pain or tenderness; redness, inflammation or skin discoloration; mass; or local hypersensitivity reaction. Such local reactions are usually self-limited and require no therapy.

As with other aluminum-containing vaccines, a nodule may occasionally be palpable at the injection site for several weeks.40

Postmarketing Experience

In addition to reports in clinical trials, the following adverse events have been reported since market introduction of Prevnar® worldwide. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to the vaccine. The following adverse events were included based on strength of causal association, severity, or frequency of reporting for Prevnar®.

Administration site conditions: injection site dermatitis, injection site urticaria, injection site pruritus

Blood and lymphatic system disorders: lymphadenopathy localized to the region of the injection site

Immune system disorders: hypersensitivity reaction including face edema, dyspnea, bronchospasm; anaphylactic/anaphylactoid reaction including shock

Psychiatric disorders: crying

Skin and subcutaneous tissue disorders: angioneurotic edema, erythema multiforme

Respiratory: apnea

Postmarketing Observational Safety Surveillance Study

Safety outcomes were evaluated in an observational study that included 65,927 infants. Primary safety outcomes analyses included an evaluation of pre-defined adverse events occurring in temporal relationship to immunization. Rates of adverse events occurring within various time periods post-vaccination (e.g., 0-2, 0-7, 0-14, 0-30 days) were compared to the rates of those events occurring within a control time window (i.e., 31-60 days). Secondary safety outcomes analyses included comparisons to a historical control population of infants (1995-1996, N=40,223) prior to the introduction of Prevnar®. In addition, the study included extended follow-up of subjects originally enrolled in the NCKP efficacy trial (N=37,866).

The primary safety outcomes analyses did not demonstrate a consistently elevated risk of healthcare utilization for croup, gastroenteritis, allergic reactions, seizures, wheezing diagnoses, or breath-holding across doses, health care settings, or multiple time windows. As in pre-licensure trials, fever was associated with Prevnar® administration. In analyses of secondary safety outcomes, the adjusted relative risk of hospitalization for reactive airways disease was 1.23 (95% CI: 1.11, 1.35). Potential confounders, such as differences in concomitantly administered vaccines, yearly variation in respiratory infections, or secular trends in reactive airways disease incidence, could not be controlled. Extended follow-up of subjects originally enrolled in the NCKP efficacy trial revealed no increased risk of reactive airways disease among Prevnar® recipients. In general, the study results support the previously described safety profile of Prevnar®.41,42

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