Drug Detail:Ervebo (intramuscular) (Ebola zaire vaccine, live [ ee-bow-luh-zaa-eer-vak-seen, lyve ])
Drug Class:
Highlights of Prescribing Information
ERVEBO® (Ebola Zaire Vaccine, Live) Suspension for intramuscular injection
Initial U.S. Approval: 2019
Recent Major Changes
| Indications and Usage (1) | 07/2023 |
Indications and Usage for Ervebo
ERVEBO® is a vaccine indicated for the prevention of disease caused by Zaire ebolavirus in individuals 12 months of age and older. (1)
Limitations of Use (1.1)
- The duration of protection conferred by ERVEBO is unknown.
- ERVEBO does not protect against other species of Ebolavirus or Marburgvirus.
- Effectiveness of the vaccine when administered concurrently with antiviral medication, immune globulin (IG), and/or blood or plasma transfusions is unknown.
Ervebo Dosage and Administration
- Administer a single 1 mL dose of ERVEBO intramuscularly. (2.1)
Dosage Forms and Strengths
- 1 mL suspension for injection supplied as a single-dose vial. (3)
Contraindications
- Severe allergic reaction (e.g., anaphylaxis) to any component of ERVEBO. (4)
Warnings and Precautions
- Anaphylaxis has been observed following administration of ERVEBO. Appropriate medical treatment and supervision must be available in case of anaphylactic event following the administration of ERVEBO. (5.1)
- Vaccinated individuals should continue to adhere to infection control practices to prevent Zaire ebolavirus infection and transmission. (5.2)
- Vaccine virus RNA has been detected in blood, saliva, urine, and fluid from skin vesicles of vaccinated individuals; transmission of vaccine virus is a theoretical possibility. (5.4)
Adverse Reactions/Side Effects
The most commonly reported local and systemic adverse events in clinical trials were:
- Individuals 18 years of age and older: injection-site pain (70%); headache (55%); feverishness (39%); muscle pain (33%); somnolence, reduced activity, fatigue (26%); joint pain, arthralgia (19%); chills (17%); injection-site swelling (17%); decreased appetite (15%); abdominal pain (13%); injection-site redness (12%); nausea (10%); arthritis (5%); vomiting (4%), rash (4%); abnormal sweating (3%) and mouth ulceration (2%). (6.1)
- Individuals 12 months through 2 years of age: feverishness (83%); crying (31%); decreased appetite (27%); injection-site pain (26%); somnolence, reduced activity, fatigue (20%); diarrhea (19%); vomiting (17%); irritability (11%); screaming (10%); mouth ulceration (6%); chills (5%); injection-site swelling (5%); headache (4%); abdominal pain (2%); abnormal sweating (2%) and injection-site erythema (1%). (6.1)
- Individuals 3 years through 11 years of age: feverishness (65%); headache (50%); injection-site pain (40%); decreased appetite (24%); somnolence, reduced activity, fatigue (22%); abdominal pain (21%); chills (14%); myalgia (12%); vomiting (11%);dizziness (8%); nausea (8%); injection-site pruritus (7%); crying (3%); arthralgia (3%); diarrhea (3%); injection-site swelling (3%); abnormal sweating (1%); mouth ulceration (2%) and irritability (1%). (6.1)
- Individuals 12 years through 17 years of age: headache (59%); injection-site pain (52%); feverishness (48%); myalgia (30%); somnolence, reduced activity, fatigue (28%); decreased appetite (21%); chills (19%); dizziness (17%); abdominal pain (16%); arthralgia (16%); nausea (8%); abnormal sweating (5%); diarrhea (4%); vomiting (4%); injection-site pruritus (3%); injection-site swelling (3%) and mouth ulceration (2%). (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme LLC at 1-877-888-4231 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 7/2023
Full Prescribing Information
1. Indications and Usage for Ervebo
ERVEBO® is indicated for the prevention of disease caused by Zaire ebolavirus in individuals 12 months of age and older.
1.1 Limitations of Use
- The duration of protection conferred by ERVEBO is unknown.
- ERVEBO does not protect against other species of Ebolavirus or Marburgvirus.
- Effectiveness of the vaccine when administered concurrently with antiviral medication, immune globulin (IG), and/or blood or plasma transfusions is unknown.
2. Ervebo Dosage and Administration
FOR INTRAMUSCULAR ADMINISTRATION ONLY.
2.2 Preparation
Thaw vial at room temperature until no visible ice is present. Do not thaw the vial in a refrigerator. Gently invert vial several times. The vaccine is a colorless to slightly brownish-yellow liquid with no particulates visible. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either of these conditions exist, discard the vial.
Use the vaccine immediately after thawing. If not used immediately, the vaccine may be stored for 4 hours at room temperature (up to 25°C; 77°F) protected from light. DO NOT REFREEZE [see How Supplied/Storage and Handling (16)].
Withdraw the 1 mL dose of vaccine from the vial using a sterile needle and sterile syringe.
3. Dosage Forms and Strengths
ERVEBO is a suspension for injection supplied as a 1 mL dose in single-dose vials.
4. Contraindications
Do not administer ERVEBO to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine, including rice protein [see Description (11)].
5. Warnings and Precautions
5.1 Management of Acute Allergic Reactions
Among 18,616 participants vaccinated with at least one dose of ERVEBO in clinical trials, there were two reports of anaphylaxis [see Adverse Reactions (6.1)]. Monitor individuals for signs and symptoms of hypersensitivity reactions following vaccination with ERVEBO. Appropriate medical treatment and supervision must be available in case of an anaphylactic event following the administration of ERVEBO.
5.2 Limitations of Vaccine Effectiveness
Vaccination with ERVEBO may not protect all individuals. Vaccinated individuals should continue to adhere to infection control practices to prevent Zaire ebolavirus infection and transmission.
5.3 Immunocompromised Individuals
The safety and effectiveness of ERVEBO have not been assessed in immunocompromised individuals. The effectiveness of ERVEBO in immunocompromised individuals may be diminished. The risk of vaccination with ERVEBO, a live virus vaccine, in immunocompromised individuals should be weighed against the risk of disease due to Zaire ebolavirus.
6. Adverse Reactions/Side Effects
6.1 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.
The clinical development program for ERVEBO included clinical studies conducted in North America, Europe and Africa, in which 609 participants 12 months through 17 years of age and 18,007 participants 18 years of age and older received at least one dose of ERVEBO. The number of participants vaccinated with ERVEBO in double-blind, placebo-controlled trials was 2,913 and in open-label trials was 15,703.
In Study 1 (NCT02344407), conducted in Liberia (N=1,000), participants 18 years of age and older were randomized 1:1 to receive ERVEBO or saline placebo. Participants were assessed at Week 1 and Month 1 postvaccination for solicited local and systemic reactions. In a subset of participants (n=201), joint symptoms and signs were also solicited during a Week 2 visit. Memory aids were not used and postvaccination temperatures were measured only at study visits. Unsolicited adverse events were collected through Month 1 postvaccination. The median age of participants was 29 years, 63.6% were male and 100% were Black. Serious adverse events were monitored through 1-year postvaccination.
In Study 2 (NCT02503202), conducted in the United States, Canada and Spain (N=1,197), participants 18 through 65 years of age were randomized to receive ERVEBO (n=1,061) or saline placebo (n=133). Participants used a memory aid to record solicited local reactions from Days 1 to 5 postvaccination, and daily temperature measurements and solicited joint and skin events from Days 1 to 42 postvaccination. Unsolicited adverse reactions were collected through Day 42 postvaccination. The median age of participants was 42 years; 46.8% were male; 67.9% were White, 29.2% were Black or African American, 1.4% were Multi-racial, 0.8% were Asian, 0.4% were American Indian or Alaska Native, and 0.3% were Native Hawaiian or Pacific Islander; 14.5% were Hispanic or Latino. Serious adverse events were monitored through 6 months postvaccination, and a subset of participants (n=511) were monitored through 24 months postvaccination.
In Study 3 (Pan African Clinical Trials Registry, PACTR201503001057193), an open-label cluster-randomized study conducted in the Republic of Guinea, 5,643 participants 18 years of age and older received a dose of ERVEBO. The median age of vaccinated participants was 37 years, 68% were male and 100% were Black. Serious adverse events were monitored through 84 days postvaccination.
In Study 4 (NCT02378753), a randomized open-label study conducted in Sierra Leone, 7,998 participants 18 years of age and older received a dose of ERVEBO. The median age of participants was 31 years, 63% were male; 99.8% were Black and 0.2% collectively were Multi-racial, Asian or White. Serious adverse events were monitored through 180 days postvaccination.
In Study 5 (Pan African Clinical Trials Registry, PACTR201503001057193), an open-label safety and immunogenicity trial conducted in vaccinated frontline workers in the Republic of Guinea, implemented as Part B of Study 3, 2,016 participants 18 years of age and older received a dose of ERVEBO. The median age of vaccinated participants was 30 years, 75% were male and 100% were Black. Serious adverse events were monitored through 85 days postvaccination.
Study 6 (NCT02876328) is an ongoing, double-blind, randomized placebo-controlled study conducted in Liberia, Sierra Leone, Mali and the Republic of Guinea in which participants received ERVEBO or an investigational Ebola vaccine or placebo. A total of 155 participants 12 months through 2 years of age, 515 participants 3 through 11 years of age, 328 participants 12 through 17 years of age and 1,004 participants 18 years of age and older received a single dose of ERVEBO and saline placebo administered 56 days apart, or two doses of ERVEBO administered 56 days apart (not an approved dosing regimen), or two doses of saline placebo. Memory aids were not used. Participants were observed at the study site for 30 minutes after vaccination. Participants were assessed for solicited local and systemic reactions at study visits on day of vaccination (Day 0), Day 7, Day 14 and Day 28 after each vaccination. Postvaccination temperatures were obtained from participants 12 months through 17 years of age at daily contacts on Days 1 through 7, and on Day 14 and Day 28 after the first vaccination and Days 1 through 7 after the second vaccination. Postvaccination temperatures were obtained from participants 18 years of age and older at study visits. At each study visit, participants or their caregivers were queried about the occurrence of unsolicited adverse events. In this study, Grade 3 events were defined as symptoms causing inability to perform usual social and functional activities. Grade 4 events were defined as symptoms causing inability to perform basic self-care functions or medical or operative intervention indicated to prevent permanent impairment, persistent disability, or death. The median age of participants 18 years of age and older was 27 years and 54.6% were male, and the median age of participants 12 months through 17 years of age was 8 years and 54.7% were male. Serious adverse events were monitored through 12 months postvaccination.
Eight additional studies (NCT02269423, NCT02280408, NCT02374385, NCT02314923, NCT02287480, NCT02283099, NCT02296983) contributed to the assessment of serious adverse reactions.
Adverse Reactions in Participants 18 Years of Age and Older
Table 1 presents the proportion of participants reporting solicited adverse reactions in Study 1.
| ERVEBO % | PLACEBO % |
|
|---|---|---|
|
||
| Injection-site reactions* | N=500 | N=500 |
| Injection site pain | 34.0 | 11.2 |
| Local reactions (redness/swelling) | 1.8 | 0.8 |
| Systemic adverse reactions† | N=498 | N=499 |
| Headache | 36.9 | 23.2 |
| Feverishness | 34.3 | 14.8 |
| Muscle pain | 32.5 | 22.8 |
| Fatigue | 18.5 | 13.4 |
| Nausea | 8.0 | 4.4 |
| Joint pain/tenderness‡ | 7.0 | 5.8 |
| Rash | 3.6 | 3.2 |
| Abnormal sweating | 3.2 | 2.6 |
| Arthropathy (joint redness/warmth)‡ | 0.6 | 0.2 |
| Joint swelling‡ | 0.4 | 0.4 |
| Joint stiffness‡ | 0.4 | 0.2 |
In Study 1, 56.4% of participants reported at least one of the solicited systemic adverse reactions listed in Table 1 within seven days after vaccination. With the exception of one participant who reported events of moderate intensity (causing greater than minimal interference with daily activity), all others reported events of mild intensity (causing no or minimal interference with daily activity).
Table 2 presents the proportion of participants 18 years of age and older reporting solicited adverse reactions in Study 2.
| ERVEBO % | PLACEBO % |
|
|---|---|---|
|
||
| Injection-site reactions* | N=1051 | N=133 |
| Injection-site pain | 69.5 | 12.8 |
| Injection-site swelling | 16.5 | 3.0 |
| Injection-site redness | 11.9 | 1.5 |
| Systemic adverse reactions† | N=1051 | N=133 |
| Joint pain | 17.9 | 3.0 |
| Arthritis (composite term)‡ | 4.7 | 0.0 |
| Rash (composite term)§ | 3.8 | 1.5 |
| Vesicular lesions¶ | 1.5 | 0.0 |
In Study 2, 29 participants (2.8%) reported injection-site pain of severe intensity. Severe arthritis (arthritis and joint swelling) was reported by 8 participants (0.8%) and severe arthralgia was reported by 14 participants (1.3%). In this study, severe events were defined as incapacitating with inability to work or do usual activity.
Table 3 presents the proportion of participants 18 years of age and older reporting solicited adverse reactions in Study 6 within 28 days following administration of the first dose.
| ERVEBO
% | PLACEBO
% |
|
|---|---|---|
|
||
| Injection-site reactions* | N=592 | N=412 |
| Injection-site pain | 21.5 | 4.1 |
| Injection-site swelling | 3.7 | 2.9 |
| Injection-site erythema | 1.4 | 2.4 |
| Systemic adverse reactions* | N=592 | N=412 |
| Headache | 55.1 | 43.4 |
| Feverishness† | 39.2 | 22.8 |
| Myalgia | 29.6 | 15.8 |
| Somnolence‡ | 25.5 | 13.6 |
| Arthralgia | 18.6 | 10.7 |
| Chills | 16.7 | 8.5 |
| Decreased appetite | 15.2 | 9.5 |
| Abdominal pain | 13.0 | 11.2 |
| Nausea | 9.5 | 6.3 |
| Vomiting | 4.4 | 1.2 |
| Mouth ulceration | 2.2 | 0.5 |
| Abnormal sweating | 1.4 | 1.0 |
| Joint swelling | 0.7 | 0.0 |
Most (>98%) reactions presented in Table 3 were mild to moderate in intensity.
Adverse Reactions in Participants 12 Months through 17 Years of Age
Table 4 presents the proportion of participants reporting solicited adverse reactions within 28 days following administration of the first dose in Study 6.
| 12 Months through 2 Years of Age | 3 Years through 11 Years of Age | 12 Years through 17 Years of Age | ||||
|---|---|---|---|---|---|---|
| ERVEBO
% N=95 | PLACEBO
% N=60 | ERVEBO %
N=310 | PLACEBO
% N=205 | ERVEBO %
N=203 | PLACEBO
% N=123 |
|
| N/A: Not applicable because not assessed in this age group. | ||||||
|
||||||
| Injection-site reactions* | ||||||
| Injection-site pain | 26.3 | 8.3 | 39.4 | 8.8 | 52.2 | 17.1 |
| Injection-site swelling | 5.3 | 3.3 | 2.6 | 2.0 | 2.5 | 2.4 |
| Injection-site erythema | 1.1 | 3.3 | 0.3 | 0.5 | 0.5 | 0 |
| Injection-site pruritus | N/A | N/A | 6.5 | 0 | 2.5 | 0.8 |
| Systemic adverse reactions* | ||||||
| Feverishness† | 83.2 | 66.7 | 64.8 | 37.1 | 48.3 | 27.6 |
| Crying | 30.5 | 6.7 | 3.2 | 2.4 | N/A | N/A |
| Decreased appetite | 27.4 | 15.0 | 23.9 | 13.2 | 20.7 | 14.6 |
| Somnolence‡ | 20.0 | 8.3 | 21.6 | 9.8 | 28.1 | 19.5 |
| Diarrhea | 18.9 | 16.7 | 2.9 | 4.4 | 3.9 | 4.1 |
| Vomiting | 16.8 | 10.0 | 11.0 | 8.8 | 3.9 | 3.3 |
| Irritability | 10.5 | 1.7 | 1.0 | 0.0 | N/A | N/A |
| Screaming | 9.5 | 1.7 | 0.6 | 0.5 | N/A | N/A |
| Mouth ulceration | 6.3 | 1.7 | 1.9 | 0.5 | 1.5 | 0 |
| Chills | 5.3 | 3.3 | 14.2 | 10.7 | 19.2 | 16.3 |
| Headache | 4.2 | 5.0 | 49.7 | 34.6 | 59.1 | 39.0 |
| Abdominal pain | 2.1 | 3.3 | 21.0 | 14.1 | 15.8 | 13.0 |
| Abnormal sweating | 2.1 | 3.3 | 1.3 | 2.0 | 4.9 | 0.8 |
| Arthralgia | N/A | N/A | 3.2 | 2.0 | 15.8 | 8.1 |
| Dizziness | N/A | N/A | 8.4 | 4.4 | 16.7 | 11.4 |
| Myalgia | N/A | N/A | 11.6 | 3.9 | 29.6 | 9.8 |
| Nausea | 0 | 1.7 | 8.4 | 3.4 | 8.4 | 8.1 |
Most (>98%) reactions presented in Table 4 were mild to moderate in intensity.
Table 5 presents the proportion of participants 12 months through 17 years of age reporting fever within 7 days following administration of the first dose in Study 6.
| Age | Maximum Temperature
(Temporal) | ERVEBO
% | PLACEBO
% |
|---|---|---|---|
|
|||
| 12 Months through 2 Years of Age |
≥38.0°C to ≤38.4°C >38.4°C to ≤38.9°C >38.9°C to ≤40.0°C >40.0°C | N=95
3.2 3.2 0.0 0.0 | N=60
1.7 1.7 1.7 0.0 |
| 3 Years through 11 Years of Age |
≥38.0°C to ≤38.4°C >38.4°C to ≤38.9°C >38.9°C to ≤40.0°C >40.0°C | N=310
4.2 1.0 1.3 0.0 | N=205
0.5 1.5 0.0 0.0 |
| 12 Years through 17 Years of Age |
≥38.0°C to ≤38.4°C >38.4°C to ≤38.9°C >38.9°C to ≤40.0°C >40.0°C | N=203
2.5 2.5 2.5 0.0 | N=122
0.8 0.8 0.8 0.0 |
7. Drug Interactions
7.1 Interference with Laboratory Tests
Following vaccination with ERVEBO, individuals may test positive for anti-Ebola glycoprotein (GP) antibody and/or Ebola GP nucleic acid or antigens. GP-based testing may have limited diagnostic value during the period of vaccine viremia, in the presence of vaccine-derived Ebola GP, and following antibody response to the vaccine [see Pharmacokinetics (12.3)].
8. Use In Specific Populations
8.1 Pregnancy
Data
Animal Data
In a developmental toxicity study, female rats received a single human dose of ERVEBO by intramuscular injection on four occasions: 28 days and 7 days prior to mating, gestation day 6 and lactation day 7. No adverse effects on pre-weaning development up to post-natal day 21 were observed. There were no vaccine-related fetal malformations or variations observed.
8.4 Pediatric Use
The safety and effectiveness of ERVEBO in individuals 12 months through 17 years of age have been established [see Adverse Reactions (6.1) and Clinical Studies (14.2)]. The safety and effectiveness of ERVEBO in individuals younger than 12 months of age have not been established.
8.5 Geriatric Use
Across the clinical development program, the total number of participants ≥65 years of age who received at least one dose of ERVEBO was 554.
Clinical studies of ERVEBO did not include sufficient numbers of participants 65 years of age and older to determine whether they respond differently from younger participants.
11. Ervebo Description
ERVEBO (Ebola Zaire Vaccine, Live) is a sterile suspension for intramuscular injection. ERVEBO is a live recombinant viral vaccine consisting of a vesicular stomatitis virus (VSV) backbone deleted for the VSV envelope glycoprotein and substituted with the envelope glycoprotein of the Zaire ebolavirus (Kikwit 1995 strain). The vaccine virus is grown in serum-free Vero cell cultures. The virus is harvested from the cell culture medium, purified, formulated with stabilizer solution, filled into vials and stored frozen. When thawed, ERVEBO is a colorless to slightly brownish-yellow liquid with no particulates visible.
Each 1 mL dose of ERVEBO contains a minimum of 72 million plaque forming units (pfu) of vaccine virus in a stabilizer solution containing 10 mM Tromethamine (Tris) and 2.5 mg/mL rice-derived recombinant human serum albumin. Each 1 mL dose may contain residual amounts of host cell DNA (≤10 ng) and benzonase (≤15 ng). The vaccine may contain trace amounts of rice protein. The product contains no preservatives.
The vaccine vial stopper is not made with natural rubber latex.
12. Ervebo - Clinical Pharmacology
12.1 Mechanism of Action
Immunization with ERVEBO results in an immune response and protection from disease caused by Zaire ebolavirus. The relative contributions of innate, humoral and cell-mediated immunity to protection from Zaire ebolavirus are unknown.
14. Clinical Studies
14.1 Clinical Efficacy
Clinical efficacy of ERVEBO was assessed in Study 3.
Study 3 (Ring vaccination study) was an open-label, randomized cluster (ring) vaccination study conducted in the Republic of Guinea during the 2014 outbreak. Each cluster was composed of contacts and contacts of contacts of individuals with laboratory-confirmed Ebola virus disease (EVD). Clusters were randomized to receive either an "immediate" vaccination or a 21-day "delayed" vaccination. In the primary efficacy analysis, 3,537 participants ≥18 years of age were considered contacts and contacts of contacts of an index case with laboratory-confirmed EVD. Of these, 2,108 were included in 51 immediate vaccination clusters, and 1,429 were included in 46 delayed vaccination clusters.
The median age of participants in the primary efficacy analysis was 40 years. The majority were male, comprising 70.4% and 70.3% in the randomized immediate and delayed clusters, respectively.
In the primary efficacy analysis, the number of cases of laboratory-confirmed EVD in participants vaccinated in immediate vaccination clusters was compared to the number of cases in participants in delayed vaccination clusters. Cases of EVD that occurred between Day 10 and Day 31 post-randomization of the cluster were included in the analysis. Vaccine efficacy was 100% (95% CI: 63.5% to 100%); no cases of confirmed EVD were observed in the immediate vaccination clusters, and 10 confirmed cases of EVD were observed in a total of 4 delayed vaccination clusters between Day 10 and Day 31 post-randomization.
14.2 Clinical Immunogenicity
A measure of the immune response that confers protection against EVD is unknown.
Clinical Immunogenicity in Individuals 18 Years of Age and Older Across Geographic Areas
Four studies assessed antibody responses to ERVEBO in participants 18 years of age and older (Study 1, Study 2, Study 4 and Study 5), including 477 participants in Liberia, 506 participants in Sierra Leone, 915 participants in the US, Canada, and Spain (n=865 US participants) and 1,217 participants in the Republic of Guinea. Zaire ebolavirus (Kikwit) GP-specific immunoglobulin G (IgG) was detected by enzyme linked immunosorbent assay (GP-ELISA). Vaccine virus neutralizing antibody was detected by a plaque reduction neutralization test (PRNT).
Antibody responses among participants in the study conducted in the US, Canada, and Spain (Study 2) were similar to those among participants in the studies conducted in Liberia (Study 1), Sierra Leone (Study 4) and the Republic of Guinea (Study 5).
Clinical Immunogenicity in Individuals 12 Months through 17 Years of Age
A fifth study (Study 6) conducted in Liberia, Sierra Leone, Mali and the Republic of Guinea assessed antibody geometric mean titers (GMT) to ERVEBO in 386 participants 12 months through 17 years of age compared to 386 participants 18 years of age and older. Zaire ebolavirus (Kikwit) GP-specific immunoglobulin G (IgG) was detected by enzyme linked immunosorbent assay (GP-ELISA). GMTs at Day 28 after vaccination with ERVEBO in participants 12 months through 17 years of age were non-inferior to those in participants 18 years of age and older (see Table 6).
| Individuals 12 Months through 17 Years of Age n=499 | Individuals 18 Years of Age and Older n=519 | GMT ratio* (95% CI) |
|---|---|---|
| The Per-Protocol Immunogenicity Population was the primary population for the immunogenicity analyses in Study 6 and includes all vaccinated participants with serology data who were compliant with the protocol and had a serum sample collected within an acceptable day range. n=Number of participants contributing to the analysis. CI=Confidence interval; GMT=geometric mean titer; GP-ELISA=glycoprotein enzyme-linked immunosorbent assay. Study 6 used gamma irradiation of specimens to reduce risk of wild-type Ebola virus infection of laboratory workers. |
||
|
||
| GMT (95% CI) | GMT (95% CI) | 1.42 (1.24, 1.62) |
| 1748.8 (1585.6, 1928.7) | 1234.4 (1132.5, 1345.4) | |
17. Patient Counseling Information
Advise the vaccine recipients, parents or guardians to read the FDA-approved patient labeling (Patient Information).
Advise vaccine recipients, parents or guardians of the following:
- ERVEBO has not been demonstrated to provide protection against disease caused by viruses other than Zaire ebolavirus. After vaccination with ERVEBO, individuals at risk should continue to protect themselves from exposure to Zaire ebolavirus.
- ERVEBO may not protect all vaccinated individuals.
- Transmission of vaccine virus is a theoretical possibility. Vaccine virus RNA has been detected in blood, saliva, or urine for up to 14 days after vaccination. The duration of shedding is not known; however, samples taken 28 days after vaccination tested negative. Vaccine virus RNA has been detected in fluid from skin vesicles that appeared after vaccination.
Instruct vaccine recipients, parents or guardians to:
- Report any adverse reactions to their health care provider.
- Seek immediate medical attention if any signs or symptoms of a hypersensitivity reaction occur after vaccination [see Contraindications (4)].
| ERVEBO
zaire ebolavirus (strain kikwit-95) envelope glycoprotein injection, solution |
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
| Labeler - Merck Sharp & Dohme LLC (118446553) |
