ERVEBO Vaccine Description
ERVEBO, Ebola Zaire Vaccine, Live, formerly known as V920, is a recombinant, replication-competent Ebola vaccine, consisting of a vesicular stomatitis virus (VSV), which has been genetically engineered to express a glycoprotein from the Zaire ebolavirus so as to provoke a neutralizing immune response to the Ebola virus.
ERVEBO's active ingredient is live Vesicular Stomatitis Virus, in which its surface protein has been replaced with that of Zaire ebolavirus. Inactive ingredients include recombinant human serum albumin, tromethamine (Tris) buffer. This vaccine contains a trace amount of rice protein.
The U.S. FDA granted this application Priority Review and a Tropical Disease Priority Review Voucher on September 17, 2019. The FDA also granted Breakthrough Therapy designation for Ervebo to facilitate the development and scientific evaluation of the vaccine.
On December 19, 2019, the FDA announced today the approval of Ervebo, the first FDA-approved vaccine for the prevention of Ebola virus disease (EVD), caused by Zaire ebolavirus in individuals 18 years of age and older.
Merck announced on February 15, 2020, that 4 African countries, including the Democratic Republic of the Congo, Burundi, Ghana, and Zambia, have approved the use of ERVEBO.
Since the beginning of the ERVEBO vaccination program in central Africa in 2019, approximately 260,000 persons have been vaccinated with the Ervebo vaccine. Merck is working to initiate the manufacturing of licensed vaccine doses and expects these doses to start becoming available in approximately the 3rd quarter of 2020.
After getting vaccinated, you should continue to protect yourself from being exposed to the Ebola virus, as Ervebo might not protect everyone who gets the vaccine.
Merck & Co. Inc. licensed the global R&D and manufacturing rights from Newlink Genetics Corp.'s phase I Ebola vaccine in 2014. The Public Health Agency of Canada, which originally developed the vaccine, retained noncommercial rights in the agreement.
The Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM-CBRN) helped provide a test that allowed Merck to test human and non-human primate samples. Comparing the two samples is part of the FDA’s requirements for licensure.
ERVEBO Vaccine Indication
The ERVEBO vaccine is indicated for the prevention of disease caused by Zaire ebolavirus in individuals 18 years of age and older. 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.
People cannot get the Ebola virus disease from the Ervebo vaccine.
Ebola cases are very rare in the U.S., and those that have occurred have been the result of infections acquired by individuals in other countries who then traveled to the U.S., or health care workers who became ill after treating patients with EVD.
Ebola virus can be detected in blood after the onset of symptoms. It may take up to 3 days after symptoms start for the virus to reach detectable levels. The CDC’s new Health Alert recommends that Ebola virus testing be conducted only for people who have an epidemiologic risk factor within 21 days of symptom onset and who have an Ebola compatible clinical syndrome.
Following vaccination with the ERVEBO vaccine, 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.
Polymerase chain reaction (PCR) is one of the most commonly used diagnostic methods because of its ability to detect low levels of the Ebola virus, says the CDC.
As of January 16, 2020, ERVEBO vaccines have been administered to over 260,000 people in Africa.
ERVEBO Vaccine Dosage
The ERVEBO vaccine is administered as a single-dose intramuscular injection. You will get this vaccine as an injection at the top of your arm.
Merck says '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.' And, the safety and effectiveness of ERVEBO have not been assessed in immunocompromised individuals.
And, there are no adequate and well-controlled studies of ERVEBO in pregnant women, and human data available from clinical trials with ERVEBO are insufficient to establish the presence or absence of vaccine-associated risk during pregnancy. The decision to vaccinate a woman who is pregnant should consider the woman’s risk of exposure to Zaire ebolavirus.
Furthermore, previous clinical studies of ERVEBO did not include sufficient numbers of subjects 65 years of age and older to determine whether they respond differently from younger subjects.
Ervebo Vaccine News
May 26, 2020 - Merck and IAVI announced a collaboration to develop an investigational vaccine targeted against the SARS-CoV-2 coronavirus. This vaccine candidate will use the recombinant vesicular stomatitis virus (rVSV) technology that is the basis for Merck’s Ebola Zaire virus vaccine, ERVEBO, which was the first rVSV vaccine approved for use in humans.
May 6, 2020 - The Lancet: Pregnancy and breastfeeding in the context of Ebola: a systematic review.
February 14, 2020 - Merck confirmed that four African countries, including the Democratic Republic of the Congo (DRC), have approved the ERVEBO vaccine. ERVEBO has now been registered by National Health Authorities in the following countries in Africa – DRC, Burundi, Ghana, and Zambia. Approvals in additional countries in Africa are anticipated in the near future, said Merck. As previously announced, Merck is working to initiate the manufacturing of licensed doses and expects these doses to start becoming available in approximately the third quarter of 2020.
December 19, 2019 - The U.S. Food and Drug Administration announced today the approval of Ervebo, the first FDA-approved vaccine for the prevention of Ebola virus disease (EVD), caused by Zaire ebolavirus in individuals 18 years of age and older. Ervebo was determined to be 100% effective in preventing Ebola cases with symptom onset greater than 10 days after vaccination. No cases of EVD with symptom onset greater than 10 days after vaccination were observed in the “immediate” cluster group, compared with 10 cases of EVD in the 21-day “delayed” cluster group.
November 14, 2019 - The FDA granted Priority Review and a Tropical Disease Priority Review Voucher and also granted Breakthrough Therapy designation for the Ervebo vaccine.
November 11, 2019 - The European Commission announced the granting of marketing authorization to Merck Sharp & Dohme B.V. for its Ebola Zaire vaccine. This announcement follows the recommendation from the European Medicines Agency (EMA), which has assessed the benefits and risks of the vaccine. Formally known as v920 (rVSVΔG-ZEBOV-GP), Ervebo is a recombinant, replication-competent Ebola vaccine, consisting of a vesicular stomatitis virus (VSV), which has been genetically engineered to express a glycoprotein from the Zaire ebolavirus, so as to provoke a neutralizing immune response to the Ebola virus.
October 18, 2019 - The EMA’s human medicines committee (CHMP) has recommended granting a conditional marketing authorization in the European Union for Ervebo V920 (rVSVΔG-ZEBOV-GP),
July 10, 2019 - The DRC’s Minister of Health decided that ‘due to the lack of sufficient scientific evidence on the efficacy and safety of other Ebola vaccine candidates, as well as the risk of confusion among the population, it was decided that no additional clinical vaccine trials will be allowed throughout the country.’ Which means, Merck's V920 will be the only Ebola Vaccine available in the DRC.
May 23, 2019 - The Ethics Committee of the School of Public Health of the University of Kinshasa approved the amendment of the compassionate belt vaccination protocol for the rVSV-ZEBOV vaccine aimed at expanding the targets pregnant women after the first trimester and lactating women identified as contacts. For minors, it is maintained that children can be vaccinated from the age of 6 years. Between 26 November 2018 and 26 May 2019, 319 pregnant women and 603 lactating women registered as contacts could not be vaccinated.
July 25, 2016 - Merck announced two regulatory milestones for the company’s investigational vaccine for Ebola Zaire, V920 (rVSV∆G-ZEBOV-GP, live attenuated): the U.S. Food and Drug Administration has granted the vaccine candidate Breakthrough Therapy Designation, and the European Medicines Agency has granted PRIME status.
December 23, 2015 - Merck announced that the application for Emergency Use Assessment and Listing (EUAL) for the company’s investigational Ebola Zaire vaccine, V920 (rVSV∆G-ZEBOV-GP, live attenuated), has been accepted for review by the World Health Organization.
Ervebo Vaccine Clinical Trails
Clinical Trial NCT02503202 Phase 3: Evaluation of the Safety and Immunogenicity of Three Consistency Lots and a High-Dose Lot of rVSV-ZEBOV-GP (V920 Ebola Vaccine) in Healthy Adults (V920-012)
- This Phase 3 study evaluated the safety and immunogenicity of 3 consistency lots and a high-dose lot of rVSV-ZEBOV-GP (V920 Ebola Vaccine) in healthy adults. The primary purpose of this study was to demonstrate consistency in the immune responses of participants receiving 3 separate lots of V920 through 28 days postvaccination. In addition to the 3 lot groups, a high-dose group and a placebo group were studied. A subset of participants representative of all treatment groups continued through 24 months postvaccination in the extension study for the evaluation of long-term safety. The primary hypothesis states that the geometric mean titer of anti-Zaire ebolavirus envelope (ZEBOV) glycoprotein antibody at 28 days postvaccination is equivalent across the three consistency lots.
Clinical Trial NCT03031912 Phase 2: African-Canadian Study of HIV-Infected Adults and a Vaccine for Ebola - ACHIV-Ebola
- This Phase 2 study s a randomized, placebo-controlled, multi-site, double-blind trial of V920 (rVSVΔG-ZEBOV-GP) Ebola Virus vaccine candidate in subjects with HIV infection to be conducted in conformance with Good Clinical Practices. The study will take place at 2 Canadian sites (Centre Hospitalier de l'Université de Montréal and Ottawa General Hospital) and 2 African sites (Centre MURAZ, Burkina Faso and Centre Hospitalier National Aristide Le Dantec, Dakar, Senegal).
Clinical Trial NCT02314923: Placebo-Controlled, Dose-Response, Safety and Immunogenicity Study of Vesicular Stomatitis Virus (VSV) Ebola Vaccine in Healthy Adults (V920-004)
- This is a Phase 1 safety and tolerability study to evaluate a novel vaccine to Ebola using a live replicating vesicular stomatitis virus (VSV) replacing the gene encoding the G envelope glycoprotein with the gene encoding the envelope glycoprotein from the Zaire strain of Ebola (VSVΔG-ZEBOV also known as BPSC-1001).