Ebola Vaccines 2023
Ebola Vaccines 2023
The first wave of Ebola vaccine development focused on attempts to inactivate the ebolavirus that causes Ebola Virus Disease (EVD). Since 2014, Ebola vaccine candidate technologies have included replication-deficient adenovirus vectors, replication-competent vesicular stomatitis, human parainfluenza vectors, and virus-like nanoparticle preparations, says the World Health Organization (WHO). Ebolavirus, previously known as Ebola hemorrhagic fever, has six defined subtypes, says the WHO.
As of February 2, 2023, Zaire Ebola vaccines and antibody treatments remain in limited distribution in the U.S. Contact local or state health departments for availability requirements. On December 14, 2022, the peer-review New England Journal of Medicine (JAMA) published Orginal Research conducted by the PREVAC Study Team that concluded three Ebola Zaire vaccine regimens produced immune responses seen from day 14 through month 12. ClinicalTrials.gov number, NCT02876328; EudraCT numbers, 2017-001798-18 and 2017-001798-18/3rd; Pan African Clinical Trials Registry number, PACTR201712002760250.
Zaire Ebolavirus Vaccines 2023
Zaire Ebolavirus vaccines have been approved by the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), the WHO, and the U.K. since 2019. In addition, the U.S. Centers for Disease Control and Prevention (CDC) updated the Ebola VIS on June 30, 2022, and published the 'current state of Ebola vaccines on March 8, 2022.
Merck's Ervebo® vaccine
J&J's Zabdeno and Mvabea Ebola Vaccine Regimem
CanSinoBio's Ad5-EBOV vaccine
U.S. NIAID/NIH with Okairos produced cAd3-EBOZ/MVA-BN-Filo vaccine
Sudan Ebolavirus Vaccine Candidates 2023
The WHO Africa announced on January 11, 2023, there are no approved vaccines protecting people against SUDV. However, the WHO confirmed three candidate vaccines are being tested in human studies called the Solidarity Against Ebola or Tokomeza Ebola. the Republic of Uganda in 2023. SUDV vaccine candidates include, but are not limited to, the following vaccines:
biEBOV bivalent adenovirus vectored vaccine is conducting a phase 1 study (NCT05301504), last updated on November 2, 2022.
ChAd3-SUDV monovalent adenovirus vector vaccine is produced by the Sabin Vaccine Institute USA.
IAVI's rVSV Sudan ebolavirus vaccine candidate (rVSVΔG-SUDV-GP) is in preclinical research.
GeoVax Labs, Inc.'s vectored vaccine MVA-VLP-SUDV was generated against Sudan Ebolavirus. Data published on July 25, 2022, demonstrate single dose protection and potency of the MVA-VLP platform for use in emergencies to contain outbreaks.
Soligenix, Inc. is proposing the develop SuVax™, a single-vial, adjuvanted, heat-stable subunit vaccine to prevent filovirus infection for use in the event of a Sudan ebolavirus outbreak.
The Sabin Vaccine Institute is developing a single-dose vaccine candidate for Sudan Ebolavirus. The U.S. government will initially invest $35 million to produce up to 100,000 doses of ChAd3-SUDV. These vaccines may be used as part of ongoing U.S. preparedness efforts and in response to future global outbreaks.
Ebolavirus Human Monoclonal Antibody
The U.S. National Institutes of Health (NIH) says monoclonal antibodies (mAbs) are made in a laboratory to fight a particular infection and are administered during an infusion. mAbs are different than vaccines, says the NIH.
Approved Ebola mAbs included but are not limited to:
Ebanga (mAb114) is a human IgG1 MAb targeted to the Zaire ebolavirus glycoprotein, available in a lyophilized form. The WHO issued a strong recommendation in August 2022. On December 22, 2020, Ridgeback Biotherapeutics L.P. confirmed that the U.S. FDA approved Ebanga to treat Zaire Ebola.
On May 2, 2022, the U.S. FDA issued a priority review voucher for a material threat medical countermeasure (MCM) product application for INMAZEB (atoltivimab, maftivimab, and odesivimab-ebgn), Zaire ebolavirus, manufactured by Regeneron Pharmaceuticals, Inc. As a result, the FDA approved Inmazed in October 2020.
On October 14, 2020, the U.S. FDA approved an antibody cocktail from Regeneron that's been shown to reduce Ebola-related mortality rates. The treatment, known as REGN-EB3, is a mixture of (3) monoclonal antibodies (atoltivimab, maftivimab, and odesivimab-ebgn) and is marketed under the brand name Inmazeb. Inmazeb is indicated to treat infection caused by Zaire ebolavirus in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Zaire ebolavirus infection.
The U.S. Administration for Strategic Preparedness and Response announced on October 4, 2022, a $109.8 million contract with Mapp Biopharmaceutical Inc. for the advanced development and potential purchase of a mAb therapy to treat Sudan Ebolavirus.
Marburg Vaccines 2023
Marberg vaccine candidates are conducting clinical trials as of February 2023.
Ebola Vaccine News 2023
February 2, 2023 - INOVIO announced positive results from a Phase 1b clinical trial evaluating INO-4201, a DNA vaccine candidate, as a booster in healthy adult participants who previously received a single injection of Ervebo. INO-4201 was well-tolerated and boosted humoral responses in 100% of treated participants.
January 25, 2023 - EverGlade Consulting announced it helped Sabin Vaccine Institute successfully secure up to $214 million in funding to advance the development and production of single-dose vaccine candidates for Ebola Sudan and Marburg virus diseases.
January 12, 2022 - The Sabin Vaccine Institute announced that the U.S. Biomedical Advanced Research and Development Authority awarded a potential $214 million to advance the development and production of single-dose vaccine candidates for SUDV.
January 11, 2023 - The WHO Africa confirmed the SUDV vaccine development process was ongoing in the Republic of Africa.
December 19, 2022 - A Sudan ebolavirus vaccine and antibody therapeutic candidates tested at Texas Biomedical Research Institute have been sent to the Republic of Uganda as part of efforts to control the current outbreak. "There are only a few labs that can perform the regulated and specialized studies required by FDA to support approval of a vaccine or treatment for these types of pathogens," explains Ricardo Carrion, Jr., Ph.D., who directs Texas Biomed's Maximum Containment Contract Research unit.
December 14, 2022 - IAVI reported: As the Ebola outbreak fades, hope for a vaccine remains.
December 8, 2022 - @WHOUganda confirmed 1,200 doses would be used in the Tokomeza Ebola vaccine trial.
October 27, 2022 - Soligenix, Inc. announced today that the Company had been invited to submit a complete contract proposal for developing single-vial, adjuvanted, heat-stable subunit vaccines to prevent filovirus infection from Sudan and Marburg virus infections.
October 25, 2022 - IAVI and Merck entered into an agreement that could enable IAVI to accelerate the entry of a Sudan ebolavirus (SUDV) vaccine candidate into human clinical evaluation. As a result, Merck hopes to be able to deliver approximately 55,000 doses by the end of 2022.
October 23, 2022 - Jon Cohen with Science.org reported Merck Inc. had about 100,000 doses of a Sudan ebolavirus vaccine candidate.
October 17, 2022 - The Serum Institute of India confirmed plans to manufacture about 30,000 doses of an experimental Sudan Ebolavirus vaccine by the end of November 2022.