Ebola Virus Vaccine [CRACKED]

Ervebo was licensed in November 2019 by the European Medicines Agency and prequalified by WHO. The United States Food and Drug Administration licensed the vaccine in December 2019. Since then Burundi, Central African Republic, the Democratic Republic of the Congo, Ghana, Guinea, Rwanda, Uganda and Zambia have also approved the vaccine.

The vaccine is safe and protective against the species Zaire ebolavirus. It is recommended by the Strategic Advisory Group of Experts (SAGE) on Immunization as part as a broader set of Ebola outbreak response tools.

Ebola Virus Vaccine

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In May 2020, the European Medicines Agency recommended to grant marketing authorisation to a second new vaccine delivered in 2 doses called Zabdeno (Ad26.ZEBOV) and Mvabea (MVA-BN-Filo) for individuals 1 year and older.

The vaccine is delivered in 2 doses: Zabdeno is administered first and Mvabea is given approximately 8 weeks later as a second dose. This prophylactic 2-dose regimen is therefore not suitable for an outbreak response where immediate protection is necessary.

For individuals at imminent risk of exposure to Ebola (for example, health care professionals and those living in or visiting areas with an ongoing Ebola virus disease outbreak) who completed the Zabdeno and Mvabea 2-dose vaccination regimen, a Zabdeno booster vaccination should be considered if more than 4 months have passed since the second dose was administered.

The Zabdeno and Mvabea vaccine was studied in a total of 3 367 adults, adolescents and children who participated in 5 clinical studies conducted in Europe, Africa and the United States of America. These studies demonstrated that the vaccine regimen is safe and could induce an immune response against the Ebola virus. Efficacy data in humans has been extrapolated from animal studies. The exact level of protection provided by the vaccine regimen is not yet fully known.

A global stockpile will be available starting in January 2021 and will be managed through the International Coordinating Group (ICG) on Vaccine Provision. As is currently the case for stockpiles of cholera, meningitis and yellow fever vaccines, the ICG will be the decision-making body for allocation of the vaccine.

The Strategic Advisory Group of Experts (SAGE) on Immunization is currently reviewing the available evidence on Ervebo and Zabdeno and Mvabea vaccine and is expected to issue policy recommendations for preventive use in 2021.

However, during the 2018-2020 outbreak in Ituri, North Kivu and South Kivu in the Democratic Republic of the Congo, the vaccine was used as recommended by the Strategic Advisory Group of Experts (SAGE) on Immunization in children over 6 months old and in pregnant and lactating women under a compassionate use clinical protocol. The Strategic Advisory Group of Experts (SAGE) on Immunization is reviewing the safety data for the use of this vaccine in these populations and further recommendations are expected in early 2021.

If a person receiving the vaccine was already infected with the Ebola virus before he/she was vaccinated, they could develop Ebola virus disease after they receive the vaccine. If they develop any symptom of illness, they should immediately contact the vaccination team.

ERVEBO (Ebola Zaire Vaccine, Live also known as V920, rVSVG-ZEBOV-GP or rVSV-ZEBOV) is approved by the U.S. Food and Drug Administration (FDA) for the prevention of disease caused by Ebola virus (EBOV; species Zaire ebolavirus) in individuals 12 months of age and older as a single dose administration. ERVEBO is a replication-competent, live, attenuated recombinant vesicular stomatitis virus (rVSV) vaccine manufactured by Merck. It is not possible to become infected with EBOV from the vaccine because the vaccine only contains a gene from the Ebola virus, not the whole virus. Specifically, it contains a gene for the EBOV glycoprotein that replaces the gene for the native VSV glycoprotein. ERVEBO does not provide protection against other species of Ebolavirus or Marburgvirus.

The correlate of protection, or the specific immune response to the ERVEBO vaccine that closely relates to protection against infection with EBOV, is unknown and still being studied. It is also not known whether it is effective when administered concurrently with antiviral medication, immune globulin, and/or blood or plasma transfusion. The duration of protection conferred by an initial dose of ERVEBO is also unknown. A booster dose for people who have been previously vaccinated may extend the duration of protection for ERVEBO. Scientists continue to monitor people who have received the vaccine to learn more.

In the areas where Ebola disease is most common, ebolaviruses are believed to spread at low rates among certain animal populations. Ebolaviruses can spread to a person when they come in contact with an infected animal. Once infected, a person can become sick with Ebola disease and spread the virus to other people who come in contact with them.

The U.S. Food and Drug Administration (FDA) approved the Ebola vaccine rVSV-ZEBOV (called Ervebo) on December 19, 2019. This vaccine is given as a single dose vaccine and has been found to be safe and protective against Ebola virus (species Zaire ebolavirus) only, which has caused the largest and most deadly Ebola outbreaks to date. This is the first FDA-approved vaccine for an ebolavirus.

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. Cases of EVD 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.

Confirmed outbreaks of EVD have been documented since the 1970s, primarily in areas of sub-Saharan Africa, where scientists believe the virus is always present at low levels in certain infected wild animals. On rare occasions, people become sick with EVD after coming into direct contact with infected animals, which can then lead to EVD outbreaks when the virus spreads between people.

An outbreak in three West African countries (Guinea, Liberia and Sierra Leone) from 2014 to 2016 resulted in more than 28,000 cases of EVD and more than 11,000 deaths that were caused by Zaire ebolavirus.

The FDA granted this application Priority Review and a Tropical Disease Priority Review Voucher under a program intended to encourage development of new drugs and biologics for the prevention and treatment of certain tropical diseases. The FDA also granted Breakthrough Therapy designation for Ervebo to facilitate the development and scientific evaluation of the vaccine. Because of the public health importance of a vaccine to prevent EVD, the FDA worked closely with the company and completed its evaluation of the safety and effectiveness of Ervebo in less than six months.

Ebola virus disease is a rare but severe and often fatal illness. Between 25% to 90% of the patients who contracted the disease died in past outbreaks. The largest outbreak to date occurred in West Africa in 2014-2016 with more than 11,000 deaths. Currently, the Democratic Republic of Congo (DRC) is fighting an Ebola epidemic. It was declared a public health emergency of international concern by the World Health Organization (WHO) in July 2019. So far, more than 3,400 people in DRC have been infected with the Ebola virus during the ongoing outbreak, and approximately 67% of those infected have died.

The recommendation to grant a marketing authorisation for the new vaccine follows the approval of the first Ebola vaccine in November 2019. The new Ebola vaccine consists of two components, Zabdeno (Ad26.ZEBOV) and Mvabea (MVA-BN-Filo). Zabdeno is given first and Mvabea is administered approximately eight weeks later as a booster. This prophylactic 2-dose regimen is therefore not suitable for an outbreak response where immediate protection is necessary. As a precautionary measure, a Zabdeno booster vaccination should be considered for individuals at imminent risk of exposure to Ebola virus, for example healthcare professionals and those living in or visiting areas with an ongoing Ebola virus disease outbreak, who completed the Zabdeno, Mvabea 2-dose primary vaccination regimen more than four months ago.

The ability to make the immune system respond to the virus after vaccination with Zabdeno and Mvabea was studied in a total of 3,367 adults, adolescents and children who participated in five clinical studies conducted in Europe, Africa and the USA. These studies demonstrated that the vaccine regimen is safe and could induce an immune response against Ebola virus. Efficacy data in humans has been extrapolated from animal studies. The exact level of protection provided by the vaccine regimen is however unknown.

As protection against Ebola virus disease is considered to be of major public health interest, Zabdeno and Mvabea were evaluated under EMA's accelerated assessment mechanism, a tool which aims to speed up patients' access to new medicines if there is an unmet medical need.

Currently, there are no therapies approved for Ebola. EMA is working together with regulatory authorities around the world to support WHO and to advise on possible pathways for the development, evaluation and approval of medicines and vaccines to fight Ebola.

Zabdeno and Mvabea received a positive opinion for marketing authorisations under exceptional circumstances because the applicant was able to demonstrate that it is not possible to conduct a randomised controlled study that might generate comprehensive clinical data on the efficacy of the new Ebola vaccine even after authorisation. This was considered acceptable in light of the ongoing Ebola outbreak and high mortality rates in DRC.

Methods: We undertook 2 phase 1 studies assessing safety and immunogenicity of the viral vector modified vaccinia Ankara virus vectored Ebola Zaire vaccine (MVA-EBO-Z), manufactured rapidly on a new duck cell line either alone or in a heterologous prime-boost regimen with recombinant chimpanzee adenovirus type 3 vectored Ebola Zaire vaccine (ChAd3-EBO-Z) followed by MVA-EBO-Z. Adult volunteers in the United Kingdom (n = 38) and Senegal (n = 40) were vaccinated and an accelerated 1-week prime-boost regimen was assessed in Senegal. Safety was assessed by active and passive collection of local and systemic adverse events. e24fc04721