Johnson & Johnson Receives Positive CHMP Opinion for Janssen’s Two-Dose Ebola Vaccine Regimen (Ad26.ZEBOV, MVA-BN-Filo), Awaiting Final EU Approval Within Two Months

Jun 10, 2020 18:25 CST Updated 18:25

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Committee for Medicinal Products for Human Use

Committee for Medicinal Products for Human Use (CHMP)The Committee for Medicinal Products for Human Use (CHMP) is the committee within the European Medicines Agency (EMA) responsible for human medicines. The CHMP replaced the former Committee for Proprietary Medicinal Products (CPMP) in May 2004.The CHMP plays a vital role in the authorization of medicines in the European Union (EU). In the centralized procedure, the CHMP is responsible for: 1) conducting initial assessments of marketing authorization applications across the EU; assessing modifications or extensions to existing marketing authorizations (“variations”); considering recommendations from the Agency’s Pharmacovigilance Risk Assessment Committee regarding the safety of medicines on the market, and, where necessary, advising the European Commission to amend the marketing authorization of a medicinal product, or to suspend or withdraw it from the market.The CHMP also evaluates medicines authorized at the national level that are referred to the EMA, with the aim of maintaining a harmonized position throughout the EU.Furthermore, the CHMP and its working groups promote the development of medicines and pharmaceutical regulation by: providing scientific advice to companies researching and developing new medicines; developing scientific and regulatory guidelines to assist pharmaceutical companies in preparing marketing authorization applications for human medicines; and collaborating with international partners to harmonize regulatory requirements.

European Commission

The European Commission, abbreviated as the EU Commission, is a supranational body under the European Union. Within the EU political system, the European Commission primarily undertakes executive tasks, thus being roughly equivalent to the government in a national system. However, the European Commission has other functions as well. In particular, except for the few circumstances specified in the treaties, the European Commission is the only institution with legislative power in the EU legislative process.

June 10, 2020 /BioValleyBIOON/ -- Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion, recommending approval of its Ebola vaccine regimen (a two-dose immunization schedule) for the prevention of Ebola virus disease (EVD) caused by the Zaire ebolavirus species. The CHMP’s opinion will now be submitted to the European Commission (EC) for review, with a final decision expected within two months.

Johnson & Johnson submitted two parallel Marketing Authorization Applications (MAAs) to the EMA, supporting each vaccine (Ad26.ZEBOV, MVA-BN-Filo) in the two-dose immunization regimen. Last September, the CHMP granted accelerated assessment status for these MAAs.

The vaccine regimen is as follows: (1) Ad26.ZEBOV, developed based on Janssen’s AdVac technology, is administered as the first dose; (2) approximately eight weeks later, MVA-BN-Filo, developed based on Bavarian Nordic’s MVA-BN technology, is administered as the second dose. The two Marketing Authorization Applications (MAAs) are supported by data from Phase I, II, and III clinical studies that evaluated the safety and immunogenicity of this vaccine regimen in adults and children, along with preclinical studies and immunobridging analysis data. These studies demonstrate that the vaccine regimen is well tolerated and induces a robust and durable immune response against the Zaire ebolavirus species.

Janssen’s Ebola vaccine regimen is specifically designed to support preventive vaccination in countries and regions at risk of Ebola outbreaks, as well as among other high-risk groups (such as healthcare workers, Biosafety Level 4 laboratory personnel, nationally deployed military forces, airport staff and travelers in high-risk countries, etc.). Currently, Janssen is collaborating with the World Health Organization (WHO) on prequalification of the vaccine to expand access to its Ebola vaccine regimen in African countries with the highest demand and to facilitate its registration in African nations.

Approval by the European Commission (EC) will help accelerate this process. In addition, Janssen is also in discussions with the U.S. FDA to determine, based onFDAsubmit the data required for the aforementioned Ebola vaccine regimen via the regulatory pathway for animal (efficacy) rules.

The most recent Ebola outbreak occurred in the Democratic Republic of the Congo (DRC) in 2018, making it the second-largest recorded outbreak in history. It has resulted in more than 3,000 cases and over 2,000 deaths, with a case fatality rate of 65%.。

In May 2019, the Strategic Advisory Group of Experts (SAGE) on Immunization of the World Health Organization (WHO) recommended the use of Janssen’s Ebola vaccine regimen as part of efforts to contain the outbreak in the Democratic Republic of the Congo (DRC). More than 50,000 people were vaccinated in the DRC and Rwanda. To date, approximately 60,000 individuals have received this preventive Janssen Ebola vaccine regimen in clinical studies and vaccination initiatives.

Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson, stated: “In the current outbreak in the Democratic Republic of the Congo (DRC), vaccines coordinated through comprehensive public health response measures—including Janssen’s novel two-dose vaccine regimen—have been deployed on a large scale for the first time. We are pleased with the positive opinion from the Committee for Medicinal Products for Human Use (CHMP), as it brings us closer to realizing Johnson & Johnson’s ultimate vision: to further prevent Ebola outbreaks before they occur and to assist the communities at highest risk.”

Johan Van Hoof, M.D., Global Therapeutic Area Head at Janssen Pharmaceuticals, stated: “The CHMP’s positive opinion validates the potential of Janssen’s vaccine technology, which we aim to apply against a range of existing and emerging epidemic threats, including the COVID-19 pandemic. If our investigational Ebola vaccine regimen receives approval from the European Commission, it will mark Janssen’s first vaccine approval and represent a significant step forward in our efforts to help protect populations at risk of Ebola virus disease. We are deeply grateful for the expertise and dedication of our numerous partners worldwide, without which the accelerated development and delivery of our Ebola vaccine would not have been possible.”

Ebola virus is the causative agent of Ebola hemorrhagic fever (EHF), an acute viral hemorrhagic infectious disease. Symptoms include fever, headache, joint and muscle pain, fatigue, diarrhea, vomiting, abdominal pain, loss of appetite, and abnormal bleeding. These symptoms can appear 2 to 21 days after infection, most commonly within 8 to 10 days. Ebola is not a water-borne or food-borne disease, nor is it airborne. It is transmitted through direct contact with the body fluids of infected individuals or with objects contaminated by the virus (such as needles).

In November 2019, Merck & Co.’s Ebola vaccine Ervebo (V920, rVSV∆G-ZEBOV-GP, a live-attenuated vaccine) received approval from the European Union, becoming the world’s first Ebola vaccine. This vaccine is indicated for active immunization in individuals aged 18 years and older to prevent Ebola virus disease (EVD) caused by the Zaire ebolavirus. In December 2019, Ervebo also received approval in the United StatesFDAApproved. In February 2020, Ervebo received approval from the first four African countries (the Democratic Republic of the Congo, Burundi, Ghana, and Zambia), with additional approvals expected from more African nations in the future.

Ervebo (V920) utilizes a defective vesicular stomatitis virus (VSV) capable of infecting livestock, in which one viral gene has been replaced by a gene from the Ebola virus. V920 was initially developed by the Public Health Agency of Canada (PHAC) and subsequently licensed to NewLink Genetics in 2010. In late 2014, when the Ebola outbreak in West Africa reached its peak, Merck & Co., Inc. entered into a global exclusive licensing agreement with NewLink Genetics to acquire this Ebola vaccine. Since then, Merck has collaborated closely with several external partners and, with partial funding from the U.S. government, has undertaken an extensive clinical development program to further develop the vaccine. (Bioon.com)

Original Source: Johnson & Johnson Receives Positive CHMP Opinion for Janssen’s Investigational Preventive Ebola Vaccine Regimen