Johnson & Johnson JNJ ("J&J") announced that the European Commission (EC) has granted marketing approval to its two-dose Ebola vaccine regimen for the prevention of Ebola Virus caused by Zaire strain.
Two marketing authorization applications (MAAs) were submitted to the European Medicines Agency (EMA) for the vaccines that are made of Zabdeno (Ad26.ZEBOV) and Mvabea (MVA-BN-Filo). Ad26.ZEBOV is a monovalent vaccine and MVA-BN-Filo is a multivalent vaccine and both are designed to provide active specific acquired immunity to fight the Ebola virus.
The MAAs also received a positive opinion fromthe EMA’s Committee for Medicinal Products for Human Use (CHMP) in September 2019.
The MAAs were supported by data from eleven phase I, II and III studies evaluating the safety and immunogenicity of the vaccine regimen. The studies were conducted in more than 6,500 adults and children aged one year and above across the United States, Europe and Africa.
Janssen is also collaborating with the World Health Organization on vaccine pre-qualification to accelerate theregistration of its treatment in Africa.
Shares of the company have decreased 2% compared with the industry’s 0.4% decline.
The European approval of theEbola vaccine regimen marks the first major regulatory approval of a vaccine developed by Janssen. The Ebola vaccine regimen leverages Janssen’s AdVac technologyplus Bavarian Nordic’s established MVA-BN technology. The AdVac technology is also being used to develop vaccine candidates to protect against SARS-CoV-2, as well as Zika, RSV and HIV.
We note that Bavarian Nordic is a biotechnology company specializing in research, development and manufacture of active cancer immunotherapies and vaccines for infectious diseases.
The approval of the vaccine is a landmark moment for the company as it brings forth a vaccine to treat the deadly Ebola virus. Ebola virus outbreak in 2018 caused more than2,000 deaths — a mortality rate of 65%.
We note that another company, Merck MRK, received FDA approval in December 2019 for its vaccine Ervebo (V920) to treat Ebola. The vaccine was approved for active immunization of individuals 18 years of age or older.
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Zacks Rank & Stocks to Consider
J&J currently carries a Zacks Rank #3 (Hold). A few better-ranked stocks worth considering in the large-cap pharma sector include AbbVie Plc ABBV and Eli Lilly and Company LLY, both carrying a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
AbbVie’s earnings estimates have increased from $9.71 to $10.54 for 2020 and from $11.22 to $12.03 for 2021 over the past 60 days.
Eli Lilly’s earnings estimates have increased from $6.81 to $6.82 for 2020 over the past 60 days.
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