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Merck's Ebola Vaccine Ervebo Gets Approval in United States

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Merck & Co., Inc. (MRK - Free Report) announced that the FDA has granted approval to its vaccine for Ebola Zaire disease, Ervebo (V920). The vaccine has been approved for active immunization of individuals 18 years of age or older It is the first FDA-approved vaccine for the prevention of Ebola virus disease (“EVD”).

We note that Ervebo received conditional marketing approval in Europe last month.

Per a FDA press release, the approval for Ervebo was based on data from a study, which was conducted in Guinea during the 2014-2016 EVD outbreak in patients aged 18 years or older. The study evaluated Ervebo in different patient groups and administration schedules. Data from the study showed that Ervebo was 100% effective in preventing Ebola cases with symptom onset greater than 10 days after vaccination.

Merck’s shares have risen 17.8% this year so far compared with the industry’s increase of 10.2%.

 

 

Ebola virus disease is rare but it can become severe and prove to be fatal. The disease can also spread fast causing an outbreak. The press release states that risk of EVD in the United States is low. However, the U.S. government is committed to fight EVD outbreaks in Africa. Ervebo, being the only FDA-approved Ebola vaccine, holds significant potential. The vaccine has already been used by the World Health Organization and The Democratic Republic of the Congo during 2018 to mitigate an outbreak in Congo. Areas of sub-Saharan Africa have been facing EVD outbreaks at least since 1970s. Any such current or future outbreaks will bring higher revenues for Merck.

Some other companies like Inovio Pharmaceuticals’ (INO - Free Report) and Regeneron (REGN - Free Report) are also currently developing Ebola vaccine candidates. In August, Glaxo (GSK - Free Report) granted exclusive technology license to Sabin Vaccine Institute to develop its Ebola vaccine candidates.

Merck has a strong vaccines portfolio, which generated more than $6 billion in the first nine months of 2019. It has several marketed vaccines in its portfolio like Gardasil/Gardasil 9, ProQuad/M-M-R II/Varivax, RotaTeq, Pneumovax 23 and Zostavax. Among these, human papillomavirus vaccine, Gardasil/Gardasil 9 is a key top-line driver of the company, recording sales of more than $3 billion in the first nine months of 2019. The company’s new bacterial infection vaccine, MK-7655A, is under review in Europe. It is also developing 15-valent pneumococcal conjugate vaccine candidate, V114, in late-stage studies.

Zacks Rank

Merck currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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