Tuesday, 28 January, 2020

FDA approves first vaccine for prevention of Ebola virus

A girl receives a vaccine against Ebola from a nurse in Goma in the Democratic Republic of the Congo on Aug. 7 2019 FDA follows EMA with approval of Merck's Ebola vaccine
Anita Tucker | 23 December, 2019, 00:44

There are very rare cases of Ebola virus diseases (EVD) in the United States.

Merck & Co's Ebola vaccine Ervebo has been cleared for marketing in the USA, just weeks after getting a world-first regulatory approval in Europe. The largest outbreak occurred from 2014 to 2016 in the West African nations of Guinea, Liberia and Sierra Leone.

Announced on December 19, 2019, the Ervebo (v920) became the first FDA-approved vaccine for individuals 18 years of age and older.

The vaccine is given as a single injection and appears to be most effective when patients have time to build immunity before being exposed to the virus. The effectiveness of some inoculations can fade over time.

Despite the development of an effective vaccine and treatments, a recent surge in violence by rebel militias and criminal bands near Congo's borders with Uganda and Rwanda has hampered efforts to contain the outbreak.

The Zaire strain of the deadly virus has killed upwards of 2,000 people in the current outbreak in the Democratic Republic of the Congo.

In the US, Ebola has typically been brought back by patients infected elsewhere who have in some rare circumstances infected the nurses and doctors caring for them.

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Meanwhile, the FDA approval of Ervebo was the second bit of good news for Merck in the United States this week, coming after its cancer immunotherapy Keytruda (pembrolizumab) was backed by an FDA advisory committee as a treatment for high-risk, non-muscle invasive bladder cancer (NMIBC).

"While the risk of Ebola virus disease in the U.S.remains low, the US government remains deeply committed to fighting devastating Ebola outbreaks in Africa, including the current outbreak in the Democratic Republic of the Congo", said FDA Deputy Commissioner Anna Abram.

In the Guinea test, two different sorts of vaccine, either an "immediate" vaccination with Ervebo or a 21-day "delayed" vaccination with Ervebo. More than 258,000 people have been vaccinated in the outbreak zone so far.

According to Merck, Ervebo is expected to be available in the third quarter of 2020.

The company hasn't established a price for the drug.

The Ervebo vaccine is a live, recombinant, replication-competent Ebola vaccine, consisting of a vesicular stomatitis virus (VSV), which has been genetically engineered to express a glycoprotein from the Zaire ebolavirus, so as to provoke a neutralizing immune response to the Ebola virus. This research approach was precedent-setting in the course of a public health emergency.

Merck shares rose as much as up 2.8% to record high of US$92.55 on Friday.

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