As an Ebo­la out­break rages on in the De­mo­c­ra­t­ic Re­pub­lic of Con­go — the FDA has ap­proved the first vac­cine to pro­tect against the dead­ly he­m­or­rhag­ic virus, months ear­li­er than ex­pect­ed. Man­u­fac­tured by Mer­ck the de­vel­op­ment of the vac­cine, chris­tened Erve­bo, be­gan dur­ing the West African out­break that oc­curred be­tween 2014 and 2016, which killed more than 11,000.

The ap­proval for the ge­net­i­cal­ly en­gi­neered at­ten­u­at­ed live vac­cine comes about five weeks af­ter its Eu­ro­pean en­dorse­ment. Mer­ck ex­pects to launch the vac­cine in the third quar­ter of 2020.

“We have not yet es­tab­lished a price for ERVE­BO. Mer­ck has com­mit­ted to mak­ing the vac­cine avail­able to Gavi (the Vac­cine Al­liance)-el­i­gi­ble coun­tries at the low­est pos­si­ble ac­cess price,” a com­pa­ny spokesper­son told End­points News.

Erve­bo has been test­ed in rough­ly 16,000 in­di­vid­u­als aged 18 and above in tri­als con­duct­ed in Africa, Eu­rope, and the Unit­ed States, and da­ta show the vac­cine is ef­fec­tive against the Zaire Ebo­la virus that cir­cu­lat­ed in West Africa in 2014-2016, as well as the cur­rent out­break in DRC.

In the Guinea tri­al, 3,537 con­tacts, and con­tacts of con­tacts, of in­di­vid­u­als with lab­o­ra­to­ry-con­firmed Ebo­la virus dis­ease re­ceived ei­ther “im­me­di­ate” or 21-day “de­layed” vac­ci­na­tion with Erve­bo. Some 2,108 in­di­vid­u­als were in the “im­me­di­ate” vac­ci­na­tion arm and 1,429 were in the “de­layed” vac­ci­na­tion group, and the re­sults show that Erve­bo was found to be 100% ef­fec­tive in pre­vent­ing Ebo­la cas­es with symp­tom on­set greater than 10 days af­ter vac­ci­na­tion. No Ebo­la cas­es with symp­tom on­set greater than 10 days af­ter vac­ci­na­tion were ob­served in the im­me­di­ate clus­ter group, com­pared with 10 such Ebo­la cas­es in the 21-day de­layed clus­ter group.

An­ti­body re­spons­es to Erve­bo were as­sessed in 477 in­di­vid­u­als in Liberia, rough­ly 500 in Sier­ra Leone and about 900 in­di­vid­u­als in Cana­da, Spain, and the Unit­ed States — across ge­og­ra­phy, the an­ti­body re­spons­es were sim­i­lar.

Ebo­la is thought to have in­fil­trat­ed the hu­man pop­u­la­tion through close con­tact with the blood, se­cre­tions, or­gans or oth­er bod­i­ly flu­ids of in­fect­ed an­i­mals such as fruit bats, chim­panzees, go­ril­las, mon­keys, for­est an­te­lope or por­cu­pines. Even­tu­al­ly, it spread be­tween hu­mans through di­rect con­tact, via the blood or bod­i­ly flu­ids of an in­fect­ed per­son.

The cur­rent out­break in the De­mo­c­ra­t­ic Re­pub­lic of Con­go has shown case fa­tal­i­ty rates of more than 65%, the WHO has es­ti­mat­ed. Al­though there has been a re­cent spike in in­fec­tions, the cur­rent in­fec­tion rates are well be­low the 120 cas­es a week re­port­ed dur­ing the peak of the out­break in late April. On Thurs­day, the WHO said it had record­ed the first Ebo­la re­lapse in the cur­rent epi­dem­ic.

Ear­li­er this year the WHO de­clared the out­break — which so far has in­fect­ed more than 3,350 peo­ple — a pub­lic health emer­gency of in­ter­na­tion­al con­cern. As of De­cem­ber 17, over a quar­ter of all con­firmed Ebo­la cas­es in the DRC have been in chil­dren aged less than 18 years. A Mer­ck spokesper­son said the com­pa­ny has stud­ies un­der­way test­ing Erve­bo (same for­mu­la­tion, same dose) in chil­dren.

The vac­cine was ini­tial­ly en­gi­neered by sci­en­tists from the Pub­lic Health Agency of Cana­da’s Na­tion­al Mi­cro­bi­ol­o­gy Lab­o­ra­to­ry and sub­se­quent­ly li­censed to a unit of NewLink Ge­net­ics Corp. In 2014, as the virus wreaked hav­oc in West Africa, Mer­ck ac­quired the tech­nol­o­gy from NewLink (Bat­tered by a se­ries of set­backs, Newlink in Oc­to­ber be­came the ve­hi­cle for a re­verse merg­er).

In re­sponse to re­quests from the WHO, since May 2018, the large US drug­mak­er has do­nat­ed 275,000 dos­es of the vac­cine to com­bat the out­break in the DRC. With the FDA ap­proval, Mer­ck has al­so qual­i­fied for a trop­i­cal dis­ease pri­or­i­ty re­view vouch­er (PRV) — these vouch­ers, used to has­ten drug re­views, have been sold in the past for mil­lions, rang­ing from $95 mil­lion to even $350 mil­lion.

The rel­a­tive­ly few Ebo­la cas­es in the Unit­ed States have been due to in­ter­na­tion­al trav­el­ers or health care work­ers who have con­tract­ed the virus af­ter treat­ing Ebo­la pa­tients.

“While the risk of Ebo­la virus dis­ease in the U.S. re­mains low, the U.S. gov­ern­ment re­mains deeply com­mit­ted to fight­ing dev­as­tat­ing Ebo­la out­breaks in Africa, in­clud­ing the cur­rent out­break in the De­mo­c­ra­t­ic Re­pub­lic of the Con­go,” said An­na Abram, FDA Deputy Com­mis­sion­er for Pol­i­cy, Leg­is­la­tion, and In­ter­na­tion­al Af­fairs, in a state­ment.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended nine drugs for approval this week while also giving thumbs up for six expanded indications, including Novo Nordisk’s approved obesity medication Wegovy for younger people. Wegovy is already approved as an obesity treatment in the EU for adults, and the new indication would allow prescriptions for adolescents aged 12 and older.

RNA biotech GreenLight Biosciences has been handed an offer for potential acquisition.

GreenLight said in a release that it has received a non-binding “indication of interest” from Fall Line Endurance Fund to acquire GreenLight’s capital stock for $0.60 per share in cash. The release said any potential agreement between the two parties would depend on certain conditions.

Through a special committee, the biotech will evaluate the offer but added there’s no certainty a deal will go forward. GreenLight will also not make any more announcements until a deal comes through or “otherwise determines” a statement is necessary.

A public T cell biotech’s chief executive has decided to leave the company.

TScan Therapeutics said Friday morning that CEO David Southwell stepped down earlier this week, leaving both his chief executive and board member roles. Filling in is Gavin MacBeath, the company’s CSO and COO. He became the acting CEO on Tuesday, and will continue to remain CSO and COO, TScan’s announcement read.

The German life science group Sartorius will be picking up French contract manufacturer Polyplus for the price of €2.4 billion, or $2.6 billion.

On Friday, Sartorius announced the acquisition through its French subgroup, Sartorius Stedim Biotech, which will be acquiring Polyplus from private investors ARCHIMED and WP GG Holdings IV. Polyplus has 270 employees and produces materials and components that go into making viral vectors that are used in cell and gene therapies. This includes DNA/RNA reagents as well as plasmid DNA. Polyplus has locations in France, Belgium, China and the US.