World Health Organization Director-General Tedros Adhanom Ghebreyesus attends a press conference following an emergency committee meeting over Ebola epidemic in Democratic Republic of Congo at the WHO headquarters in Geneva on October 18, 2019. (via Getty Images)

As Con­go Ebo­la out­break fes­ters, FDA ap­proves first vac­cine to com­bat dead­ly virus

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 Cana­daSpain, 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.

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