Francis Collins, NIH director (Sean Zanni/Patrick McMullan via Getty Images)

NIH kicks off Covid-19 vac­cine, mon­o­clon­al an­ti­body re­search net­work

The NIH to­day an­nounced the kick­off of a na­tion­al clin­i­cal tri­als net­work to test vac­cines and oth­er treat­ments that could pre­vent in­fec­tion with SARS-CoV-2, the virus that caus­es in­fec­tion with Covid-19.

The net­work has been es­tab­lished by the Na­tion­al In­sti­tute of Al­ler­gy and In­fec­tious Dis­eases (NI­AID) through the merg­er of four pre­vi­ous­ly ex­ist­ing clin­i­cal tri­als net­works that fo­cused on HIV/AIDS.

Alex Azar HHS

“Start­ing this sum­mer, this new net­work will lever­age ex­ist­ing in­fra­struc­ture and en­gage com­mu­ni­ties to se­cure the thou­sands of vol­un­teers need­ed for late-stage clin­i­cal tri­als of promis­ing vac­cines,” said Health and Hu­man Ser­vices Sec­re­tary Alex Azar.

The net­work, dubbed the Covid-19 Pre­ven­tion Tri­als Net­work (COVPN), is a func­tion­al unit of Op­er­a­tion Warp Speed, the fed­er­al part­ner­ship fo­cused on speed­ing the de­vel­op­ment and de­liv­ery of COVID-19 di­ag­nos­tics, ther­a­peu­tics and vac­cines.

Vac­cine test­ing is to be led by Lar­ry Corey of Fred Hutchin­son Can­cer Re­search Cen­ter (Seat­tle), and Kath­leen Neuzil of the Uni­ver­si­ty of Mary­land (Col­lege Park). The vac­cine arm of COVPN will use a har­mo­nized pro­to­col that per­mits cross-tri­al analy­sis, with more than 100 US and in­ter­na­tion­al tri­al sites be­ing planned.

Mod­er­na’s mR­NA-1273 vac­cine, which was de­vel­oped joint­ly with NI­AID, is ex­pect­ed to be test­ed in the first phase 3 clin­i­cal tri­al con­duct­ed through COVPN, with a start date ex­pect­ed this sum­mer.

Mon­o­clon­al an­ti­body test­ing will be an­oth­er COVPN fo­cus; this arm will be led by My­ron Co­hen of the Uni­ver­si­ty of North Car­oli­na (Chapel Hill) and Emory Uni­ver­si­ty’s David Stevens.

The COVPN web­site fea­tures a se­cure, be­spoke da­ta col­lec­tion plat­form that al­lows in­di­vid­u­als to en­roll in a rolling clin­i­cal tri­al par­tic­i­pant reg­istry from which po­ten­tial study par­tic­i­pants can be con­tact­ed and screened for study par­tic­i­pa­tion.

The hub of op­er­a­tions will be at Fred Hutchin­son Can­cer Re­search Cen­ter, where staff will over­see a com­mu­ni­ty en­gage­ment frame­work de­signed to achieve quick re­cruit­ment of large num­bers of re­search vol­un­teers.

“Each of the Phase 3 clin­i­cal tri­als that the COVPN will con­duct will re­quire thou­sands of vol­un­teers,” said NIH Di­rec­tor Fran­cis Collins. “Com­mu­ni­ty en­gage­ment, par­tic­u­lar­ly with the com­mu­ni­ties most vul­ner­a­ble to COVID-19’s se­vere out­comes, will be crit­i­cal to the suc­cess of this re­search en­deav­or.”

“Hav­ing a safe and ef­fec­tive med­ical coun­ter­mea­sure to pre­vent COVID-19 would en­able us to not on­ly save lives but al­so help end the glob­al pan­dem­ic,” said NI­AID Di­rec­tor An­tho­ny Fau­ci. “Cen­tral­iz­ing our clin­i­cal re­search ef­forts in­to a sin­gle tri­als net­work will ex­pand the re­sources and ex­per­tise need­ed to ef­fi­cient­ly iden­ti­fy safe and ef­fec­tive vac­cines and oth­er pre­ven­tion strate­gies against COVID-19.”

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Jan Hatzius (Photographer: Christopher Goodney/Bloomberg via Getty Images)

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Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

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Sean Nolan and RA Session II

Less than 3 months af­ter launch, the AveX­is crew’s Taysha rais­es $95M Se­ries B. Is an IPO next?

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Myovant is getting ready to roll out its commercial operations to back relugolix, now under FDA review for prostate cancer.

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President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

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