Prob­lem­atic part­ner­ship

CANADA’S ROLE IN CHI­NESE FIRM’S COVID-19 VAC­CINE DE­VEL­OP­MENT RAISES QUES­TIONS

Calgary Herald - - NP - TOM BLACKWELL

When Prime Min­is­ter Justin Trudeau an­nounced last month that Canada would soon be hold­ing hu­man tri­als of a new COVID-19 vac­cine, there was a lot of ex­cite­ment, and some con­fu­sion.

The de­vel­oper of the would-be vac­cine was a Chi­nese com­pany called Cansino Bi­o­log­ics, hardly a house­hold name in the phar­ma­ceu­ti­cal in­dus­try.

But not only is Cansino a leader in the in­ter­na­tional race to find a pre­ven­tive so­lu­tion to the pan­demic — work­ing along­side the Chi­nese mil­i­tary’s med­i­cal-science di­vi­sion — it has sur­pris­ingly deep roots in this coun­try.

The vac­cine is based on a cell line de­vel­oped by the Na­tional Re­search Coun­cil. The com­pany has worked with the NRC pre­vi­ously on an Ebola vac­cine, and with sci­en­tists at the coun­cil and Mcmaster Univer­sity on a tu­ber­cu­lo­sis shot. More re­cently, it part­nered with a Van­cou­ver-based biotech­nol­ogy com­pany that came up with its own COVID-19 vac­cine can­di­date.

Cansino reached a sig­nif­i­cant mile­stone last month, be­com­ing the first com­pany in the world to pub­lish peer-re­viewed re­sults of a COVID-19 vac­cine trial.

But at a time of his­tor­i­cally sour re­la­tions be­tween Canada and China, some ex­perts are ques­tion­ing Ottawa’s de­ci­sion to in­vest in the pro­ject.

Those early trial re­sults were a mixed bag at best, ar­gues Amir At­taran, a Univer­sity of Ottawa health pol­icy pro­fes­sor, while other COVID vac­cines seem more promis­ing and are backed by ma­jor Western uni­ver­si­ties and com­pa­nies.

“Why would we not choose to be af­fil­i­ated with those ef­forts, and in­stead pick as our pre­ferred part­ner the Chi­nese mil­i­tary and a Chi­nese com­pany?” asked At­taran, who has a doc­tor­ate in im­munol­ogy from Ox­ford Univer­sity. “This vac­cine can­di­date is noth­ing but a dead man walk­ing now.”

Gary Kob­inger, a Laval Univer­sity pro­fes­sor who fa­mously helped de­velop an Ebola vac­cine and treat­ment while at Canada’s Na­tional Mi­cro­bi­ol­ogy Lab, said he ac­tu­ally ap­plauds the gov­ern­ment for ig­nor­ing pol­i­tics and work­ing with China. But the phase 1 re­sults sug­gest Cansino’s vac­cine is not the one to bet on, he said.

“There are a lot of chal­lenges this vac­cine plat­form will face … This will be a lit­tle bit like win­ning the lot­tery to get this to the end,” he said. “That’s why I’m a bit at a loss about this. I still don’t un­der­stand: how did that work? What was the de­ci­sion mech­a­nism to in­vest in this?”

Oth­ers ar­gue that Cansino’s prod­uct — called Ad5-ncov — seems to have at least some po­ten­tial, and that even an im­per­fect vac­cine is bet­ter than none.

“You can raise is­sues, less with safety than with ef­fi­cacy, with most of the vac­cines that are un­der de­vel­op­ment,” said Dr. Al­li­son Mcgeer, a Toronto-based in­fec­tious dis­ease spe­cial­ist who cri­tiqued the trial re­sults in The Lancet jour­nal. “This one makes sense as much as any­thing else.”

Cansino could not be reached for com­ment.

Trudeau an­nounced May 12 that Canada had struck an agree­ment with the Tian­jin-based firm to con­duct an­other phase 1 trial, which es­sen­tially mea­sures whether the vac­cine is safe and gen­er­ates an im­mune re­sponse, fol­lowed if suc­cess­ful by phase 2 and 3 tri­als here.

The gov­ern­ment re­fuses to re­veal how much it’s spend­ing on the stud­ies, to be over­seen by Dal­housie Univer­sity’s Cana­dian Cen­tre for Vac­ci­nol­ogy. Par­tic­u­lars of the Cansino deal are shielded by “com­mer­cial con­fi­den­tial­ity,” said Hans Par­mar, an In­no­va­tion, Science and Eco­nomic De­vel­op­ment Canada spokesman. But Ottawa has com­mit­ted $1 bil­lion to COVID-19 re­search gen­er­ally.

The Na­tional Re­search Coun­cil would pro­duce the vac­cine for the Cana­dian mar­ket at a man­u­fac­tur­ing fa­cil­ity in Mon­treal if the tri­als prove suc­cess­ful. It says it should be able to make 70,000 to 100,000 doses a month by the end of the year.

It’s a mass-pro­duc­tion role the coun­cil doesn’t typ­i­cally play, but it would po­ten­tially make Cana­di­ans “among the first in the world to have ac­cess to a safe and ef­fec­tive vac­cine against COVID-19,” says the agency.

The vac­cine is based on rel­a­tively re­cent tech­nol­ogy that ge­net­i­cally en­gi­neers an ade­n­ovirus — ef­fec­tively the drug’s de­liv­ery ve­hi­cle — to in­clude the new coro­n­avirus’s spike pro­tein. That ideally prompts the body’s im­mune sys­tem to stave off COVID-19.

The com­pany’s phase 1 re­sults, pub­lished in the Lancet, were a good-news, bad­news story.

The study found an im­mune re­sponse to SARSCOV-2, the virus caus­ing COVID-19, in most of the 108 sub­jects, but it was “damp­ened” in about half of them.

The trial con­firmed wor­ries that the vac­cine’s ade­n­ovirus type-5 back­bone curbs the im­mune re­ac­tion. That’s be­cause most peo­ple have been ex­posed to Ad-5, which causes colds, and have an­ti­bod­ies that re­ject it.

Kob­inger noted that the best im­mune re­sponse came from the high­est dose, but that ver­sion also pro­duced sig­nif­i­cant side ef­fects, like el­e­vated fever. A phase 2 trial now start­ing in China is study­ing only lower doses.

“A vac­cine that gives you grade-3 side ef­fects in phase 1 is not a prime can­di­date,” he said.

Still, Mcgeer said it’s un­clear how much of an im­mune re­sponse is needed to re­pel the COVID-19 virus, and even the less­ened ef­fects at lower doses might be enough.

In fact, the fed­eral gov­ern­ment says it hasn’t put all its COVID-19 eggs in one bas­ket. It is fund­ing a num­ber of Cana­dian vac­cine projects, in­clud­ing one at the Univer­sity of Saskatchew­an that’s mov­ing to­ward hu­man tri­als soon.

But if Canada wanted an in­ter­na­tional part­ner­ship, other projects seem to have more po­ten­tial, in­sists At­taran. He points, for in­stance, to one led by Ox­ford Univer­sity and As­trazeneca, which is in phase 2 tri­als and has been set­ting up man­u­fac­tur­ing ar­range­ments world­wide. Canada has yet to join.

Ottawa has in­vested in a small Bos­ton-area com­pany, VBI Vac­cines, de­vel­op­ing a vac­cine against COVID-19 and two other coro­n­aviruses, SARS and MERS. And the gov­ern­ment is seek­ing to part­ner with ma­jor in­ter­na­tional vac­cine-mak­ers and the U.K.’S Vac­cine Task Force, said Par­mar.

At­taran also ques­tions what ben­e­fit, if any, Canada re­ceived from Cansino in ex­change for the NRC’S cell lines and, now, an un­known amount of fund­ing for clin­i­cal tri­als.

The re­search coun­cil stresses the agree­ment would pro­vide Cana­di­ans rapid ac­cess to the vac­cine. But asked whether it was paid for the cell lines, NRC said only that it had pro­vided Cansino non-ex­clu­sive li­cences, as it does other firms and re­searchers. As for get­ting pref­er­en­tial pric­ing for the vac­cine in Canada, drug costs are not the coun­cil’s re­spon­si­bil­ity, a spokesman said.

This is far from the first dance be­tween the Cana­dian gov­ern­ment agency and the Chi­nese com­pany. They’ve worked to­gether for more than a decade, start­ing with a joint ven­ture in 2007 to de­velop a tu­ber­cu­lo­sis vac­cine.

A few years later, in 2013, the NRC li­censed its ver­sion of the HEK 293 cell line to Cansino to pro­duce one of the world’s first Ebola vac­cines.

In 2011, Cansino says it ac­quired global rights to a TB vac­cine de­vel­oped by re­searchers at Mcmaster Univer­sity in Hamil­ton. The Mcmaster team was as­sisted by $3.6 mil­lion in fed­eral fund­ing, the univer­sity said in a later ar­ti­cle that de­scribed Cansino as an “in­dus­trial part­ner.”

Sim­i­lar to the new COVID-19 vac­cine, Cansino worked on the Ebola prod­uct with the Chi­nese Academy of Mil­i­tary Med­i­cal Sciences’ bio­engi­neer­ing in­sti­tute.

There’s no ev­i­dence the academy has played any in­ap­pro­pri­ate role in the coro­n­avirus pro­ject.

But the mil­i­tary ap­pel­la­tion is no mere for­mal­ity, ac­cord­ing to an ar­ti­cle last year by U.S. re­searchers. China’s de­fence plan­ners are in­creas­ingly in­ter­ested in “bi­ol­ogy as an emerg­ing do­main of warfare,” warns the piece co-au­thored by Elsa Ka­nia, a re­search fel­low at Ge­orge­town Univer­sity’s Cen­ter for Security and Emerg­ing Tech­nol­ogy.

STRINGER / REUTERS

A re­searcher works at a lab of Cansino Bi­o­log­ics in Tian­jin, China. The com­pany, which is de­vel­op­ing a COVID-19 vac­cine can­di­date, has sur­pris­ingly deep roots in Canada.

PETR DAVID JOSEK / THE AS­SO­CI­ATED PRESS

Se­myon By­chkov, chief con­duc­tor of the Czech Phil­har­monic, led the en­tire or­ches­tra in a live show on Wed­nes­day in the Czech Repub­lic.

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