Ox­ford, As­traZeneca re­sume trial for coro­n­avirus vaccine

Chicago Tribune (Sunday) - - CORONAVIRU­S OUTBREAK - By Pan Pylas

LONDON — Ox­ford Univer­sity an­nounced Satur­day it was re­sum­ing a trial for a coro­n­avirus vaccine it is de­vel­op­ing with phar­ma­ceu­ti­cal com­pany As­traZeneca, a move that comes days af­ter the study was sus­pended fol­low­ing a re­ported side ef­fect in a U.K. pa­tient.

In a state­ment, the univer­sity con­firmed the restart across all of its U.K. clin­i­cal trial sites af­ter reg­u­la­tors gave the goa­head fol­low­ing the pause.

“The in­de­pen­dent re­view process has con­cluded and fol­low­ing the rec­om­men­da­tions of both the in­de­pen­dent safety re­view com­mit­tee and the U.K. reg­u­la­tor, the MHRA, the tri­als will recom­mence in the U.K.,” it said.

The vaccine be­ing de­vel­oped by Ox­ford and As­traZeneca is widely per­ceived to be one of the strong­est con­tenders among the dozens of coro­n­avirus vac­cines in var­i­ous stages of test­ing around the world.

Bri­tish Health Sec­re­tary Matt Han­cock wel­comed the restart, say­ing in a tweet that it was “good news for ev­ery­one” that the trial is “back up and run­ning.”

The univer­sity said in large tri­als such as this “it is ex­pected that some par­tic­i­pants will be­come un­well and ev­ery case must be care­fully eval­u­ated to en­sure care­ful as­sess­ment of safety.”

It said glob­ally some 18,000 peo­ple have re­ceived its vaccine so far in Bri­tain, Brazil and South Africa. Around 30,000 vol­un­teers are be­ing re­cruited in the U.S.

Al­though Ox­ford would not dis­close in­for­ma­tion about the pa­tient’s ill­ness due to par­tic­i­pant con­fi­den­tial­ity, an As­traZeneca spokesman said last week that a wo­man had de­vel­oped se­vere neu­ro­log­i­cal symp­toms that prompted the pause. Specif­i­cally, the wo­man is said to have de­vel­oped symp­toms con­sis­tent with transverse myeli­tis, a rare in­flam­ma­tion of the spinal cord.

The univer­sity in­sisted that it is “com­mit­ted to the safety of our par­tic­i­pants and the high­est stan­dards of con­duct in our stud­ies and will con­tinue to mon­i­tor safety closely.”

Pauses in drug tri­als are com­mon­place and the tem­po­rary hold led to a sharp fall in As­traZeneca’s share price fol­low­ing the an­nounce­ment Tues­day.

The Ox­ford-As­traZeneca study had been pre­vi­ously stopped in July for sev­eral days af­ter a par­tic­i­pant de­vel­oped neu­ro­log­i­cal symp­toms that turned out to be an un­di­ag­nosed case of mul­ti­ple scle­ro­sis that re­searchers said was un­re­lated to the vaccine.

Dur­ing the third and fi­nal stage of test­ing, re­searchers look for any signs of pos­si­ble side ef­fects that may have gone un­de­tected in ear­lier pa­tient re­search. Be­cause of their large size, the stud­ies are con­sid­ered the most im­por­tant study phase for pick­ing up less com­mon side ef­fects and es­tab­lish­ing safety. The tri­als also as­sess ef­fec­tive­ness by track­ing who gets sick and who doesn’t be­tween pa­tients get­ting the vaccine and those re­ceiv­ing a dummy shot.

Dr. Char­lotte Sum­mers, a lec­turer in in­ten­sive care medicine at the Univer­sity of Cam­bridge, said the pause was a sign that the Ox­ford team was putting safety is­sues first, but that it led to “much un­help­ful spec­u­la­tion.”

“To tackle the global COVID-19 pan­demic, we need to develop vac­cines and ther­a­pies that peo­ple feel com­fort­able us­ing, there­fore it is vi­tal to main­tain­ing pub­lic trust that we stick to the ev­i­dence and do not draw con­clu­sions be­fore in­for­ma­tion is avail­able,” she said.

Sci­en­tists around the world, in­clud­ing those at the World Health Or­ga­ni­za­tion, have sought to keep a lid on ex­pec­ta­tions of an im­mi­nent break­through for coro­n­avirus vac­cines, stress­ing that vaccine tri­als are rarely straight­for­ward.

Two other vac­cines are in huge, fi­nal-stage tests in the United States, one made by Moderna Inc. and the other by Pfizer and Ger­many’s BioN­Tech.


Lab­o­ra­tory tech­ni­cians han­dle capped vials Fri­day for the Univer­sity of Ox­ford’s COVID-19 vaccine tri­als near Rome.

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