Coro­n­avirus vac­cine trial re­sumes in U.K. af­ter week-long pause

The Washington Post Sunday - - SUNDAY OPINION - BY CAROLYN Y. JOHN­SON carolyn.john­son@wash­

A coro­n­avirus vac­cine trial re­sumed Satur­day in the United King­dom af­ter the study was paused for a week be­cause of an un­ex­plained ill­ness in a trial par­tic­i­pant.

The rec­om­men­da­tion to re­sume hu­man test­ing of the vac­cine can­di­date be­ing de­vel­oped by the Univer­sity of Ox­ford and phar­ma­ceu­ti­cal gi­ant As­traZeneca was made by an in­de­pen­dent safety re­view com­mit­tee and by the U.K. health reg­u­la­tor. Author­i­ties made no fur­ther in­for­ma­tion avail­able about the na­ture of the par­tic­i­pant’s ill­ness, cit­ing pri­vacy pro­tec­tions.

“Glob­ally some 18,000 in­di­vid­u­als have re­ceived study vac­cines as part of the trial. 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,” the Univer­sity of Ox­ford said in a state­ment.

As­traZeneca re­leased a state­ment that it was work­ing with global health author­i­ties to “be guided as to when other clin­i­cal tri­als can re­sume,” in­clud­ing the 30,000-per­son trial in the United States that be­gan in late Au­gust.

The tem­po­rary hold on the trial be­cause of a sin­gle ill­ness was seen by many ex­perts as ev­i­dence that sys­tems in place to pro­tect pa­tient safety are func­tion­ing prop­erly. Na­tional In­sti­tutes of Health Di­rec­tor Francis S. Collins tes­ti­fied be­fore Congress that the ill­ness that stopped the trial was trans­verse myeli­tis, an in­flam­ma­tion of the spinal cord, but the di­ag­no­sis was not con­firmed by the drug com­pany or by Ox­ford re­searchers.

Trans­verse myeli­tis is a rare, treat­able con­di­tion. It can oc­cur in pa­tients with mul­ti­ple scle­ro­sis but can also be “id­io­pathic,” the med­i­cal term for a con­di­tion that has no clear cause. Years of in­ves­ti­ga­tion to try to un­der­stand if it could be trig­gered by vac­ci­na­tions have never shown a clear link.

“It can be very dif­fi­cult, if not im­pos­si­ble, to ever con­clu­sively prove what a trig­ger was for id­io­pathic trans­verse myeli­tis,” said Ben­jamin Green­berg, a neu­rol­o­gist at the Univer­sity of Texas South­west­ern Med­i­cal Cen­ter who treats the con­di­tion.

With hun­dreds of mil­lions of vac­ci­na­tions given each year, Green­berg said, peo­ple inevitably — and by co­in­ci­dence — fall sick in the days or weeks af­ter re­ceiv­ing the in­oc­u­la­tion. A per­son may have a heart at­tack the day af­ter tak­ing an as­pirin, for ex­am­ple, but it doesn’t mean the med­i­ca­tion caused the event. The im­por­tant thing is to study whether it’s likely that a vac­cine trig­gered any ad­verse event, Green­berg said.

Green­berg said in an in­ter­view a day be­fore the trial re­sumed that safety guardrails ap­peared to be work­ing in the vac­cine trial.

“It’s nice to see the sys­tem worked in terms of vac­cine de­vel­op­ment . . . the study be­ing put on hold out of an abun­dance of cau­tion, de­spite the fact there are enor­mous pres­sures to get a vac­cine de­vel­oped and avail­able,” Green­berg said. “Every­body did what they are sup­posed to — that was very re­as­sur­ing.”

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