Covid-19 roundup: EMA of­fi­cial says 'clear' link be­tween As­traZeneca shot and blood clots — re­port; No­vavax al­lows place­bo group to get vac­cine

For the first time Tues­day, health of­fi­cials ac­knowl­edged a link be­tween the As­traZeneca/Ox­ford Uni­ver­si­ty Covid-19 vac­cine and blood clots fol­low­ing a tense few weeks of coun­tries across Eu­rope sus­pend­ing use of the shot.

A top vac­cine ex­pert at the EMA said in an in­ter­view with Ital­ian news­pa­per Il Mes­sag­gero that there is a con­nec­tion be­tween the vac­cines and throm­bot­ic events, but the caus­es re­main un­known. The in­di­vid­ual ap­peared to dis­close the in­for­ma­tion sep­a­rate­ly from an of­fi­cial EMA an­nounce­ment but not­ed that the agency would do so lat­er Tues­day and pro­vide up­dat­ed guide­lines on the shot Wednes­day, ac­cord­ing to The Guardian.

“In my opin­ion we can now say it, it is clear that there is an as­so­ci­a­tion with the vac­cine. How­ev­er, we still do not know what caus­es this re­ac­tion,” EMA head of vac­cines Mar­co Cav­a­leri told the pa­per.

Cav­a­leri no­tably did not pro­vide any ev­i­dence to back up his claims. As­traZeneca did not im­me­di­ate­ly re­spond to an End­points News re­quest for com­ment.

Re­ports of the blood clots first popped up in ear­ly March af­ter a 49-year-old woman in Aus­tria died from “se­vere co­ag­u­la­tion dis­or­ders” af­ter re­ceiv­ing the shot. Soon af­ter, sev­er­al EU mem­ber states be­gan sus­pend­ing use of the shot while stud­ies in­to the blood clots be­gan. The EMA is still look­ing in­to 14 deaths among in­di­vid­u­als who had re­ceived the shot by March 22.

In a cul­mi­na­tion of the sus­pen­sions, Ger­many, the de fac­to leader of the EU, halt­ed vac­cine ad­min­is­tra­tion for its un­der-60 pop­u­la­tion just last week.

As­traZeneca has main­tained that the shots are safe, and re­ceived back­ing from the EMA and the World Health Or­ga­ni­za­tion, who both said the ben­e­fits of tak­ing the shot out­weigh the risks. Dur­ing a press con­fer­ence last week with the EMA safe­ty com­mit­tee, known as PRAC, the agency re­port­ed that though the blood clot cas­es are rare, they ap­pear to be oc­cur­ring more fre­quent­ly in young and mid­dle-aged women than oth­er groups.

The to­tal cas­es showed that about 1 in 100,000 in­di­vid­u­als who re­ceived the As­traZeneca shot are see­ing these rare and se­vere events in Eu­rope, the EMA said. An an­nounce­ment pro­vid­ing up­dates of the PRAC stud­ies was ex­pect­ed this week.

Tues­day’s com­ments come as Eu­ro­pean coun­tries con­tin­ue to block ex­ports of the shots from leav­ing their shores. The EU has blocked about 3.1 mil­lion vac­cines head­ed for Aus­tralia so far, Reuters re­port­ed.

No­vavax al­lows place­bo group to re­ceive vac­cines

No­vavax has up­dat­ed its vac­cine tri­al pro­to­col to al­low pa­tients in the place­bo arm to re­ceive the shot, the com­pa­ny an­nounced Mon­day.

The crossover al­lows for those in No­vavax’s UK and US/Mex­i­co Phase III stud­ies to re­ceive an ad­di­tion­al round of in­jec­tions while re­main­ing blind­ed. In­di­vid­u­als who re­ceived the vac­cine in the ini­tial round will get the place­bo, and vice ver­sa.

In the com­pa­ny’s South Africa Phase IIb study, vol­un­teers who re­ceived the place­bo will al­so get the vac­cine, while those who re­ceived the vac­cine will get a boost­er shot. Par­tic­i­pants from all three arms will con­tin­ue to be fol­lowed for up to two years.

“The crossover arms en­sure that all par­tic­i­pants have ac­cess to an ac­tive vac­cine can­di­date while al­low­ing No­vavax to con­tin­ue to mon­i­tor the safe­ty and ef­fi­ca­cy of our vac­cine over the long term,” CMO Fil­ip Dubovsky said in a state­ment.

Last month, No­vavax’s UK tri­al showed a fi­nal ef­fi­ca­cy of 96% in the arm against mild, mod­er­ate and se­vere Covid-19 cas­es in the UK. But that num­ber fell pre­cip­i­tous­ly in the South Africa arm, where it reg­is­tered on­ly 50% ef­fi­ca­cy.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

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Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
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