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.

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.