UP­DAT­ED: J&J to restart Covid vac­cine ship­ments to Eu­rope as EMA adds safe­ty warn­ing over rare blood clots

The Eu­ro­pean Med­i­cines Agency’s safe­ty com­mit­tee on Tues­day rec­om­mend­ed adding a warn­ing to the J&J Covid-19 vac­cine re­gard­ing the rare but some­times fa­tal blood clots with low blood platelets. Short­ly there­after, J&J said it would re­sume ship­ments of the vac­cine to the EU, Nor­way and Ice­land, and up­date its vac­cine’s Sum­ma­ry of Prod­uct Char­ac­ter­is­tics and Pack­age Leaflet to in­clude in­for­ma­tion on the di­ag­no­sis and man­age­ment of these very rare ad­verse events.

The com­mit­tee, which said the over­all risk-ben­e­fit of the vac­cine still re­mains pos­i­tive, re­viewed eight cas­es (in­clud­ing one that was fa­tal) of the rare side ef­fects among al­most 8 mil­lion Amer­i­cans vac­ci­nat­ed with the J&J vac­cine.

Emer Cooke, ex­ec­u­tive di­rec­tor of the EMA, said in a press con­fer­ence the vac­cine is due to be rolled out very short­ly in Eu­rope. In­ves­ti­ga­tions in­to the rare events are planned to con­tin­ue and J&J will con­duct ad­di­tion­al stud­ies. She not­ed that be­cause Eu­rope has a very good phar­ma­covig­i­lance sys­tem, very rare side ef­fects can be spot­ted ear­ly, which is a sign the sys­tem works, es­pe­cial­ly as the safe­ty com­mit­tee made its rec­om­men­da­tion pri­or to the vac­cine’s launch in Eu­rope.

The blood clots, which the com­mit­tee said were “very sim­i­lar” to side ef­fects linked to As­traZeneca’s Covid-19 vac­cine, oc­curred “most­ly at un­usu­al sites such as in veins in the brain (cere­bral ve­nous si­nus throm­bo­sis, CVST) and the ab­domen (splanch­nic vein throm­bo­sis) and in ar­ter­ies, to­geth­er with low lev­els of blood platelets and some­times bleed­ing.”

Pe­ter Ar­lett, head of the phar­ma­covig­i­lance and epi­demi­ol­o­gy de­part­ment at the EMA, not­ed that as of April 13, in ad­di­tion to the 8 to­tal cas­es for the J&J vac­cine, there have been 287 cas­es of the rare blood clots and low platelets fol­low­ing ad­min­is­tra­tion of the As­traZeneca vac­cine, in­clud­ing 142 in the Eu­ro­pean Eco­nom­ic Area, and 25 cas­es among those vac­ci­nat­ed with Pfiz­er and five for Mod­er­na. But in cas­es that oc­curred in the US, there was no low platelet count for Pfiz­er and Mod­er­na vac­cines, EMA clar­i­fied.

As far as why the blood clots with low platelets are oc­cur­ring, the EMA said the most plau­si­ble ex­pla­na­tion is an im­mune re­sponse lead­ing to a con­di­tion sim­i­lar to what can be seen some­times in pa­tients treat­ed with he­parin, called he­parin-in­duced throm­bo­cy­tope­nia.

Mean­while, J&J on Tues­day re­port­ed $100 mil­lion in Covid-19 vac­cine sales in the first quar­ter of 2021. CSO Paul Stof­fels said the com­pa­ny is try­ing to re­store pub­lic con­fi­dence in its vac­cine, and that the com­pa­ny re­mains com­mit­ted to re­sum­ing ship­ments to Eu­rope. The con­ti­nent has pur­chased 200 mil­lion dos­es.

In the US, where the gov­ern­ment signed a $1 bil­lion deal for 100 mil­lion dos­es (and the po­ten­tial for 200 mil­lion more), dos­es of the vac­cine have been paused since last Tues­day. The CDC will hold an­oth­er meet­ing of its ad­vi­so­ry com­mit­tee on Fri­day to dis­cuss the safe­ty is­sues fur­ther.

Man­u­fac­tur­ing is­sues at an Emer­gent site in Bal­ti­more al­so have raised ques­tions about whether J&J, which has tak­en con­trol of the fa­cil­i­ty, will be able to pro­duce enough vac­cines for the US. Emer­gent agreed not to ini­ti­ate the man­u­fac­tur­ing of any new ma­te­r­i­al at its Bayview fa­cil­i­ty last Fri­day. J&J said Tues­day that it’s pre­ma­ture to spec­u­late on any tim­ing is­sues with vac­cine de­liv­er­ies from the site, but it is work­ing with FDA to close the in­spec­tion this week and will work to ad­dress any ob­ser­va­tion­al find­ings.

Mov­ing Out of the Clin­ic with Dig­i­tal Tools: Mo­bile Spirom­e­try Dur­ing COVID-19 & Be­yond

An important technology in assessing lung function, spirometry offers crucial data for the diagnosis and monitoring of pulmonary system diseases, as well as the ongoing measurement of treatment efficacy. But trends in the healthcare industry and new challenges introduced by the COVID-19 pandemic are causing professionals in clinical practice and research to reevaluate spirometry’s deployment methods and best practices.

Paul Hudson (Getty Images)

Sanofi, Glax­o­SmithK­line jump back in­to the PhI­II race for a Covid vac­cine — as the win­ners con­gre­gate be­hind the fin­ish line

Sanofi got out early in the race to develop a vaccine using more of a traditional approach, then derailed late last year as their candidate failed to work in older people. Now, after likely missing the bus for the bulk of the world’s affluent nations, they’re back from that embarrassing collapse with a second attempt using GSK’s adjuvant that may get them back on track — with a potential Q4 launch that the rest of the world will be paying close attention to.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 105,400+ biopharma pros reading Endpoints daily — and it's free.

How to man­u­fac­ture Covid-19 vac­cines with­out the help of J&J, Pfiz­er or Mod­er­na? Bi­ol­yse sees the dif­fi­cul­ties up close

When Biolyse, an Ontario-based manufacturer of sterile injectables, forged a deal with Bolivia last week to manufacture up to 50 million J&J Covid-19 vaccine doses, the agreement kicked off what will prove to be a test case for how difficult the system of compulsory licenses is to navigate.

The first problem: When Biolyse asked J&J, via a March letter, to license its Covid-19 vaccine, manufacture it in Canada and pay 5% royalties on shipments to needy, low-income countries, J&J rejected the offer, refusing to negotiate. J&J also did not respond to a request for comment.

SCO­TUS de­clines to re­view En­brel biosim­i­lar case, tee­ing up 30+ years of ex­clu­siv­i­ty and $20B more for Am­gen’s block­buster

As the House Oversight Committee is set to grill AbbVie CEO Richard Gonzalez on Tuesday over tactics to block competition for its best-selling drug of all time, another decision on Capitol Hill on Monday opened the door for billions more in Amgen profits over the next eight years.

The Supreme Court on Monday denied Novartis subsidiary Sandoz’s petition to review a Federal Circuit’s July 2020 decision concerning its biosimilar Erelzi (etanercept-szzs), which FDA approved in 2016 as a biosimilar to Amgen’s Enbrel (etanercept). Samsung’s Enbrel biosimilar Eticovo also won approval in 2019 and remains sidelined.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 105,400+ biopharma pros reading Endpoints daily — and it's free.

Tim Mayleben (L) and Sheldon Koenig (Esperion)

On the heels of a sting­ing Q1 set­back, Es­pe­ri­on's long­time cham­pi­on is ex­it­ing the helm and turn­ing the wheel over to a mar­ket­ing pro

Just days after getting stung by criticism from a badly disappointed group of analysts, there’s a big change happening today at the helm of Esperion $ESPR.

Longtime CEO Tim Mayleben, who championed the company for 9 years from early clinical through a lengthy late-stage drive to successfully get their cholesterol drug approved for a significant niche of patients in the US, is out of the C suite, effective immediately. Sheldon Koenig — hired at the end of 2020 with a resume replete with Big Pharma CV sales experience —  is stepping into his place, promising to right a badly listing commercial ship that’s been battered by market forces.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 105,400+ biopharma pros reading Endpoints daily — and it's free.

No­var­tis' En­tresto takes its 2nd fail­ure of the week­end at ACC, show­ing no ben­e­fit in most dire heart fail­ure pa­tients

Novartis’ Entresto started the ACC weekend off rough with a trial flop in heart attack patients, slowing the drug’s push into earlier patients. Now, an NIH-sponsored study is casting doubt on Entresto’s use in the most severe heart failure patients, another black mark on the increasingly controversial drug’s record.

Entresto, a combination of sacubitril and valsartan, could not beat out valsartan alone in an outcomes head-to-head for severe heart failure patients with a reduced ejection fraction (HFrEF), according to data presented Monday at the virtual American College of Cardiology meeting.

Matt Gline (L) and Vivek Ramaswamy

In­sid­er ac­count of Roivan­t's SPAC deal — and that $7.3B val­u­a­tion — re­veals a few se­crets as Matt Gline po­si­tions the com­pa­ny as the new ‘Big Phar­ma’

It was Oct. 7, 2020, and Matt Gline wasn’t wasting any time.

The CEO of Roivant had word that KKR vet Jim Momtazee’s SPAC had priced late the night before, triggering a green light for anyone interested in pursuing a big check for future operations and riding the financial instrument to Nasdaq. So he wrote a quick email congratulating Momtazee, whom he knew, for the launch.

Oh, and maybe Momtazee would like to schedule something with Gline and his executive chairman, Roivant founder Vivek Ramaswamy, to chat about Roivant and its business?

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Ursula von der Leyen, president of the European Commission (AP Images)

Covid-19 roundup: EU to sup­port vac­cine man­u­fac­tur­ing ef­forts in Africa — re­port; Sput­nik Light ap­proved for use in Venezuela

The EU is expected to back an effort to expand vaccine manufacturing in Africa, unnamed officials told the Financial Times. 

Only 1% of Covid-19 vaccines administered worldwide have been given in Africa — down from 2% a few weeks ago, the WHO reported on Friday. The country normally gets many of its vaccine doses from the Serum Institute of India, which is now diverting its Covid-19 shots for domestic use.

$DNA is once again on NYSE; FDA clears Soliris chal­lenger for the mar­ket; Flag­ship’s think­ing big again with eR­NA; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

I still remember the uncertainty in the air last year when nobody was sure whether ASCO would cancel their in-person meeting. But it’s now back again for the second virtual conference, and Endpoints News is here for it. Check out our 2-day event reviewing the landscape of cancer R&D and send news our way.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 105,400+ biopharma pros reading Endpoints daily — and it's free.