UP­DAT­ED: J&J paus­es vac­cine roll­out as feds probe rare cas­es of blood clots

The FDA and CDC have joint­ly de­cid­ed to stop ad­min­is­ter­ing J&J’s Covid-19 vac­cine af­ter re­view­ing da­ta in­volv­ing six re­port­ed US cas­es of a rare and se­vere type of blood clot in in­di­vid­u­als af­ter re­ceiv­ing the vac­cine.

CDC will con­vene a meet­ing of its Ad­vi­so­ry Com­mit­tee on Im­mu­niza­tion Prac­tices on Wednes­day to fur­ther re­view these cas­es and as­sess their po­ten­tial sig­nif­i­cance. “FDA will re­view that analy­sis as it al­so in­ves­ti­gates these cas­es. Un­til that process is com­plete, we are rec­om­mend­ing a pause in the use of this vac­cine out of an abun­dance of cau­tion,” Pe­ter Marks, di­rec­tor of the FDA’s Cen­ter for Bi­o­log­ics Eval­u­a­tion and Re­search and Anne Schuchat, Prin­ci­pal Deputy Di­rec­tor of the CDC, said in a joint state­ment Tues­day morn­ing.

Marks said in a me­dia call that the prob­a­ble cause may be a sim­i­lar mech­a­nism seen in oth­er ade­n­ovirus vec­tor vac­cines, like the As­traZeneca Covid-19 vac­cine, which un­der­went a sim­i­lar safe­ty re­view in Eu­rope. He said one per­son has died and one per­son is in crit­i­cal con­di­tion from the blood clots. FDA act­ing com­mis­sion­er Janet Wood­cock added that the time­frame for this re­view of the J&J vac­cine “will be a mat­ter of days.”

J&J said in a state­ment on Tues­day that it has made the de­ci­sion to proac­tive­ly de­lay the roll­out of its vac­cine in Eu­rope. “The safe­ty and well-be­ing of the peo­ple who use our prod­ucts is our num­ber one pri­or­i­ty,” the com­pa­ny said.

“All six cas­es oc­curred among women be­tween the ages of 18 and 48, and symp­toms oc­curred 6 to 13 days af­ter vac­ci­na­tion,” they not­ed, adding that al­most 7 mil­lion dos­es of the vac­cine have now been ad­min­is­tered in the US. The CDC and FDA said that peo­ple who have re­ceived the J&J vac­cine and who de­vel­op se­vere headache, ab­dom­i­nal pain, leg pain, or short­ness of breath 3 weeks af­ter vac­ci­na­tion should con­tact their health care provider.

Treat­ment of this spe­cif­ic type of blood clot is dif­fer­ent from he­parin, which is the treat­ment that might typ­i­cal­ly be ad­min­is­tered, as in this set­ting, CDC and FDA said, “ad­min­is­tra­tion of he­parin may be dan­ger­ous, and al­ter­na­tive treat­ments need to be giv­en.”

Sen­a­tors on Tues­day be­gan weigh­ing in on what the FDA should do with its re­view.

Jeff Zients, White House Covid-19 re­sponse co­or­di­na­tor, said in a state­ment that the Biden ad­min­is­tra­tion is work­ing with states to resched­ule J&J ap­point­ments for Morder­na or Pfiz­er vac­cines. New York said all ap­point­ments for J&J vac­cines to­day at New York State mass vac­ci­na­tion sites will be hon­ored with the Pfiz­er vac­cine.

The news comes as the Eu­ro­pean Med­i­cines Agency’s safe­ty com­mit­tee said last Fri­day that it has ini­ti­at­ed a re­view of four “se­ri­ous cas­es of un­usu­al blood clots with low blood platelets,” in­clud­ing one death, re­port­ed af­ter peo­ple re­ceived the J&J vac­cine in the US.

As of April 4, EMA said a to­tal of 169 cas­es of cere­bral ve­nous si­nus throm­bo­sis (CVST) and 53 cas­es of splanch­nic vein throm­bo­sis were re­port­ed to the data­base, among 34 mil­lion peo­ple who have been vac­ci­nat­ed with the As­traZeneca vac­cine in the EEA and UK. By com­par­i­son, the agency not­ed that for the J&J vac­cine, 3 CVST cas­es were found among 4.5 mil­lion vac­ci­nat­ed world­wide, for Pfiz­er, 35 CVST cas­es world­wide were found and 54 mil­lion re­ceived the vac­cine in the EEA, and for Mod­er­na, 5 CVST cas­es world­wide were among 4 mil­lion vac­ci­nat­ed in the EEA.

Mod­er­na said in a state­ment on Tues­day that more than 64.5 mil­lion dos­es of its vac­cine have been ad­min­is­tered glob­al­ly and its as­sess­ment of the da­ta “does not sug­gest an as­so­ci­a­tion with cere­bral ve­nous si­nus throm­bo­sis (CVST) or throm­bot­ic events.”

Anne Schuchat, prin­ci­pal deputy di­rec­tor at the CDC, al­so said on the me­dia call that they are not see­ing con­cerns with these clot­ting events for the Mod­er­na or Pfiz­er vac­cines.

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.

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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.

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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.

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.

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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?

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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

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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.

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