Covid-19 roundup: 60 mil­lion J&J dos­es from Emer­gent to be tossed; EMA up­dates As­traZeneca vac­cine warn­ings

Af­ter a two-month hold on mil­lions of dos­es of the J&J vac­cine, the FDA will an­nounce that it is re­leas­ing 10 mil­lion dos­es and trash­ing 60 mil­lion that were made at a trou­bled Bal­ti­more plant, The New York Times scooped on Fri­day morn­ing.

Emer­gent BioSo­lu­tions re­port­ed that the dos­es were con­t­a­m­i­nat­ed af­ter drug ma­te­r­i­al in­tend­ed for the As­traZeneca vac­cine came in close con­tact with me­dia pre­pared for a J&J run. As a re­sult, the dos­es were held from dis­tri­b­u­tion, caus­ing a shake­up in ear­ly avail­abil­i­ty.

Lat­er, a Form 483 from the FDA re­vealed im­prop­er de­con­t­a­m­i­na­tion meth­ods from staff and oth­er un­san­i­tary con­di­tions like paint chip­ping on the walls and mold grow­ing in the build­ing.

An­oth­er 60 mil­lion dos­es of As­traZeneca’s could be­come avail­able as well. The FDA has not de­ter­mined whether Emer­gent can re­sume pro­duc­tion again, sev­er­al out­lets re­port­ed. — Josh Sul­li­van

EMA up­dates As­traZeneca vac­cine warn­ings, con­tin­ues re­view of my­ocardi­tis and peri­cardi­tis for mR­NA vac­cines

The Eu­ro­pean Med­i­cines Agency said Fri­day that it has con­clud­ed that peo­ple who have pre­vi­ous­ly had cap­il­lary leak syn­drome must not be vac­ci­nat­ed with As­traZeneca’s Covid vac­cine Vaxzevria.

“The Com­mit­tee car­ried out an in-depth re­view of 6 cas­es of cap­il­lary leak syn­drome in peo­ple who had re­ceived Vaxzevria. Most of the cas­es oc­curred in women and with­in 4 days of vac­ci­na­tion. Three of those af­fect­ed had a his­to­ry of cap­il­lary leak syn­drome and one of them sub­se­quent­ly died. As of 27 May 2021, more than 78 mil­lion dos­es of Vaxzevria had been ad­min­is­tered in the EU/EEA and the UK,” EMA said.

The agency al­so said it’s con­tin­u­ing its re­view of my­ocardi­tis (in­flam­ma­tion of the heart mus­cle) and peri­cardi­tis (in­flam­ma­tion of the mem­brane around the heart) in a small num­ber of peo­ple fol­low­ing vac­ci­na­tion with Covid vac­cines, in­clud­ing the one from Pfiz­er.

As of the end of May 2021, cas­es of my­ocardi­tis re­port­ed in the EEA from Eu­dravig­i­lance data­base were 122 (Pfiz­er’s Comir­naty), 16 (Mod­er­na’s vac­cine) and 38 (As­traZeneca’s Vaxzevria) and 0 for J&J. The ex­po­sure in the EEA for each vac­cine was around 160 mil­lion dos­es for Comir­naty, 19 mil­lion dos­es for Mod­er­na, 40 mil­lion for Vaxzevria and 2 mil­lion for Janssen.

And as of the end of May 2021, EMA said cas­es of peri­cardi­tis re­port­ed in the EEA data­base were 126 (Comir­naty), 18 (Mod­er­na), 47 (Vaxzevria) and 1 (Janssen).

“For Comir­naty and COVID-19 Vac­cine Mod­er­na the PRAC is re­view­ing cas­es of my­ocardi­tis and peri­cardi­tis in the con­text of a safe­ty sig­nal, un­der an ac­cel­er­at­ed timetable (fi­nal­i­sa­tion ex­pect­ed in Ju­ly),” EMA said.

The CDC on Thurs­day, at an FDA ad­vi­so­ry com­mit­tee meet­ing on vac­ci­nat­ing chil­dren, al­so pre­sent­ed its find­ings on my­ocardi­tis and peri­cardi­tis fol­low­ing mR­NA vac­ci­na­tion, not­ing 488 to­tal re­ports for the Pfiz­er-BioN­Tech vac­cine and 301 re­ports for Mod­er­na through the end of May. CDC found that of the re­ports, the me­di­an age af­ter the first dose was 30, and 24 for the sec­ond dose, with more males than fe­males re­port­ing my­ocardi­tis and peri­cardi­tis. CDC said 15 are still hos­pi­tal­ized and three are in the in­ten­sive care unit.

While the slides show no sta­tis­ti­cal sig­nal yet, CDC’s ACIP has sched­uled a meet­ing for next Fri­day to fur­ther up­date the da­ta, and dis­cuss its eval­u­a­tion of my­ocardi­tis fol­low­ing mR­NA vac­ci­na­tions, as well as to as­sess the ben­e­fit-risk bal­ance. — Zachary Bren­nan

Pfiz­er has emer­gency plan to pro­duce an­oth­er vac­cine in months, if need­ed

Dur­ing the G7 sum­mit Thurs­day, Pfiz­er CEO Al­bert Bourla an­nounced that if a new vac­cine were need­ed, the com­pa­ny has a process to en­sure it could be de­vel­oped with­in 100 days. He al­so re­in­forced that ac­cord­ing to his com­pa­ny’s da­ta, none of the ex­ist­ing vari­ant strains have es­caped pro­tec­tion from the vac­cine.

“I re­peat: none,” he said. “Not one.”

Pfiz­er sci­en­tists are al­so pur­su­ing an oral treat­ment against Covid-19, the ini­tial re­sults of which Bourla called “promis­ing.” If things go ac­cord­ing to plan, the com­pa­ny could ap­ply for ap­proval by the end of 2021.

The Group of Sev­en is ex­pect­ed to do­nate 1 bil­lion Covid-19 vac­cine dos­es to low-in­come coun­tries, British Prime Min­is­ter Boris John­son said Thurs­day.

The news came just a few hours af­ter Pres­i­dent Joe Biden an­nounced that the US was set to do­nate at least 500 mil­lion Pfiz­er-BioN­Tech shots, Reuters re­ports. The group is ex­pect­ed to agree to the do­na­tion dur­ing the three-day sum­mit at Car­bis Bay in Eng­land.

Eng­land is ex­pect­ed to do­nate 100 mil­lion of those shots, 80 mil­lion of which will go to CO­V­AX,  John­son has said.

Both coun­tries have rolled out suc­cess­ful vac­ci­na­tion cam­paigns. Near­ly 52% of the to­tal US pop­u­la­tion, and 61.5% of adults have re­ceived at least one dose of the vac­cine. In Eng­land, 77% of adults have re­ceived a jab.

But one bil­lion dos­es may not be enough. An­na Mar­riott, the glob­al pover­ty or­ga­ni­za­tion Ox­fam’s health pol­i­cy man­ag­er, said that if the best lead­ers can do is do­nate 1 bil­lion dos­es, the sum­mit will have been a fail­ure. Mar­riott called for 11 bil­lion dos­es to end the pan­dem­ic, and called for in­tel­lec­tu­al prop­er­ty waivers, Reuters re­port­ed. Near­ly 4 bil­lion peo­ple are de­pen­dent up­on vac­cines from CO­V­AX, the pro­gram from Gavi, the vac­cine al­liance to pro­vide shots to low- and mid­dle-in­come coun­tries.

The virus has led to the deaths of 3.9 mil­lion peo­ple since its start in Chi­na in 2019. — Josh Sul­li­van

Ger­many de­bates bail­ing on Cure­Vac as the wait con­tin­ues

Ger­man Health Min­is­ter Jens Spahn no longer plans to use Cure­Vac’s Covid-19 vac­cine for the cur­rent vac­ci­na­tion cam­paign, RP On­line has re­port­ed.

EMA ap­proval was orig­i­nal­ly ex­pect­ed by May, but on Tues­day news broke that reg­u­la­to­ry ap­proval of the vac­cine shouldn’t be ex­pect­ed to come be­fore Au­gust.

Chief pro­duc­tion of­fi­cer Flo­ri­an von der Mülbe has blamed de­lays on sup­ply chain is­sues. In Ju­ly 2020, GSK an­nounced it would in­vest $293 mil­lion in the jab and take on man­u­fac­tur­ing re­spon­si­bil­i­ties. — Josh Sul­li­van

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

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

Endpoints Premium

Premium subscription required

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

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

FDA hands ac­cel­er­at­ed nod to Seagen, Gen­mab's so­lo ADC in cer­vi­cal can­cer, but com­bo stud­ies look even more promis­ing

Biopharma’s resident antibody-drug conjugate expert Seagen has scored a clutch of oncology approvals in recent years, finding gold in what are known as “third-gen” ADCs. Now, another of their partnered conjugates is ready for prime time.

The FDA on Monday handed an accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv, or “TV”) in second-line patients with recurrent or metastatic cervical cancer who previously progressed after chemotherapy rather than PD-(L)1 systemic therapy, the companies said in a release.

President Biden and Pfizer CEO Albert Bourla (Patrick Semansky/AP Images)

Chaot­ic ad­comm sees Pfiz­er/BioN­Tech boost­ers re­ject­ed for gen­er­al pop­u­la­tion, but rec­om­mend­ed for old­er and high-risk pop­u­la­tions

With just days before President Joe Biden’s Covid-19 booster rollout is set to go into effect, an FDA advisory committee appeared on the verge of not recommending boosters for anyone in the US before a last-minute change of wording laid the groundwork for older adults to have access to a third dose.

The FDA’s adcomm on Vaccines and Related Biological Products (VRBPAC) roundly rejected Pfizer/BioNTech booster shots for all individuals older than 16 by a 16-2 vote Friday afternoon. Soon after, however, the agency posed committee members a new question limiting booster use to the 65-and-older population and individuals at high risk of disease due to occupational exposure or comorbidities.

Dave Lennon, former president of Novartis Gene Therapies

Zol­gens­ma patent spat brews be­tween No­var­tis and Re­genxbio as top No­var­tis gene ther­a­py ex­ec de­parts

Regenxbio, a small licensor of gene therapy viral vectors spun out from the University of Pennsylvania, is now finding itself in the middle of some major league patent fights.

In addition to a patent suit with Sarepta Therapeutics from last September, Novartis, is now trying to push its smaller partner out of the way. The Swiss biopharma licensed Regenxbio’s AAV9 vector for its $2.1 million spinal muscular atrophy therapy Zolgensma.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 117,700+ biopharma pros reading Endpoints daily — and it's free.

Volker Wagner (L) and Jeff Legos

As Bay­er, No­var­tis stack up their ra­dio­phar­ma­ceu­ti­cal da­ta at #ES­MO21, a key de­bate takes shape

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 117,700+ biopharma pros reading Endpoints daily — and it's free.

Rafaèle Tordjman (Jeito Capital)

Con­ti­nu­ity and di­ver­si­ty: Rafaèle Tord­j­man's women-led VC firm tops out first fund at $630M

For a first-time fund, Jeito Capital talks a lot about continuity.

Rafaèle Tordjman had spotlighted that concept ever since she started building the firm in 2018, promising to go the extra mile(s) with biotech entrepreneurs while pushing them to reach patients faster.

Coincidentally, the lack of continuity was one of the sore spots listed in a report about the European healthcare sector published that same year by the European Investment Bank — whose fund is one of the LPs, alongside the American pension fund Teacher Retirement System of Texas and Singapore’s Temasek, to help Jeito close its first fund at $630 million (€534 million). As previously reported, Sanofi had chimed in €50 million, marking its first investment in a French life sciences fund.

Mi­rati tri­umphs again in KRAS-mu­tat­ed lung can­cer with a close­ly watched FDA fil­ing now in the cards

After a busy weekend at #ESMO21, which included a big readout for its KRAS drug adagrasib in colon cancer, Mirati Therapeutics is ready to keep the pressure on competitor Amgen with lung cancer data that will undergird an upcoming filing.

In topline results from a Phase II cohort of its KRYSTAL-1 study, adagrasib posted a response rate of 43% in second-line-or-later patients with metastatic non-small cell lung cancer containing a KRAS-G12C mutation, Mirati said Monday.