Covid-19 roundup: Emer­gen­t's er­ror costs J&J a vac­cine batch; Pfiz­er head says EU re­stric­tions slow vac­cine dis­tri­b­u­tion process

J&J has run in­to a snag in pro­duc­tion of its Covid-19 vac­cine af­ter its qual­i­ty pa­trol spot­ted prob­lems with one batch of drug sub­stance.

The is­sue — which the New York Times re­port­ed was due to a mix-up be­tween the vec­tors used in J&J and As­traZeneca’s vac­cines — sent J&J in­to trou­ble-shoot­ing mode. The com­pa­ny said it’s send­ing ad­di­tion­al ex­perts in man­u­fac­tur­ing, tech­ni­cal op­er­a­tions and qual­i­ty to su­per­vise on­site at Emer­gent’s Bayview fa­cil­i­ty, which was once tout­ed for its ca­pac­i­ty to rapid­ly scale man­u­fac­tur­ing.

In a state­ment, J&J didn’t con­firm whether the batch would in­deed trans­late to 15 mil­lion dos­es, as the Times re­port­ed. It in­stead em­pha­sized that the Emer­gent site has not yet been au­tho­rized by the FDA to make the ac­tive in­gre­di­ents of its one-shot, ade­n­ovirus vec­tor-based vac­cine, and that it’s on track to de­liv­er a to­tal of 1 bil­lion dos­es by 2021.

But while a board mem­ber has pre­vi­ous­ly pre­dict­ed they would de­liv­er a to­tal of 100 mil­lion dos­es to the US by April, J&J is now push­ing that goal to the end of May. Through April, they ex­pect to have 24 mil­lion dos­es, on top of the 20 mil­lion al­ready in arms.

“This batch was nev­er ad­vanced to the fill­ing and fin­ish­ing stages of our man­u­fac­tur­ing process,” the com­pa­ny added. “This is an ex­am­ple of the rig­or­ous qual­i­ty con­trol ap­plied to each batch of drug sub­stance.”

Emer­gent, which had inked a $480 mil­lion deal to sup­ply J&J’s Covid vac­cine for the next two years, had been known as the mak­er of an an­thrax vac­cine pri­or to the pan­dem­ic.

Billed as a cen­ter for in­no­va­tion in ad­vanced de­vel­op­ment and man­u­fac­tur­ing (CIADM), the Bayview site was built as part of a part­ner­ship with BAR­DA to speed de­vel­op­ment and pro­duc­tion of vac­cines or treat­ments for pan­dem­ic re­sponse.

Pfiz­er head says EU re­stric­tions slow vac­cine dis­tri­b­u­tion process

The Eu­ro­pean Union has seen a short­age in Covid-19 vac­cine avail­abil­i­ty, and Pfiz­er head Dan­ny Hen­drikse wants it to be known that new EU re­stric­tions won’t make end­ing that short­age any eas­i­er.

The VP of glob­al sup­ply spoke out against new EU rules about the free move­ment of goods across bor­ders, say­ing that it made it more dif­fi­cult for the com­pa­ny to ex­port the vac­cine.

“Ul­ti­mate­ly what we would like our col­leagues to do is to fo­cus on mak­ing and dis­trib­ut­ing the vac­cine,” he told the UK’s Tele­graph. “The com­po­nents don’t just come from Eu­rope, but from all over the world.”

Pfiz­er told EU lead­ers that the amount of time it takes to make the vac­cine has been cut in half from 110 days to 60, thanks to an in­crease of pro­duc­tion at its Bel­gium plant. But that batch is start­ed in the US, with DNA plas­mids.

The news comes on the back of Ger­many’s sus­pen­sion of the As­traZeneca vac­cine for pa­tients un­der the age of 40 due to a rare, but fa­tal, blood clot called ve­nous throm­bo­sis. The clot was par­tic­u­lar­ly present in young women, a re­port said. EU’s med­ical reg­u­la­tor said that there was no ev­i­dence to sup­port the de­ci­sion to stop us­ing the vac­cine, how­ev­er.

Pfiz­er and BioN­Tech con­firm high ef­fi­ca­cy, no se­ri­ous safe­ty con­cerns af­ter sec­ond Covid-19 vac­cine dose

Six months af­ter Pfiz­er and BioN­Tech’s Phase III clin­i­cal tri­al par­tic­i­pants re­ceived the sec­ond dose of their Covid-19 vac­cine, the com­pa­nies have an­nounced that there are no se­ri­ous safe­ty con­cerns.

Of the 927 con­firmed symp­to­matic cas­es, 850 of the cas­es were in the place­bo group and 77 were in the group giv­en BNT162b2, good for a vac­cine ef­fi­ca­cy of 91.3%, ac­cord­ing to a re­lease. Six-month re­sults al­so showed 100% ef­fi­ca­cy in pre­vent­ing se­vere dis­ease.

Vac­cine safe­ty has now been eval­u­at­ed in 44,000 par­tic­i­pants ages 16 and up. Sci­en­tists have deemed the vac­cine 100% ef­fec­tive in South Africa, where the B.1.351 vari­a­tion is preva­lent.

“The high vac­cine ef­fi­ca­cy ob­served through up to six months fol­low­ing a sec­ond dose and against the vari­ant preva­lent in South Africa pro­vides fur­ther con­fi­dence in our vac­cine’s over­all ef­fec­tive­ness,” Pfiz­er CEO Al­bert Bourla said in a state­ment.

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

Aduhelm OK 'bit­ter­sweet' for ALS ad­vo­cates; Con­trast­ing Covid-19 vac­cine read­outs; GSK joins TIG­IT bat­tle; 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.

With the busiest days of June now behind us, we’re starting to think seriously about the second half of the year. In August, we have scheduled a special report where Endpoints will compile a list of the 20 most influential R&D executives in biopharma. Know a luminary who should definitely be included? Nominate them now.

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In­side Track: Be­hind the Scenes of a Ma­jor Biotech SPAC

Dr. David Hung and Michelle Doig are no strangers to the SPAC phenomenon. As Founder and CEO of Nuvation Bio, a biotech company tackling some of the greatest unmet needs in oncology, Dr. Hung recently took the company public in one of this year’s biggest SPAC related deals. And as Partner at Omega Funds, Doig not only led and syndicated Nuvation Bio’s Series A, but is now also President of the newly formed, Omega-sponsored, Omega Alpha SPAC (Nasdaq: OMEG; oversubscribed $138m IPO priced January 6, 2021).

Michael Chambers (L) and John Ballantyne

Dana­her strikes deal to buy boom­ing next-gen man­u­fac­tur­er Alde­vron for $9.6B

Life sciences conglomerate Danaher Corp. $DHR has struck a deal to buy the fast-growing Aldevron, one of the world’s top manufacturers of hotly sought-after plasmid DNA, mRNA and recombinant proteins for the burgeoning world of vaccine and drugmakers pushing some game-changing technologies.

Buyout talks set the stage for Danaher to settle on a $9.6 billion cash pact to acquire the private Fargo, ND-based company — a key supplier for a disruptive new Covid vaccine as well as a host of gene and cell therapy and CRISPR gene editing players — founded by Michael Chambers and CSO John Ballantyne as a crew of 2 back in 1998.

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Who are the lu­mi­nar­ies dri­ving the biggest ad­vances in bio­phar­ma R&D? End­points News is ask­ing for your nom­i­na­tions for a spe­cial re­port

In biopharma, driving a drug to market is the ultimate goal — but none of that happens without a strong research and development program. At the most successful companies, those R&D efforts are spearheaded by true innovators in the field who are always looking for that next novel mechanism of action or breakthrough safety profile.

Now, Endpoints News is asking you to tell us who those guiding lights are.

Bris­tol My­ers breaks the bank on Ei­sai's fo­late re­cep­tor ADC drug, lay­ing out more than $3B+ for rights

For years, innovation in oncology has been a crapshoot with Big Pharma — the whales at the table — dropping the big bucks for the key to the next generation of tumor fighters. Bristol Myers Squibb hasn’t exactly made a name for being an innovator in the space, but that doesn’t mean it won’t splash in when it sees a potential winner.

Now, with a massive check in hand, the drugmaker is willing to put its intuition to the test.

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President Biden (AP Images)

Biden in­vests $3B in­to an­tivi­ral de­vel­op­ment for Covid-19

The Biden administration on Thursday unveiled a new plan to invest more than $3 billion into speeding new antivirals to treat Covid-19.

The plan will allow NIH to evaluate, prioritize and advance antiviral candidates to Phase II clinical trials, using contractors and the NIH’s National Center for Advancing Translational Sciences laboratories to de-risk early stage development.

“New antivirals that prevent serious COVID-19 illness and death, especially oral drugs that could be taken at home early in the course of disease, would be powerful tools for battling the pandemic and saving lives,” said NIAID director Anthony Fauci.

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Covid-19 man­u­fac­tur­ing roundup: As the US gov­ern­ment bags an­oth­er 100M dos­es of Mod­er­na shot, the biotech is chip­ping in on UAE roll­out

President Joe Biden’s administration has ordered another round of shots.

Moderna and the US government have reached a deal that will provide the company with another 200 million doses of its Covid-19 vaccine, and include the option to purchase other candidates from the company’s pipeline, Moderna announced Wednesday. The agreement brings the total number of Moderna shots to 500 million. Another 110 million will be delivered in Q4 of 2021 and 90 million are expected in Q1 of 2021.

FDA's con­tro­ver­sial Aduhelm de­ci­sion leaves ALS pa­tients feel­ing spurned

The FDA’s controversial approval of Biogen’s Aduhelm drug for Alzheimer’s disease has been met with fierce resistance from all corners of the biopharma industry, but few seem to be as upset with the decision as ALS patients and advocacy groups.

For all that’s already been written and discussed about the agency’s announcement, from the drug’s exorbitantly high price of $56,000 per year to criticism over lowered standards, ALS patients see something more. ALS patients and associations say they largely regarded Aduhelm’s approval as a bittersweet double standard: happy that those with Alzheimer’s have a new drug available, but questioning how the FDA evaluated Biogen’s drug compared to the experimental programs being studied for their own disease.

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Spring reg­u­la­to­ry agen­da: What’s com­ing soon-ish from the FDA

The FDA’s lack of a permanent commissioner does not seem to be halting its progress to propose and finalize dozens of new regulations, with the latest batch covering everything from adverse event reporting to supplemental application submissions to annual reports for INDs.

Overall, FDA expects to release more than 40 new proposed regulations and finalize another 24 in the coming months and years.

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