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.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

FDA warns Proc­ter & Gam­ble over NyQuil la­bel's in­gre­di­ent list­ings

The FDA on Tuesday released a warning letter sent earlier this month to the Mason, OH-based site of Procter & Gamble Manufactura, raising questions about the list of ingredients on the label and in the electronic filing.

The warning says that for P&G’s over-the-counter Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion, there’s a “mismatched” list of active ingredients between the labeling and the electronic listing file. The listing file for the active ingredients did not match the active ingredients in the electronic file.

Andy Plump, Takeda R&D chief (Jeff Rumans for Endpoints News)

What kind of PhI­Ib da­ta is worth $4B cash? Take­da’s Andy Plump has some thoughts on that

A few months back, when Takeda caused jaws to drop with its eye-watering $4 billion cash upfront for a mid-stage TYK2 drug from Nimbus, it had already taken a deep dive on the solid Phase IIb data Nimbus had assembled from its dose-ranging study in psoriasis.

Now, it’s rolling that data out, eager to demonstrate what inspired the global biopharma to go long in a neighboring, but new, disease arena for the pipeline. And the most avid students of the numbers will likely be at Bristol Myers Squibb, who will have a multi-year head start on pioneering the TYK2 space with Sotyktu (deucravacitinib) as Takeda makes its lunge for best-in-class status.

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No­vo Nordisk re­mains un­der UK scruti­ny as MHRA con­ducts its own re­view in 'in­cred­i­bly rare' case

The UK’s Medicines and Healthcare products Regulatory Agency is now reviewing Novo Nordisk’s marketing violation that resulted in its loss of UK trade group membership last week. Novo Nordisk was suspended on Thursday from the Association of the British Pharmaceutical Industry (ABPI) for two years after an investigation by its regulatory arm found the pharma broke its conduct rules.

MHRA said on Tuesday that its review of the Prescription Medicines Code of Practice Authority (PMCPA) investigation is standard practice. An MHRA spokesperson emphasized in an email to Endpoints News that the situation with Novo Nordisk is “incredibly rare” while also noting ABPI took “swift and proportionate action.”

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Growth hor­mone from No­vo Nordisk is in short­age over man­u­fac­tur­ing de­lays

Novo Nordisk’s growth hormone Norditropin is in shortage because of manufacturing delays, according to an FDA site that tracks drug shortages as well as the American Society of Health-System Pharmacists’ shortages list.

The FDA has shortages of the drug listed for its 5, 10, 15 and 30 mg doses, while the pharmacists’ group, also known as ASHP, reported shortages of the same doses, except for the 15 mg version.

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FDA in­di­cates will­ing­ness to ap­prove Bio­gen ALS drug de­spite failed PhI­II study

Ahead of Wednesday’s advisory committee hearing to discuss Biogen’s ALS drug tofersen, the FDA appeared open to approving the drug, newly released briefing documents show.

Citing the need for flexibility in a devastating disease like ALS, regulators signaled a willingness to consider greenlighting tofersen based on its effect on a certain protein associated with ALS despite a failed pivotal trial. The documents come after regulatory flexibility was part of the same rationale the agency expressed when approving an ALS drug last September from Amylyx Pharmaceuticals, indicating the FDA’s openness to approving new treatments for the disease.

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President Joe Biden (AP Photo/Susan Walsh)

Biden signs law re­quir­ing more de­clas­si­fi­ca­tions on Covid-19's ori­gins

President Joe Biden yesterday signed into law a bill requiring the Office of the Director of National Intelligence to declassify information on the origins of Covid-19 within 90 days.

The new law directs the federal government to “declassify any and all information relating to potential links between the Wuhan Institute of Virology and the origin of the Coronavirus Disease 2019”, including information regarding researchers at the lab who fell ill in the fall of 2019 like names, symptoms, and job roles.

Mar­ket­ingRx roundup: What could a US Tik­Tok ban mean for phar­ma? Pfiz­er, Lil­ly lead phar­ma March Mad­ness ad­ver­tis­ers

Just as pharma marketers finally make moves into TikTok, the threat of a US ban on the social media channel is now looming. Already banned on federal employee phones by an initial Congressional act, more bills and maybe bans are on the way. With rare bipartisan agreement, lawmakers have introduced legislation that would give the US president the power to ban TikTok (although not mentioned by name) and other foreign-owned technology platforms that represent a security threat to the US.

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Chat­G­PT with phar­ma da­ta de­buts for med­ical meet­ings, be­gin­ning with AACR

What do you get when you combine ChatGPT generative AI technology with specific pharma and clinical datasets? A time-saving tool that can answer questions about medical conference abstracts and clinical findings in seconds in one new application from ZoomRx called FermaGPT.

ZoomRx is debuting a public version of its generative AI product specifically for medical conferences beginning this week for the upcoming American Association for Cancer Research (AACR) annual meeting that runs April 14-19.

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