As­traZeneca/Ox­ford score first vote of con­fi­dence as UK au­tho­rizes their Covid-19 vac­cine

As­traZeneca and Ox­ford have land­ed the first au­tho­riza­tion for their Covid-19 vac­cine. And with this par­tic­u­lar shot, the UK may be much fur­ther ahead than the rest of the world.

The MHRA rec­om­mend­ed an emer­gency OK to the UK gov­ern­ment al­most two months af­ter it start­ed a rolling re­view — al­though the de­vel­op­ers on­ly sub­mit­ted the full ap­pli­ca­tion last week. Reg­u­la­tors have de­ter­mined that “the vac­cine has met its strict stan­dards of safe­ty, qual­i­ty and ef­fec­tive­ness,” ac­cord­ing to a state­ment, even though ex­perts in oth­er coun­tries have raised ques­tions.

While da­ta from a sub­group sug­gest­ed that a reg­i­men in which peo­ple first re­ceive a half dose, fol­lowed by a full dose has a high­er ef­fi­ca­cy fig­ure at 90%, the MHRA gave the thumbs up to the 62% ef­fec­tive full-full dose reg­i­men, which is sup­port­ed by more ev­i­dence from two tri­als con­duct­ed in the UK and South Africa.

Hav­ing be­come the first coun­try to au­tho­rize and start ad­min­is­ter­ing the Pfiz­er/BioN­Tech vac­cine, the UK has or­dered enough of that mR­NA jab for 20 mil­lion peo­ple. Its deal with As­traZeneca now gives it ac­cess to an­oth­er 50 mil­lion ade­n­ovirus-based vac­cines, more than enough to vac­ci­nate a pop­u­la­tion of 66 mil­lion-plus.

The OK trig­gers an im­me­di­ate re­lease of its batch­es, As­traZeneca said, and mil­lions of dos­es will be ready for vac­ci­na­tion ear­ly in the new year.

No­tably, the two dos­es of its vac­cine — dubbed ChA­dOx1 nCoV-19 and AZD1222 at var­i­ous points of its short life — can be giv­en four to 12 weeks apart. Ac­cord­ing to ear­li­er com­ments by Adar Poon­awal­la, CEO of the Serum In­sti­tute of In­dia, giv­ing them 2 to 3 months apart boosts the ef­fi­ca­cy to 95% (his com­pa­ny is mass-man­u­fac­tur­ing the vac­cine). By com­par­i­son, doc­tors are rec­om­mend­ed to give the sec­ond dose of Pfiz­er/BioN­Tech’s BNT162b2, now chris­tened Comir­naty, 21 days af­ter the first.

UK au­thor­i­ties made no ref­er­ence to that claim but said that means they can pri­or­i­tize giv­ing one, par­tial­ly pro­tec­tive As­traZeneca/Ox­ford vac­cine to as many peo­ple as pos­si­ble, with­out hav­ing to rush to the next shot.

Matt Han­cock, the Sec­re­tary of State for Health and So­cial Care, called it “a mo­ment to cel­e­brate British in­no­va­tion.”

Oth­er coun­tries, though, haven’t been as en­thu­si­as­tic. Mon­cef Slaoui, the sci­en­tif­ic chief of Op­er­a­tion Warp Speed, has re­marked that As­traZeneca would like­ly need the re­sults from its US tri­al to file for an emer­gency use au­tho­riza­tion with the FDA. In­dia had passed on grant­i­ng an ear­ly OK to As­traZeneca. Ear­li­er this week, a top EMA of­fi­cial not­ed that Eu­ro­pean au­thor­i­ties have yet to re­ceive the non-clin­i­cal da­ta nec­es­sary to con­firm vac­cine “qual­i­ty” for au­tho­riza­tion, mean­ing they like­ly can’t make a de­ci­sion any time soon.

For its part, As­traZeneca has been tout­ing the sta­bil­i­ty — it can be stored, trans­port­ed and han­dled at nor­mal re­frig­er­a­tor tem­per­a­tures of 2-8 de­grees Cel­sius — and the low cost of its vac­cine as it makes plans to sup­ply bil­lions of vac­cines to less de­vel­oped re­gions.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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Can strug­gling Iterum turn the cor­ner to an an­tibi­ot­ic suc­cess sto­ry? They will know in six months

More than five years after Corey Fishman and Michael Dunne dusted sulopenem off Pfizer’s shelves — the second castoff antibiotic they’ve brought out of the pharma giant — and founded Iterum Therapeutics around that single drug, they have lined up a quick shot at approval with priority review from the FDA.

The decision, six months from now, will mark a make-or-break moment for a struggling biotech that has just enough cash to keep the lights on until the third quarter.

Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

Covid-19 roundup: Mod­er­na dou­bles down on Covid-19 with new boost­er tri­als; Aus­tralia plans do­mes­tic pro­duc­tion of As­traZeneca vac­cine amid dis­tri­b­u­tion lag

As Merck bows out of the global race to develop vaccines for Covid-19, Moderna is doubling down to make sure they can quell new variants that have recently emerged and quickly spread.

The Cambridge, MA-based biotech put out word on Monday that in vivo studies indicate their mRNA vaccine works well enough against two strains first detected in the UK and South Africa. But with a six-fold reduction in neutralizing titers observed against the latter strain, the company is launching a new study of a booster version to make sure it can do the job.

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Ron Cooper, Albireo CEO

Al­bireo just ad­vanced down to the 10-yard line at the FDA. And Ron Coop­er’s team is get­ting prepped for the next big play

When Albireo Pharma’s board $ALBO moved to bring in Ron Cooper as the CEO more than 5 years ago, the development-stage company went with an experienced commercial player who had a big-time position on his resume after running Bristol Myers’ commercial ops in Europe.

Now, after successfully navigating a pivotal study, putting them in a foot race with a rival toward an FDA OK, Cooper is getting a boost from regulators on the last drive back to an arena he understands completely.

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Bahija Jallal, Immunocore

Buried in Im­muno­core's IPO fil­ings? A kick­back scheme from a now for­mer em­ploy­ee

Immunocore spent much of 2019 dealing with the fallout of the Neil Woodford scandal, as the former star investor’s fall crashed the biotech’s valuation out of unicorn range. Now it turns out that the company spent 2020 dealing with another internal scandal.

The longtime UK biotech darling disclosed in their IPO filing last week that they had fallen victim to an alleged kickback scheme involving one of their employees. After a whistleblower came forward, they said in their F-1, they spent the summer and spring investigating, finding fraud on the part of an employee and two outside vendors.

Matt Gline (L) and Vivek Ramaswamy

Scoop: Vivek Ra­maswamy is hand­ing the CEO job to a top lieu­tenant at Roivant — but he’s not ex­act­ly leav­ing the biotech scene

Over the past 7 years since founding Roivant, Vivek Ramaswamy has been a constant blur of biotech building motion.

He launched his first biotech with an Alzheimer’s drug he picked up cheap, and watched the experiment implode in one of the highest profile pivotal disasters seen in the last decade. But it didn’t slow the 30-something exec down; if anything, he hit the accelerator. Ramaswamy blazed global paths and went on to raise billions to spur the creation of a large lineup of little Vants promising big things at a fast pace. He sold off a section of the Vant brigade to Sumitomo Dainippon for $3 billion. And more recently the relentless dealmaker has been building a computational discovery arm to add an AI-driven approach to kicking up new programs and companies, supplementing the in-licensing drive while pursuing advances that have created more than 700 jobs at Roivant, with $2 billion in reserves.

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Jean-Christophe-Hyvert, Lonza

Lon­za look­ing to build on 'd­if­fer­en­ti­at­ed ad­van­tage' in Covid-19, CD­MO mar­ket­place in 2021

It’s not new for Lonza, the Swiss CDMO nearing its quasquicentennial anniversary, to be in the upper echelon of the biotech manufacturing industry.

But 2020 — as it was for many CDMOs — was a special year even by Lonza’s standards. The company inked a deal to produce 1 billion worldwide doses of Moderna’s Covid-19 vaccine and tapped pharma vet Pierre-Alain Ruffieux to lead its operations, moves which have allowed Lonza to make a myriad of other deals that will continue to ramp up its global production capacity.

News brief­ing: Jef­frey Lei­den to chair Tmu­ni­ty board of di­rec­tors; Op­di­vo wins new ap­proval in ad­vanced RCC

Longtime Vertex CEO Jeffrey Leiden is taking on a new role.

Leiden has been appointed chairman of Tmunity’s board of directors, the company announced Monday. The move comes about a year and a half after Leiden announced he’d be stepping down from his position at Vertex.

Vertex saw immense growth under Leiden, leading the company from its exit out of hepatitis C, when cures were moving in, and into cystic fibrosis. The company’s cystic fibrosis triple combo therapy Trikafta is already its best-seller, reaching the distinction just six weeks after launch and recording the strongest first quarter of sales for any drug, per some estimates.