Covid-19 roundup: As­traZeneca cuts Q1 vac­cine sup­ply to EU by a third — re­port; Sanofi, Trans­late ush­er an­oth­er mR­NA shot in­to clin­ic

Ten­sions be­tween As­traZeneca and the EU are far from set­tling, as the phar­ma re­port­ed­ly plans to cut sup­ply of its Ox­ford-part­nered vac­cine to the bloc by about a third in the first quar­ter.

Ac­cord­ing to doc­u­ments re­viewed by Reuters, As­traZeneca now plans to de­liv­er about 30 mil­lion dos­es to the EU by the end of March, as op­posed to the 90 mil­lion ini­tial­ly promised in its con­tract. An­oth­er 20 mil­lion dos­es are now set to come in April, Reuters re­port­ed.

The news comes as the EU’s vac­cine roll­out lags be­hind sched­ule. In late Jan­u­ary, As­traZeneca no­ti­fied the bloc that it would de­liv­er over 60% few­er dos­es than promised, blam­ing pro­duc­tion at a Bel­gian fac­to­ry. The EU had al­ready been deal­ing with de­lays of the Pfiz­er/BioN­Tech vac­cine, with coun­tries like Italy and Poland threat­en­ing to take le­gal ac­tion against the de­vel­op­ers.

As­traZeneca CEO Pas­cal So­ri­ot has main­tained that the con­tract was based on a “best-ef­fort” de­liv­ery clause, which was ap­par­ent­ly con­firmed by unredact­ed por­tions of the phar­ma’s sup­ply con­tract un­cov­ered by Ger­man jour­nal­ists. The EU lat­er apol­o­gized for leav­ing por­tions of the con­tract unredact­ed.

“I see ef­forts, but not ‘best ef­forts,’” EU in­dus­try com­mis­sion­er Thier­ry Bre­ton post­ed on Twit­ter Thurs­day. “That’s not good enough yet for@As­traZeneca to meet its Q1 oblig­a­tions.”

Last week, Italy and the EC blocked the ship­ment of about 250,000 dos­es of the As­traZeneca/Ox­ford vac­cine in­tend­ed for Aus­tralia, the first such in­ter­ven­tion in vac­cine ex­ports since the EU in­tro­duced new rules gov­ern­ing such ship­ments in late Jan­u­ary. — Nicole De­Feud­is

Sanofi, Trans­late ush­er an­oth­er mR­NA shot in­to clin­ic

As Pfiz­er/BioN­Tech and Mod­er­na rack up more pos­i­tive da­ta for their mR­NA vac­cines and set sights on ver­sions 2.0, Sanofi and its part­ners at Trans­late Bio are ready to put a new can­di­date in­to the clin­ic.

In­ves­ti­ga­tors will re­cruit 415 pa­tients for the Phase I/II tri­al of MRT5500, which is de­signed to tar­get the orig­i­nal SARS-CoV-2 anti­gen. The part­ners say they are run­ning pre­clin­i­cal stud­ies for ad­di­tion­al ex­per­i­men­tal vac­cines against emerg­ing vari­ants.

In­ter­im re­sults are ex­pect­ed in Q3.

For Sanofi, launch­ing the tri­al rep­re­sents an­oth­er big move af­ter they fi­nal­ly got a Phase II tri­al off the ground with a ‘re­fined’ for­mu­la­tion of a re­com­bi­nant-pro­tein boost­ed with a Glax­o­SmithK­line ad­ju­vant. It fol­lowed a lengthy de­lay due to weak im­mune re­spons­es in an ear­li­er study.

The com­pa­nies note that they’re al­so work­ing to im­prove the tem­per­a­ture sta­bil­i­ty of their can­di­date, with a tar­get of -20°C stor­age tem­per­a­ture for late-stage clin­i­cal tri­als and at launch — and go even fur­ther to store it at rou­tine re­frig­er­a­tor tem­per­a­ture (2-8°C). — Am­ber Tong

Thai­land slams brakes on roll­out of As­traZeneca/Ox­ford vac­cine

Thai­land has joined a grow­ing list of coun­tries sus­pend­ing the use of As­traZeneca and Ox­ford Uni­ver­si­ty’s vac­cine due to re­ports of blood clots.

The Asian coun­try is the first out­side Eu­rope to do so, Reuters re­port­ed.

Aus­tria pulled a spe­cif­ic batch of the shot on Sun­day af­ter a 49-year-old woman died of “se­vere co­ag­u­la­tion dis­or­ders,” and an­oth­er 35-year-old woman suf­fered a pul­monary em­bolism, ac­cord­ing to the coun­try’s Fed­er­al Of­fice for Safe­ty in Health Care (BASG).

“Based on the known clin­i­cal da­ta, a causal re­la­tion­ship can­not be es­tab­lished, as throm­bot­ic events in par­tic­u­lar are not among the known or typ­i­cal side ef­fects of the vac­cine in ques­tion,” the BASG said in a state­ment. “The im­me­di­ate­ly ini­ti­at­ed in­ter­na­tion­al analy­sis of side ef­fect re­ports al­so shows no ac­cu­mu­la­tion of sim­i­lar case re­ports so far.”

Es­to­nia, Latvia, Lithua­nia and Lux­em­bourg have all sus­pend­ed use of the same batch as Aus­tria, ac­cord­ing to BBC. Italy pulled dif­fer­ent batch­es as Aus­tria. And Den­mark, Nor­way and Ice­land have all tem­porar­i­ly paused roll­out of the vac­cine.

The EMA is cur­rent­ly re­view­ing the cas­es, and said in a state­ment on Wednes­day that there’s no ev­i­dence the vac­cines caused the events.

“The in­for­ma­tion avail­able so far in­di­cates that the num­ber of throm­boem­bol­ic events in vac­ci­nat­ed peo­ple is no high­er than that seen in the gen­er­al pop­u­la­tion,” the EMA’s safe­ty com­mit­tee PRAC said.

Thai­land re­ceived more than 117,000 dos­es of the vac­cine last week, the first of which was sup­posed to go out to­day, Reuters re­port­ed.

“As­traZeneca is still a good vac­cine but with what has hap­pened … the health min­istry based on this ad­vice would like to post­pone the us­age of the As­traZeneca vac­cine mo­men­tar­i­ly,” Ki­at­ti­phum Wongjit, per­ma­nent sec­re­tary for the coun­try’s Pub­lic Health Min­istry, said per Reuters.

Mean­while, nu­mer­ous coun­tries in­clud­ing France, Ger­many, Cana­da, Aus­tralia, the Philip­pines and South Ko­rea have said they’ll go ahead with the vac­cine, ac­cord­ing to BBC and Reuters. — Nicole De­Feud­is

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

Qual­i­ty Con­trol in Cell and Gene Ther­a­py – What’s Re­al­ly at Stake?

In early 2021, Bluebird Bio was forced to suspend clinical trials of its gene therapy for sickle cell disease after two patients in the trial developed cancer. As company scientists rushed to assess whether there was any causal link between the therapy and the cancer cases, Bluebird’s stock value plummeted – as did those of multiple other biopharma companies developing similar therapies.

While investigations concluded that the gene therapy was unlikely to have caused cancer, investors and the public may be more skittish regarding the safety of gene and cell therapies after this episode. This recent example highlights how delicate the fields of cell and gene therapy remain today, even as they show great promise.

Novavax CEO Stanley Erck at the White House in 2020 (Andrew Harnik, AP Images)

As fears mount over J&J and As­traZeneca, No­vavax en­ters a shaky spot­light

As concerns rise around the J&J and AstraZeneca vaccines, global attention is increasingly turning to the little, 33-year-old, productless, bankruptcy-flirting biotech that could: Novavax.

In the now 16-month race to develop and deploy Covid-19 vaccines, Novavax has at times seemed like the pandemic’s most unsuspecting frontrunner and at times like an overhyped also-ran. Although they started the pandemic with only enough cash to last 6 months, they leveraged old connections and believers into $2 billion and emerged last summer with data experts said surpassed Pfizer and Moderna. They unveiled plans to quickly scale to 2 billion doses. Then they couldn’t even make enough material to run their US trial and watched four other companies beat them to the finish line.

Law pro­fes­sors call for FDA to dis­close all safe­ty and ef­fi­ca­cy da­ta for drugs

Back in early 2018 when Scott Gottlieb led the FDA, there was a moment when the agency seemed poised to release redacted complete response letters and other previously undisclosed data. But that initiative never gained steam.

Now, a growing chorus of researchers are finding that a dearth of public data on clinical trials and pharmaceuticals means industry and the FDA cannot be held accountable, two law professors from Yale and New York University write in an article published Wednesday in the California Law Review.

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FDA of­fers scathing re­view of Emer­gent plan­t's san­i­tary con­di­tions, em­ploy­ee train­ing af­ter halt­ing pro­duc­tion

The FDA wrapped up its inspection of Emergent’s troubled vaccine manufacturing plant in Baltimore on Tuesday, after halting production there on Monday. By Wednesday morning, the agency already released a series of scathing observations on the cross contamination, sanitary issues and lack of staff training that caused the contract manufacturer to dispose of millions of AstraZeneca and J&J vaccine doses.

Brad Bolzon (Versant)

Ver­sant pulls the wraps off of near­ly $1B in 3 new funds out to build the next fleet of biotech star­tups. And this new gen­er­a­tion is built for speed

Brad Bolzon has an apology to offer by way of introducing a set of 3 new funds that together pack a $950 million wallop in new biotech creation and growth.

“I want to apologize,” says the Versant chairman and managing partner, laughing a little in the intro, “that we don’t have anything fancy or flashy to tell you about our new fund. Same team, around the same amount of capital, same investment strategy. If it ain’t broke, don’t fix it.”

But then there’s the flip side, where everything has changed. Or at least speeded into a relative blur. Here’s Bolzon:

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Sen. Patty Murray (D-WA) (Graeme Sloan/Sipa USA/Sipa via AP Images)

Sen­a­tors to NIH: Do more to pro­tect US bio­med­ical re­search from for­eign in­flu­ence

Although Thursday’s Senate health committee hearing was focused on how foreign countries and adversaries might be trying to steal or negatively influence biomedical research in the US, the only country mentioned by the senators and expert witnesses was China.

Committee chair Patty Murray (D-WA) made clear in her opening remarks that the US cannot “let the few instances of bad actors” overshadow the hard work of the many immigrant researchers in the US, many of which have won Nobel prizes for their work. But she also said, “There is more the NIH can be doing here.”

Covid-19 man­u­fac­tur­ing roundup: Mary­land looks to grow biotech ca­pac­i­ty with $400M check; Rus­sia lands sec­ond Sput­nik V part­ner this week

A Maryland real estate project has added three new biotech-focused manufacturing and research buildings to an office park to keep up with demand created by the pandemic, the Washington Business Journal reported.

The Milestone Business Park — located off of I-270 in Germantown, MD — will see the new buildings and a total of 532,000 square feet as the campus rebrands to Milestone Innovation Park.

In a sup­ply chain short­age workaround, Aus­trali­a's Vic­to­ria state aims to build its own mR­NA fa­cil­i­ty

As countries all around the world have experienced troubles with vaccine shortages, Australia’s Victoria state is developing its own mRNA manufacturing facility in an effort to up its number of vaccinated residents.

Victoria will spend $39 million to set up the facility, which could be the first in the southern hemisphere, Reuters reported. The mRNA technology is used in the Pfizer-BioNTech and Moderna vaccines, and has gotten more attention, as adenovirus-based vaccines from AstraZeneca and J&J have had reports of rare, but similar blood clots in some patients. There have been no reports of major side effects in either Moderna or Pfizer’s jab.

Jenny Rooke (Genoa Ventures)

Ear­ly Zymer­gen in­vestor Jen­ny Rooke re­flects on 'chimeras' in biotech, what it takes to spot a $500M gem

When Jenny Rooke first heard of Zymergen back in 2014, she knew she was looking at something different and exciting. The Emeryville, CA biotech held the promise of blending biology and technology to solve a huge unmet need for cost-effective chemicals — of all things — and a stellar founding team to boot.

But back then, West Coast venture capitalists didn’t see in Zymergen the one thing they were looking for in a winning biotech: therapeutic potential. Rooke, however, saw an opportunity and made her bets. Seven years later, that bet is paying off in a big way.

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