Ursula von der Leyen (AP Images)

Covid-19 roundup: Fac­ing sup­ply de­lay, UK fires shot at Eu­rope af­ter EU threat­ens to ban As­traZeneca vac­cine ex­ports

In the wake of Brex­it, lin­ger­ing ten­sion be­tween Britain and the EU has on­ly grown more pro­nounced with the bumpy roll­out of As­traZeneca’s Covid-19 vac­cine. Now, the for­mer mem­ber state is at odds with the con­ti­nent over ex­ports re­lat­ed to the shot.

Eu­ro­pean Com­mis­sion head Ur­su­la von der Leyen threat­ened on Wednes­day to ban EU ex­ports of Covid-19 vac­cines to Britain in or­der to en­sure mem­ber states had enough ac­cess, as the con­ti­nent is see­ing an emerg­ing third wave of the virus and more than a dozen Eu­ro­pean na­tions sus­pend­ed use of the As­traZeneca shot.

“We are still wait­ing for dos­es to come from the UK,” von der Leyen said, per Reuters. She lat­er added, “If this sit­u­a­tion does not change, we will have to re­flect on how to make ex­ports to vac­cine-pro­duc­ing coun­tries de­pen­dent on their lev­el of open­ness.”

That prompt­ed a harsh re­buke from British health min­is­ter Matt Han­cock, who as­sert­ed the UK has a le­gal right to the shots be­cause they helped fund, de­vel­op and set up the As­traZeneca sup­ply chain.

As­traZeneca has been in hot wa­ter for the last few months, af­ter say­ing ear­li­er this year that they would not be able to meet the num­ber of vac­cines orig­i­nal­ly promised in their con­tracts. Ad­di­tion­al­ly, re­ports of blood clots are caus­ing sev­er­al coun­tries — in­clud­ing Ger­many, Nor­way and Den­mark — to tem­porar­i­ly halt the roll­out of As­traZeneca’s Covid-19 vac­cine.

The tit-for-tat be­tween von der Leyen and Han­cock comes as the UK gov­ern­ment said Thurs­day that dis­tri­b­u­tion of the As­traZeneca/Ox­ford Uni­ver­si­ty shots will be slow­er than orig­i­nal­ly hoped due to a lack of sup­ply an­tic­i­pat­ed at the end of the month, ac­cord­ing to Reuters.

UK health of­fi­cials had not giv­en a rea­son for the slow­down, though As­traZeneca and Pfiz­er said that they’re both on sched­ule and their sup­ply chains are not ex­pe­ri­enc­ing any dis­rup­tion. But it emerged ear­ly Thurs­day that the short­fall is in part due to a de­lay in de­liv­ery from the Serum In­sti­tute of In­dia.

Per the BBC, a ship­ment of five mil­lion dos­es has been held up for at least four weeks. The goal had been to ship the vac­cines some­time this month, but there was no spe­cif­ic time out­lined for the de­liv­ery.

UK hous­ing sec­re­tary Robert Jen­rick told the net­work that nei­ther a sin­gle fac­to­ry nor a coun­try was re­spon­si­ble for sup­ply is­sues. He added that the coun­try’s goal to of­fer shots to every­one over 50 by April 15 will not be af­fect­ed by the de­lay.

But the UK is al­so draw­ing crit­i­cism for or­der­ing vac­cines from a com­pa­ny that is a promi­nent sup­pli­er of CO­V­AX, the or­ga­ni­za­tion pro­vid­ing vac­cines to low- and mid­dle-in­come coun­tries.

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.

Endpoints Premium

Premium subscription required

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

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:

Endpoints Premium

Premium subscription required

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

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 107,500+ biopharma pros reading Endpoints daily — and it's free.