As­traZeneca ex­pects US vac­cine da­ta ‘soon’ — with 50M dos­es ready by the end of April

As­traZeneca said it’s ready­ing the re­lease of da­ta from its US-based Phase III tri­al, which has more than 32,000 par­tic­i­pants, for its up­com­ing emer­gency use au­tho­riza­tion ap­pli­ca­tion.

“We ex­pect da­ta from our US Phase III tri­al to be avail­able soon, in the com­ing weeks, and we plan to file for emer­gency use au­tho­riza­tion short­ly there­after,” a com­pa­ny spokesper­son said via email.

A snap de­ci­sion on the vac­cine would put the US months be­hind the EU in au­tho­riz­ing it, but re­cent con­cerns about blood clots pushed Nor­way, Den­mark and Ice­land to halt the vac­cine’s use. The Eu­ro­pean Med­i­cines Agency, how­ev­er, not­ed, “As of 9 March 2021, 22 cas­es of throm­boem­bol­ic events had been re­port­ed among the 3 mil­lion peo­ple vac­ci­nat­ed with COVID-19 Vac­cine As­traZeneca in the Eu­ro­pean Eco­nom­ic Area.”

Es­to­nia, Lithua­nia, Lux­em­bourg, Latvia have sus­pend­ed one par­tic­u­lar batch (1 mil­lion dos­es) of the vac­cine, which was de­liv­ered to 17 EU coun­tries. Still, oth­er coun­tries are seek­ing dos­es of the vac­cine.

In Fri­day’s Covid-19 press brief­ing with the Biden ad­min­is­tra­tion, a Reuters re­porter asked about the un­will­ing­ness of the US to share some of its sup­plies of the As­traZeneca vac­cine (the New York Times al­so re­port­ed Fri­day on its front page that the US is hoard­ing about 30 mil­lion of dos­es of the As­traZeneca vac­cine). And As­traZeneca’s spokesper­son con­firmed that it was aware of oth­er gov­ern­ments that may have reached out to the US gov­ern­ment about do­nat­ing dos­es, “and we’ve asked the US gov­ern­ment to give thought­ful con­sid­er­a­tion to these re­quests. If those do­na­tion ac­tions were to pro­ceed, we would seek guid­ance from the US Gov­ern­ment on re­place­ment of dos­es for use in the US.”

As far as how many dos­es are to be ex­pect­ed in the com­ing months in the US, should the vac­cine win an au­tho­riza­tion, the As­traZeneca spokesper­son said: “We be­lieve we will have rough­ly 30 mil­lion dos­es avail­able to the US gov­ern­ment by the end of March, and an­oth­er 20 mil­lion, for a to­tal of up to 50 mil­lion, by the end of April.”

And the Biden ad­min­is­tra­tion is mak­ing clear that it has no in­ten­tion of giv­ing those dos­es up right now.

Jeff Zients, Biden’s coro­n­avirus czar, told re­porters on Fri­day:

As to As­traZeneca, we’re fol­low­ing the ex­act same process that we did with the oth­er three now-ap­proved vac­cines — Mod­er­na, Pfiz­er, and J&J. And just as we did with those vac­cines, as we await­ed for the com­ple­tion of the clin­i­cal tri­al — and right now, my un­der­stand­ing is that As­traZeneca is in the mid­dle of its phase three tri­al — and then an FDA de­ter­mi­na­tion of when they sub­mit the da­ta from the clin­i­cal tri­al, we have a small in­ven­to­ry of As­traZeneca so that, if ap­proved, we can get that in­ven­to­ry out to the Amer­i­can peo­ple as quick­ly as pos­si­ble, as we just did with J&J.  So, As­traZeneca, we’re await­ing the clin­i­cal tri­al and then the de­ci­sion by the FDA and CDC.

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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