Covid-19 roundup: Ger­many sus­pends As­traZeneca vac­cine as British drug­mak­er de­fends shot amid blood clot scare

Fol­low­ing a raft of fel­low EU mem­bers sus­pend­ing use of the As­traZeneca/Ox­ford Covid-19 vac­cine, Ger­many has be­come the lat­est to pause dis­tri­b­u­tion of the shot.

The Ger­man gov­ern­ment said Mon­day it’s sus­pend­ing ad­min­is­tra­tion of the vac­cine af­ter re­ports of blood clots prompt­ed oth­er Eu­ro­pean na­tions to tem­porar­i­ly stop giv­ing the vac­cines to its cit­i­zens, the AP re­port­ed. As the de fac­to Eu­ro­pean eco­nom­ic pow­er­house, Ger­many be­comes the high­est-pro­file coun­try to en­dorse fur­ther in­ves­ti­ga­tion of the blood clot cas­es.

Ger­many’s health min­istry said the move was tak­en as a “pre­cau­tion” and called for fur­ther in­ves­ti­ga­tion of the events.

Con­cerns over the blood clots first emerged last week af­ter two pa­tients in Aus­tria de­vel­oped throm­bot­ic events, in­clud­ing a pul­monary em­bolism. Since then, sev­er­al coun­tries have sus­pend­ed use of the shot. — Max Gel­man

As­traZeneca de­fends vac­cine af­ter sus­pen­sions and re­ports of blood clots

Amid a pan­icked round of vac­cine sus­pen­sions trig­gered by re­ports of blood clots among those giv­en the As­traZeneca-Ox­ford shot, the British drug­mak­er has come out to clear the pub­lic record.

As­traZeneca’s state­ment, like a sep­a­rate re­sponse re­leased by the UK’s MHRA on Sun­day, em­pha­sized there’s no ev­i­dence sug­gest­ing that the ade­n­ovirus-based vac­cine had caused those throm­bot­ic events.

On Mon­day, the Nether­lands be­came the lat­est coun­try to pause use of the vac­cine, fol­low­ing in the foot­steps of oth­er Eu­ro­pean coun­tries like Den­mark, Ire­land and Bul­gar­ia. The con­cerns about blood clots reached as far as Thai­land, where au­thor­i­ties de­layed the roll­out for sev­er­al days.

Cit­ing a “care­ful re­view of all avail­able safe­ty da­ta” from more than 17 mil­lion vac­ci­nat­ed in the EU and UK, As­traZeneca not­ed that there have been 15 re­port­ed cas­es of deep vein throm­bo­sis and 22 of pul­monary em­bolism as of March 8.

“This is much low­er than would be ex­pect­ed to oc­cur nat­u­ral­ly in a gen­er­al pop­u­la­tion of this size and is sim­i­lar across oth­er li­censed COVID-19 vac­cines,” the com­pa­ny wrote in a state­ment. CMO Ann Tay­lor added that usu­al­ly you would ex­pect hun­dreds of cas­es among the same num­ber of peo­ple.

In fact, in clin­i­cal tri­als, the num­ber of throm­bot­ic events were low­er in the vac­ci­nat­ed group ver­sus the place­bo group — al­though the num­bers are small there.

Per­haps in re­sponse to some coun­tries opt­ing to sus­pend cer­tain batch­es of their vac­cine, As­traZeneca al­so made a note about qual­i­ty con­trol:

In terms of qual­i­ty, there are al­so no con­firmed is­sues re­lat­ed to any batch of our vac­cine used across Eu­rope, or the rest of the world. Ad­di­tion­al test­ing has, and is, be­ing con­duct­ed by our­selves and in­de­pen­dent­ly by Eu­ro­pean health au­thor­i­ties and none of these re-tests have shown cause for con­cern. Dur­ing the pro­duc­tion of the vac­cine more than 60 qual­i­ty tests are con­duct­ed by As­traZeneca, its part­ners and by more than 20 in­de­pen­dent test­ing lab­o­ra­to­ries. All tests need to meet strin­gent cri­te­ria for qual­i­ty con­trol and this da­ta is sub­mit­ted to reg­u­la­tors with­in each coun­try or re­gion for in­de­pen­dent re­view be­fore any batch can be re­leased to coun­tries.

Pledg­ing to up­hold trans­paren­cy, they added that a month­ly safe­ty re­port will be made pub­lic on the EMA web­site in the fol­low­ing week.

Phil Bryan, the MHRA vac­cines safe­ty lead, not­ed they are close­ly re­view­ing the re­ports but for now, “Peo­ple should still go and get their COVID-19 vac­cine when asked to do so.” — Am­ber Tong

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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