Covid-19 man­u­fac­tur­ing roundup: As­traZeneca de­nies stock­pil­ing claims; Vir­chow Biotech to make Sput­nik V vac­cine in In­dia — Reuters

As­traZeneca has de­nied claims that it is stock­pil­ing dos­es of its Covid-19 vac­cine at its Anag­ni plant in Italy.

Ital­ian po­lice of­fi­cers dis­cov­ered 29 mil­lion dos­es of the vac­cine over the week­end, ac­cord­ing to The New York Times. 

“There are no ex­ports cur­rent­ly planned oth­er than to CO­V­AX coun­tries,” the com­pa­ny said in a state­ment. “There are 13 mil­lion dos­es of vac­cine wait­ing for qual­i­ty con­trol re­lease to be dis­patched to CO­V­AX as part of the Com­pa­ny’s com­mit­ment to sup­ply mil­lions of dos­es to low-in­come coun­tries.”

The vac­cine was made out­side of the Eu­ro­pean Union and brought to Anag­ni to be filled in­to vials, the state­ment said. There are plans to re­lease 10 mil­lion dos­es in EU coun­tries dur­ing the last week of March, and the rest to be de­liv­ered in April.

“It is in­cor­rect to de­scribe this as a stock­pile,” the state­ment said. “The process of man­u­fac­tur­ing vac­cines is very com­plex and time con­sum­ing. In par­tic­u­lar, vac­cine dos­es must wait for qual­i­ty con­trol clear­ance af­ter the fill­ing of vials is com­plet­ed.”

As bloc lim­its Covid-19 ex­ports, EU and UK look to end vac­cine bat­tle

Eu­rope and the UK are work­ing to­ward de­fus­ing a fight over vac­cine sup­plies fol­low­ing an EU plan mak­ing it easy to block ex­ports, a re­cent state­ment said.

The two sides are work­ing to ex­pand de­liv­er­ies to in­crease sup­ply for all of its cit­i­zens, a state­ment said.

“In the end, open­ness and glob­al co­op­er­a­tion of all coun­tries will be key to fi­nal­ly over­come this pan­dem­ic and en­sure bet­ter prepa­ra­tion for meet­ing fu­ture chal­lenges,” the state­ment said.

John­son & John­son gains ap­proval to pro­duce Covid-19 vac­cine in US

Catal­ent has been ap­proved to pro­duce John­son & John­son’s Covid-19 vac­cine in its Bloom­ing­ton, In­di­ana, fa­cil­i­ty, ac­cord­ing to Reuters.

The FDA au­tho­rized the vac­cine in Feb­ru­ary, but on­ly for pro­duc­tion in the Nether­lands and a small fill-and-fin­ish plant in the US. The com­pa­ny had promised to de­liv­er 20 mil­lion shots by the end of March.

Vir­chow Biotech to make Sput­nik V vac­cine in In­dia

In­dia’s Vir­chow Biotech has reached an agree­ment with Rus­sia’s RDIF sov­er­eign wealth fund to pro­duce up to 200 mil­lion dos­es a year of the Sput­nik V vac­cine, Reuters re­ports.

The largest drug man­u­fac­tur­ing coun­try in the world, sim­i­lar pro­duc­tion con­tracts have al­so been an­nounced with In­di­an com­pa­nies Gland Phar­ma, Stelis Bio­phar­ma and Het­ero.

Stelis will pro­duce 200 mil­lion dos­es for 100 mil­lion peo­ple, and Gland will pro­duce 252 mil­lion dos­es for 126 mil­lion peo­ple, ac­cord­ing to the RDIF.

In Au­gust, Rus­sia be­came the first com­pa­ny to ap­prove a Covid-19 vac­cine with the an­nounce­ment of Sput­nik V. Sci­en­tists from oth­er coun­tries crit­i­cized the ap­proval, how­ev­er, as it was done with­out a Phase III tri­al.

Drug reg­u­la­tors in In­dia asked de­vel­op­ers for more da­ta in Feb­ru­ary, when Dr. Red­dy’s Lab­o­ra­to­ries Ltd re­quest­ed emer­gency-use ap­proval.

Firms in Brazil, Chi­na and South Ko­rea are al­so pro­duc­ing Sput­nik V.

“In­dia is a true Sput­nik V pro­duc­tion part­ner and vac­cine man­u­fac­tur­ing hub of many vac­cine for the world,” said Suren Mkrtchyan, spokesper­son for the RDIF.

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.

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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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.

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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Why re­mote drug man­u­fac­tur­ing eval­u­a­tions won't re­al­ly re­duce FDA's back­log of in­spec­tions

For the first several months of the pandemic last spring, the FDA continued to plow through its user fee-enabled work on new drug and biologic applications, meeting nearly all of its goal dates.

But by last fall and into the winter, complete response letters and other delays began arriving in companies’ mailboxes as the agency struggled to catch up to a growing backlog of both domestic and foreign drug manufacturing inspections.

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House Committee on Oversight and Reform Chairwoman Carolyn Maloney (Getty Images)

House De­moc­rats call on Emer­gent ex­ecs to tes­ti­fy on qual­i­ty is­sues next month

The House Oversight Committee is investigating Covid-19 vaccine producer Emergent BioSolutions, which secured a $628 million US government contract to make AstraZeneca and J&J vaccines despite “a long, documented history” of quality control issues, Democrats said in a letter to the contract manufacturer’s executives.

Emergent’s Baltimore plant, which was shuttered on Monday by FDA, has been embroiled in controversy after being forced to destroy millions of AstraZeneca and J&J doses due to an ingredient mix-up and possible contamination.

JP Gabriel, Ocugen

JP Gabriel watched from the bleach­ers as the pan­dem­ic raged. Now head of sup­ply chain at Ocu­gen, he's ready to bat

The world was in the middle of the most pressing public health risk his generation had ever seen, and JP Gabriel felt like he was sitting on the sidelines. As a VP of biologics and mRNA manufacturing at Ultragenyx, Gabriel watched from the sidelines as players like Pfizer/BioNTech and Moderna used mRNA tech to chase their own Covid-19 vaccines.

This month, Gabriel got the chance to get his hands dirty against the pandemic — but it won’t be with mRNA.

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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.”