Covid vac­cine roundup: US vac­cine sup­plies grow, but ex­perts warn of po­ten­tial hic­cups in sup­ply chain; Emer­gent touts grow­ing Covid vac­cine ca­pac­i­ty

The Biden ad­min­is­tra­tion has been rais­ing hopes in the US that there will be am­ple vac­cine sup­plies to in­oc­u­late more than 250 mil­lion Amer­i­can adults by May. There have been new deals with Mod­er­na and Pfiz­er to ramp up 400 mil­lion dos­es, to cov­er 200 mil­lion, with 100 mil­lion sin­gle-shot vac­cines from J&J top fin­ish the job.

But some ex­perts are sound­ing a warn­ing that there could be a lot more to this than sim­ply sign­ing con­tracts. Vac­cine man­u­fac­tur­ing is not an easy busi­ness.

“You can be go­ing along and get­ting a cer­tain yield and then all of the sud­den your yield drops and you don’t know why,” vac­cine pro­duc­tion con­sul­tant Robert Van Ex­an tells USA To­day. “Test de­lays or fail­ures, raw ma­te­r­i­al sup­ply chain, lot fail­ures and yield prob­lems are just some of the ex­am­ples of things that can re­sult in sup­ply dis­rup­tions.”

Emer­gent touts abil­i­ty to man­u­fac­ture more than 1B dos­es of Covid vac­cine each year

Af­ter ink­ing a $480 mil­lion deal to sup­ply J&J’s Covid vac­cine for the next 2 years, Emer­gent BioSo­lu­tions says that it has now de­vel­oped enough ca­pac­i­ty to make more than a bil­lion dos­es of vac­cine a year.

“We are op­er­at­ing at a lev­el where our ca­pac­i­ty is well in ac­cess of 1 bil­lion dos­es an­nu­al­ly for those prod­ucts,” CEO Bob Kramer said in a “Mad Mon­ey” in­ter­view.

Emer­gent al­so has an arrange­ment to make As­traZeneca’s vac­cine, which is be­ing dis­trib­uted around the world.

Once the ini­tial roll­out is fin­ished it’s like­ly that we’ll see bil­lions of more boost­er shots on of­fer every year, mark­ing a ma­jor new add-on to the world’s vac­cine busi­ness.

EU au­dit in In­dia could be tied to fresh sup­plies — re­port

EU reg­u­la­tors are au­dit­ing the Serum In­sti­tute of In­dia’s man­u­fac­tur­ing site.

There’s no word in the re­port just why they’re do­ing the au­dit, but Reuters notes that it could be a pre­lim­i­nary step to al­low­ing in sup­plies of As­traZeneca’s vac­cine shot, de­vel­oped with Ox­ford. The SII is mak­ing sup­plies for de­vel­op­ing na­tions, though there have been re­ports that its first du­ty is to sup­ply the sub­con­ti­nent.

As­traZeneca has seen some sig­nif­i­cant back­lash against the vac­cine, as doubts were raised about its ef­fi­ca­cy among old­er peo­ple as well as the new vari­ants that are mak­ing the rounds. Ger­many, though, just cleared it for those over 65, sig­nal­ing a more open at­ti­tude that could spark wider us­age on the con­ti­nent.

WTO wants vac­cine man­u­fac­tur­ers to triple glob­al pro­duc­tion in cri­sis

While vac­cine sup­plies are flow­ing in grow­ing quan­ti­ties to the most af­flu­ent coun­tries, poor na­tions are find­ing them­selves at the back of the line. Now the head of the World Trade Or­ga­ni­za­tion is urg­ing its mem­ber na­tions to ne­go­ti­ate new li­cens­ing deals while push­ing vac­cine man­u­fac­tur­ers to triple pro­duc­tion from the usu­al 3.5 bil­lion vac­cine dos­es a year to 10 bil­lion.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data is messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data is exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

David Lockhart, ReCode Therapeutics CEO

Pfiz­er throws its weight be­hind LNP play­er eye­ing mR­NA treat­ments for CF, PCD

David Lockhart did not see the meteoric rise of messenger RNA and lipid nanoparticles coming.

Thanks to the worldwide fight against Covid-19, mRNA — the genetic code that can be engineered to turn the body into a mini protein factory — and LNPs, those tiny bubbles of fat carrying those instructions, have found their way into hundreds of millions of people. Within the biotech world, pioneers like Alnylam and Intellia have demonstrated just how versatile LNPs can be as a delivery vehicle for anything from siRNA to CRISPR/Cas9.

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Leen Kawas (L) has resigned as CEO of Athira and will be replaced by COO Mark Litton

Ex­clu­sive: Athi­ra CEO Leen Kawas re­signs af­ter in­ves­ti­ga­tion finds she ma­nip­u­lat­ed da­ta

Leen Kawas, CEO and founder of the Alzheimer’s upstart Athira Pharma, has resigned after an internal investigation found she altered images in her doctoral thesis and four other papers that were foundational to establishing the company.

Mark Litton, the company’s COO since June 2019 and a longtime biotech executive, has been named full-time CEO. Kawas, meanwhile, will no longer have ties to the company except for owning a few hundred thousand shares.

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Some can­cer pa­tients now have to find oth­er op­tions as Bris­tol My­er­s' Abrax­ane falls in­to short­age from man­u­fac­tur­ing woes

When Beth Hogan, a metastatic pancreatic cancer patient, showed up for her infusion at Yale’s Smilow Cancer Hospital in New Haven, CT on Oct. 11, she said she was informed that day that she would not be receiving Bristol Myers Squibb’s Abraxane, part of her combo treatment, because of a shortage.

“I was told we don’t know when you can have it,” she told Endpoints News via email, adding that she doesn’t expect to receive any Abraxane this coming Monday at her treatment appointment either, and she doesn’t know when things will change.

Man­u­fac­tur­ing woes for No­vavax’s Covid jab bad­ly dis­rupt plans for roll­out to the poor — re­port

Production problems at a Novavax facility in Maryland have led to delays in the Covax vaccine sharing program. Now, a shortage of 1 billion doses is expected, as the supplier tries to navigate producing a shot up to regulators’ standards, Politico reported Tuesday.

The company has run into trouble with the purity of the vaccine. Novavax has had trouble proving it can produce a shot consistently up to standards, and it has caused significant delays in the rollout to low- and middle-income countries. This follows several delays at Novavax that has put the executive crew on the defensive.

House pass­es two bills on con­tin­u­ous man­u­fac­tur­ing, stock­pil­ing ahead of fu­ture pan­demics

The House of Representatives this week passed two bills to strengthen America’s national stockpile of medical supplies and to allow the FDA to designate colleges and universities as National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing.

The stockpile bill, known as HR 3635, passed by a vote of 397-22. Introduced by Rep. Elissa Slotkin (D-MI) and 15 other cosponsors, the bill would improve America’s ability to respond to future pandemics, as well as handle the ongoing Covid-19 pandemic too.

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Martine Rothblatt (AP Photo/Jack Plunkett)

FDA re­jects Unit­ed's po­ten­tial PAH drug due to a man­u­fac­tur­ing is­sue

United Therapeutics said Monday that it received a complete response letter for its potential pulmonary arterial hypertension drug Tyvaso DPI, due to an issue with a third-party facility that performs drug substance testing. The company said it expects an approval will come by next summer.

The inspection issue appears to be the only problem the FDA took notice of, according to United. There were no issues with packaging, manufacturing or testing Tyvaso DPI at the MannKind Corporation facility, the company said.