Pfizer CEO Albert Bourla (L) and BioNTech CEO Ugur Sahin (AP Images)

Covid-19 roundup: FDA au­tho­rizes Pfiz­er/BioN­Tech vac­cine for 12- to 15-year-olds; No­vavax shares sink as com­pa­ny de­lays vac­cine time­line

Back-to-school sea­son could look much dif­fer­ent this year, as Pfiz­er and BioN­Tech’s Covid-19 vac­cine has be­come the first in the US to be au­tho­rized for chil­dren as young as 12 years old.

On Mon­day, the FDA ex­pand­ed its emer­gency use au­tho­riza­tion for the jab — which was orig­i­nal­ly OK’d for those 16 years and old­er — based on ef­fi­ca­cy da­ta from 190 ado­les­cents which showed their im­mune re­sponse to the vac­cine was at least as good as the re­sponse seen in old­er par­tic­i­pants.

Pfiz­er and BioN­Tech al­so con­duct­ed an analy­sis sev­en days af­ter the ado­les­cents were giv­en their sec­ond dos­es. No Covid-19 cas­es were found among 1,005 12- to 15-year-olds who re­ceived the vac­cine, ver­sus 16 cas­es in the place­bo group, sug­gest­ing the vac­cine was 100% ef­fec­tive.

Side ef­fects ex­pe­ri­enced by a group of 2,260 ado­les­cents who were test­ed for safe­ty — pain at the in­jec­tion site, tired­ness, headache, chills, mus­cle pain, fever and joint pain — were con­sis­tent with old­er groups, ac­cord­ing to the agency. More than half of the par­tic­i­pants were fol­lowed for at least two months af­ter their sec­ond dose, ac­cord­ing to the com­pa­nies.

Pe­ter Marks, di­rec­tor of the FDA’s Cen­ter for Bi­o­log­ics Eval­u­a­tion and Re­search (CBER), told re­porters in a me­dia brief­ing that the dos­es won’t be ad­min­is­tered to 12- to 15-year-olds un­til Thurs­day (af­ter the CDC holds an Ad­vi­so­ry Com­mit­tee on Im­mu­niza­tion Prac­tices meet­ing).

“We rec­og­nize that the next crit­i­cal step is hav­ing vac­cines avail­able for use through­out the pe­di­atric pop­u­la­tion,” Marks said in a state­ment on Mon­day.

Both the Mod­er­na and John­son & John­son vac­cines are cur­rent­ly au­tho­rized for adults 18 years and old­er, though Mod­er­na said last month that its Phase II/III Teen­COVE study was ful­ly en­rolled with about 3,000 par­tic­i­pants be­tween the ages of 12 and 17 in the US.

CBER is plan­ning to con­vene a vir­tu­al meet­ing of the Vac­cines and Re­lat­ed Bi­o­log­i­cal Prod­ucts Ad­vi­so­ry Com­mit­tee (VRB­PAC) on June 10 to pro­vide a sta­tus up­date on the au­tho­riza­tion of Covid-19 vac­cines for kids 12 and up, and the da­ta need­ed to sup­port a BLA or EUA in those younger than 12.

“As with the ini­tial COVID-19 vac­cine au­tho­riza­tions, we want to en­sure that the pub­lic has a clear un­der­stand­ing of our ex­pec­ta­tions for the da­ta and in­for­ma­tion need­ed to sup­port re­quests for emer­gency use au­tho­riza­tion and bi­o­log­ics li­cense ap­pli­ca­tions for vac­cines in­tend­ed to pre­vent COVID-19 in this pe­di­atric age range,” Marks said.

Pfiz­er will con­tin­ue to mon­i­tor the safe­ty of the vac­cine.

No­vavax shares sink as com­pa­ny de­lays vac­cine time­line

No­vavax $NVAX shares slipped near­ly 8.8% on Tues­day morn­ing, as the com­pa­ny once again de­layed its time­line for vac­cine pro­duc­tion and reg­u­la­to­ry fil­ings.

In its Q1 earn­ings call, No­vavax said it’s now aim­ing to sub­mit reg­u­la­to­ry fil­ings in the US, UK and EU in Q3, ver­sus its pre­vi­ous plans to file in Q2. The com­pa­ny cit­ed the de­vel­op­ment of qual­i­fy­ing and po­ten­cy as­says to sat­is­fy the CMC por­tion of reg­u­la­to­ry sub­mis­sions as the pri­ma­ry rea­son for de­lay, ac­cord­ing to Jef­feries an­a­lyst Kelechi Chikere.

The com­pa­ny now ex­pects to hit its pro­duc­tion tar­get of 100 mil­lion dos­es a month by the end of Q3 and full pro­duc­tion ca­pac­i­ty in Q4 (rather than Q3). Here, No­vavax said sourc­ing raw ma­te­ri­als was its key is­sue.

“Mgmt re­mains very con­fi­dent that they will hit 150M dos­es per month be­fore the end of the year and ex­pects to main­tain that through­out 2022 and be­yond,” Chikere wrote.

This isn’t the first time No­vavax has pushed back its time­line for full-speed vac­cine pro­duc­tion. Last month, Reuters re­port­ed that sup­ply short­ages that in­clude bags used to grow cells have led to a de­lay in pro­duc­tion. Pre­vi­ous­ly, No­vavax had said that it ex­pect­ed full-scale pro­duc­tion by May or June, and clear­ance from the US as ear­ly as May.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

Tom Barnes, Orna Therapeutics CEO

UP­DAT­ED: 'We have failed to fail': Mer­ck gam­bles $250M cash on a next-gen ap­proach to mR­NA — af­ter punt­ing its big al­liance with Mod­er­na

Merck went in deep on its collaboration with Moderna on new mRNA programs, and dropped them all over time, including their RSV partnership. But after writing off what turned out as one of the most successful infectious disease players in the business, Merck is coming in this morning with a new preclinical alliance — this time embracing a biotech that hopes to eventually outdo the famously successful mRNA in a new run at vaccines and therapeutics.

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Bayer's first DTC ad campaign for chronic kidney disease drug Kerendia spells out its benefits

Bay­er aims to sim­pli­fy the com­plex­i­ties of CKD with an ABC-themed ad cam­paign

Do you know the ABCs of CKD in T2D? Bayer’s first ad campaign for Kerendia tackles the complexity of chronic kidney disease with a play on the acronym (CKD) and its connection to type 2 diabetes (T2D).

Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.

In the TV commercial launched this week, A is for awareness, B is for belief and C is for cardiovascular, explained in the ad as awareness of the connection between type 2 and kidney disease, belief that something can be done about it, and cardiovascular events that may be reduced with treatment.

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James Mock, incoming CFO at Moderna

Mod­er­na taps new CFO from PerkinElmer af­ter for­mer one-day CFO oust­ed

When Moderna hired a new CFO last year,  it didn’t expect to see him gone after only one day. Today the biotech named his — likely much more vetted — replacement.

The mRNA company put out word early Wednesday that after the untimely departure of then brand-new CFO Jorge Gomez, it has now found a replacement in James Mock, the soon-to-be former CFO at diagnostics and analytics company PerkinElmer.

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Etleva Kadilli, director of UNICEF’s supply division

GSK lands first-ever UNICEF con­tract for malar­ia vac­cine worth $170M

GSK has landed a new first from UNICEF the first-ever contract for malaria vaccines, worth up to $170 million for 18 million vaccine doses distributed over the next three years.

The vaccine, known as Mosquirix or RTS,S, won WHO’s backing last October after a controversial start, but UNICEF said these doses will potentially save thousands of lives every year.

“We hope this is just the beginning,” Etleva Kadilli, director of UNICEF’s supply division, said. “Continued innovation is needed to develop new and next-generation vaccines to increase available supply, and enable a healthier vaccine market. This is a giant step forward in our collective efforts to save children’s lives and reduce the burden of malaria as part of wider malaria prevention and control programmes.”

Paul Perreault, CSL Behring CEO

CSL CEO Paul Per­reault de­ter­mined to grow plas­ma col­lec­tion af­ter full-year sales dip

As the ink dries on CSL’s $11.7 billion Vifor buyout, the company posted a dip in profits, due in part to a drop in plasma donations amid the pandemic.

However, CEO Paul Perreault assured investors and analysts on the full-year call that the team has left “no stone unturned” when assessing options to grow plasma volumes. The chief executive also spelled out positive results for the company’s monoclonal antibody garadacimab in hereditary angioedema (HAE), though he isn’t revealing the exact numbers just yet.

Blaise Coleman, Endo International CEO

En­do files for Chap­ter 11 as it looks to fin­ish off its opi­oid lit­i­ga­tion

Irish drugmaker Endo International is entering into bankruptcy as it faces the weight of serious litigation related to its involvement in the opioid epidemic in the US.

The company has filed Chapter 11 proceedings in the US Bankruptcy Court for the Southern District of New York, with the company expected to file recognition proceedings in Canada, the UK and Australia. The company’s bankruptcy filing showed the company had assets and liabilities in the range of $1 billion to $10 billion.

Joe Jonas (Photo by Anthony Behar/Sipa USA)(Sipa via AP Images)

So­lo Jonas broth­er car­ries Merz's new tune in Botox ri­val cam­paign

As the lyrics of his band’s 2019 pop-rock single suggest, Joe Jonas is only human — and that means even he gets frown lines. The 33-year-old singer-songwriter is Merz’s newest celebrity brand partner for its Botox rival Xeomin, as medical aesthetics brands target a younger audience.

Merz kicked off its “Beauty on Your Terms” campaign on Tuesday, featuring the Jonas brother in a video ad for its double-filtered anti-wrinkle injection Xeomin.

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Marisol Peron, Genmab SVP of communications and corporate affairs

Gen­mab launch­es cor­po­rate cam­paign am­pli­fy­ing its ‘knock your socks off’ an­ti­bod­ies

Genmab often talks about its “knock-your-socks-off” antibodies — and now the term is getting its own logo and corporate campaign.

The teal and purple logo for the acronym KYSO — Genmab pronounces it “ky-so” — debuts on Wednesday and comes on the heels of Genmab’s newly announced 2030 vision. That aspiration aims to expand Genmab’s drug development beyond oncology to include other serious diseases, while also doubling down on its own drug development.

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