CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

The FDA’s Vac­cines and Re­lat­ed Bi­o­log­i­cal Prod­ucts Ad­vi­so­ry Com­mit­tee (VRB­PAC) vot­ed unan­i­mous­ly in fa­vor of “har­mo­niz­ing” Covid vac­cine com­po­si­tions, mean­ing all cur­rent vac­cine re­cip­i­ents would re­ceive a bi­va­lent vac­cine, re­gard­less of whether they’ve got­ten their pri­ma­ry se­ries.

Paul Of­fit

The vote marks an ef­fort to clear up con­fu­sion around vary­ing for­mu­la­tions and dos­ing sched­ules for cur­rent pri­ma­ry se­ries and boost­er vac­cines, as well as “get clos­er to the strains that are cir­cu­lat­ing,” ac­cord­ing to com­mit­tee mem­ber Paul Of­fit, pro­fes­sor of pe­di­atrics at the Chil­dren’s Hos­pi­tal of Philadel­phia.

“Right now, BA.4 is gone. BA.5 prob­a­bly rep­re­sents less than 5% of the pop­u­la­tion of what’s cir­cu­lat­ing, but it’s cer­tain­ly a lot clos­er than Wuhan [the orig­i­nal strain],” he said.

As Mark Sawyer, pe­di­atrics pro­fes­sor at the UC San Diego School of Med­i­cine, sum­ma­rized: “Bi­va­lent is bet­ter. Sim­ple is bet­ter.”

“I be­lieve we still need to vac­ci­nate the un­vac­ci­nat­ed, and so any­thing that re­sults in bet­ter pub­lic com­mu­ni­ca­tion would be ex­treme­ly valu­able,” ac­cord­ing to Hen­ry Bern­stein, VRB­PAC mem­ber and pro­fes­sor of pe­di­atrics at the Zuck­er School of Med­i­cine at Hof­s­tra/North­well.

The de­ci­sion comes amid slow up­take for up­dat­ed boost­ers in the US, with just about 15% of those 5 years and old­er hav­ing rolled up their sleeves. The FDA au­tho­rized boost­ers for kids 6 months and old­er at the end of last year, though vac­cine rates in chil­dren re­main par­tic­u­lar­ly low.

Ac­cord­ing to da­ta from an open-la­bel study pre­sent­ed by Mod­er­na, kids 6 months to 5 years with no pri­or Covid in­fec­tion saw a 22.9-fold in­crease in BA.1 neu­tral­iz­ing an­ti­bod­ies fol­low­ing a BA.1-spe­cif­ic boost­er dose, com­pared to a 12.2-fold rise in a his­tor­i­cal con­trol group of those who re­ceived the orig­i­nal vac­cine.

Pfiz­er pre­sent­ed sim­i­lar da­ta sug­gest­ing “im­proved Omi­cron BA.4/5 neu­tral­iz­ing re­sponse” com­pared to the orig­i­nal vac­cine in a sub­set of around 60 chil­dren evalu­able be­tween 6 months and 5 years in an on­go­ing study. In to­tal, the study is ex­pect­ed to en­roll about 300 kids.

In brief­ing doc­u­ments re­leased ahead of the meet­ing, the FDA pro­posed a sim­pli­fied vac­ci­na­tion sched­ule that would re­quire a two-dose se­ries for some young chil­dren, old­er adults and those who are im­muno­com­pro­mised, and a one-dose se­ries for every­one else. How­ev­er, ad­vi­so­ry com­mit­tee mem­bers said they’d need more da­ta be­fore reach­ing a de­ci­sion.

Archana Chat­ter­jee

“Par­tic­u­lar­ly for the young chil­dren, we would, at least I would, want to see a lot more da­ta. The num­bers are just too few for us to re­al­ly make sci­en­tif­i­cal­ly sound de­ci­sions re­gard­ing this ques­tion,” said Archana Chat­ter­jee, dean of the Ros­alind Franklin Uni­ver­si­ty’s Chica­go Med­ical School.

“We need the CDC to tell us ex­act­ly who it is that’s get­ting hos­pi­tal­ized and dy­ing from this virus. What are their ages? What specif­i­cal­ly are their co­mor­bidi­ties? If they’re im­mune-com­pro­mised, in what man­ner are they im­mune-com­pro­mised? Did they re­cent­ly get a vac­cine? Were they treat­ed with an­tivi­rals?” Of­fit said. “Then, and on­ly then, can we re­al­ly best make the de­ci­sion about who gets vac­ci­nat­ed with what and when.”

FDA al­so said in brief­ing doc­u­ments that it an­tic­i­pates hold­ing an as­sess­ment of Covid vari­ants and a VRB­PAC meet­ing “at least an­nu­al­ly” around ear­ly June to dis­cuss strain se­lec­tion for the fall. The process, ac­cord­ing to the agency, would be “sim­i­lar in many ways to that used for sea­son­al in­fluen­za vac­cines.”

How­ev­er, mul­ti­ple VRB­PAC mem­bers em­pha­sized on the call that Covid “is not in­fluen­za.”

“I think it is crit­i­cal­ly im­por­tant that we pay at­ten­tion to the epi­demi­ol­o­gy and what is hap­pen­ing with the emerg­ing vari­ants, how the vac­cines are con­tin­u­ing to hold up against them,” Chat­ter­jee said. “We’ve had much dis­cus­sion to­day about not want­i­ng to chase vari­ants, and I agree with that. But on the oth­er hand, we do have to be mind­ful and pay at­ten­tion to make sure that vac­cines con­tin­ue to be ef­fec­tive.”

CBER Di­rec­tor Pe­ter Marks said the agency “to­tal­ly agree[s] with every­one.”

“This isn’t flu,” he said. “On the oth­er hand, you know, in­fluen­za has served the mod­el of how in­fluen­za strain se­lec­tion has worked, not to a T,  but just the gen­er­al mod­el has been a very im­por­tant pub­lic health ad­vance, and so we can take the best of that mod­el and then es­sen­tial­ly, ad­just around it.”

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Stéphane Bancel, Moderna CEO (AP Photo/Markus Schreiber)

Mod­er­na so­lid­i­fies deal with Kenya to build mR­NA man­u­fac­tur­ing fa­cil­i­ty

The mRNA player Moderna is further cementing its presence on the African continent.

Moderna announced on Thursday that it has finalized an agreement with Kenya’s government to partner up and bring an mRNA manufacturing facility to the east African nation. The new facility aims to manufacture up to 500 million doses of vaccines annually. Moderna also said the new facility will have the ability to spike its production capabilities to respond to public health emergencies on the continent or globally.

Ribbon cutting ceremony for Thermo Fisher's new cell therapy manufacturing site in San Francisco

Ther­mo Fish­er moves on cam­pus with new cell man­u­fac­tur­ing site in San Fran­cis­co

Thermo Fisher Scientific is putting down more roots in the Bay Area.

The manufacturer opened the doors to a new cell therapy manufacturing facility next to the University of California-San Francisco Medical Center’s Mission Bay campus and on the university’s campus.

UCSF and Thermo Fisher have had a partnership since 2021, with the new site focusing on manufacturing cell therapeutics for certain cancers, including glioblastoma and multiple myeloma. The new site plans to use Thermo Fisher’s expertise in manufacturing services to help UCSF accelerate the development of cell therapies and eventually get them into the clinic, said Dan Herring, the general manager of cell therapy services at Thermo Fisher, in an interview with Endpoints News.

Luke Miels, GSK chief commercial officer

GSK picks up Scynex­is' FDA-ap­proved an­ti­fun­gal drug for $90M up­front

GSK is dishing out $90 million cash to add an antifungal drug to its commercial portfolio, in a deal spotlighting the pharma giant’s growing focus on infectious diseases.

The upfront will lock in an exclusive license to Scynexis’ Brexafemme, which was approved in 2021 to treat a yeast infection known as vulvovaginal candidiasis, except in China and certain other countries where Scynexis already out-licensed the drug.

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Ivana Magovčević-Liebisch, Vigil Neuroscience CEO

FDA lifts par­tial clin­i­cal hold on Vig­il Neu­ro­science's TREM2 an­ti­body, re­mov­ing dos­ing cap

When Vigil Neuroscience filed its IPO papers in late 2021, the biotech revealed that the FDA had just cleared its Phase I trial — but with a partial clinical hold that limited dosing to under a certain level.

More than a year later, the FDA has lifted the hold.

Vigil is now free to dose VGL101, an antibody targeting TREM2, at levels higher than 20 mg/kg in its ongoing and future clinical trials in patients with adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP), an inherited condition that affects the brain and spinal cord.

Feng Zhang (Susan Walsh/AP Images)

In search of new way to de­liv­er gene ed­i­tors, CRISPR pi­o­neer turns to mol­e­c­u­lar sy­ringes

Bug bacteria are ruthless.

Some soil bacteria have evolved tiny, but deadly injection systems that attach to insect cells, perforate them and release toxins inside — killing a bug in just a few days’ time. Scientists, on the other hand, want to leverage that system to deliver medicines.

In a paper published Wednesday in Nature, MIT CRISPR researcher Feng Zhang and his lab describe how they engineered these syringes made by bacteria to deliver potential therapies like toxins that kill cancer cells and gene editors. With the help of an AI program, they developed syringes that can load proteins of their choice and selectively target human cells.

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CSL CEO Paul McKenzie (L) and CMO Bill Mezzanotte

Q&A: New­ly-mint­ed CSL chief ex­ec­u­tive Paul McKen­zie and chief med­ical of­fi­cer Bill Mez­zan­otte

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

Boehringer re­ports ro­bust sales led by type 2 di­a­betes and pul­monary drugs, promis­es more to come high­light­ing obe­si­ty

Boehringer Ingelheim reported human pharma sales of €18.5 billion on Wednesday, led by type 2 diabetes and heart failure drug Jardiance and pulmonary fibrosis med Ofev. Jardiance sales reached €5.8 billion, growing 39% year over year, while Ofev took in €3.2 billion, notching its own 20.6% annual jump.

However, Boehringer is also looking ahead with its pipeline, estimating “In the next seven years the company expects about 20 regulatory approvals in human pharma.”

Man­u­fac­tur­ing roundup: Catal­ent to pro­duce low-cost ver­sion of nalox­one; CSL opens R&D site

Catalent will be manufacturing a low-cost version of the opioid overdose treatment naloxone as part of a contract with Harm Reduction Therapeutics.

Catalent plans to manufacture the treatment at its facility in Morrisville, NC. No financial details on the deal were disclosed.

Harm Reduction was granted priority review status for the NDA on its spray last year. The company has been working on a naloxone product since 2017. It is anticipating approval in July of this year and a US launch in early 2024.