FDA re­ports ini­tial 'no sig­nal' for stroke risk with Pfiz­er boost­ers, launch­es con­comi­tant flu shot study

The FDA hasn’t de­tect­ed any po­ten­tial safe­ty sig­nals, in­clud­ing for stroke, in peo­ple aged 65 years and old­er who have re­ceived Pfiz­er’s bi­va­lent Covid boost­er, one se­nior of­fi­cial told mem­bers of the agency’s Vac­cines and Re­lat­ed Bi­o­log­i­cal Prod­ucts Ad­vi­so­ry Com­mit­tee (VRB­PAC) on Thurs­day.

The up­date comes as the FDA and CDC in­ves­ti­gate a “pre­lim­i­nary sig­nal” that may in­di­cate an in­creased risk of is­chemic stroke in old­er Amer­i­cans who re­ceived Pfiz­er’s up­dat­ed shot.

As of Jan. 11, 21.3 mil­lion bi­va­lent boost­ers had been ad­min­is­tered in those 65 years and old­er, ac­cord­ing to Tom Shimabukuro, di­rec­tor of the CDC’s Im­mu­niza­tion Safe­ty Of­fice. Just one of the CDC’s mul­ti­ple safe­ty sys­tems, Vac­cine Safe­ty Datalink, found a po­ten­tial prob­lem, ac­cord­ing to a joint state­ment from the FDA and CDC:

Rapid-re­sponse in­ves­ti­ga­tion of the sig­nal in the VSD raised a ques­tion of whether peo­ple 65 and old­er who have re­ceived the Pfiz­er-BioN­Tech COVID-19 Vac­cine, Bi­va­lent were more like­ly to have an is­chemic stroke in the 21 days fol­low­ing vac­ci­na­tion com­pared with days 22-44 fol­low­ing vac­ci­na­tion.

While Nico­la Klein, di­rec­tor of the Kaiser Per­ma­nente Vac­cine Study Cen­ter, said that mon­i­tor­ing sys­tem has been “sig­nal­ing for sev­er­al weeks,” she al­so not­ed that “re­sults may have been in­flu­enced by con­founders that vary over time.”

Re­searchers saw a “sub­tle al­though present” clus­ter of pa­tients 65 and old­er who ex­pe­ri­enced is­chemic stroke 11 to 22 days af­ter re­ceiv­ing the boost­er, while the num­ber of in­ci­dents ap­peared to re­duce over time. She al­so added that there may have been low­er-than-ex­pect­ed in­ci­dence rates in the com­para­tor group.

Last week, Is­rael and EU drug reg­u­la­tors an­nounced they had not found a link be­tween the boost­er shot and is­chemic stroke.

“There have been no ex­cess re­ports of stroke from VAERS. I just re­port­ed on what we found in our CMS se­quen­tial analy­sis show­ing no in­creased risk in stroke. The Vet­er­ans Af­fairs data­base has al­so done a pre­lim­i­nary run and did not find an in­crease in stroke,” said Richard For­shee, deputy di­rec­tor of the FDA’s Of­fice of Bio­sta­tis­tics and Phar­ma­covig­i­lance.

He con­firmed on Thurs­day that the on­ly safe­ty sig­nal ob­served in the adult pop­u­la­tion fol­low­ing the Pfiz­er boost­er has been my­ocardi­tis and peri­cardi­tis in in­di­vid­u­als be­tween 18 and 35 years old, which was al­so ob­served fol­low­ing the mono­va­lent pri­ma­ry vac­cine se­ries. And while the CDC’s analy­ses sug­gest a po­ten­tial height­ened risk among those who re­ceived a con­comi­tant flu vac­cine, For­shee said the FDA’s analy­sis — in­clud­ing 4.25 mil­lion dos­es of Pfiz­er’s vac­cine in those 65 and old­er, 38% of whom re­ceived a con­comi­tant flu shot — hasn’t de­tect­ed such a risk.

“We’re con­tin­u­ing to do more work to seg­ment out the dif­fer­ent in­fluen­za vac­cines ad­min­is­tered. And again no sig­nal at this time has been seen for he­m­or­rhag­ic stroke even though we have 38% that re­ceived a con­comi­tant in­fluen­za vac­ci­na­tion,” For­shee said.

For­shee said the agency has launched a for­mal epi­demi­o­log­i­cal study fo­cus­ing in par­tic­u­lar on con­comi­tant ad­min­is­tra­tion of a high-dose or flu vac­cine.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

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.

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.

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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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.

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.”