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.

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.

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.

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.

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.

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 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.”