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.

US regulators cleared an ultra-rare drug from Pharming Group, by way of Novartis, on Friday afternoon.

The Dutch biotech said the FDA greenlit leniolisib for an immunodeficiency disease known as activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome, or APDS. People 12 years and older can receive the oral drug, to be marketed as Joenja, beginning early next month, Pharming said, five days ahead of the decision deadline set by the FDA as part of a priority review.

A California judge will allow a plaintiff in a state court case to introduce expert testimony connecting a potential carcinogen in former blockbuster medicine Zantac to cancer.

The order was handed down on Thursday from state judge Evelio Grillo, who is now allowing both parties to introduce expert testimony in an upcoming trial after what’s known as a Sargon hearing, where a judge determines the admissibility of expert witnesses and expert opinions.

The European Commission has once again delayed the release of its proposal for an overhaul of the continent’s pharmaceutical legislation.

The release, previously anticipated on March 29, will occur “slightly later” than expected due to the “very busy College agendas of the last few weeks,” a Commission spokesperson told Endpoints News via email.

While the agency hasn’t provided an updated timeline, the spokesperson said the agenda is “always indicative and adoption dates of Commission proposals may change any time, especially when these proposals concern reforms of complex legislations of major importance.”