Israel, EU drug regulator find no link between Pfizer Covid shot and stroke – Endpoints News

One week af­ter the FDA and CDC found a po­ten­tial safe­ty con­cern link­ing is­chemic stroke in old­er adults to the up­dat­ed Pfiz­er vac­cine, Is­rael and EU drug reg­u­la­tors an­nounced they had not found a link be­tween the two.

Is­chemic strokes oc­cur when blood clots or oth­er par­ti­cles block the blood ves­sels to the brain.

Reuters first re­port­ed on Thurs­day that an Is­rael health min­istry of­fi­cial said there were no links found be­tween the vac­cine made by Pfiz­er and its Ger­man part­ner BioN­Tech, and strokes.

“We have not turned up such a find­ing, even af­ter we went back and rechecked all our da­ta af­ter the FDA an­nounce­ment,” Salman Zar­ka, the head of Is­rael’s coro­n­avirus task force, said in a video brief­ing sent to Reuters last week.

On Jan. 18, the Eu­ro­pean Med­i­cines Agency al­so told Reuters that it hasn’t found a safe­ty con­cern in the EU with the vac­cine but that it would con­tin­ue to mon­i­tor da­ta.

In a state­ment joint­ly post­ed by the FDA and CDC re­gard­ing the safe­ty sig­nal, the agency not­ed that on­ly one of its mul­ti­ple safe­ty sys­tems, Vac­cine Safe­ty Datalink, found a po­ten­tial prob­lem:

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.

Fol­lowup analy­ses of the da­ta al­so did not find a safe­ty sig­nal in Pfiz­er-BioN­Tech’s vac­cine, and no is­sues were de­tect­ed with Mod­er­na’s shot, ac­cord­ing to the FDA. The fol­lowup analy­ses in­clud­ed oth­er large vac­cine datasets from Medicare, the Unit­ed States De­part­ment of Vet­er­ans Af­fairs, Pfiz­er’s and BioN­Tech’s own mon­i­tor­ing pro­grams and a vac­cine side-ef­fect re­port­ing col­lec­tion tool known as VAERS.

The FDA and CDC do not rec­om­mend any “change in vac­ci­na­tion prac­tice.”

Ac­cord­ing to da­ta col­lect­ed by the CDC, 69% of the US pop­u­la­tion has com­plet­ed the orig­i­nal vac­cine se­ries, and 16% — about 50 mil­lion peo­ple — have re­ceived the up­dat­ed boost­er.

Any vac­cine car­ries some lev­el of risk or side ef­fect, though typ­i­cal­ly far small­er than the con­se­quences of dis­eases they are meant to guard against.

In an emailed state­ment to End­points News, Pfiz­er said “there is no ev­i­dence to con­clude that is­chemic stroke is as­so­ci­at­ed with the use of the com­pa­nies’ COVID-19 vac­cines.

“Com­pared to pub­lished in­ci­dence rates of is­chemic stroke in this old­er pop­u­la­tion, the com­pa­nies to date have ob­served a low­er num­ber of re­port­ed is­chemic strokes fol­low­ing the vac­ci­na­tion with the Omi­cron BA.4/BA.5-adapt­ed bi­va­lent vac­cine,” the state­ment con­tin­ued. “With hun­dreds of mil­lions of dos­es of the orig­i­nal and Omi­cron BA.4/BA.5-adapt­ed bi­va­lent Pfiz­er-BioN­Tech COVID-19 vac­cine ad­min­is­tered glob­al­ly, the ben­e­fit-risk pro­file of our vac­cines re­mains pos­i­tive for all au­tho­rized in­di­ca­tions and age groups.”