Is­rael, EU drug reg­u­la­tors find no link be­tween Pfiz­er Covid shot and stroke

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.”

Image courtesy of The Janssen Pharmaceutical Companies of Johnson & Johnson.

Pro­tect­ing the glob­al phar­ma­ceu­ti­cal in­no­va­tion ecosys­tem – what’s at stake?

We are living in a new era of healthcare that is rapidly advancing progress impacting patient outcomes and experiences. We’ve seen a remarkable pace of transformational innovation, applied research, and advanced clinical development over the last decade.

Despite this tremendous progress, there is much more work to be done, and patients are counting on us – now more than ever – to continue that momentum. At the heart of our industry is a focus on developing and delivering medicines for some of the world’s most challenging diseases, including those that have few or no effective treatments today.

Roger Perl­mut­ter lines up deals, fresh fund­ing at Eikon; Sec­ond RSV vac­cine ap­proved; Sev­er­al biotechs flash­ing red; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

As you come back to our website this weekend for ASCO news, don’t forget to check out our updated event lineup at BIO, which will cover everything from the current state of VC investing in biotech to top pharma R&D chiefs discussing how to make pipeline decisions.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,400+ biopharma pros reading Endpoints daily — and it's free.

Roger Perlmutter, Eikon Therapeutics CEO

Roger Perl­mut­ter builds Eikon's pipeline with deal-mak­ing flur­ry, rais­ing $106M more

Eikon Therapeutics announced three business development deals on Thursday, effectively dropping in a pipeline of cancer drugs alongside more than $100 million in fresh funding.

The Hayward, CA-based company has become one of biotech’s richest startups since its 2019 founding, having raised nearly $775 million. It’s developing a massive, automated research approach built around Nobel Prize-winning microscope science to peer inside cells and watch proteins in action. After its Series B last year, PitchBook reported a $3.02 billion valuation. And while CEO Roger Perlmutter declined to comment on that figure, he said its first tranche of nearly $106 million in Series C funding is a “meaningful step-up to our Series B valuation.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,400+ biopharma pros reading Endpoints daily — and it's free.

Grail’s blood test charts path for di­ag­nos­ing pa­tients sus­pect­ed of hav­ing can­cer in large study: #AS­CO23

Grail’s vision is simple but bold. The blood testing company has long held that people are often diagnosed with cancer too late. If seemingly healthy people were screened for early signs of the disease before symptoms appear, they may be able to get more effective treatments that nip cancer in the bud.

That premise is the basis of Grail’s commercial blood test, Galleri, which searches for the genetic fingerprints of cancer in the blood. The test, launched in 2021, reaped $55 million in sales last year, but now the company is setting its sights on a new market: patients suspected of having cancer due to symptoms such as abdominal pain, rectal bleeding or unexplained weight loss. Rather than administering expensive scans or conducting invasive biopsies right away, Grail hopes doctors will consider a simple blood test.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,400+ biopharma pros reading Endpoints daily — and it's free.

Novartis headquarters in Basel, Switzerland (Kyle LaHucik for Endpoints News)

No­var­tis’ Kisqali pre­vents breast can­cer from com­ing back for longer — but can it best Eli Lil­ly’s Verzenio? #AS­CO23

CHICAGO — Novartis’ CDK4/6 inhibitor Kisqali helped early breast cancer patients stay cancer-free for longer after surgery, according to interim study results presented at ASCO.

In a Phase III study, Kisqali was added on top of endocrine therapy — the current standard treatment for early breast cancer patients. Kisqali reduced the risk of disease relapse by 25% compared with endocrine therapy alone in patients with Stage II or III HR-positive, HER2-negative breast cancer.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,400+ biopharma pros reading Endpoints daily — and it's free.

GSK pro­motes rou­tine im­mu­niza­tions for adults amid post-pan­dem­ic vac­cine back­slide

GSK launched a new initiative on Thursday and committed up to $1 million in grant funding to improve adult routine vaccination rates.

While the pandemic spotlight was trained on the race for novel Covid-19 vaccines, other routine vaccination rates plummeted, raising concerns that missed doses may put children and even some adults at risk of preventable diseases such as measles or shingles. The World Health Organization last year reported the largest drop in childhood vaccinations in roughly three decades.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,400+ biopharma pros reading Endpoints daily — and it's free.

Tammie Denyse speaks up about Black women and breast cancer inequity in Gilead's first TikTok campaign. (Gilead Sciences)

Gilead joins Tik­Tok with on­col­o­gy aware­ness cam­paign fea­tur­ing di­verse group of can­cer ad­vo­cates

Gilead Sciences is taking over the opening page on TikTok for the next two weeks. A Gilead-sponsored video, featuring cancer advocates talking about equity and other issues, will show up as the landing page, called the “For You” page, for millions of TikTok watchers.

The cancer awareness campaign will begin on Monday and run for two weeks, a Gilead spokesperson told Endpoints News. The TikTok ad debut is timed around the ASCO medical conference, but the work is aimed more broadly at healthcare professionals, as well as people touched by cancer and people interested in advancing Black and general health equity.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,400+ biopharma pros reading Endpoints daily — and it's free.

Stephen MacMillan, Hologic CEO (Photo by Riccardo Savi/Getty Images for Concordia Summit)

Il­lu­mi­na names Ho­log­ic CEO as new board mem­ber and chair

Illumina’s board appointed two new members, including Hologic CEO Stephen MacMillan as the non-executive chair, a move that followed a proxy fight that saw shareholders oust the company’s board chair.

The DNA sequencing company also appointed Scott Ullem, the CFO of Edwards Lifesciences, to the board, according to a company statement.

Illumina’s plans to add two new board members came as Carl Icahn waged a board proxy campaign culminating with shareholders electing his candidate, Andrew Teno, over board chair John Thompson. Illumina CEO Francis deSouza survived a threat to his board seat by securing more than twice the shareholder votes than his challenger. Another Illumina candidate, Robert Epstein, was also elected and remained on the board.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,400+ biopharma pros reading Endpoints daily — and it's free.

Catal­ent makes ad­di­tion­al lay­offs at In­di­ana fa­cil­i­ty

Contract manufacturer Catalent is making more staff cuts at one of its locations in the US amid dramatic corrective actions it’s been taking over the past few months.

In an email to Endpoints News, a Catalent spokesperson confirmed the company is making “a number of personnel changes” at a manufacturing facility in Bloomington, IN. While a specific number was not given to Endpoints, several local media outlets, including Indiana Public Media and the Bloomington Herald-Times, have put the number of layoffs at 150. No postings have been made to the Indiana Department of Workforce Development’s WARN notice.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,400+ biopharma pros reading Endpoints daily — and it's free.