US in­ves­ti­gates po­ten­tial safe­ty sig­nal with Pfiz­er Covid boost­ers

The FDA and the CDC are in­ves­ti­gat­ing a “pre­lim­i­nary sig­nal” of whether there might be an in­creased risk of stroke for peo­ple who got Pfiz­er and BioN­Tech’s up­dat­ed Covid-19 vac­cine boost­er.

In a state­ment post­ed on the CDC’s web­site, the agency said its mon­i­tor­ing sys­tem for vac­cine side ef­fects had been trig­gered to look for a po­ten­tial is­sue with the shots in peo­ple ages 65 and old­er.

The CDC called the find­ings high­ly pre­lim­i­nary, and said that “no oth­er safe­ty sys­tems have shown a sim­i­lar sig­nal and mul­ti­ple sub­se­quent analy­ses have not val­i­dat­ed this sig­nal.” That in­clud­ed analy­sis of oth­er large vac­cine datasets from Medicare, the Unit­ed States De­part­ment of Vet­er­ans Af­fairs, the com­pa­nies’ own mon­i­tor­ing pro­grams and a vac­cine side-ef­fect re­port­ing col­lec­tion tool known as VAERS.

That means that it’s pos­si­ble the warn­ing could end up be­ing sta­tis­ti­cal noise, or a side ef­fect that’s very rare but enough to trig­ger an ear­ly warn­ing: “Of­ten these safe­ty sys­tems de­tect sig­nals that could be due to fac­tors oth­er than the vac­cine it­self,” the CDC said. No such sig­nal was found with Mod­er­na’s up­dat­ed boost­er.

Pfiz­er, in an emailed state­ment, said it was aware of the gov­ern­ment’s re­port and that its own da­ta showed low­er rates of strokes fol­low­ing vac­ci­na­tion in pa­tients who had been vac­ci­nat­ed, com­pared with typ­i­cal rates of stroke. “Vac­cine safe­ty re­mains of ut­most pri­or­i­ty for Pfiz­er and BioN­Tech,” the com­pa­ny said.

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.

The CDC said it wasn’t mak­ing any changes to its vac­cine rec­om­men­da­tions at this time. Ac­cord­ing to da­ta col­lect­ed by the agency, 69% of the US pop­u­la­tion has com­plet­ed the orig­i­nal vac­cine se­ries, and 16% — about 50 mil­lion peo­ple — have re­ceived the up­dat­ed boost­er.

The shots re­main very ef­fec­tive in pre­vent­ing hos­pi­tal­iza­tion or death from Covid-19. Un­vac­ci­nat­ed peo­ple are about six times more like­ly to die from the dis­ease than are vac­ci­nat­ed peo­ple, ac­cord­ing to on­go­ing sur­veil­lance da­ta col­lect­ed by the agency. That gap grows sub­stan­tial­ly when com­par­ing un­vac­ci­nat­ed peo­ple to those who have re­ceived the up­dat­ed boost­er dose. The US con­tin­ues to re­port more than 2,000 Covid-re­lat­ed deaths a week.

Vac­cine risk track­ing

The CDC iden­ti­fied the safe­ty sig­nal through its vac­cine-safe­ty datalink sys­tem, or VSD, which it calls a “near re­al-time” mon­i­tor­ing sys­tem. The sys­tem trig­gered an in­ves­ti­ga­tion to look at whether peo­ple 65 and over who got Pfiz­er’s boost­er were more like­ly to have a stroke in the 21 days af­ter get­ting the shot than in days 22 to 42 af­ter vac­ci­na­tion.

“Al­though the to­tal­i­ty of the da­ta cur­rent­ly sug­gests that it is very un­like­ly that the sig­nal in VSD rep­re­sents a true clin­i­cal risk, we be­lieve it is im­por­tant to share this in­for­ma­tion with the pub­lic,” the CDC said in its state­ment.

The safe­ty sig­nal was spe­cif­ic to Pfiz­er’s up­dat­ed bi­va­lent vac­cine, which tar­gets two dif­fer­ent strains of the coro­n­avirus and was rolled out last year. The orig­i­nal and up­dat­ed vac­cine are huge sell­ers for Pfiz­er and its part­ner BioN­Tech.

The agen­cies didn’t share the spe­cif­ic rate or the num­ber of stroke cas­es that they are in­ves­ti­gat­ing. The da­ta will be up for dis­cus­sion at the FDA’s Vac­cines and Re­lat­ed Bi­o­log­i­cal Prod­ucts Ad­vi­so­ry Com­mit­tee meet­ing on Jan. 26.

In 2020, when John­son & John­son’s vac­cine was first rolled out to the pub­lic, re­ports came back of clots and strokes in a hand­ful of peo­ple who had re­ceived it.

A re­view of the J&J vac­cine side ef­fects, pub­lished in the An­nals of In­ter­nal Med­i­cine, found 3.83 cas­es per mil­lion dos­es of the J&J shots de­vel­oped blood clots and low platelet counts dur­ing the De­cem­ber 2020 to Au­gust 2021 pe­ri­od. The cas­es were more com­mon in women, and about 15% of hos­pi­tal­ized cas­es were fa­tal. The re­view al­so looked at the Pfiz­er and Mod­er­na mR­NA vac­cines in use at the time, and found the rates were far low­er — 0.00855 cas­es per mil­lion dos­es.

The side ef­fects of the J&J vac­cine, while rel­a­tive­ly rare, were wide­ly cov­ered by the me­dia at the time and con­tributed to a drop in use of the com­pa­ny’s shots.

Am­gen lays off about 300 work­ers, cit­ing 'in­dus­try head­wind­s'

Amgen has laid off about 300 employees, a company spokesperson confirmed to Endpoints News via email Sunday night.

Employees posted to LinkedIn in recent days about layoffs hitting Amgen last week. The Thousand Oaks, CA-based biopharma, which employs about 24,000 people, said the reduction “mainly” impacted US-based workers on its commercial team.

Drug developers of all sizes, including small upstarts and pharma giants, have let employees go in recent months as the biopharma market drags through a quarters-long winter doldrum.

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Bob Bradway, Amgen CEO (Stephen Lam/Reuters)

Am­gen launch­es the first US Hu­mi­ra biosim­i­lar at two dif­fer­ent list prices

The bizarre dynamics of the US prescription drug market were on full display once again this morning as Amgen announced that it would launch the first US biosimilar for Humira, the best-selling drug of all time, at two completely different list prices.

One price for Amgen’s Amjevita (adalimumab-atto) will be 55% below the current Humira list price, which is about $84,000 per year, and another at a list price 5% below the current Humira list price, but presumably (pharma companies don’t disclose rebates) with high rebates to attract PBMs and payers.

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Boehringer In­gel­heim touts pre­ven­tion re­sults in rarest form of pso­ri­a­sis

Boehringer Ingelheim uncorked some positive results suggesting that Spevigo can help prevent flare-ups in patients with a severe form of psoriasis, months after the drug was approved to treat existing flares.

Spevigo, an IL-36R antibody also known as spesolimab, met its primary and a key secondary endpoint in the Phase IIb EFFISAYIL 2 trial in patients with generalized pustular psoriasis (GPP), Boehringer announced on Monday. While the company is keeping the hard numbers under wraps until later this year, it said in a news release that it anticipates sharing the results with regulators.

As­traZeneca, No­vo Nordisk and Sanofi score 340B-re­lat­ed ap­peals court win over HHS

AstraZeneca, Novo Nordisk, and Sanofi won an appeals court win on Monday, as the US Court of Appeals for the Third Circuit found that the companies cannot be forced to provide 340B-discounted drugs purchased by hospitals from an unlimited number of community and specialty pharmacies.

“Legal duties do not spring from silence,” the decision says as the court makes clear that the federal government’s interpretation of the “supposed requirement” that the 340B program compels drugmakers to supply their discounted drugs to an unlimited number of contract pharmacies is not correct, noting:

Ap­peals court toss­es J&J's con­tro­ver­sial 'Texas two-step' bank­rupt­cy case

A US appeals court has ruled against Johnson & Johnson’s use of bankruptcy to deal with mounting talc lawsuits, deciding that doing so would “create a legal blind spot.”

The Third Circuit Court of Appeals reversed a previous bankruptcy court decision on Monday, calling for the dismissal of a Chapter 11 filing by J&J’s subsidiary LTL Management.

Faced with more than 38,000 lawsuits alleging its talc-based products caused cancer, J&J spun its talc liabilities into a separate company called LTL Management back in October 2021 and filed for bankruptcy, a controversial move colloquially referred to as a “Texas two-step” bankruptcy. Claimants argued that the strategy is a misuse of the US bankruptcy code — and on Monday, a panel of judges agreed.

Troy Tazbaz, FDA's newly-named director of the Digital Health Center of Excellence (Oracle via YouTube)

Or­a­cle ex­ec­u­tive Troy Tazbaz named new FDA di­rec­tor of dig­i­tal health

The FDA has found a brand new director of the Digital Health Center of Excellence in Troy Tazbaz, a former senior vice president at Oracle.

According to Tazbaz’s LinkedIn, he took a five-month break after leaving an 11-year career at Oracle before joining the FDA in January. Stat News first reported the hire. Tazbaz also said on his LinkedIn that he biked all the way from Chesapeake Bay to the San Francisco Bay over 58 days during his career break.

Credit: Shutterstock

New York City in­vests $20M in­to biotech 'in­no­va­tion space' at the Brook­lyn Navy Yard

New York City is investing $20 million in biotech this year in the form of a 50,000-square-foot “innovation space” at the Brooklyn Navy Yard, complete with offices, research laboratories and events and programming space to grow biotech startups and companies.

Mayor Eric Adams said during his State of The City Address last Thursday that there will be an “emphasis” on making more opportunities for women and people of color to further diversify the industry. The City first reported the news.

Dirk Thye, Quince Therapeutics CEO

Af­ter piv­ot­ing from Alzheimer's to bone con­di­tions, biotech piv­ots again — and halves its head­count

When troubled public biotech Cortexyme bought a private startup named Novosteo and handed the keys to its executive team, the company — which changed its name to Quince Therapeutics — said it would shift its focus from an unorthodox Alzheimer’s approach to Novosteo’s bone-targeting drug platform.

Less than a year later, Quince is pivoting again.

The biotech has decided to out-license its bone-targeting drug platform and its lead drug, NOV004, and instead look for clinical-stage programs to in-license or acquire, according to a press release.

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Richard Gonzalez, AbbVie CEO (Chris Kleponis/picture-alliance/dpa/AP Images)

Up­dat­ed: $100B+ in sav­ings? Why the in­com­ing Hu­mi­ra biosim­i­lars will take time to catch on

The 20-year reign of AbbVie’s best-selling biologic of all time — the autoimmune disease biologic Humira (adalimumab) that has brought in upwards of $200 billion during its monopoly — is coming to an end tomorrow with the launch of Amgen’s biosimilar Amjevita.

The launch comes more than four years after Europe saw the exact same competition, leading to steep discounts in price, higher uptake, and big cost savings across the board.

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