Biden forges new $475M cam­paign to dri­ve up­take of Pfiz­er and Mod­er­na's bi­va­lent Covid vac­cines

As on­ly about 11% of Amer­i­cans have so far re­ceived the bi­va­lent boost­er shots from Pfiz­er and Mod­er­na, and on­ly 30% of those over 65 years of age, the Biden ad­min­is­tra­tion on Tues­day launched a 6-week, $475 mil­lion push to in­crease those num­bers as tens of mil­lions of jabs sit on shelves.

The Biden team not­ed that there are now more than 70,000 lo­ca­tions of­fer­ing the up­dat­ed vac­cines, and HHS is ex­pand­ing to mo­bile and rur­al set­tings with more flex­i­ble or­der­ing op­tions for providers.

Pfiz­er and part­ner BioN­Tech said last week that the im­mune re­sponse in­duced by their bi­va­lent Covid-19 vac­cine against the new­er sub­lin­eages, in­clud­ing BA.4.6, BA.2.75.2, BQ.1.1 and XBB.1, saw a greater in­crease in neu­tral­iz­ing an­ti­body titers when com­pared to the orig­i­nal ver­sion of Comir­naty. Mod­er­na’s boost­er al­so met its pri­ma­ry end­point, with sig­nif­i­cant­ly high­er neu­tral­iz­ing an­ti­body titers against BA.4/BA.5 com­pared to a boost­er of the orig­i­nal Spike­vax vac­cine.

The CDC on Tues­day al­so re­leased new da­ta on the bi­va­lent vac­cines that looked at ab­solute vac­cine ef­fi­ca­cy (aVE), cal­cu­lat­ed by com­par­ing the odds of re­ceipt of a bi­va­lent boost­er dose (af­ter two, three, or four mono­va­lent vac­cine dos­es) to be­ing un­vac­ci­nat­ed (ze­ro dos­es of any Covid vac­cine) among case- and con­trol-pa­tients.

“aVE of a bi­va­lent boost­er dose re­ceived af­ter ≥2 mono­va­lent dos­es (com­pared with be­ing un­vac­ci­nat­ed) was sim­i­lar among per­sons aged 50–64 years (28%) and ≥65 years (22%) but var­ied some­what by num­ber of pre­vi­ous mono­va­lent vac­cine dos­es,” the CDC said. “Among adults aged 18–49 years, aVE af­ter ≥2 mono­va­lent dos­es(43%) was high­er than that for old­er age groups and did not vary among those who re­ceived 2 or 3 pre­vi­ous mono­va­lent vac­cine dos­es.”

The Cen­ters al­so re­leased new da­ta on Pfiz­er’s block­buster an­tivi­ral Paxlovid, which again proved to be help­ful for those who were old­er and more at risk.

Dur­ing the 30 days af­ter a COVID-19 di­ag­no­sis among the group that CDC looked at, 5,229 (or 0.75%) per­sons were hos­pi­tal­ized; 3,311 (63.3%) of these hos­pi­tal­iza­tions oc­curred among per­sons aged ≥65 years. “Among the 198,927 Paxlovid re­cip­i­ents, 930 (0.47%) were hos­pi­tal­ized com­pared with 4,299 (0.86%) of non­re­cip­i­ents,” the CDC said.

“Paxlovid works in those at high risk of pro­gres­sion,” Walid Gel­lad, pro­fes­sor at the Uni­ver­si­ty of Pitts­burgh, told End­points News. “We’ve just lost sight of who is at high risk of pro­gres­sion.”

On the vac­cines, Gel­lad al­so ques­tioned why those who are aged 18 to 49 with three Covid-19 vac­cine dos­es al­ready ad­min­is­tered “are en­cour­aged to get the bi­va­lent af­ter 2 months or else they are not up to date. Based on this vac­cine ef­fi­ca­cy?”

The dri­ve to get more bi­va­lent shots in­to arms from Biden will al­so come with fund­ing. HHS said it will in­vest $350 mil­lion in­to com­mu­ni­ty health cen­ters, which they can use for mo­bile, dri­ve-up, walk-up, or com­mu­ni­ty-based vac­ci­na­tion events, as well as part­ner­ships with com­mu­ni­ty and faith-based or­ga­ni­za­tions for vac­ci­na­tion ac­tiv­i­ties, rais­ing aware­ness of the up­dat­ed shot, and more.

An­oth­er $125 mil­lion will go to ef­forts to get more old­er Amer­i­cans and peo­ple with dis­abil­i­ties vac­ci­nat­ed, in­clud­ing through ac­ces­si­ble vac­ci­na­tion clin­ics, in-home vac­ci­na­tions, trans­porta­tion, out­reach and ed­u­ca­tion.

“HHS is stand­ing up pop-up vac­cine clin­ics and ed­u­ca­tion­al booths at ma­jor com­mu­ni­ty gath­er­ings – from li­braries to sport­ing events to coun­ty fairs, and more,” the ad­min­is­tra­tion said. “Or­ga­ni­za­tions around the coun­try are an­swer­ing the call to host more com­mu­ni­ty-based vac­ci­na­tion clin­ics in New Or­leans, LA, Al­bu­querque, NM, Hous­ton, TX, Jack­son, MS, Mi­a­mi, FL, Justin, TX, San An­to­nio, TX, Dal­las, TX, At­lanta, GA, Berea, OH, and Sal­is­bury, MD.”

Big Phar­ma's Twit­ter ex­o­dus; Mer­ck wa­gers $1.35B on buy­out; $3.5M gene ther­a­py; and more

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Paul Perreault, CSL Behring CEO

CSL lands FDA ap­proval for he­mo­phil­ia B gene ther­a­py, sets $3.5M list price

The FDA has approved the world’s first gene therapy for hemophilia B, ushering into the market a treatment that’s historic in both what it promises to do and how much it will cost.

CSL will be marketing the drug, Hemgenix, at a list price of $3.5 million — which sets a new record for the most expensive single-use gene therapy in the US.

In a statement provided to Endpoints News, the Australian company noted that the current costs of treating people with moderate to severe hemophilia B can be significant over a lifetime. By some estimates, healthcare systems could spend more than $20 million per person.

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Elon Musk (GDA via AP Images)

Biggest drug com­pa­nies halt­ed Twit­ter ad buys af­ter Lil­ly in­sulin spoof

Almost all of the drug industry’s biggest advertisers cut their spending on Twitter to zero or near-zero over the last two weeks amid worries about impersonation of their brands by pranksters and the future of the social media company.

Among 18 of the biggest pharmaceutical advertisers in the US market, 12 cut their Twitter ad spending to nothing for the week beginning Nov. 14, according to Pathmatics, which tracks data on prescription drug ad spending as well as general corporate advertising. The list of drugmakers cutting spending to zero includes Merck, AstraZeneca, Eli Lilly, Novartis, Pfizer and others.

Rob Davis, Merck CEO

Up­dat­ed: No Seagen here: 'Do more' means a small $1.35B pur­chase of Ima­go for Mer­ck

Merck is making an acquisition, the Big Pharma announced before Monday’s opening bell. No, Seagen is not entering the fold, as had been speculated for quarters.

Folding under Merck’s wings will be Pfizer-backed Imago BioSciences. For nearly a year, Merck CEO Rob Davis has been saying the pharma giant needs to “do more” on the business development front after its 2021 $11.5 billion acquisition of Acceleron.

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Isao Teshirogi, Shionogi president and CEO (Kyodo via AP Images)

Sh­ionogi's Covid an­tivi­ral lands first ap­proval in Japan's new emer­gency ap­proval path­way

Japanese regulators on Tuesday signed off on Shionogi’s homegrown antiviral for Covid-19, known as Xocova (ensitrelvir), making it the first approval under Japan’s emergency regulatory approval system.

The emergency approval, following a back-and-forth with regulators since last February, is based on a safety profile with more than 2,000 patients who have accessed the pill, and clinical symptomatic efficacy for five typical Omicron-related symptoms (primary endpoint) and antiviral efficacy (key secondary endpoint) in patients with mild to moderate SARS-CoV-2 infection, regardless of risk factors or vaccination status, and during the Omicron-dominant phase of the pandemic.

Stanley Erck, Novavax CEO (Andrew Harnik/AP Images)

No­vavax pulls out of Covid-19 vac­cine al­liance with Gavi

Novavax is pulling out of its Covid-19 vaccine deal with Gavi, the Vaccine Alliance, a global partnership tasked with ensuring vaccine access in lower-income countries, following an alleged contract violation.

The Maryland-based company claimed on Friday that Gavi failed to purchase at least 350 million doses of its protein-based vaccine Nuvaxovid by the end of the year, per an advanced purchase agreement. Gavi, the World Health Organization and the Coalition for Epidemic Preparedness Innovations (CEPI) are co-leaders of COVAX, an effort to ensure that all participating countries, regardless of income levels, have access to vaccines.

Alzheimer’s drug bites the dust; Re­struc­ture, re­struc­ture, re­struc­ture; Land­mark di­a­betes OK; 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.

Being in the news business can give one a warped sense of time — it feels like quite a while since we published some of these stories below. But next Saturday’s Endpoints Weekly will definitely be shorter, as we take off Thursday and Friday for Thanksgiving. We will still have the abbreviated edition in your inbox at the usual time.

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MIT re­searchers re­veal DNA "Paste" tech be­hind lat­est gene edit­ing start­up

MIT scientists have developed a tool that they say can insert large gene sequences where they want in the genome.

In a paper published Thursday in Nature Biotechnology, MIT fellows Omar Abudayyeh, Jonathan Gootenberg and colleagues detail a technology they call PASTE, which they say can potentially be used to insert long strands of DNA and treat genetic diseases caused by many different mutations, such as cystic fibrosis and Leber congenital amaurosis, a rare eye disorder that causes blindness.

J&J's Spra­va­to pulls a PhI­II win against Sero­quel XR in treat­ment-re­sis­tant de­pres­sion

A day before Thanksgiving, J&J’s Janssen has a new cut of Phase III Spravato data to be grateful for.

The pharma giant announced on Wednesday that its nasal spray, also known as esketamine, beat extended-release quetiapine, previously sold by AstraZeneca as Seroquel XR, in treatment-resistant depression (TRD). Of 676 adults, a significantly higher number of patients on Spravato were able to achieve remission and avoid relapse after 32 weeks, according to J&J.