Covid-19 roundup: CDC study shows good pro­tec­tion from mR­NA boost­er plus J&J's sin­gle-dose vac­cine; White House launch­es test-to-treat Paxlovid site

Con­cerns about rare but life-threat­en­ing blood clots have lim­it­ed the use of J&J’s Covid-19 vac­cine — once pitched as the on­ly one-shot op­tion in the mix — with the FDA cut­ting it off ex­cept in lim­it­ed cir­cum­stances. Yet there’s some good news for those who did re­ceive it: A sin­gle boost­er dose of an mR­NA vac­cine for re­cip­i­ents of a sin­gle prim­ing dose of Ad26.COV2.S (the J&J vac­cine) pro­vid­ed pro­tec­tion close to that of a three-dose mR­NA vac­cine reg­i­men.

That’s ac­cord­ing to a new analy­sis from the CDC that looked at the ef­fec­tive­ness of four vac­ci­na­tion reg­i­mens dur­ing a pe­ri­od when Omi­cron was the pre­dom­i­nant cir­cu­lat­ing vari­ant.

They were a sin­gle prim­ing dose of Ad26.COV2.S; a sin­gle prim­ing dose of Ad26.COV2.S plus a boost­er dose of Ad26.COV2.S (Ad26.COV2.S/Ad26.COV2.S); a sin­gle prim­ing dose of Ad26.COV2.S plus a boost­er dose of mR­NA vac­cine (Ad26.COV2.S/mR­NA); and two prim­ing dos­es of an mR­NA vac­cine plus a boost­er dose of mR­NA vac­cine (mR­NA/mR­NA/mR­NA)

The sci­en­tists then ex­am­ined test­ing da­ta span­ning more than 500,000 tests in or­der to de­ter­mine the re­spec­tive ef­fi­ca­cy of these reg­i­mens. As they wrote in a let­ter cor­re­spon­dence in the New Eng­land Jour­nal of Med­i­cine:

Our re­sults show that all the reg­i­mens that in­clud­ed a boost­er dose, as com­pared with no vac­ci­na­tion, of­fered pro­tec­tion against symp­to­matic omi­cron in­fec­tion (the 95% con­fi­dence in­ter­vals did not in­clude 0), al­though vac­cine ef­fec­tive­ness was high­est for the reg­i­mens that in­clud­ed a boost­er dose of an mR­NA vac­cine and was low­est for the ho­mol­o­gous Ad26.COV2.S/Ad26.COV2.S reg­i­men.

The re­sults “sup­port the cur­rent rec­om­men­da­tion of a boost­er dose of mR­NA vac­cine at least 2 months af­ter pri­ma­ry vac­ci­na­tion with sin­gle-dose Ad26.COV2.S or at least 4 months af­ter an Ad26.COV2.S boost­er dose,” the sci­en­tists added.

White House in­tro­duces new mod­el for dis­trib­ut­ing Pfiz­er’s Paxlovid

The Biden ad­min­is­tra­tion has launched its first test-to-treat site as part of a cam­paign to get more Paxlovid, the oral an­tivi­ral de­vel­oped by Pfiz­er, in­to pa­tients’ hands.

While pa­tients cur­rent­ly have to get a pre­scrip­tion from a health provider be­fore they can pick up a course of the drug, any­one who vis­its the clin­ic in Rhode Is­land will be able to get as­sessed by a med­ical provider and, if pre­scribed, grab their Paxlovid in one go.

The deal an­nounce­ment comes as the use of Paxlovid spikes in the US, sig­nal­ing not on­ly ris­ing case num­bers but more aware­ness of how to ac­cess it.

Vas Narasimhan (Photographer: Jason Alden/Bloomberg via Getty Images)

No­var­tis de­tails plans to axe 8,000 staffers as Narasimhan be­gins sec­ond phase of a glob­al re­org

We now know the number of jobs coming under the axe at Novartis, and it isn’t small.

The pharma giant is confirming a report from Swiss newspaper Tages-Anzeiger that it is chopping 8,000 jobs out of its 108,000 global staffers. A large segment will hit right at company headquarters in Basel, as CEO Vas Narasimhan axes some 1,400 of a little more than 11,000  jobs in Switzerland.

The first phase of the work is almost done, the company says in a statement to Endpoints News. Now it’s on to phase two. In the statement, Novartis says:

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Peter Marks (Jim Lo Scalzo/Pool via AP Images)

FDA's VRB­PAC votes in fa­vor of adapt­ing the Covid-19 vac­cine to the lat­est Omi­cron vari­ant

The FDA’s Vaccine and Related Biological Products Advisory Committee on Tuesday gave the thumbs up — by a vote of 19-2 — that the FDA should require an Omicron-related component in this next season’s booster dose for Covid-19, which both Pfizer/BioNTech and Moderna are hard at work on.

And while neither booster will likely be ready to go with adequate supplies for all American adults by the beginning of the next school year, the situation is still complex and fluid, with CBER Director Peter Marks telling the committee that it’ll take companies at least three months to ready their supplies for this expected next wave.

Bob Nelsen (Lyell)

As bear mar­ket con­tin­ues to beat down biotech, ARCH clos­es a $3B ear­ly-stage fund

One of the biggest names in biotech investing has a whole lot of new money to spend.

ARCH Venture Partners closed its 12th venture fund early Wednesday morning, the firm said, bringing in almost $3 billion to invest in early-stage biotechs. The move comes about a year and a half after ARCH announced its previous fund, for almost $2 billion back in January 2021.

In a statement, ARCH managing director and co-founder Bob Nelsen appeared to brush off concerns about the broader market troubles, alluding to the downturn that’s seen several biotechs downsize and the XBI fall back to almost pre-pandemic levels.

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Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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Sanofi to cut in­sulin prices for unin­sured from $99 to $35, match­ing the in­sulin cap com­ing through Con­gress

As the House-passed bill to cap the monthly price of insulin at $35 nationwide makes its way for a Senate vote soon, Sanofi announced Wednesday morning that beginning next month it will cut the monthly price of its insulins for uninsured Americans to $35, down from $99 previously.

The announcement from Sanofi, which allows the uninsured to buy one or multiple Sanofi insulins (Lantus, Insulin Glargine U-100, Toujeo, Admelog, and Apidra) at $35 for a 30-day supply effective July 1, follows House passage (232-193) of the monthly cap in March, with just 12 Republicans voting in favor of the measure.

Hank Safferstein, Generian CEO

Astel­las sub­sidiary to part­ner with Pitts­burgh up­start in search for 'un­drug­gable' pro­teins

As Astellas continues its drive to build out its gene therapy portfolio and capabilities, a subsidiary of the Japanese pharma company has entered into a collaboration with a little-known Pittsburgh biotech.

Astellas-owned Mitobridge and Generian Pharmaceuticals announced on Wednesday that they will work together in a new deal for “undruggable” protein targets. Generian will net an undisclosed upfront payment and could get up to $180 million in milestones, should anything from its platform prove successful, as well as single-digit royalties on global net sales.

Adam Simpson, Icosavax CEO

Reel­ing from Covid flop, Icosavax says its RSV can­di­date passed ear­ly test. But in­vestors need some more con­vinc­ing

Three months separated from a disappointing readout of its Covid-19 vaccine, Icosavax is back with what it calls positive topline data for a different VLP vaccine candidate — although investors aren’t impressed.

IVX-121, a vaccine candidate for respiratory syncytial virus (RSV), appeared to generate “robust” immune responses among both young and older adults, as measured by neutralizing antibodies, and appeared generally well-tolerated, Icosavax reported.

(AP Photo/Gemunu Amarasinghe)

Some phar­ma com­pa­nies promise to cov­er abor­tion-re­lat­ed trav­el costs — while oth­ers won't go that far yet

As the US Department of Health and Human Services promises to support the millions of women who would now need to cross state lines to receive a legal abortion, a handful of pharma companies have said they will pick up employees’ travel expenses.

GSK, Sanofi, Johnson & Johnson, BeiGene, Alnylam and Gilead have all committed to covering abortion-related travel expenses just four days after the Supreme Court overturned Roe v. Wade and revoked women’s constitutional right to an abortion.

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