Covid-19 roundup: Sci­en­tists find long-last­ing re­sults from mR­NA vac­cines; As­traZeneca back on track for vac­cine de­liv­er­ies

While dis­cus­sions sur­round­ing Covid-19 vac­cines among lead­ers in the phar­ma­ceu­ti­cal in­dus­try have re­volved around the near-cer­tain need for boost­ers, sci­en­tists re­port­ed that the Pfiz­er/BioN­Tech and Mod­er­na vac­cines may pro­tect against the virus for years.

The find­ings were pub­lished in Na­ture on Mon­day and add to the the­o­ry that those who have been im­mu­nized with mR­NA vac­cines might not need boost­ers, de­pend­ing on the sever­i­ty of the mu­ta­tions of the virus. The study didn’t ex­am­ine J&J’s vac­cine.

A re­port from Ali Ellebedy in May found that the im­mune cells that rec­og­nize the virus sit in­ac­tive in bone mar­row for at least eight months af­ter in­fec­tion, and that same re­port al­so found that those who have re­ceived a vac­cine but nev­er be­came in­fect­ed with the virus would like­ly need a boost­er shot in the fu­ture. An­oth­er study said that mem­o­ry B cells ma­ture and strength­en for at least a year af­ter in­fec­tion, The New York Times re­port­ed.

Ellebedy’s study con­sist­ed of 41 peo­ple, eight of whom had been pre­vi­ous­ly in­fect­ed by Covid-19, who re­ceived both jabs of the Pfiz­er/BioN­Tech vac­cine. Sci­en­tists ex­tract­ed lymph node sam­ples in 14 pa­tients from as long as 15 weeks af­ter the pa­tients’ first dose of the shot. The team found that the num­ber of mem­o­ry cells that rec­og­nized the virus re­mained the same, and the ger­mi­nal cen­ter was ac­tive in all of the pa­tients.

“Usu­al­ly by four to six weeks, there’s not much left,” Deep­ta Bhat­tacharya, an im­mu­nol­o­gist at the Uni­ver­si­ty of Ari­zona, told the Times. But ger­mi­nal cen­ters stim­u­lat­ed by the mR­NA vac­cines are “still go­ing, months in­to it, and not a lot of de­cline in most peo­ple.”

As­traZeneca back on track for vac­cine de­liv­er­ies

Af­ter some de­lays, As­traZeneca is on sched­ule to pro­vide Covid-19 vac­cines to coun­tries in South­east Asia, Reuters re­port­ed Mon­day.

Thai­land will re­ceive its quo­ta of 6 mil­lion dos­es by the end of June, and ex­ports will start in ear­ly Ju­ly. As­traZeneca said that Siam Bio­science will pro­duce 180 mil­lion jabs this year.

Siam is owned by Thai­land’s king Ma­ha Va­ji­ra­longko­rn. It is that com­pa­ny’s first time mak­ing a vac­cine, and ques­tions sur­round­ing pro­duc­tion tar­gets are sen­si­tive, be­cause pub­lish­ing the monar­chy is pun­ish­able by 15 years in prison in Thai­land.

Last week, the drug­mak­er gave 1.8 mil­lion dos­es to the Thai gov­ern­ment, but de­liv­er­ies to the Philip­pines and Tai­wan both were de­layed.

As­traZeneca vac­cine proved strong re­sponse against coro­n­avirus a year af­ter jab: re­port

As­traZeneca’s vac­cine, pro­duced through a col­lab­o­ra­tion with Ox­ford Uni­ver­si­ty, pro­vid­ed “strong im­mune re­sponse” for up to a year fol­low­ing a sin­gle dose or third boost­er shot, the com­pa­ny an­nounced Mon­day.

A pa­per pub­lished by Ox­ford in The Lancet found that an­ti­body lev­els stayed above the base­line for at least a year af­ter a sin­gle dose, and a third dose of vaxzevria giv­en at least six months af­ter the sec­ond dose in­creased an­ti­body lev­els six-fold, and helped fight off the Al­pha, Be­ta and Delta vari­ants of the virus.

An­drew Pol­lard, di­rec­tor of the Ox­ford Vac­cine Group, said that the re­sponse to a sec­ond dose was “ex­cel­lent,” es­pe­cial­ly af­ter a 10-month de­lay from the first shot.

Pa­tients in the study were be­tween 18 and 55 years old, and had ei­ther re­ceived one or both dos­es of vaxzevria.

Vaxzevria us­es a repli­ca­tion-de­fi­cient chim­panzee vi­ral vec­tor based on a week­end ver­sion of an ade­n­ovirus. It’s been grant­ed emer­gency use au­tho­riza­tion in 80 coun­tries.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

The End­points 11: They've got mad mon­ey and huge am­bi­tions. It's time to go big or go home

These days, selecting a group of private biotechs for the Endpoints 11 spotlight begins with a sprint to get ahead of IPOs and the M&A teams at Big Pharma. I’ve had a couple of faceplants earlier this year, watching some of the biotechs on my short list choose a quick leap onto Nasdaq or into the arms of a buyer.

Vividion, you would have been a great pick for the Endpoints 11. I’m sorry I missed you.

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Sen. Mitch McConnell (R-KY) at the Capitol (J. Scott Applewhite/AP Images)

Mitch Mc­Connell, top Re­pub­li­cans ques­tion Biden on get­ting ahead of FDA on Covid-19 boost­ers

Senate Minority Leader Mitch McConnell, Senate Health Committee ranking member Richard Burr and other top Republicans are questioning the Biden administration’s decision to get out in front of the FDA and announce that Covid-19 vaccine boosters would be ready for administration by this week.

While Burr praised the FDA’s EUA for the boosters Wednesday evening, the Republicans earlier in the day called on White House coronavirus response coordinator Jeffrey Zients to release an updated strategy on leveraging vaccines to end the pandemic and to clarify what exactly happened with the premature announcement on the boosters.

In step for­ward for re­ju­ve­na­tion field, re­searchers turn back the clock on mice hearts

When Thomas Braun was starting out as a young professor at Germany’s University of Würzburg in 1997, he decided to try his hand at a new field: heart regeneration, a sci-fi-esque premise that could offer a way to treat patients recovering from a heart attack. He thought it would take a few years before they got results.

“We were,” he acknowledges now, “rather naïve.”

But on Thursday, after two and a half decades of fitful starts and abandoned leads, Braun and a team of researchers at the Max Planck Institute showed that they could reprogram heart cells in mice and get the animals to regenerate cardiac tissue after a heart attack. The breakthrough, published in Scienceadds new evidence that it will eventually be possible to help patients recover muscle lost in heart attacks and gives another boon to anti-aging researchers who want to one day apply these rejuvenation techniques across much of the body.

Lon­za un­veils new ex­pan­sion plans at Swiss man­u­fac­tur­ing sites, cap­ping off a very busy pan­dem­ic

Lonza will expand its drug development in Switzerland yet again with investments in three of its manufacturing sites, the company announced Wednesday, capping off a very busy year for the Euro giant.

The expansion will feature the addition of an aseptic filling line for clinical supply of drug products in Stein, as well as additions to support both clinical and commercial manufacturing at Basel and Visp.

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FDA's can­cer drug ad­vi­sors will re­view 2 more dan­gling ac­cel­er­at­ed ap­provals for mul­ti­ple myelo­ma, leukemia

In an attempt to get its house of accelerated approvals in order, the FDA is holding its second adcomm of 2021 to review cancer drugs that won accelerated approvals but failed to confirm clinical benefit in subsequent trials or have taken a long time to read those data out.

On Dec. 2, the FDA’s Oncologic Drugs Advisory Committee will review two accelerated approvals from Secura Bio’s Farydak (panobinostat), a third-line multiple myeloma drug, and Acrotech Biopharma’s Marqibo, as a third-line drug for adult patients with Philadelphia chromosome negative acute lymphoblastic leukemia. Both drugs have been marketed for more than five years under their accelerated approvals but have recorded negligible sales in their respective indications in recent years.

Michel Vounatsos, Biogen CEO (Credit: World Economic Forum/Valeriano Di Domenico)

Fol­low­ing con­tro­ver­sial Aduhelm ap­proval, DC-based neu­rol­o­gy cen­ter bans Bio­gen rep­re­sen­ta­tives from its of­fices — re­port

CEO Michael Vounatsos confessed earlier this month that Biogen was struggling to get its controversial new Alzheimer’s drug Aduhelm off the ground, with some major health systems refusing to administer it.

Now, a DC-based medical center is taking its small rebellion against the drug’s approval one step further.

The Neurology Center has reportedly banned all Biogen representatives from its seven DC-area offices, according to a photo circulating on Twitter.

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Martin Babler, Esker CEO

Fore­site re­cruits Prin­cip­ia vet Mar­tin Babler — and his old team — to oc­cu­py the C-suite of a start­up

Almost a year to the day after Sanofi closed on its $3.7 billion Principia buyout, handing CEO Martin Babler $81 million for his chunk of equity, the biotech exec is ending his sabbatical and getting back to the helm of a startup. And he’s bringing the old Principia team along with him for the R&D scrimmage ahead.

Babler is taking over the top post at Esker Therapeutics from June Lee, who helped found the upstart, which Foresite hatched out of its labs and endowed with a $70 million launch round. The immunology specialist broke out of stealth mode back in May with a tiny staff and a Phase I plan for a TYK2 drug — initially for psoriasis — part of its plan to address genetically defined patient groups in a field dominated by blockbusters and blockbuster wannabes.

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FDA au­tho­rizes Pfiz­er's vac­cine boost­er for se­niors, those at high risk for se­vere Covid-19

The Biden administration’s goal of kicking off its booster shot drive for the entire US population this week is not quite going as planned.

First, Pfizer applied for approval of a supplemental application for the booster shots, but since last Friday’s adcomm reviewing them, the plan has devolved into an EUA, which the FDA issued late Wednesday evening.

The population that is now eligible for the booster, six months after receiving the first pair of Pfizer-BioNTech vaccines, also narrowed from what Pfizer applied for (everyone who’s eligible for the initial Pfizer shots) to just those who are 65 or older, or at high-risk of a Covid infection, including health care workers and others with occupational hazards.