Albert Bourla, Pfizer CEO (AP Images)

Covid-19 roundup: US and Pfiz­er strike deal for 100M more dos­es; NIH and part­ners cut crit­i­cal­ly ill pa­tients out of blood thin­ner tri­al

The US gov­ern­ment has sealed a deal with Pfiz­er and BioN­Tech for 100 mil­lion ad­di­tion­al dos­es of their Covid-19 vac­cine, dou­bling the coun­try’s dose or­der.

Pfiz­er and BioN­Tech say they can de­liv­er the full 200 mil­lion dos­es by Ju­ly 31, 2021. The deal al­so in­cludes an op­tion for the US to pur­chase up to 400 mil­lion more down the road. The US is pay­ing an­oth­er $1.95 bil­lion for the ad­di­tion­al dos­es, at least 70 mil­lion of which should be de­liv­ered by June 30. The re­main­ing will be de­liv­ered by Ju­ly 31, ac­cord­ing to the com­pa­nies.

“Se­cur­ing more dos­es from Pfiz­er and BioN­Tech for de­liv­ery in the sec­ond quar­ter of 2021 fur­ther ex­pands our sup­ply of dos­es across the Op­er­a­tion Warp Speed port­fo­lio,” HHS Sec­re­tary Alex Azar said in a state­ment. “This new fed­er­al pur­chase can give Amer­i­cans even more con­fi­dence that we will have enough sup­ply to vac­ci­nate every Amer­i­can who wants it by June 2021

The US en­tered ne­go­ti­a­tions with Pfiz­er last week — rough­ly a month af­ter the gov­ern­ment al­leged­ly passed up an of­fer to ac­quire more dos­es. The gov­ern­ment has al­ready dou­bled down on its or­der from Mod­er­na, ink­ing a deal for 100 mil­lion more dos­es. The ad­di­tion­al Mod­er­na shots will be de­liv­ered in Q2, on top of an ini­tial 20 mil­lion dos­es that are ex­pect­ed to ship this month. The re­main­der of the ini­tial dose or­der is due in Q1.

OWS chief Mon­cef Slaoui told Fox News Sun­day last week that he hopes 100 mil­lion peo­ple will be vac­ci­nat­ed by the end of March, with about 40 mil­lion dos­es of vac­cine dis­trib­uted by the end of De­cem­ber.

“With these 100 mil­lion ad­di­tion­al dos­es, the Unit­ed States will be able to pro­tect more in­di­vid­u­als and hope­ful­ly end this dev­as­tat­ing pan­dem­ic more quick­ly,” Pfiz­er CEO Al­bert Bourla said in a state­ment. “We look for­ward to con­tin­u­ing our work with the U.S. gov­ern­ment and health­care providers around the coun­try.”

NIH and part­ners cut crit­i­cal­ly ill pa­tients out of blood thin­ner tri­al

An­oth­er NIH tri­al for the treat­ment of Covid-19 has come up short in one sub­group of pa­tients.

Stud­ies con­duct­ed by the NIH’s AC­TIV-4 pro­gram, the Ran­dom­ized, Em­bed­ded, Mul­ti­fac­to­r­i­al Adap­tive Plat­form Tri­al for Com­mu­ni­ty-Ac­quired Pneu­mo­nia (REMAP-CAP), and An­tithrom­bot­ic Ther­a­py to Ame­lio­rate Com­pli­ca­tions of COVID-19 (AT­TACC) have stopped en­rolling crit­i­cal­ly ill pa­tients in the ICU, af­ter the drugs didn’t re­duce the need for or­gan sup­port.

Covid-19 is as­so­ci­at­ed with in­flam­ma­tion and wide­spread blood clots. Many pa­tients with the virus, in­clud­ing some who died, have formed blood clots through­out their bod­ies, “even in their small­est blood ves­sels,” which can lead to com­pli­ca­tions like lung fail­ure, heart at­tack and stroke, ac­cord­ing to the NIH.

But for crit­i­cal­ly ill pa­tients, “a po­ten­tial for harm in this sub-group could not be ex­clud­ed,” the NIH said in a state­ment. “In­creased bleed­ing is a known com­pli­ca­tion of full-dose an­ti­co­ag­u­la­tion.”

Pa­tients who don’t re­quire ICU care will still be en­rolled, per rec­om­men­da­tion from over­sight boards. Re­searchers are look­ing to see if full-dose blood thin­ners are more ef­fec­tive than low­er dose ones in non-crit­i­cal­ly ill pa­tients.

This isn’t the first time an NIH tri­al for a Covid-19 treat­ment turned up neg­a­tive re­sults. The agency halt­ed its clin­i­cal tri­al of hy­drox­y­chloro­quine back in June af­ter find­ing the drug pro­vides no ben­e­fit, de­spite Pres­i­dent Don­ald Trump tout­ing its ef­fects. The agency al­so threw cold wa­ter on Trump’s so-called “his­toric break­through” with con­va­les­cent plas­ma in Sep­tem­ber, say­ing there was no ev­i­dence of its safe­ty or ef­fi­ca­cy.

The agency ex­pand­ed its study of con­va­les­cent plas­ma in Sep­tem­ber, af­ter FDA com­mis­sion­er Stephen Hahn came un­der fire for is­su­ing mis­lead­ing state­ments about its ef­fec­tive­ness.

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

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Covid-19 roundup: EU and As­traZeneca trade blows over slow­downs; Un­usu­al unions pop up to test an­ti­bod­ies, vac­cines

After coming under fire for manufacturing delays last week, AstraZeneca’s feud with the European Union has spilled into the open.

The bloc accused the pharma giant on Wednesday of pulling out of a meeting to discuss cuts to its vaccine supplies, the AP reported. AstraZeneca denied the reports, saying it still planned on attending the discussion.

Early Wednesday, an EU Commission spokeswoman said that “the representative of AstraZeneca had announced this morning, had informed us this morning that their participation is not confirmed, is not happening.” But an AstraZeneca spokesperson later called the reports “not accurate.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,900+ biopharma pros reading Endpoints daily — and it's free.

Pfiz­er's big block­buster Xel­janz flunks its post-mar­ket­ing safe­ty study, re­new­ing harsh ques­tions for JAK class

When the FDA approved Pfizer’s JAK inhibitor Xeljanz for rheumatoid arthritis in 2012, they slapped on a black box warning for a laundry list of adverse events and required the New York drugmaker to run a long-term safety study.

That study has since become a consistent headache for Pfizer and their blockbuster molecule. Last year, Pfizer dropped the entire high dose cohort after an independent monitoring board found more patients died in that group than in the low dose arm or a control arm of patients who received one of two TNF inhibitors, Enbrel or Humira.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,900+ biopharma pros reading Endpoints daily — and it's free.

Adeno-associated virus-1 illustration; the use of AAVs resurrected the gene therapy field, but companies are now testing the limits of a 20-year-old technology (File photo, Shutterstock)

Af­ter 3 deaths rock the field, gene ther­a­py re­searchers con­tem­plate AAV's fu­ture

Nicole Paulk was scrolling through her phone in bed early one morning in June when an email from a colleague jolted her awake. It was an article: Two patients in an Audentes gene therapy trial had died, grinding the study to a halt.

Paulk, who runs a gene therapy lab at the University of California, San Francisco, had planned to spend the day listening to talks at the American Association for Cancer Research annual meeting, which was taking place that week. Instead, she skipped the conference, canceled every work call on her calendar and began phoning colleagues across academia and industry, trying to figure out what happened and why. All the while, a single name hung in the back of her head.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,900+ biopharma pros reading Endpoints daily — and it's free.

Anthony Fauci, NIAID director (AP Images)

As new Covid-19 task force gets un­der­way, threat looms of vac­cine, mon­o­clon­al an­ti­body-re­sis­tant vari­ants

Hours before President Biden’s Covid-19 team gave their first virtual press conference, the famed AIDS researcher David Ho delivered concerning news in a new pre-print: SARS-CoV-2 B.1.351, the variant that emerged in South Africa, is “markedly more resistant” to antibodies from convalescent plasma and vaccinated individuals.

The news for several monoclonal antibodies, including Eli Lilly’s bamlanivimab, was even worse: Their ability to neutralize was “completely or markedly abolished,” Ho wrote. Lilly’s antibody cocktail, which was just shown to dramatically reduce the risk of hospitalizations or death, also became far less potent.

Eli Lil­ly demon­strates that 2 an­ti­bod­ies beat 1 for guard­ing against se­vere Covid-19. But can that solve the first an­ti­body’s prob­lem amid slow up­take?

It seems safe to say that two antibodies are better than one.

Eli Lilly released the largest results yet on Tuesday for their Covid-19 neutralizing antibody cocktail, announcing that the combo reduced deaths and hospitalizations in coronavirus patients by 70%. Across 1,000 patients, there were 11 such events in the treatment group and 36 in the placebo group.

The breakdown for deaths alone was even starker: 10 in the placebo group and 0 in the treatment group. Lilly added that the drug hit secondary endpoints for reducing viral load and alleviating symptoms, although they did not disclose numbers.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,900+ biopharma pros reading Endpoints daily — and it's free.

George Yancopoulos (L) and Len Schleifer (Regeneron)

Re­gen­eron touts pos­i­tive pre­lim­i­nary im­pact of its Covid an­ti­body cock­tail, pre­vent­ing symp­to­matic in­fec­tions in high-risk group

Regeneron flipped its cards on an interim analysis of the data being collected for its Covid-19 antibody cocktail used as a safeguard against exposure to the virus. And the results are distinctly positive.

The big biotech reported Tuesday morning that their casirivimab and imdevimab combo prevented any symptomatic infections from occurring in a group of 186 people exposed to the virus through a family connection, while the placebo arm saw 8 of 223 people experience symptomatic infection. Symptomatic combined with asymptomatic infections occurred in 23 people among the 223 placebo patients compared to 10 of the 186 subjects in the cocktail arm.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,900+ biopharma pros reading Endpoints daily — and it's free.

Pascal Soriot, AP

As­traZeneca CEO Pas­cal So­ri­ot sev­ers an un­usu­al board con­nec­tion, steer­ing clear of con­flicts while re­tain­ing im­por­tant al­liances

CSL Behring chief Paul Perreault scored an unusual coup last summer when he added AstraZeneca CEO Pascal Soriot to the board, via Zoom. It’s rare, to say the least, to see a Big Pharma CEO take any board post in an industry where interests can simultaneously connect and collide on multiple levels of operations.

The tie set the stage for an important manufacturing connection. The Australian pharma giant agreed to supply the country with 10s of millions of AstraZeneca’s Covid-19 vaccine, once it passes regulatory muster.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.