Covid-19 roundup: Zy­dus Cadi­la sub­mits 3-dose vac­cine for reg­u­la­to­ry ap­proval; US do­nates Mod­er­na jabs to Pak­istan dur­ing short­age

In­dia’s sec­ond home-grown vac­cine could be ap­proved by reg­u­la­tors soon as Zy­dus Cadi­la an­nounced Thurs­day it has ap­plied for emer­gency use ap­proval with reg­u­la­tors in that na­tion.

The jab has demon­strat­ed ef­fi­ca­cy of 66.6%, and the com­pa­ny says stud­ies have shown it is safe for chil­dren be­tween the ages of 12 and 18 years old. The vac­cine’s piv­otal study was car­ried out in more than 50 clin­i­cal sites across In­dia dur­ing the peak of the coun­try’s sec­ond wave, which Cadi­la says reaf­firms the ef­fi­ca­cy against the Delta vari­ant.

Af­ter the third dose, sci­en­tists ob­served 100% ef­fi­ca­cy for mod­er­ate cas­es of the virus, Cadi­la said.

“This break­through marks a key mile­stone in sci­en­tif­ic in­no­va­tion and ad­vance­ment in tech­nol­o­gy,” Sharvil Pa­tel, the man­ag­ing di­rec­tor of Cadi­la Health­care, said in a state­ment. “As the first ever plas­mid DNA vac­cine for hu­man use, Zy­CoV-D has proven its safe­ty and ef­fi­ca­cy pro­file in our fight against COVID-19. The vac­cine when ap­proved will help not on­ly adults but al­so ado­les­cents in the 12 to 18 years age group.”

Zy­dus has al­so eval­u­at­ed a two-dose ver­sion of the vac­cine that us­es three mi­cro-dose por­tions.

Last year, Cadi­la an­nounced it was re­search­ing two vac­cine can­di­dates for Covid, one that us­es DNA to tar­get the vi­ral en­try mem­brane pro­tein, and an­oth­er that used a live at­ten­u­at­ed re­com­bi­nant measles virus.

US do­nates Mod­er­na jabs to Pak­istan dur­ing short­age

Pak­istan has re­ceived 2.5 mil­lion dos­es of Mod­er­na’s vac­cine Fri­day, US State De­part­ment spokesman Ned Price con­firmed on Twit­ter.

“This de­liv­ery un­der­scores our ties with the peo­ple of Pak­istan and our com­mit­ment to beat the pan­dem­ic glob­al­ly by vac­ci­nat­ing as many as pos­si­ble, as quick­ly as pos­si­ble,” the tweet said.

The de­liv­ery eas­es pres­sure on the cap­i­tal of Is­lam­abad in the midst of a vac­cine short­age.

The vac­cines were de­liv­ered in part­ner­ship with CO­V­AX, UNICEF and the Pak­istani gov­ern­ment, the As­so­ci­at­ed Press re­port­ed. The do­na­tion was part of the 80 mil­lion dos­es the US has pledged to share with the world.

Ger­many locks in dos­es for 2022 ahead of any pos­si­ble vari­ants

The Ger­man gov­ern­ment will spend big mon­ey to se­cure an­oth­er 204 mil­lion dos­es of vac­cines, and 50.1 mil­lion of those dos­es will be from J&J and Mod­er­na, Reuters re­ports. The spree is an at­tempt to avoid pro­duc­tion bot­tle­necks and pro­tec­tion against pos­si­ble vari­ants.

The Robert Koch In­sti­tute has ad­vised the gov­ern­ment that there should be suf­fi­cient mR­NA vac­cines avail­able to ful­ly cov­er the coun­try’s pop­u­la­tion, but al­ter­na­tives should be brought on in case of any “un­fore­seen prob­lems,” ac­cord­ing to Reuters.

A to­tal of 70 mil­lion com­bined dos­es will come from Sanofi, No­vavax and Val­ne­va. Near­ly 85 mil­lion of the dos­es will come from Pfiz­er/BioN­Tech, as they are al­ready con­tract­ed through the EU’s pro­cure­ment scheme.

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

No­var­tis reshuf­fles its wild cards; Tough sell for Bio­gen? Googling pro­teins; Ken Fra­zier's new gig; 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.

If you enjoy the People section in this report, you may also want to check out Peer Review, my colleagues Alex Hoffman and Kathy Wong’s comprehensive compilation of comings and goings in biopharma.

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Demis Hassabis, DeepMind CEO (Qianlong/Imaginechina via AP Images)

Google's Deep­Mind opens its pro­tein data­base to sci­ence — po­ten­tial­ly crack­ing drug R&D wide open

Nearly a year ago, Google’s AI outfit DeepMind announced they had cracked one of the oldest problems in biology: predicting a protein’s structure from its sequence alone. Now they’ve turned that software on nearly every human protein and hundreds of thousands of additional proteins from organisms important to medical research, such as fruit flies, mice and malaria parasite.

The new database of roughly 350,000 protein sequences and structures represents a potentially monumental achievement for the life sciences, one that could hasten new biological insights and the development of new drugs. DeepMind said it will be free and accessible to all researchers and companies.

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In­side Bio­gen's scram­ble to sell Aduhelm: Pro­ject 'Javelin' and pres­sure to ID as many pa­tients as pos­si­ble

In anticipation of Aduhelm’s approval for Alzheimer’s in June, Biogen employees were directed to identify and guarantee treatment centers would administer the drug through a program called “Javelin,” a senior Biogen employee told Endpoints News.

The program identified about 800 centers for use, he said, and Biogen now pays for the use of bioassays to identify beta amyloid in potential patients having undergone a lumbar puncture procedure, the employee said — and one center preparing to administer the drug confirmed its participation in the bioassay program.

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Vas Narasimhan, Novartis CEO (Jason Alden/Bloomberg via Getty Images)

No­var­tis dis­cards one of its ‘wild card’ drugs af­ter it flops in key study. But it takes one more for the hand

Always remember just how risky it is to gamble big on small studies.

A little more than 4 years ago, Novartis reportedly put up a package worth up to $1 billion for the dry eye drug ECF843 after a small biotech called Lubris put it through its paces in a tiny study of 40 moderate to severe patients, tracking some statistically significant markers of efficacy.

By last fall, the program had risen up to become one of CEO Vas Narasimhan’s top “wild card” programs in line for a potential breakthrough year in 2021. These drugs were all considered high-risk, high-reward efforts. And in this case, risk won.

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EMA re­jects FDA-ap­proved Parkin­son's drug, signs off on Mod­er­na vac­cine use in ado­les­cents ahead of FDA

The European Medicines Agency on Friday rejected Kyowa Kirin’s Parkinson’s disease drug Nouryant (istradefylline), which the US FDA approved in 2019 under the brand name Nourianz.

EMA said it considered that the results of the clinical studies used to support the application “were inconsistent and did not satisfactorily show that Nouryant was effective at reducing the ‘off’ time. Only four out of the eight studies showed a reduction in ‘off’ time, and the effect did not increase with an increased dose of Nouryant.”

Albert Bourla, Pfizer CEO (Evan Vucci/AP Images)

Covid-19 roundup: Pfiz­er to sup­ply US with 200M more vac­cines as UK study finds high­er an­ti­bod­ies in 8-10 week in­ter­vals

The US government has purchased 200 million more doses of the Pfizer/BioNTech vaccine, the companies announced Friday morning.

Pfizer and BioNTech expect to deliver 110 million of the additional doses by Dec. 31, with the remaining 90 million doses to be delivered no later than April 30, 2022. The price was not disclosed, and the US government has the option to acquire an updated version of the vaccine to address potential variants, as well as new formulations of the vaccine, if available and authorized.

6 top drug­mak­ers of­fer per­spec­tives on FDA's new co­vari­ates in RCTs guid­ance

Back in May, the FDA revised and expanded a 2019 draft guidance that spells out how to adjust for covariates in the statistical analysis of randomized controlled trials.

Building on the ICH’s E9 guideline on the statistical principles for clinical trials, the 3-page draft was transformed into an 8-page draft, with more detailed recommendations on linear and nonlinear models to analyze the efficacy endpoints in RCTs.

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Mol­e­c­u­lar Di­ag­nos­tics Can Trans­form Can­cer Care. Let’s Make It Hap­pen.

Like so many people around the world, my life has been profoundly shaped by cancer. Those personal experiences, along with a deep love of clinical laboratory science and a passion to apply the power of genomics in medicine, motivated me to launch a company that would improve cancer care through better diagnostics. Thirteen years later, I am proud that we are delivering more accurate information at multiple points along the patient journey, with a focus on eight of the 10 cancers that are most commonly diagnosed in the United States.

Albert Bourla, Pfizer CEO (John Thys, Pool via AP Images)

Pfiz­er and BioN­Tech team up with South African man­u­fac­tur­er, but it will on­ly han­dle fill-fin­ish

The manufacturing expansion into Africa continued Wednesday with Pfizer and BioNTech’s announcement that the two companies signed on with the Biovac Institute to manufacture its Covid-19 vaccine to distribute throughout Africa. But while the continent is in dire need of doses, vaccines from the expansion won’t be available until the start of next year.

Biovac will only handle distribution and fill-finish duties. Drug substance for these batches will come from European facilities. When fully operational, the facility will pump out 100 million doses a year, set to be evenly distributed among the 55 member states of the African Union.