Yin Weidong, Sinovac CEO (Nicolas Bock/Bloomberg via Getty Images)

Covid-19 roundup: Sino­vac shot com­plete­ly pre­vents se­vere cas­es at 14-day mark, com­pa­ny says

Sino­vac has made some big da­ta claims on its way to a ten­ta­tive ap­proval in Chi­na for its Covid-19 vac­cine. New Phase III da­ta show promis­ing re­sults in pre­vent­ing se­vere dis­ease, but will it be enough to con­vince in­ter­na­tion­al reg­u­la­tors?

Phase III tri­als of the vac­cine, al­so called Coro­n­aVac, be­gan back in Ju­ly and were on­go­ing in Brazil, Turkey, In­done­sia and Chile us­ing a 0/14 day sched­ule with a to­tal en­roll­ment of 25,000 par­tic­i­pants.

The tri­als in Brazil and Turkey com­prised 12,396 health care work­ers over the age of 18, and on­ly 253 pos­i­tive cas­es were found dur­ing the ob­ser­va­tion­al pe­ri­od in the ran­dom­ized, dou­ble-blind and place­bo-con­trolled stud­ies.

Four­teen days af­ter re­ceiv­ing two dos­es of the vac­cine, Coro­n­aVac pre­vent­ed 50.65% for all Covid-19 cas­es, 83.70% of cas­es re­quir­ing med­ical treat­ment, and 100% of hos­pi­tal­iza­tions, and se­vere or fa­tal cas­es.

Al­so of note for the tri­al in Turkey, a sec­ond stage of test­ing in­clud­ed mem­bers of the gen­er­al pop­u­la­tion be­tween the ages of 18 and 59. There were 6,453 par­tic­i­pants in­volved in the lat­ter tri­al (in ad­di­tion to 918 par­tic­i­pants in the health care work­er-ex­clu­sive tri­al), and 1,322 peo­ple com­plet­ed the two-dose vac­ci­na­tion.

Sino­vac said that an analy­sis of 29 of those cas­es re­vealed a vac­cine ef­fi­ca­cy rate for pre­vent­ing Covid-19 of 91.25% af­ter 14 days.

The re­sults were promis­ing enough that the com­pa­ny said it had of­fi­cial­ly filed for con­di­tion­al mar­ket au­tho­riza­tion for Coro­n­aVac with Chi­na’s Na­tion­al Med­ical Prod­ucts Ad­min­is­tra­tion and con­tin­ues to ac­tive­ly seek reg­u­la­to­ry ap­proval for Coro­n­aVac in oth­er coun­tries.

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

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Stéphane Bancel, Moderna CEO

'This is not go­ing to be good': Mod­er­na CEO Ban­cel warns of a 'ma­te­r­i­al drop' in vac­cine ef­fi­ca­cy as Omi­cron spreads

Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.

Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?

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Ap­peals court puts the fi­nal nail in the cof­fin for Tec­fidera patent, adding to Bio­gen's bur­geon­ing set­backs

In another setback for Biogen, the big biotech lost its appeal to revive a patent for the once-blockbuster drug Tecfidera, marking a likely conclusion to the case.

The US Court of Appeals for the Federal Circuit issued the ruling Tuesday morning, saying Biogen failed to satisfy the “written description” requirement for patent law. As a result, Mylan-turned-Viatris will be able to sell its multiple sclerosis generic without fear of infringement and Biogen will have to find a new revenue driver elsewhere.

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Philip Dormitzer, new GSK global head of vaccines R&D

Glax­o­SmithK­line poach­es Pfiz­er's vi­ral vac­cines lead in rush to cap­i­tal­ize on fu­ture of mR­NA

GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.

Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.

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In­tro­duc­ing End­points Stu­dio, a new way to ad­ver­tise with End­points-craft­ed brand­ing cam­paigns

Since our start in 2016, Endpoints has grown fast while executing our mission to cover biopharma’s most critical developments for industry pros worldwide. As readership has grown, our advertising business has too. Endpoints advertising partners support the mission and engage their desired audiences through announcements on our email and web platforms, brand recognition in our event coverage and sponsorships of Endpoints daily and weekly reports.

Covid-19 roundup: As­pen to pro­duce gener­ic J&J vac­cine for Africa; First boost­ers for un­der-18-year-olds could come next week — re­port

After some ups and downs surrounding the manufacturing of J&J’s Covid-19 vaccine as the South African company’s site, Aspen Pharmacare has announced an agreement with the pharma to make and sell an Aspen-branded Covid-19 vaccine through the continent.

The agreement will expand the already-existing tech transfer and agreement to give Aspen the right to make vaccines from drug substance supplied by J&J, and sell the finished form under the name Aspenovax to public sector markets in Africa.

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Tillman Gerngross (Adagio)

Till­man Gern­gross on Omi­cron: 'It is a grim sit­u­a­tion...we’re go­ing to see a sig­nif­i­cant drop in vac­cine ef­fi­ca­cy'

Tillman Gerngross, the rarely shy Dartmouth professor, biotech entrepreneur and antibody expert, has been warning for over a year that the virus behind Covid-19 would likely continue to mutate, potentially in ways that avoid immunity from infection and the best defenses scientists developed. He spun out a company, Adagio, to build a universal antibody, one that could snuff out any potential mutation.

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In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

Mar­ket­ingRx roundup: Ab­b­Vie’s Hu­mi­ra TV turns fo­cus to HS skin con­di­tion; Sanofi amps par­ent­ing pol­i­cy

After years as the top spending pharma TV advertiser, AbbVie’s Humira brand finally downshifted earlier this year, ceding much of its marketing budget to up-and-coming sibling meds Skyrizi and Rinvoq. However, now Humira is back on TV with ads for another condition — Hidradenitis suppurativa (HS).

The chronic and painful skin condition results in lumps and abscesses caused by inflammation or infection of sweat glands, most often in the armpits or groin. Humira was first approved to treat HS in 2015 and remains the only FDA-approved drug for the condition. Two TV ads both note more than 30,000 people with HS have been prescribed Humira.