As­traZeneca/Ox­ford score first vote of con­fi­dence as UK au­tho­rizes their Covid-19 vac­cine

As­traZeneca and Ox­ford have land­ed the first au­tho­riza­tion for their Covid-19 vac­cine. And with this par­tic­u­lar shot, the UK may be much fur­ther ahead than the rest of the world.

The MHRA rec­om­mend­ed an emer­gency OK to the UK gov­ern­ment al­most two months af­ter it start­ed a rolling re­view — al­though the de­vel­op­ers on­ly sub­mit­ted the full ap­pli­ca­tion last week. Reg­u­la­tors have de­ter­mined that “the vac­cine has met its strict stan­dards of safe­ty, qual­i­ty and ef­fec­tive­ness,” ac­cord­ing to a state­ment, even though ex­perts in oth­er coun­tries have raised ques­tions.

While da­ta from a sub­group sug­gest­ed that a reg­i­men in which peo­ple first re­ceive a half dose, fol­lowed by a full dose has a high­er ef­fi­ca­cy fig­ure at 90%, the MHRA gave the thumbs up to the 62% ef­fec­tive full-full dose reg­i­men, which is sup­port­ed by more ev­i­dence from two tri­als con­duct­ed in the UK and South Africa.

Hav­ing be­come the first coun­try to au­tho­rize and start ad­min­is­ter­ing the Pfiz­er/BioN­Tech vac­cine, the UK has or­dered enough of that mR­NA jab for 20 mil­lion peo­ple. Its deal with As­traZeneca now gives it ac­cess to an­oth­er 50 mil­lion ade­n­ovirus-based vac­cines, more than enough to vac­ci­nate a pop­u­la­tion of 66 mil­lion-plus.

The OK trig­gers an im­me­di­ate re­lease of its batch­es, As­traZeneca said, and mil­lions of dos­es will be ready for vac­ci­na­tion ear­ly in the new year.

No­tably, the two dos­es of its vac­cine — dubbed ChA­dOx1 nCoV-19 and AZD1222 at var­i­ous points of its short life — can be giv­en four to 12 weeks apart. Ac­cord­ing to ear­li­er com­ments by Adar Poon­awal­la, CEO of the Serum In­sti­tute of In­dia, giv­ing them 2 to 3 months apart boosts the ef­fi­ca­cy to 95% (his com­pa­ny is mass-man­u­fac­tur­ing the vac­cine). By com­par­i­son, doc­tors are rec­om­mend­ed to give the sec­ond dose of Pfiz­er/BioN­Tech’s BNT162b2, now chris­tened Comir­naty, 21 days af­ter the first.

UK au­thor­i­ties made no ref­er­ence to that claim but said that means they can pri­or­i­tize giv­ing one, par­tial­ly pro­tec­tive As­traZeneca/Ox­ford vac­cine to as many peo­ple as pos­si­ble, with­out hav­ing to rush to the next shot.

Matt Han­cock, the Sec­re­tary of State for Health and So­cial Care, called it “a mo­ment to cel­e­brate British in­no­va­tion.”

Oth­er coun­tries, though, haven’t been as en­thu­si­as­tic. Mon­cef Slaoui, the sci­en­tif­ic chief of Op­er­a­tion Warp Speed, has re­marked that As­traZeneca would like­ly need the re­sults from its US tri­al to file for an emer­gency use au­tho­riza­tion with the FDA. In­dia had passed on grant­i­ng an ear­ly OK to As­traZeneca. Ear­li­er this week, a top EMA of­fi­cial not­ed that Eu­ro­pean au­thor­i­ties have yet to re­ceive the non-clin­i­cal da­ta nec­es­sary to con­firm vac­cine “qual­i­ty” for au­tho­riza­tion, mean­ing they like­ly can’t make a de­ci­sion any time soon.

For its part, As­traZeneca has been tout­ing the sta­bil­i­ty — it can be stored, trans­port­ed and han­dled at nor­mal re­frig­er­a­tor tem­per­a­tures of 2-8 de­grees Cel­sius — and the low cost of its vac­cine as it makes plans to sup­ply bil­lions of vac­cines to less de­vel­oped re­gions.

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.

FDA can­cels ODAC meet­ing this week to re­view two more dan­gling ac­cel­er­at­ed ap­provals — but won't ex­plain why

The FDA’s Oncologic Drugs Advisory Committee has decided to cancel a planned meeting on Thursday to discuss two cancer drugs that previously won accelerated approvals but failed to confirm clinical benefit in required follow-up trials or have taken a long time to finish those trials.

The FDA said in a statement that the meeting “is no longer needed” but did not offer further detail on why exactly it was canceled, telling Endpoints News to contact the companies. Attempts to contact both Secura Bio and Acrotech went unreturned. The companies may have decided to pull these treatments from the market, or they’ve come to new agreements with the agency on their confirmatory trials.

How to use reg­istry da­ta to sup­port FDA de­ci­sion mak­ing: Agency ex­plains in new guid­ance

Drugmakers looking to design a new registry or use an existing one to support a regulatory decision on a drug’s effectiveness or safety will need to consult with a new draft guidance released Monday by the FDA.

The agency’s reliance on registry data for regulatory decisions dates back more than two decades, at least, as in 1998 Bayer won approval for its anticoagulant Refludan (withdrawn from the market in 2013 for commercial reasons) based in part on a historical control group pulled from a registry.

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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