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

Covid-19 roundup: Eu­rope re­serves 1.8 bil­lion dos­es of Pfiz­er vac­cines; Re­pub­li­cans slam Biden's TRIPS waiv­er sup­port

The Eu­ro­pean Com­mis­sion on Thurs­day signed a con­tract with Pfiz­er and BioN­Tech that will al­low for the pur­chase of 900 mil­lion dos­es of the cur­rent vac­cine and of a vac­cine adapt­ed to vari­ants, with the op­tion to pur­chase an ad­di­tion­al 900 mil­lion dos­es.

The EU cur­rent­ly has 600 mil­lion Pfiz­er dos­es through 2021, and the ad­di­tion­al 900 mil­lion are ex­pect­ed be­gin­ning in De­cem­ber 2021 and con­tin­u­ing in­to 2023.

In to­tal, the EU may have ac­cess to up to 2.4 bil­lion Pfiz­er dos­es, all of which are planned to be man­u­fac­tured in the EU.

Pfiz­er CEO Al­bert Bourla told Ax­ios in an in­ter­view yes­ter­day that the com­pa­ny feels “quite com­fort­able” that it’ll make 3 bil­lion dos­es of its vac­cine for the world by the end of 2021, and an­oth­er up to 4 bil­lion dos­es in 2022.

He said ap­prox­i­mate­ly 1 bil­lion dos­es will go to low- and mid­dle-in­come coun­tries this year, most of which will come in the sec­ond half of the year.

Longer re­frig­er­a­tor stor­age for Pfiz­er’s vac­cines

Fol­low­ing the Eu­ro­pean Med­i­cines Agency’s lead in al­low­ing for longer re­frig­er­a­tor stor­age (from five days to a month) of un­opened but thawed vials, the FDA did the same on Thurs­day.

Pfiz­er sub­mit­ted da­ta to the FDA to demon­strate that undi­lut­ed, thawed vials of its vac­cine are sta­ble at re­frig­er­a­tor tem­per­a­tures of 2°C to 8°C (35°F to 46°F) for up to 1 month, FDA added.

Re­pub­li­can sen­a­tors to Biden trade of­fi­cials: TRIPS waiv­er is ‘dis­as­trous de­ci­sion’

Re­pub­li­can sen­a­tors blast­ed US trade rep­re­sen­ta­tive Kather­ine Tai and Com­merce Sec­re­tary Gi­na Rai­mon­do, call­ing the Biden ad­min­is­tra­tion’s sup­port for tem­porar­i­ly halt­ing in­tel­lec­tu­al prop­er­ty pro­tec­tions for Covid-19 vac­cines a “dis­as­trous de­ci­sion.”

Sens. Tom Cot­ton (R-AR), Chuck Grass­ley (R-IA), Thom Tillis (R-NC), Mike Crapo (R-ID) and 10 oth­ers claimed the waiv­er would “force Amer­i­can com­pa­nies to give their med­ical tech­nol­o­gy and man­u­fac­tur­ing process­es to for­eign ad­ver­saries like Chi­na.”

They al­so rea­soned that there are not enough vac­cine dos­es at this time be­cause “the sup­ply chain lacks the tech­no­log­i­cal ca­pac­i­ty. Vac­cine pro­duc­tion is a com­plex tech­ni­cal and lo­gis­ti­cal process, with lim­it­ed tech­ni­cal re­sources (e.g., skilled sci­en­tists and tech­ni­cians at com­pa­nies). At best, all Pres­i­dent Biden’s give­away to Chi­na and In­dia and oth­ers will do is fos­ter un­co­or­di­nat­ed vac­cine na­tion­al­ism, as coun­tries jump in to try to co­erce tech­nol­o­gy trans­fer and man­u­fac­tur­ing lo­cal­ly.”

Pfiz­er and Mod­er­na have al­so both made clear in re­cent weeks that they are not go­ing to help any com­pa­nies try­ing to make copy­cat ver­sions of their prod­ucts, es­pe­cial­ly as they would be vy­ing for the same raw ma­te­ri­als and nec­es­sary equip­ment.

Tai, who’s re­spon­si­ble for ne­go­ti­at­ing the waiv­er at the WTO on be­half of the Biden ad­min­is­tra­tion, tes­ti­fied be­fore the Sen­ate Fi­nance Com­mit­tee last week. For coun­tries where less than 2% of their peo­ple are vac­ci­nat­ed, this is an ex­is­ten­tial cri­sis, Tai said, stress­ing the ur­gency and tem­po­rary na­ture of the de­ci­sion.

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.

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.

Like the flu vac­cine every year, the FDA could move quick­ly on a vari­ant-tar­get­ed Covid vac­cine

In the same way that the FDA signs off on flu vaccines every year without requiring large clinical trials to measure their efficacy, the FDA may employ a similar strategy in authorizing variant-focused versions of the mRNA vaccines.

As the world braces for more data on the latest variant Omicron, which may reduce vaccine efficacy, top vaccine developers like Moderna and Pfizer-BioNTech have promised they can pull together a new vaccine targeted against a specific Covid variant in about 100 days. Since Omicron emerged last week, Pfizer-BioNTech, Moderna and J&J have all said they’ve begun work on Omicron-specific vaccines, if needed.

Ursula von der Leyen, President of the European Commission

Omi­cron: Re­searchers scram­ble as new coro­n­avirus mu­ta­tion takes flight around the globe — Pfiz­er/BioN­Tech, Mod­er­na vow swift re­sponse

As Americans were waking up for their Black Friday rituals, they were greeted with the news that a new mutation of the Covid-19 virus has appeared and been sequenced — after it caught an international flight to Hong Kong. And two of the leading Covid-19 vaccine developers promised delivery of a new vaccine “within 100 days” if necessary while a third spelled out its 3-prong strategy hours later.

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Shankar Musunuri, Ocugen CEO

Ocu­gen hits an­oth­er snag in bring­ing its Bharat Biotech-part­nered Covid-19 vac­cine to the US

Back in July, Ocugen and Bharat Biotech unveiled some Phase III data suggesting their Covid-19 vaccine, Covaxin, was 77.8% effective at preventing overall disease in India. They’re now looking to launch an immuno-bridging study to see if those numbers hold up in the US — but on Friday, the FDA said not so fast.

Regulators have placed a clinical hold on the partners’ IND, Ocugen shared on Friday. Ocugen’s stock $OCGN sank 9% on the news Friday, but was up almost 7% in pre-market trading on Monday.

Covid-19 roundup: As Omi­cron spreads, African biotech re­port­ed­ly close to re­pro­duc­ing Mod­er­na's vac­cine, while WHO cre­ates pan­dem­ic pre­ven­tion body

The emergence of the Omicron variant over the holiday has reignited the focus on vaccine equity, and in its efforts to bring more shots to Africa, one South African biotech is reportedly close to reproducing Moderna’s mRNA shot.

Afrigen Biologics and Vaccines is speeding toward its pivotal trials, the Washington Post reported Sunday, though it’s doing so without Moderna’s recipe. The biotech reportedly has finished sequencing the Moderna vaccine and plans to soon compare its own recreation to Moderna’s jab.

Thanks­giv­ing edi­tion: Top 15 End­points sto­ries of 2021; Can you name that vac­cine?; Mer­ck­'s Covid an­tivi­ral dis­ap­points; FDA nom­i­nee's in­dus­try ties; 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.

Happy Thanksgiving to all those who are celebrating it — although, if we are being honest, this week’s abbreviated edition is really for those who are not. Wherever you’re tuning in from, we appreciate your support, hope you find this recap helpful and we wish you a wonderful weekend.

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What were End­points read­ers tun­ing in­to this year? Here’s a look at our 15 most pop­u­lar re­ports of the year (so far)

At the beginning of this year, I laid out a basic objective for Endpoints News as we headed to our 5th anniversary. We’ve long been doing a fine job covering the breaking news in R&D — if I do say so myself — but we needed to expand our horizons on industry coverage, increase the staff and go much, much deeper when the stories demanded it.

In a phrase: broader and deeper.

It’s safe to say, based on our daily web traffic, that you all seemed to like this idea. We’ve doubled the staff — thanks to a growing group of paid subscribers — ramped up the daily report and now publish a regular slate of in-depth articles. And traffic — those clicks you always read about — have gone up in volume too. Monthly sessions are up 43%, to close to 1.5 million. Unique readers are up 63%, to 874,480 in October, after setting a record of close to a million the month before. Page views are running at 3 million-plus a month. And the overall number of subscribers has surged to 124,000.

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