Ngozi Okonjo-Iweala, Director general of WTO (AP Photo/Keystone/Alessandro Della Bella)

Opin­ion: Waiv­ing Covid-19 vac­cine IP could save lives, but where is the man­u­fac­tur­ing ca­pac­i­ty?

Droves of House De­moc­rats in Wash­ing­ton and mem­bers of the Eu­ro­pean Par­lia­ment have now glommed on­to a ma­jor push by In­dia and South Africa at the WTO to abol­ish all IP around Covid-19 vac­cines.

At first blush, waiv­ing this IP sounds like an easy win: More Covid-19 vac­cines made lo­cal­ly for more peo­ple means more lives saved. Sim­ple enough, es­pe­cial­ly as low-in­come coun­tries have re­ceived just a tiny frac­tion of the world’s vac­cine al­lot­ment so far.

But when you be­gin to con­sid­er how this is sup­posed to play out in the re­al world, how the tech trans­fer will take time and en­er­gy and en­gage­ment from the very com­pa­nies that would lose their IP, how the le­gal chal­lenges and lo­gis­tics will com­pli­cate every­thing fur­ther, and how the man­u­fac­tur­ing site num­bers don’t re­al­ly make sense, it’s easy to won­der why there’s such a big push for this.

Take, for in­stance, Mod­er­na. Back in Oc­to­ber 2020, Mod­er­na an­nounced that it would not en­force its Covid-19 re­lat­ed patents against those mak­ing vac­cines in­tend­ed to com­bat the pan­dem­ic, even say­ing it would li­cense its IP.

Tahir Amin

Sounds great, but no one has come call­ing.

Some have not­ed that Mod­er­na doesn’t own every patent used in its vac­cine. Tahir Amin, an IP lawyer at the fore­front of push­ing for the waiv­er, al­so has ex­plained at length how man­u­fac­tur­ers need more than just the patents, say­ing oth­er vac­cine man­u­fac­tur­ers could scale up in about 6 to 8 months.

But where? What oth­er man­u­fac­tur­ers? Even Pfiz­er and Mod­era took longer than 6 to 8 months to re­al­ly ramp up.

The pub­li­ca­tion The In­ter­cept pro­posed to an­swer that ques­tion re­cent­ly in an ar­ti­cle ti­tled, “Fac­to­ry Own­ers Around the World Stand Ready to Man­u­fac­ture Covid-19 Vac­cines.” But the on­ly ex­am­ple pro­vid­ed is On­tario-based Bi­ol­yse Phar­ma, which said it can make 20 mil­lion vac­cines per year, and an­oth­er fill-fin­ish fa­cil­i­ty in Bangladesh that says it has ca­pac­i­ty.

So we’re go­ing to dis­rupt Pfiz­er and Mod­er­na, which to­geth­er are pro­duc­ing al­most 10 bil­lion dos­es of Covid-19 vac­cines over the next two years in fa­cil­i­ties that have been cleared by the top reg­u­la­tors in the world, so Bi­ol­yse can make 20 mil­lion dos­es in a year?

Even if there are hun­dreds of oth­er man­u­fac­tur­ing sites like Bi­ol­yse (which, by the way, was shut down by Health Cana­da in 2014) around the world, who’s go­ing to man­date the tech trans­fer, and who’s go­ing to en­sure the sites are built and per­form­ing prop­er­ly?

The US FDA isn’t cur­rent­ly con­duct­ing on­site for­eign in­spec­tions, and many low-in­come coun­tries don’t even have drug reg­u­la­tors. Cut­ting cor­ners on vac­cine man­u­fac­tur­ing can lead to se­ri­ous health is­sues, as we’ve seen with con­trac­tor Emer­gent’s site in Bal­ti­more, which is es­pe­cial­ly im­por­tant as these vac­cines are go­ing to healthy peo­ple.

Pres­i­dent Biden said Tues­day af­ter­noon that by Ju­ly 4, the US will do­nate 10% of its Covid-19 vac­cine stock­pile to the rest of the world. And ear­li­er this week, Mod­er­na pledged 500 mil­lion dos­es for low-in­come coun­tries. Biden’s chief med­ical ad­vis­er Tony Fau­ci told the Fi­nan­cial Times this week that while he’s ag­nos­tic on the waiv­er, he warned it could back­fire in­to a long le­gal bat­tle.

Right now, the cam­paign­ing for the IP waiv­er in the US seems to be a lot more about bash­ing Big Phar­ma than try­ing to ac­tu­al­ly in­crease vac­cine dos­es for the need­i­est. A long le­gal bat­tle with com­pa­nies like Pfiz­er and Mod­er­na isn’t go­ing to help bring the world more Covid-19 vac­cine dos­es.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

Endpoints Premium

Premium subscription required

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

FDA hands ac­cel­er­at­ed nod to Seagen, Gen­mab's so­lo ADC in cer­vi­cal can­cer, but com­bo stud­ies look even more promis­ing

Biopharma’s resident antibody-drug conjugate expert Seagen has scored a clutch of oncology approvals in recent years, finding gold in what are known as “third-gen” ADCs. Now, another of their partnered conjugates is ready for prime time.

The FDA on Monday handed an accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv, or “TV”) in second-line patients with recurrent or metastatic cervical cancer who previously progressed after chemotherapy rather than PD-(L)1 systemic therapy, the companies said in a release.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

The biggest ques­tions fac­ing gene ther­a­py, the XLMTM com­mu­ni­ty, and Astel­las af­ter fourth pa­tient death

After three patients died last year in an Astellas gene therapy trial, the company halted the study and began figuring out how to safely get the program back on track. They would, executives eventually explained, cut the dose by more than half and institute a battery of other measures to try to prevent the same thing from happening again.

Then tragically, Astellas announced this week that the first patient to receive the new regimen had died, just weeks after administration.

Endpoints Premium

Premium subscription required

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

Ex­elix­is pulls a sur­prise win in thy­roid can­cer just days ahead of fi­nal Cabome­tyx read­out

Exelixis added a thyroid cancer indication to its super-seller Cabometyx’s label on Friday — months before the FDA was expected to make a decision, and days before the company was set to unveil the final data at #ESMO21.

At a median follow-up of 10.1 months, differentiated thyroid cancer patients treated with Cabometyx (cabozantinib) lived a median of 11 months without their disease worsening, compared to just 1.9 months for patients given a placebo, Exelixis said on Monday.

Dave Lennon, former president of Novartis Gene Therapies

Zol­gens­ma patent spat brews be­tween No­var­tis and Re­genxbio as top No­var­tis gene ther­a­py ex­ec de­parts

Regenxbio, a small licensor of gene therapy viral vectors spun out from the University of Pennsylvania, is now finding itself in the middle of some major league patent fights.

In addition to a patent suit with Sarepta Therapeutics from last September, Novartis, is now trying to push its smaller partner out of the way. The Swiss biopharma licensed Regenxbio’s AAV9 vector for its $2.1 million spinal muscular atrophy therapy Zolgensma.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 117,700+ biopharma pros reading Endpoints daily — and it's free.

Volker Wagner (L) and Jeff Legos

As Bay­er, No­var­tis stack up their ra­dio­phar­ma­ceu­ti­cal da­ta at #ES­MO21, a key de­bate takes shape

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 117,700+ biopharma pros reading Endpoints daily — and it's free.

Rafaèle Tordjman (Jeito Capital)

Con­ti­nu­ity and di­ver­si­ty: Rafaèle Tord­j­man's women-led VC firm tops out first fund at $630M

For a first-time fund, Jeito Capital talks a lot about continuity.

Rafaèle Tordjman had spotlighted that concept ever since she started building the firm in 2018, promising to go the extra mile(s) with biotech entrepreneurs while pushing them to reach patients faster.

Coincidentally, the lack of continuity was one of the sore spots listed in a report about the European healthcare sector published that same year by the European Investment Bank — whose fund is one of the LPs, alongside the American pension fund Teacher Retirement System of Texas and Singapore’s Temasek, to help Jeito close its first fund at $630 million (€534 million). As previously reported, Sanofi had chimed in €50 million, marking its first investment in a French life sciences fund.