Stéphane Bancel, Moderna CEO (Nancy Lane/The Boston Herald via AP Images, Pool)

At­tempt­ing to ride boost­er ad­comm coat­tails, Mod­er­na says its Covid-19 shot is bet­ter than Pfiz­er/BioN­Tech

As the FDA pre­pares to con­vene an ad­comm to dis­cuss Pfiz­er/BioN­Tech’s Covid-19 vac­cine boost­ers lat­er this week, the oth­er ma­jor mR­NA play­er is stick­ing its thumb out and try­ing to hitch a ride on the cor­po­rate me­dia blitz.

Mod­er­na put out a press re­lease Wednes­day af­ter­noon point­ing to two re­cent­ly un­veiled stud­ies that, the biotech as­serts, so­lid­i­fy the need for Covid-19 boost­ers, leap­ing in­to the on­go­ing de­bate for the shots. The re­lease comes mere­ly hours af­ter brief­ing doc­u­ments for the Pfiz­er/BioN­Tech ad­comm went pub­lic, with Mod­er­na putting forth an ar­gu­ment for why its vac­cines are bet­ter suit­ed to com­bat the Delta vari­ant than Pfiz­er and BioN­Tech’s jab.

In par­tic­u­lar, Mod­er­na high­light­ed an in­ter­im CDC es­ti­mate re­leased last week look­ing at vac­cine ef­fec­tive­ness be­tween June and Au­gust, when Delta was the pre­dom­i­nant virus strain in the US. This analy­sis con­clud­ed that Mod­er­na vac­cine re­cip­i­ents were less like­ly to be hos­pi­tal­ized than those who re­ceived ei­ther the Pfiz­er/BioN­Tech or J&J shot.

“Across all ages, [vac­cine ef­fec­tive­ness] was sig­nif­i­cant­ly high­er among Mod­er­na vac­cine re­cip­i­ents (95%) than among Pfiz­er-BioN­Tech (80%) or Janssen (60%) vac­cine re­cip­i­ents,” the analy­sis said.

The biotech al­so drew at­ten­tion to a preprint of a re­al-world study look­ing at more than 350,000 peo­ple who had re­ceived two Mod­er­na dos­es through the end of June. Com­pared to the same num­ber of un­vac­ci­nat­ed in­di­vid­u­als, Mod­er­na saw a vac­cine ef­fi­ca­cy of 87% against Covid-19 di­ag­no­sis and 96% against hos­pi­tal­iza­tion.

Though these da­ta had been pub­lic for at least a week — the CDC da­ta came out on Sept. 10 and the preprint is dat­ed Sept. 2 — Wednes­day marked the first time Mod­er­na stressed the im­por­tance of the analy­ses. The biotech pub­lished the re­lease less than two weeks af­ter hold­ing a press brief­ing in which it laid out some yet-to-be peer-re­viewed da­ta like­ly to be in­clud­ed in boost­er shot sub­mis­sions.

The ear­li­er meet­ing large­ly out­lined Mod­er­na’s plan for boost­er shots in im­muno­com­pro­mised in­di­vid­u­als, such as those re­ceiv­ing dial­y­sis. Wednes­day’s re­lease, how­ev­er, dealt more with vac­cine ef­fec­tive­ness in the gen­er­al pop­u­la­tion.

In ad­di­tion to the two out­side stud­ies, Mod­er­na tacked on a new analy­sis com­ing from the open-la­bel ex­ten­sion of its orig­i­nal Phase III vac­cine study. This analy­sis looked at break­through in­fec­tions in study par­tic­i­pants be­tween Ju­ly 1 and Aug. 27, with Mod­er­na eval­u­at­ing both vac­cine re­cip­i­ents and those who ini­tial­ly re­ceived the place­bo but were ad­min­is­tered the shot af­ter the biotech re­ceived an EUA.

At 13 months of fol­low-up in the ac­tive tri­al arm, re­searchers ob­served 162 break­through Covid-19 cas­es, com­pared to 88 af­ter eight months in the crossover group. With a 36% re­duc­tion in in­ci­dence rates be­tween the groups, the biotech con­clud­ed that in­di­vid­u­als vac­ci­nat­ed more re­cent­ly were less like­ly to con­tract Covid-19.

“The in­creased risk of break­through in­fec­tions in COVE study par­tic­i­pants who were vac­ci­nat­ed last year com­pared to more re­cent­ly il­lus­trates the im­pact of wan­ing im­mu­ni­ty and sup­ports the need for a boost­er to main­tain high lev­els of pro­tec­tion,” Mod­er­na CEO Stéphane Ban­cel said in a state­ment. “We hope these find­ings are help­ful as health au­thor­i­ties and reg­u­la­tors con­tin­ue to as­sess strate­gies for end­ing this pan­dem­ic.”

Mod­er­na pub­lished a preprint of the break­through study on Wednes­day af­ter­noon at the same time as the press re­lease.

The boost­er de­bate has tak­en over the bio­phar­ma world in re­cent weeks as the Delta vari­ant con­tin­ues to surge in the US. Pres­i­dent Joe Biden’s ad­min­is­tra­tion had aimed to be­gin de­liv­er­ing boost­ers to the gen­er­al pub­lic as ear­ly as next week, though the tim­ing of the shots has re­port­ed­ly changed from eight months post-sec­ond dose to six months.

That an­nounce­ment, how­ev­er, sparked con­cerns over po­lit­i­cal med­dling in FDA af­fairs. In re­sponse to the White House leapfrog­ging the agency on a boost­er an­nounce­ment, two se­nior vac­cine of­fi­cials sub­mit­ted their res­ig­na­tion in protest at the end of Au­gust. Ear­li­er this week, the of­fi­cials — Mar­i­on Gru­ber and Phil Krause — co-au­thored a pa­per with the WHO in the Lancet ar­gu­ing boost­er shots are un­nec­es­sary.

Pfiz­er and the FDA will make their cas­es at the boost­er shot ad­comm on Fri­day. Mod­er­na sub­mit­ted its ini­tial boost­er plan to reg­u­la­tors ear­li­er this month, rough­ly a week af­ter wrap­ping its BLA for full ap­proval of the orig­i­nal two-dose reg­i­men. Pfiz­er and BioN­Tech re­ceived full ap­proval for their Covid-19 vac­cine on Aug. 23.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; 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.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

Susan Galbraith, Executive VP, Oncology R&D, AstraZeneca

As­traZeneca on­col­o­gy R&D chief Su­san Gal­braith: 'Y­ou're go­ing to need or­thog­o­nal com­bi­na­tion­s'

 

Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC

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Roche's Tecen­triq cross­es the fin­ish line first in ad­ju­vant lung can­cer, po­ten­tial­ly kick­ing off gold rush

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

Tillman Gerngross, Adagio CEO

Q&A: Till­man Gern­gross ex­plains why his Covid mAb will have an edge over an al­ready crowd­ed field

If anyone knows about monoclonal antibodies, it’s serial entrepreneur, Adimab CEO, and Dartmouth professor of bioengineering Tillman Gerngross.

Even the name of Gerngross’ new antibody startup Adagio Therapeutics is meant to reflect his vision behind the development of his Covid-19 mAb: slowly, he said, explaining that “everyone else, whether it’s Regeneron, Lilly, or AstraZeneca, Vir, they all valued speed over everything.”

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FDA's vac­cine ad­comm unan­i­mous­ly sup­ports Mod­er­na's boost­er in same pop­u­la­tions as Pfiz­er's boost­er

The FDA’s vaccine advisory committee on Thursday voted 19-0 in support of expanding Moderna’s Covid-19 vaccine EUA for booster doses for certain high-risk individuals. FDA is expected to authorize the Moderna booster shortly.

Similarly to the Pfizer booster shot, Moderna’s will likely be authorized for those older than 65, adults at high risk of severe Covid-19, and adults whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of Covid-19. But unlike the Pfizer adcomm, where FDA had to scramble to get the committee to vote in favor of a booster, this committee was unanimous with the Moderna shot.

David Kessler testifies during a Senate hearing in May (Jim Lo Scalzo/Pool via AP Images)

Biden's fight with Mod­er­na over pro­vid­ing vac­cines for the poor­est coun­tries in­ten­si­fies

With about $10 billion in taxpayer funds invested in Moderna so far, it would seem that the company would be more understanding of pleas from President Joe Biden and the federal government to provide more vaccine doses to low- and middle-income countries.

But the Biden-Moderna feud over supplying the world with doses of mRNA vaccines is now spilling into the public, with Biden’s chief science officer of the government’s Covid-19 response David Kessler explaining the details in an online panel discussion moderated by Yale law professor Amy Kapczynski on Wednesday.

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