Stéphane Bancel, AP Images

Fi­nal analy­sis of US-fund­ed Mod­er­na Covid vac­cine tri­al shows 98% ef­fi­ca­cy against se­vere dis­ease

A fi­nal look at the re­sults of the place­bo-con­trolled Mod­er­na tri­al in the New Eng­land Jour­nal of Med­i­cine, pub­lished Thurs­day af­ter­noon, shows how the vac­cine con­tin­ues to pre­vent Covid-19 and se­vere cas­es af­ter more than five months fol­low­ing the sec­ond shot.

Of the more than 30,000 en­rolled in the tri­al that ul­ti­mate­ly led to the vac­cine’s EUA, on­ly two peo­ple in the vac­cine group got a se­vere form of the dis­ease, com­pared to 106 in the place­bo group — lead­ing to an ef­fi­ca­cy of 98%.

As the com­pa­ny pre­pares to sub­mit da­ta to the FDA on a boost­er shot, it’ll like­ly have a dif­fi­cult time, as Pfiz­er has, show­ing that the two-shot com­bo has waned in ef­fi­ca­cy enough for the gen­er­al pop­u­la­tion to im­me­di­ate­ly re­ceive a third dose.

Ef­fi­ca­cy in pre­vent­ing over­all Covid-19 ill­ness, the pri­ma­ry end­point of the Mod­er­na tri­al, was 93%, with 55 con­firmed cas­es in the vac­cine group and 744 in the place­bo group.

“Vac­cine ef­fi­ca­cy was con­sis­tent­ly high in sub­groups, in­clud­ing par­tic­i­pants 65 years of age or old­er and 75 years of age or old­er, those with co­ex­ist­ing con­di­tions, those be­long­ing to var­i­ous racial and eth­nic groups, and those with var­i­ous cat­e­gories of oc­cu­pa­tion­al risk ex­po­sures,” Har­vard’s Lind­sey Robert Baden and Bay­lor’s Hana El Sahly, the ar­ti­cle’s lead co-au­thors, wrote.

The ar­ti­cle is the fi­nal analy­sis of the vac­cine’s blind­ed phase of the tri­al, which was fund­ed by both the US gov­ern­ment’s BAR­DA and Tony Fau­ci’s NI­AID. BAR­DA has spent bil­lions of dol­lars de­vel­op­ing and man­u­fac­tur­ing the vac­cine, now known com­mer­cial­ly as Spike­vax. And Mod­er­na is like­ly to haul in at least $20 bil­lion from it just this year, based on the ex­pect­ed man­u­fac­ture of be­tween 800 mil­lion and 1 bil­lion dos­es.

While pre­vi­ous analy­ses of this tri­al and oth­ers have shown strong vac­cine ef­fi­ca­cy against symp­to­matic or over­all Covid-19 in­fec­tions, the Mod­er­na tri­al al­so looked specif­i­cal­ly at asymp­to­matic cas­es too, which could be key with the rise of the Delta vari­ant.

In terms of pre­vent­ing asymp­to­matic in­fec­tion 14 days af­ter the sec­ond in­jec­tion, the re­sults show the ef­fi­ca­cy of the vac­cine was 63% (95% CI, 56.6 to 68.5), with 214 asymp­to­matic cas­es in the Spike­vax group and 498 in the place­bo group.

The CDC says that with Delta, it is con­tin­u­ing to as­sess da­ta on whether ful­ly vac­ci­nat­ed peo­ple with asymp­to­matic break­through in­fec­tions can trans­mit the virus. Some stud­ies have at­trib­uted the rise of Delta at least in part due to stealth asymp­to­matic in­fec­tions.

As for safe­ty, the fi­nal re­sults of Mod­er­na’s tri­al of­fer up sim­i­lar­ly en­cour­ag­ing da­ta show­ing some in­jec­tion-re­lat­ed side ef­fects, but less than 0.1% of pa­tients in both vac­cine and place­bo groups dis­con­tin­ued par­tic­i­pa­tion in the tri­al be­cause of ad­verse events af­ter ei­ther in­jec­tion.

Over­all, 0.6% of place­bo re­cip­i­ents and 0.4% of vac­cine re­cip­i­ents had ad­verse events that re­sult­ed in their not re­ceiv­ing the sec­ond dose, and ad­verse events that were con­sid­ered to be re­lat­ed to the in­jec­tions were re­port­ed by about 9% of place­bo re­cip­i­ents and 14% of vac­cine re­cip­i­ents dur­ing the ob­ser­va­tion pe­ri­od of the study and were gen­er­al­ly sim­i­lar to those re­port­ed pre­vi­ous­ly re­gard­less of age.

A to­tal of 32 deaths oc­curred by com­ple­tion of the tri­al, the au­thors not­ed, with 16 deaths each in the place­bo and vac­cine groups, al­though “no deaths were con­sid­ered to be re­lat­ed to in­jec­tions of place­bo or vac­cine.” Four of the deaths were at­trib­uted to Covid-19, with three com­ing from the place­bo group and one in the vac­cine group, al­though that one in­di­vid­ual in the vac­cine group on­ly re­ceived one dose of Spike­vax.

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.

So — that pig-to-hu­man trans­plant; Po­ten­tial di­a­betes cure reach­es pa­tient; Ac­cused MIT sci­en­tist lash­es back; 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.

We’re incredibly excited to welcome Beth Bulik, seasoned pharma marketing reporter, to the team. You can find much of her work in our new Marketing channel — and in her weekly newsletter, Endpoints PharmaRx, which will launch in early November. Add it to your subscriptions here.

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NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

No, sci­en­tists are not any clos­er to pig-to-hu­man trans­plants than they were last week

Steve Holtzman was awoken by a 1 a.m. call from a doctor at Duke University asking if he could put some pigs on a plane and fly them from Ohio to North Carolina that day. A motorcyclist had gotten into a horrific crash, the doctor explained. He believed the pigs’ livers, sutured onto the patient’s skin like an external filter, might be able to tide the young man over until a donor liver became available.

UP­DAT­ED: Agenus calls out FDA for play­ing fa­vorites with Mer­ck, pulls cer­vi­cal can­cer BLA at agen­cy's re­quest

While criticizing the FDA for what may be some favoritism towards Merck, Agenus on Friday officially pulled its accelerated BLA for its anti-PD-1 inhibitor balstilimab as a potential second-line treatment for cervical cancer because of the recent full approval for Merck’s Keytruda in the same indication.

The company said the BLA, which was due for an FDA decision by Dec. 16, was withdrawn “when the window for accelerated approval of balstilimab closed,” thanks to the conversion of Keytruda’s accelerated approval to a full approval four months prior to its PDUFA date.

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How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data are messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data are exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

Pfiz­er pitch­es its Covid-19 vac­cine for younger chil­dren ahead of ad­comm next week

Pfizer will present its case to the FDA’s vaccine adcomm next week, seeking authorization for a lower-dose version of its Covid-19 vaccine for kids ages 5 through 12, which the Biden administration said will likely begin rolling out early next month.

Two primary doses of the 10 µg vaccine (the dose for those ages 12 and up is 30 μg) given 3 weeks apart in this group of children “have shown a favorable safety and tolerability profile, robust immune responses against all variants of concern including Delta, and vaccine efficacy of 90.7% against laboratory-confirmed symptomatic COVID-19,” the company said in briefing documents ahead of next Tuesday’s meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee.

No­vo CEO Lars Fruer­gaard Jør­gensen on R&D risk, the deal strat­e­gy and tar­gets for gen­der di­ver­si­ty

 

I kicked off our European R&D summit last week with a conversation involving Novo Nordisk CEO Lars Fruergaard Jørgensen. Novo is aiming to launch a new era of obesity management with a new approval for semaglutide. And Jørgensen had a lot to say about what comes next in R&D, how they manage risk and gender diversity targets at the trendsetting European pharma giant.

John Carroll: I’m here with Lars Jørgensen, the CEO of Novo Nordisk. Lars, it’s been a really interesting year so far with Novo Nordisk, right? You’ve projected a new era of growing sales. You’ve been able to expand on the GLP-1 franchise that was already well established in diabetes now going into obesity. And I think a tremendous number of people are really interested in how that’s working out. You have forecast a growing amount of sales. We don’t know specifically how that might play out. I know a lot of the analysts have different ideas, how those numbers might play out, but that we are in fact embarking on a new era for Novo Nordisk in terms of what the company’s capable of doing and what it’s able to do and what it wants to do. And I wanted to start off by asking you about obesity in particular. Semaglutide has been approved in the United States for obesity. It’s an area of R&D that’s been very troubled for decades. There have been weight loss drugs that have come along. They’ve attracted a lot of attention, but they haven’t actually ever gained traction in the market. My first question is what’s different this time about obesity? What is different about this drug and why do you expect it to work now whereas previous drugs haven’t?

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Boost­er bo­nan­za: FDA en­dors­es 'mix-and-match' scheme, and Mod­er­na and J&J too

The FDA late Wednesday signed off on authorizing the use of heterologous — or what FDA calls a “mix and match” of a primary vaccine series and different booster doses — for all currently available Covid-19 vaccines, in addition to separately authorizing Moderna and J&J boosters.

On the mix-and-match approach, which FDA officials insisted isn’t too confusing in a press conference, the agency offered the example of an 18-year-old who received the J&J shot at least two months ago and may now receive a single booster of the J&J, a half dose of the Moderna, or the Pfizer-BioNTech booster.