Mod­er­na's Covid-19 vac­cine sales to trail Pfiz­er's to­tal sig­nif­i­cant­ly in 2021 and 2022

Pfiz­er’s and Mod­er­na’s mR­NA vac­cines to pre­vent Covid-19 are of­ten con­sid­ered equals in many re­spects. Both have shown strong pro­tec­tion from the virus, with lim­it­ed side ef­fects or safe­ty con­cerns among the hun­dreds of mil­lions who have now re­ceived them.

But in its sec­ond quar­ter earn­ings call Thurs­day, Mod­er­na re­vealed how the two are di­verg­ing when it comes to vac­cine sales, as Mod­er­na’s ex­pec­ta­tions for 2021 to­tal about $20 bil­lion, based on the ex­pect­ed man­u­fac­ture of be­tween 800 mil­lion and 1 bil­lion dos­es. Pfiz­er said last week it ex­pects about $33 bil­lion in 2021 Covid vac­cine sales on 2.1 bil­lion dos­es, al­though that amount may in­crease to about 3 bil­lion dos­es.

The quick start for Pfiz­er may even out a lit­tle more, but not by much: In 2022, Mod­er­na says it al­ready has signed con­tracts for about $12 bil­lion in vac­cine sales, with op­tions for $8 bil­lion more, and the man­u­fac­tur­ing ca­pac­i­ty to make be­tween 2 and 3 bil­lion dos­es next year. By con­trast, Pfiz­er CEO Al­bert Bourla said the com­pa­ny is ready to make about 4 bil­lion dos­es in 2022, al­though the Big Phar­ma has yet to project any 2022 sales fig­ures, a spokesper­son con­firmed.

In terms of vac­cine dose pric­ing, both com­pa­nies have seen in­creas­es in the US, and the EU, even as they both of­fer less ex­pen­sive ver­sions of their vac­cines for low- and mid­dle-in­come coun­tries.

Pfiz­er’s vac­cine price rose from $19.50 per dose to about $24 per dose in this lat­est US gov­ern­ment pur­chase of 200 mil­lion dos­es.

Mod­er­na said Thurs­day its US gov­ern­ment price has risen slight­ly from about $15 per dose (for the first 100 mil­lion dos­es) to $16.50 each (for the next 400 mil­lion dos­es), which takes in­to con­sid­er­a­tion the gov­ern­ment funds via BAR­DA to un­der­write the firm’s Phase III tri­al for the vac­cine. High­er in­come ex-US coun­tries start with a price range of $32 to $37 per dose, Mod­er­na added. But some­times there are dis­counts based on vol­ume, or for low­er- and mid­dle-in­come coun­tries, in­clud­ing sales to CO­V­AX, which Mod­er­na said are priced sig­nif­i­cant­ly cheap­er than dos­es for the US gov­ern­ment.

Both Pfiz­er and Mod­er­na are al­so de­vel­op­ing their Covid-19 vac­cine boost­er strate­gies, even as the CDC and FDA have said such boost­ers are not nec­es­sary yet, and as the WHO calls on de­vel­oped coun­tries to not pro­vide boost­ers un­til at least the end of Sep­tem­ber.

Mod­er­na pres­i­dent Stephen Hoge said on the earn­ings call the com­pa­ny be­lieves boost­ers will be need­ed be­fore win­ter, par­tic­u­lar­ly due to the Delta vari­ant. Clin­i­cal da­ta ap­pear to sup­port a 50 μg of the Mod­er­na vac­cine boost­er, the com­pa­ny said, al­though it will wait for 100 μg da­ta com­ing in the next sev­er­al weeks to con­firm the se­lec­tion of 50 μg as a boost­er dose be­fore fil­ing for EUA.

Pfiz­er said it ex­pects a boost­er shot EUA fil­ing as ear­ly as this month: “Pend­ing reg­u­la­to­ry ap­proval, we al­so plan to start an im­muno­genic­i­ty and safe­ty study in Au­gust to eval­u­ate an up­dat­ed ver­sion of our vac­cine specif­i­cal­ly de­signed to tar­get the Delta vari­ant,” Pfiz­er CSO Mikael Dol­sten said last week on its earn­ings call.

Mod­er­na al­so said in its Q&A at the end of its earn­ings call it may jump fur­ther in­to the space of gene edit­ing. As an in­no­va­tor in the worlds of lipid nanopar­ti­cles and mR­NA, Hoge said that “it’s the right time for us to ex­pand in that di­rec­tion,” point­ing to gene edit­ing.

“On the gene edit­ing ques­tion, we do have, as you know, pro­grams that tar­get the liv­er. But as we’ve pre­sent­ed at pre­vi­ous sci­ence days and even to­day, we have a plat­form tech­nol­o­gy that al­so we think al­lows us to get in broad­ly in­to the im­mune sys­tem and par­tic­u­lar­ly hematopoi­et­ic stem cells. And so what you’ll — where we imag­ine our strong suit to be is in de­liv­er­ing nu­cle­ic acid tech­nolo­gies to those ar­eas. Of course, as we look to ex­pand­ing in gene edit­ing, You’ll see us look to those tech­nolo­gies that we’ve got the most ex­pe­ri­ence with first and then bring­ing a range of dif­fer­ent pay­loads to — in­to our ca­pa­bil­i­ties,” Hoge said.

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; 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.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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Sanofi, GSK tout 72% Omi­cron ef­fi­ca­cy in PhI­II tri­al of next-gen, bi­va­lent shot — with an eye to year-end roll­out

Sometimes, being late can give you an advantage.

That’s what Sanofi and GSK are trying to say as the Big Pharma partners report positive results from a late-stage trial of their next-gen bivalent Covid-19 vaccine, which was designed to protect against both the original strain of the SARS-CoV-2 virus and the Beta variant. Specifically, against Omicron, they note, the vaccine delivered 72% efficacy in all adults and 93.2% in those previously infected.

GSK says its drug for chron­ic hep B could ‘lead to a func­tion­al cure’ — but will it be alone or in com­bi­na­tion?

GSK, newly branded and soon-to-be demerged, shared interim results from its Phase II trial on its chronic hepatitis B treatment, one that it says has the “potential to lead to a functional cure.”

At a presentation at the EASL International Liver Congress, GSK shared that in around 450 patients who received its hep B drug bepirovirsen for 24 weeks, just under 30% had hepatitis B surface antigen and viral DNA levels that were too low to detect.

Matt Kapusta, uniQure CEO

In trou­bled Hunt­ing­ton’s space, uniQure’s gene ther­a­py shows ear­ly promise

In randomized clinical trial data from a small number of patients, Dutch biotech uniQure shared that its gene therapy for Huntington’s disease seems to reduce the amount of the mutant protein responsible for the disease over the course of a year.

In seven patients with early-stage Huntington’s — four who got the treatment and three who got a placebo — mutant huntingtin protein levels in the cerebrospinal fluid decreased by an average of just over 50% in patients who got the gene therapy compared to around a 17% drop in patients who got the placebo after a year.

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Rwanda president Paul Kagame and BioNTech CEO Uğur Şahin (via BioNTech)

BioN­Tech breaks ground on first mR­NA vac­cine man­u­fac­tur­ing fa­cil­i­ty in Africa

Covid vaccine access to lower- and middle-income nations has been a concern during the length of the pandemic, but BioNTech is now pushing forward with plans to increase vaccine access for Africa.

Construction work has kicked off for an mRNA manufacturing facility in Kigali, Rwanda. According to BioNTech, the facility, dubbed the African modular mRNA manufacturing facility, has a target for the first set of manufacturing tools to be delivered to the site by the end of this year.

Stéphane Bancel (AP Photo/Charles Krupa)

Mod­er­na to se­cure a UK pres­ence with $1B+ in new man­u­fac­tur­ing and R&D fa­cil­i­ties

As Moderna keeps up the fight against Covid-19, recently winning authorization in the US for children under the age of five, the company is also looking to make a serious investment in the UK.

According to the UK government, Moderna will be looking to establish a vaccine research center and a manufacturing site for a series of vaccines.

Moderna will establish this new mRNA Innovation and Technology Centre to develop mRNA vaccines for a wide range of respiratory diseases, including Covid-19.