Joe Biden (AP Images)

Covid-19 roundup: Mod­er­na has filed for vac­cine use in chil­dren; Claim­ing lead­er­ship to com­bat Covid-19, US pledges to do­nate 500M dos­es of Pfiz­er/BioN­Tech vac­cines through CO­V­AX

Just days af­ter Mod­er­na’s vac­cine was sub­mit­ted for ap­proval for use in chil­dren in the EU and Cana­da, the com­pa­ny has an­nounced it has filed for emer­gency use au­tho­riza­tion with the FDA for the ad­min­is­tra­tion in teens be­tween 12 and 18.

Mod­er­na an­nounced in May that its Phase II/III study of the vac­cine in ado­les­cents met the pri­ma­ry end­points in near­ly 2,500 pa­tients, show­ing an ef­fi­ca­cy of 100% against se­vere symp­to­matic Covid-19. Be­cause chil­dren are less like­ly to de­vel­op se­ri­ous side ef­fects, the tri­al al­so looked at milder cas­es than ex­am­ined in the adult study. The study found that the vac­cine was 93% ef­fec­tive at stop­ping mild cas­es 14 days af­ter pa­tients were dosed.

The com­pa­ny ap­pears to be on sched­ule, as it pre­vi­ous­ly said it planned to ap­ply for au­tho­riza­tion in kids in June.

Right now, Pfiz­er-BioN­Tech’s vac­cine is the on­ly one avail­able for teens in the US. Pfiz­er an­nounced this week that it will be­gin tri­als of a re­duced dosage in chil­dren be­tween the ages of 6 months and 11 years old. — Josh Sul­li­van

Claim­ing lead­er­ship to com­bat Covid-19, US pledges to do­nate 500M dos­es of Pfiz­er/BioN­Tech vac­cines through CO­V­AX

Af­ter be­ing crit­i­cized for months for hoard­ing Covid-19 vac­cines, the Unit­ed States is mak­ing a grand ges­ture.

Pres­i­dent Joe Biden has an­nounced plans to buy 500 mil­lion dos­es of the Pfiz­er/BioN­Tech vac­cine and do­nate them to low­er-in­come coun­tries in what his ad­min­is­tra­tion brands as a his­toric move to help su­per­charge the glob­al fight against the pan­dem­ic.

The do­na­tion fol­lows a sep­a­rate ini­tia­tive to give away 80 mil­lion ex­cess vac­cine dos­es al­ready in the US stock­pile for re­dis­tri­b­u­tion through the CO­V­AX mech­a­nism, co­or­di­nat­ed by the WHO, Gavi and CEPI. That batch com­prised vac­cines from Mod­er­na, John­son & John­son, and Pfiz­er/BioN­Tech.

The new pur­chase for half a bil­lion dos­es will come en­tire­ly from Pfiz­er and, giv­en the two-shot reg­i­men, be enough to vac­ci­nate 250 mil­lion peo­ple. With ship­ments start­ing in Au­gust, 200 mil­lion dos­es are slat­ed to be de­liv­ered by the end of this year, while the rest will be de­liv­ered by June 2022.

While Pfiz­er had charged the US $19.50 per dose for do­mes­tic use, it will sell these new shots at a “not-for-prof­it” price, the Wash­ing­ton Post re­port­ed.

Fol­low­ing US al­lo­ca­tion, CO­V­AX will help de­liv­er these shots to the 92 low- and low­er-mid­dle in­come coun­tries around the world el­i­gi­ble for its fa­cil­i­ty, as well as the African Union.

On top of the vac­cine do­na­tion, the US has con­tributed $2 bil­lion to the ef­fort and pledged to sup­port lo­ca­tion pro­duc­tion of Covid-19 vac­cines.

As of Tues­day, CO­V­AX has fa­cil­i­tat­ed the dis­tri­b­u­tion of about 81 mil­lion shots world­wide.

“Thanks to the suc­cess of our vac­ci­na­tion pro­gram, the Unit­ed States is beat­ing COVID-19 here at home,” a White House fact sheet reads, with 64% of adult Amer­i­cans hav­ing re­ceived at least one shot.

Tedros Ad­hanom Ghe­breye­sus

That suc­cess, though, has ex­perts wor­ried about a dis­con­nect be­tween the de­vel­oped world and vul­ner­a­ble re­gions for whom the pan­dem­ic is far from over, with new records in dai­ly new cas­es and death tolls. Tedros Ad­hanom Ghe­breye­sus, the WHO di­rec­tor gen­er­al, ap­pealed to G7 just days ago to lever­age their pow­er in meet­ing the glob­al tar­get to vac­ci­nate at least 10% of the world’s pop­u­la­tion by Sep­tem­ber, which he said would re­quire an ad­di­tion­al 500 mil­lion dos­es.

“In­creas­ing­ly, we see a two-track pan­dem­ic: many coun­tries still face an ex­treme­ly dan­ger­ous sit­u­a­tion, while some of those with the high­est vac­ci­na­tion rates are start­ing to talk about end­ing re­stric­tions,” he told re­porters.

The dos­es, the White House was sure to add, will be pro­duced at Pfiz­er’s fa­cil­i­ties in Michi­gan, Kansas, Mis­souri and Mass­a­chu­setts. — Am­ber Tong

De­moc­rats take is­sue with Pfiz­er vac­cine price

High-pro­file De­moc­rats, in­clud­ing Sen. Eliz­a­beth War­ren (MA) and Rep. Katie Porter (CA), sent a let­ter to Pfiz­er CEO Al­bert Bourla on Tues­day, ques­tion­ing the com­pa­ny’s price tag for its Covid-19 vac­cine and its ex­pect­ed tens of bil­lions in rev­enue from the vac­cine.

With an eye to­ward fu­ture price es­ca­la­tions, the mem­bers of Con­gress note that Pfiz­er could end up caus­ing pri­vate in­sur­ers to raise pre­mi­ums and in­crease tax­pay­er costs for health care.

“Does the com­pa­ny in­tend to seek ‘a nor­mal price like [it] typ­i­cal­ly get[s] for a vac­cine—$150, $175 per dose.’? If so, when does the com­pa­ny plan to im­ple­ment these in­creas­es?” they asked Bourla, in ad­di­tion to ques­tions on how much the com­pa­ny in­vest­ed in the vac­cine. The De­moc­rats al­so asked how Pfiz­er will de­ter­mine its pric­ing for the vac­cine mov­ing for­ward. — Zachary Bren­nan

Ocu­gen to no longer pur­sue an EUA for its vac­cine

Penn­syl­va­nia-based Ocu­gen, which is look­ing to bring In­dia’s Covid-19 vac­cine from Bharat Biotech to the US, says it will no longer seek an emer­gency use au­tho­riza­tion and will in­stead seek a full ap­proval.

The com­pa­ny said FDA pro­vid­ed feed­back on the mas­ter file it had pre­vi­ous­ly sub­mit­ted and rec­om­mend­ed that Ocu­gen pur­sue a BLA sub­mis­sion in­stead of an EUA ap­pli­ca­tion for its vac­cine can­di­date and re­quest­ed ad­di­tion­al in­for­ma­tion and da­ta.

The news comes as the FDA said late last month that for the re­main­der of the pan­dem­ic, it may de­cline to re­view and process fur­ther EUA re­quests for Covid-19 vac­cines, as the coun­try still tries to ad­min­is­ter mil­lions of dos­es that it’s al­ready pur­chased of the three vac­cines that have al­ready won EUAs. — Zachary Bren­nan

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

Un­lock­ing ESG strate­gies for growth with Gilead Sci­ences

RBC Capital Markets explores what is material in ESG for biopharma companies with the ESG leads at Gilead Sciences. Gilead has long focused on sustainability but recognized a more robust framework was needed. Based on a materiality assessment, Gilead’s ESG strategy today focuses first on drug access and pricing, while also addressing D&I and climate change. Find out why Gilead’s board is “acutely aware” of the contribution that ESG makes to firm’s overall success.

On the hunt for the next Mod­er­na, in­vestors have pumped 'plat­form plays' with cash. Can any­thing slow the run­away train?

It didn’t take an expert to see that mRNA platforms could be huge.

Julie Sunderland partnered with both Moderna and BioNTech about a decade ago while she was running program-related investments for the Bill & Melinda Gates Foundation — and even then the potential for their platforms was obvious despite some well-founded concerns about whether the next-gen tech would ever cross the finish line.

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Covid-19 roundup: White House re­veals vac­cine do­na­tion plan; EU opts in for an­oth­er 150 mil­lion dos­es from Mod­er­na

President Joe Biden’s administration on Monday revealed the distribution list for 55 million of the 80 million doses of Covid-19 vaccines America plans to donate to lower-income nations:

Roughly 14 million doses will head to Latin America and the Caribbean, for a list of countries that includes Brazil, Argentina, Dominican Republic, Panama and Costa Rica.
Another 16 million doses are headed to Asia to help the following countries: India, Nepal, Bangladesh, Pakistan, Sri Lanka, Afghanistan, Maldives, Bhutan, Philippines, Vietnam, Indonesia, Thailand, Malaysia, Laos, Papua New Guinea, Taiwan, Cambodia, and the Pacific Islands.

Sen. Ron Wyden (D-OR) with reporters in the Senate Subway (Graeme Sloan/Sipa via AP Images)

Top Wyden pri­or­i­ty for drug price re­forms: Medicare ne­go­ti­a­tions

As the Biden administration tries to wrangle the details of its infrastructure bill, Senate Finance Committee Chair Ron Wyden (D-OR) took a concrete step forward on drug pricing reforms on Tuesday and unveiled five principles for such reforms, including providing Medicare with the ability to negotiate prices.

“Allowing the Secretary of HHS to negotiate the price Medicare will pay creates a much needed mechanism to achieve fairer prices when the market has failed to do so,” Wyden wrote.

Fred Upton and Diana DeGette

New DARPA-like NIH agency preps for re­al­i­ty as E&C un­veils bi­par­ti­san Cures 2.0 draft bill

House Energy & Commerce leaders Fred Upton (R-MI) and Diana DeGette (D-CO) on Tuesday released new draft legislation with wide-ranging implications for public health, the FDA, NIH, and that would create a new, $6.5 billion federal advanced research agency under NIH, with an aim to cure cancer, Alzheimer’s and other difficult diseases.

Similar to DARPA, the new NIH division to be known as ARPA-H, would be run by a small group of program managers with more latitude to pursue high-risk, high-reward projects that other government agencies would likely shy away from.

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Ken Frazier, Merck CEO (Bess Adler/Bloomberg via Getty Images)

Mer­ck­'s Keytru­da blazes a path in first-line cer­vi­cal can­cer, mak­ing good on drug­mak­er's push for ear­li­er pa­tients

In the years since I/O wonder drug Keytruda’s initial approval, Merck has struck an aggressive clinical trial program, which is now firmly focused on earlier lines of therapy. The drugmaker has scored some success there so far, and now it’s earned one of its biggest wins yet.

Keytruda plus chemotherapy with or without background Avastin significantly extended patients’ lives over those dosed with a placebo control in first-line patients with persistent, recurrent or metastatic cervical cancer, according to top-line data from the Phase III KEYNOTE-826 study revealed Tuesday.

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End­points News is now 5 years old. Here's how you can sup­port us for the next phase of growth

Endpoints News turned five years old over the weekend. I wanted to mark the happy occasion by extending our deepest gratitude to Endpoints’ premium subscribers while outlining several other ways to support us as we go broader and get bigger this year and beyond.

Same as any business, we’ve got to create value and get paid for delivering it. So if you depend on Endpoints to stay abreast on biopharma developments, we depend on you too.

Emma Walmsley, GlaxoSmithKline CEO (Credit: Fang Zhe/Xinhua/Alamy Live News)

Ac­tivist in­vestor El­liott in talks with oth­er Glax­o­SmithK­line in­vestors about re­plac­ing Em­ma Walm­s­ley, spin­ning off vac­cine busi­ness — re­port

As Emma Walmsley reveals details this Wednesday about the upcoming split of GlaxoSmithKline’s pharma and consumer units, some tough questions may be coming her way.

Elliott Management, the activist investor that’s previously threatened an attack on GSK (but eventually backed off), is floating more radical changes like replacing the CEO, further breaking up the company and spinning out the vaccine unit, or reviewing the focus on cancer drugs, the Financial Times reported.

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Roche's Alzheimer's drug spurred bio­mark­er changes but no cog­ni­tive im­pact — pa­per; vTv out-li­cens­es for­mer lead pro­gram

More than a year ago, Roche and Eli Lilly were forced to contend with a Phase II/III failure of their respective Alzheimer’s drugs. But while Eli Lilly essentially threw in the towels, Roche wasn’t ready to give up yet.

The Swiss drugmaker now has some biomarker data to spotlight as investigators continue monitoring patients in an open-label extension study.

Dubbed DIAN-TU, the study had been designed to see whether Roche’s gantenerumab and Lilly’s solanezumab could spur a cognitive benefit for a group of patients who had a rare, inherited form of Alzheimer’s that’d tied to early-onset. In short, they didn’t: Both failed the primary endpoint.