Covid-19 roundup: Mod­er­na sub­mits vac­cine for full ap­proval; WHO un­veils new Greek-based sys­tem for nam­ing vari­ants

Mod­er­na has ini­ti­at­ed its BLA sub­mis­sion process with the FDA to li­cense its Covid-19 vac­cine in adults 18 and old­er, the com­pa­ny an­nounced Tues­day.

The com­pa­ny will sub­mit da­ta on a rolling ba­sis with a re­quest for pri­or­i­ty re­view, Mod­er­na said. Cur­rent­ly, the jab is avail­able un­der EUA. And the sub­mis­sion comes amid sur­vey da­ta sug­gest­ing more Amer­i­cans may take a vac­cine that is for­mal­ly ap­proved by the FDA, rather than avail­able un­der emer­gency use.

“We are pleased to an­nounce this im­por­tant step in the U.S. reg­u­la­to­ry process for a Bi­o­log­ics Li­cense Ap­pli­ca­tion of our COVID-19 vac­cine,” said CEO Stéphane Ban­cel. “We look for­ward to work­ing with the FDA and will con­tin­ue to sub­mit da­ta from our Phase 3 study and com­plete the rolling sub­mis­sion.”

To avoid a mouth­ful of num­bers and re­duce stig­ma, the WHO turns to Greek al­pha­bet for vari­ants

In hopes of sim­pli­fy­ing the names of Covid-19 vari­ants, the World Health Or­ga­ni­za­tion an­nounced a new sys­tem for nam­ing them on Mon­day. Vari­ants will be giv­en a name from the Greek al­pha­bet, in an ef­fort to both sim­pli­fy the dis­cus­sion and re­move stig­ma from the emer­gence of new vari­ants.

The goal is to en­sure coun­tries are less hes­i­tant to re­port a new vari­ant, so long as health of­fi­cials know that it won’t be named af­ter the coun­try. B.1.1.7, for­mer­ly known as the British vari­ant, will now be known as Al­pha, and the South African B.1.351 will be called Be­ta.

If all 24 let­ters of the Greek al­pha­bet are used, then an­oth­er sim­i­lar se­ries will be an­nounced, coro­n­avirus head Maria Van Kerk­hove said. For a short while, the group con­sid­ered us­ing names of Greek gods and god­dess­es, and num­ber­ing them 1, 2 and 3. Orig­i­nal­ly, the plan was to cre­ate 2-syl­la­ble names that aren’t words, STAT re­ports. The Greek al­pha­bet even­tu­al­ly was ap­proved by a group that shared the same mem­bers as the group that changed SARS-CoV-2 to Covid-19.

The WHO will keep a list of vari­ants on its web­site.

WHO val­i­dates Chi­nese vac­cine for emer­gency use

The WHO on Tues­day val­i­dat­ed Bei­jing-based Sino­vac’s Covid-19 vac­cine, known as Coro­n­aVac, for emer­gency use, giv­ing coun­tries, fun­ders, procur­ing agen­cies and com­mu­ni­ties the as­sur­ance that it meets in­ter­na­tion­al stan­dards for safe­ty, ef­fi­ca­cy and man­u­fac­tur­ing.

WHO’s Emer­gency Use List­ing is a pre­req­ui­site for CO­V­AX Fa­cil­i­ty vac­cine sup­ply and in­ter­na­tion­al pro­cure­ment. It al­so al­lows coun­tries to ex­pe­dite their own reg­u­la­to­ry ap­proval to im­port and ad­min­is­ter Covid-19 vac­cines. The WHO said its as­sess­ment in­clud­ed on-site in­spec­tions of the pro­duc­tion fa­cil­i­ty.

Coro­n­aVac prod­uct is an in­ac­ti­vat­ed vac­cine, and its stor­age re­quire­ments make it very man­age­able and par­tic­u­lar­ly suit­able for low-re­source set­tings, WHO said.

DSMB pass­es Cure­Vac jab but no da­ta yet

Cure­Vac’s Phase IIb/III study has passed ear­ly safe­ty check from the Da­ta Safe­ty Mon­i­tor­ing Board, the com­pa­ny an­nounced Fri­day. But the com­pa­ny did not an­nounce ef­fi­ca­cy da­ta and high­light­ed the “vari­ant-rich en­vi­ron­ment” sur­round­ing the study, rais­ing ques­tions about just how much pro­tec­tion the vac­cine of­fers.

Cure­Vac did not have ac­cess to tri­al da­ta, and it will con­tin­ue to be col­lect­ed to de­ter­mine ef­fi­ca­cy, the com­pa­ny said in a re­lease. There was hope that this an­nounce­ment would make tri­al da­ta pub­lic, but the com­pa­ny said last week that more da­ta will be­come avail­able by the end of June.

The tri­al is con­duct­ed in an en­vi­ron­ment “char­ac­ter­ized by the spread of mul­ti­ple virus strains,” the press re­lease said, though it did not elab­o­rate. Three quar­ters of the study’s par­tic­i­pants are in Latin Amer­i­ca, where the P.1 vari­ant — now called Gam­ma — has spread.

A week ago, the FDA said that for the rest of the pan­dem­ic, it may de­cline to re­view and process fur­ther EUA re­quests for Covid-19 vac­cines un­less a de­vel­op­er has al­ready en­gaged with the agency. That could cause an ex­tra step for Cure­Vac, and force the com­pa­ny to sub­mit its full BLA to the FDA.

No­var­tis paired with Cure­Vac in ear­ly March to aid man­u­fac­ture the bulk drug sub­stance for the vac­cine, but the com­pa­ny may have missed the boat in both the US and the EU.

The study in­volves 40,000 par­tic­i­pants in 10 coun­tries in Latin Amer­i­ca and Eu­rope, with 75% from Latin Amer­i­can and the re­main­ing 25% from Eu­rope. The 2-dose jab, mR­NA is be­ing test­ed in pa­tients who have not had pri­or ex­po­sure to Covid-19.

Fau­ci emails from last year re­veal how he was in­un­dat­ed with re­quests

The Wash­ing­ton Post ob­tained 866 pages of emails from An­tho­ny Fau­ci, the the long­time di­rec­tor of the NIH’s Na­tion­al In­sti­tute of Al­ler­gy and In­fec­tious Dis­eases, while he was “strug­gling to bring co­her­ence to the Trump ad­min­is­tra­tion’s chaot­ic re­sponse to the virus” last year.

The emails show how Fau­ci re­ceived about 1,000 mes­sages per day from col­leagues, hos­pi­tal ad­min­is­tra­tors, for­eign gov­ern­ments and ran­dom strangers — “writ­ing to seek his ad­vice, so­lic­it his help or sim­ply of­fer en­cour­age­ment.” A doc­u­men­tary on Fau­ci is set to be re­leased lat­er this year and one email said that Robert Iger, ex­ec­u­tive chair­man of Walt Dis­ney, “was im­mense­ly sup­port­ive” of the doc­u­men­tary, which may fea­ture footage dis­creet­ly shot as the doc­tor went about his pan­dem­ic du­ties.

Oth­er in­ter­nal emails from the Trump ad­min­is­tra­tion showed sim­i­lar re­quests made to oth­er of­fi­cials.

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.