Covid-19 roundup: Mod­er­na gets the OK to use vac­cine in chil­dren ages 12-17; 23andMe finds ge­net­ic link to loss of taste and smell

Par­ents in Cana­da and Eu­rope now have two op­tions to pro­vide their chil­dren with a Covid-19 vac­cine.

Mod­er­na an­nounced that it has sub­mit­ted au­tho­riza­tion ap­proval for the use of its vac­cine in ado­les­cents with both Cana­di­an and EU health of­fi­cials on Mon­day. In May, the com­pa­ny an­nounced that the Phase II/III study of the vac­cine in chil­dren ages 12-17 met its pri­ma­ry end­points. The jab achieved 100% ef­fi­ca­cy in a study that in­volved 2,500 pa­tients who were ob­served un­der the same case de­f­i­n­i­tion in the Phase III study in adults.

In a state­ment, CEO Stéphane Ban­cel said:

We are pleased to an­nounce that we have sub­mit­ted for au­tho­riza­tion of our COVID-19 vac­cine for use in ado­les­cents with Health Cana­da. We are en­cour­aged that the Mod­er­na COVID-19 vac­cine was high­ly ef­fec­tive at pre­vent­ing COVID-19 and SARS-CoV-2 in­fec­tion in ado­les­cents. We have filed for con­di­tion­al mar­ket­ing ap­proval with the Eu­ro­pean Med­i­cines Agency and we will file for an Emer­gency Use Au­tho­riza­tion with the U.S. FDA and reg­u­la­to­ry agen­cies around the world for this im­por­tant younger age pop­u­la­tion. We re­main com­mit­ted to do­ing our part to help end the COVID-19 pan­dem­ic.

Mod­er­na an­nounced on May 25 that its vac­cine was ef­fec­tive in 3,700 chil­dren be­tween the age of 12 and 17, and showed an ef­fi­ca­cy “con­sis­tent with 100%.” 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.

Pre­vi­ous­ly, the Cam­bridge, MA drug­mak­er said it plans to ap­ply for US au­tho­riza­tion in kids in June. Though a date was not an­nounced, the com­pa­ny did dou­ble down on that plan in Mon­day’s re­lease.

The Pfiz­er-BioN­Tech vac­cine was au­tho­rized in May for use in chil­dren in the US as young as 12 years old. It was au­tho­rized for the same age group in Cana­da on May 5, and in Eu­rope on May 28.

Re­port: loss of taste and smell linked to ge­net­ic vari­ant

The loss of smell and taste has been one of the key side ef­fects for Covid-19 pa­tients, and now 23andMe has pub­lished a re­port say­ing that could be linked to a ge­net­ic vari­ant.

A pa­tient with a copy of the ge­net­ic vari­ant near two ol­fac­to­ry genes is 11.5% more like­ly to lose smell or taste if they are in­fect­ed than some­one with­out a copy, the com­pa­ny says. The re­search builds off work the com­pa­ny has done the past year sur­round­ing the role blood type plays in the sever­i­ty and sus­cep­ti­bil­i­ty to the virus.

The study us­es ge­net­ic da­ta from more than a mil­lion peo­ple, and ex­am­ined the dif­fer­ences in the genome be­tween peo­ple who did and didn’t lose their taste and smell. Sci­en­tists iden­ti­fied an as­so­ci­a­tion on chro­mo­some 4 near the ol­fac­to­ry genes UGT2A1 and UGT2A2, the com­pa­ny said.

About 68% of the par­tic­i­pants in the study who test­ed pos­i­tive for Covid-19 re­port­ed a loss of smell and taste, com­pared to 17% of those who test­ed neg­a­tive. The re­port al­so found that in those be­tween the ages of 26-35, 73% re­port­ed loss of smell com­pared to just 43% of peo­ple above the age of 85.

US sen­a­tors pledge vac­cine dos­es to Tai­wan in vis­it

As Tai­wan bat­tles a Covid-19 out­break that saw its dai­ly num­ber of cas­es raise by 700 in just a 10-day pe­ri­od, three US sen­a­tors have said their coun­try will do­nate 750,000 dos­es of the vac­cine.

The jabs come at a time when Tai­wan says Chi­na has hin­dered ef­forts to se­cure dos­es. Sen. Tam­my Duck­worth, D-IL, vis­it­ed the coun­try with Sen. Christo­pher Coons, D-DE, and Sen. Dan Sul­li­van, R-AK, to demon­strate bi­par­ti­san sup­port for the ter­ri­to­ry, Politi­co re­ports.

Tai­wan was in­clud­ed in a list of places that Pres­i­dent Joe Biden’s ad­min­is­tra­tion says is due for a share of 25 mil­lion dos­es that will be dis­trib­uted around the world. Many of those dos­es will be sent over via CO­V­AX, the pro­gram spon­sored by Gavi, the vac­cine al­liance to pro­vide low and mid­dle-in­come coun­tries with jabs.

The is­land of 24 mil­lion peo­ple has re­cent­ly seen the spike in cas­es drop slight­ly, as there were 342 new pos­i­tive cas­es re­port­ed Fri­day. Be­fore then, the is­land was ex­pe­ri­enc­ing ex­treme suc­cess bat­tling the virus, as there had on­ly been a sin­gle day be­tween Jan­u­ary 1 and May 6 in which there had been more than 10 new Covid-19 cas­es re­port­ed in a day.

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.