Covid-19 roundup: UK au­tho­rizes J&J vac­cine; UNICEF buys 220 mil­lion dos­es of Russ­ian vac­cine

UK reg­u­la­tors on Fri­day au­tho­rized the J&J Covid-19 vac­cine for adults aged 18 years and old­er, more than two months af­ter the EU signed off on it and more than three months af­ter the FDA’s EUA.

The sin­gle-dose shot is the fourth Covid-19 vac­cine to be au­tho­rized in the UK. The move fol­lows clos­er scruti­ny of it by reg­u­la­tors due to rare but some­times fa­tal blood clots and low lev­els of platelets, but the US and EU agen­cies, and now the UK’s MHRA, agreed that the ben­e­fits of the vac­cine still out­weigh the risks.

“Fa­tal out­come has been re­port­ed. These cas­es oc­curred with­in the first three weeks fol­low­ing vac­ci­na­tion, and most­ly in women un­der 60 years of age,” the UK’s MHRA said in its sum­ma­ry of prod­uct char­ac­ter­is­tics.

The US has ad­min­is­tered the J&J vac­cine to more than 10 mil­lion peo­ple, with the lat­est da­ta (as of May 7) show­ing 28 cas­es of the rare blood clots. An­oth­er 10 mil­lion dos­es have been dis­trib­uted across the coun­try. — Zachary Bren­nan

EMA ex­tends Pfiz­er vac­cine au­tho­riza­tion to chil­dren aged 12 to 15

The EMA’s hu­man med­i­cines com­mit­tee on Fri­day au­tho­rized the Pfiz­er Covid-19 vac­cine, known in the EU as Comir­naty, to chil­dren as young as 12.

The rec­om­mend­ed use is the same as it is for those old­er than 16, EMA said at a press con­fer­ence. It’s the first Covid-19 vac­cine to get the green light for chil­dren in the EU.

FDA al­so pre­vi­ous­ly ex­pand­ed its emer­gency use au­tho­riza­tion for the jab to the 12-15 age group, based on ef­fi­ca­cy da­ta from 190 ado­les­cents which showed their im­mune re­sponse to the vac­cine was at least as good as the re­sponse seen in old­er par­tic­i­pants. — Zachary Bren­nan

Sur­vey: Few who are ea­ger to get a shot re­main un­vac­ci­nat­ed

A new sur­vey from the Kaiser Fam­i­ly Foun­da­tion re­leased Fri­day shows how the share of US adults who re­port re­ceiv­ing at least one dose of a Covid vac­cine has con­tin­ued to climb from 56% in April to 62% in May.

But the share of those who say they in­tend to get the vac­cine as soon as pos­si­ble fell to just 4%, “leav­ing a very small group that is ready to get vac­ci­nat­ed right away,” the foun­da­tion said.

Full FDA ap­proval of one of the vac­cines may help push peo­ple to get vac­ci­nat­ed, the sur­vey found, with about one-third (32%) of un­vac­ci­nat­ed adults say­ing an ap­proval would make them more like­ly to get vac­ci­nat­ed. — Zachary Bren­nan

UNICEF buys 220 mil­lion dos­es of Russ­ian vac­cine

UNICEF has reached a deal with Rus­sia to pur­chase 220 mil­lion dos­es of the Sput­nik V Covid-19 vac­cine, the RDIF an­nounced Thurs­day. Sput­nik V is still await­ing emer­gency use list­ing from the WHO, af­ter sub­mit­ting an ap­pli­ca­tion in Oc­to­ber 2020.

Sput­nik V, which re­quires 2 jabs and is un­der rolling re­view at the Eu­ro­pean Med­i­cines Agency, has been reg­is­tered in more than 65 oth­er coun­tries, most­ly in South Amer­i­ca, the Mid­dle East, Asia and Africa.

An in­ter­im analy­sis of a Phase III study, pub­lished in The Lancet in Feb­ru­ary, showed the vac­cine’s ef­fi­ca­cy was 91.6%. — Josh Sul­li­van

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.