Covid-19 roundup: Sup­ply chain short­ages lead to half the Mod­er­na dos­es de­liv­ered to Cana­da; J&J shots paused out of con­cern clots would be in­ap­pro­pri­ate­ly treat­ed — re­port

The num­ber of dos­es of Mod­er­na’s vac­cine ex­pect­ed to be de­liv­ered to Cana­da by the end of April has near­ly been cut in half, ac­cord­ing to the coun­try’s pro­cure­ment min­is­ter Ani­ta Anand.

Be­tween 1 mil­lion and 2 mil­lion dos­es of the 12.3 mil­lion ex­pect­ed to be de­liv­ered in time for the sec­ond quar­ter will be de­layed un­til the third, as Mod­er­na said Fri­day that ship­ments to Cana­da and the UK are be­hind sched­ule af­ter a sup­ply chain short­age will de­lay de­liv­er­ies.

De­liv­er­ies to the EU and Switzer­land are on sched­ule, the com­pa­ny said.

These com­pli­ca­tions have short­ened the vac­cine sup­ply in Eu­rope, as side ef­fects linked to J&J and As­traZeneca’s vac­cines have led the UK to ad­vise preg­nant women to get ei­ther Mod­er­na or Pfiz­er’s shot. — Josh Sul­li­van

J&J shots paused out of con­cern clots would be in­ap­pro­pri­ate­ly treat­ed re­port

A week af­ter the CDC and FDA joint­ly de­cid­ed to pause the roll­out of John­son & John­son’s Covid-19 vac­cine due to re­ports of blood clots, we’re get­ting a clos­er look at why.

Un­named sources told the Wall Street Jour­nal that health au­thor­i­ties rec­om­mend­ed sus­pend­ing the shots out of con­cern that doc­tors would im­prop­er­ly treat the con­di­tion. The CDC has ad­vised against us­ing he­parin, which is nor­mal­ly used for blood clots, but could be dan­ger­ous in this set­ting.

Sources told the WSJ that 4 of 6 women who de­vel­oped the clots af­ter be­ing vac­ci­nat­ed with J&J’s jab were treat­ed with the an­ti­co­ag­u­lant, which may have wors­ened their con­di­tion. While the clots haven’t of­fi­cial­ly been linked to the vac­cine, of­fi­cials are be­com­ing more per­suad­ed that the cas­es are re­lat­ed, ac­cord­ing to the WSJ.

The CDC’s Ad­vi­so­ry Com­mit­tee on Im­mu­niza­tion Prac­tices held off last week on de­cid­ing whether or not to rec­om­mend lift­ing the pause, af­ter many of the com­mit­tee mem­bers said they want­ed to wait for more da­ta. They’re now sched­uled to meet again on Fri­day, to dis­cuss whether to con­tin­ue the roll­out with a warn­ing, lim­it the use of the vac­cine, or slam the brakes on the jabs al­to­geth­er.

On “Meet the Press” on Sun­day, An­tho­ny Fau­ci told NBC’s Chuck Todd that he ex­pects to know more by then.

“I think by Fri­day we’ll know which way we’re go­ing on this. Hope­ful­ly we’ll get back on track,” he said.

One of the op­tions on the ta­ble is lim­it­ing the vac­cine’s use to old­er peo­ple, as the blood clots oc­curred in younger women. —Nicole De­Feud­is

Italy throws sup­port in­to do­mes­tic mR­NA vac­cine pro­duc­tion

Af­ter sup­port for the ade­n­ovirus-based J&J and As­traZeneca Covid-19 vac­cines have wa­vered due to re­ports of safe­ty con­cerns, Italy has held talks with man­u­fac­tur­ers about pro­duc­ing more mR­NA-based vac­cines do­mes­ti­cal­ly, ac­cord­ing to the Fi­nan­cial Times.

Mod­er­na, No­var­tis and Ital­ian drug­mak­er Re­i­Thera have been in talks with the cap­i­tal in Rome about pro­duc­ing Cure­Vac’s vac­cine. All of the par­ties in­volved have de­clined to com­ment, the FT re­port­ed.

Faith in the ade­n­ovirus-based vac­cines has fal­tered af­ter a re­cent de­ci­sion in the US to tem­porar­i­ly halt ad­min­is­ter­ing the J&J vac­cine af­ter 6 re­ports of blood clots in pa­tients. Pre­vi­ous­ly, some Eu­ro­pean coun­tries have put a hold on the use of the As­traZeneca shot af­ter the EMA found a very rare link be­tween the vac­cine and sim­i­lar blood clots.

There was no in­di­ca­tion that the Ital­ian-made dos­es would be sole­ly for the peo­ple of Italy, but rather, all of Eu­rope, the FT re­port­ed. — Josh Sul­li­van

Rus­sia RDIF reach­es man­u­fac­tur­ing agree­ment for Sput­nik V

A Chi­nese drug­mak­er has reached an agree­ment with Rus­sia’s RDIF sov­er­eign wealth fund to pro­duce more than 100 mil­lion dos­es of the Sput­nik V vac­cine.

Reuters re­port­ed that the two sides have com­mit­ted to a long-term part­ner­ship, though fi­nan­cial terms or the length of that deal were not dis­closed. Last week, Ger­man Health Min­is­ter Jens Spahn said that the coun­try will en­ter pre­lim­i­nary ne­go­ti­a­tions with Rus­sia for the use of Sput­nik V, but on­ly af­ter the EMA has giv­en it au­tho­riza­tion.

The Fi­nan­cial Times re­port­ed that the EMA is in­ves­ti­gat­ing whether the vac­cine meets good clin­i­cal prac­tice (GCP) stan­dards, af­ter con­cerns that tri­als weren’t run eth­i­cal­ly. — Josh Sul­li­van

Amidst con­cerns sur­round­ing oth­er vac­cines, the EU ups its Pfiz­er vac­cine dos­es

An­oth­er 100 mil­lion dos­es of the Pfiz­er-BioN­Tech Covid-19 vac­cine are head­ed to the EU, Bloomberg has re­port­ed.

The op­tion ex­er­cised rais­es its or­der to 600 mil­lion dos­es, as part of an agree­ment signed in Feb­ru­ary. Last week, the two com­pa­nies agreed to up ship­ments to the EU by 25% this quar­ter. That brought an­oth­er 50 mil­lion dos­es to the coun­try that had orig­i­nal­ly been sched­uled to be de­liv­ered in the fourth quar­ter. — Josh Sul­li­van

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

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

The End­points 11: They've got mad mon­ey and huge am­bi­tions. It's time to go big or go home

These days, selecting a group of private biotechs for the Endpoints 11 spotlight begins with a sprint to get ahead of IPOs and the M&A teams at Big Pharma. I’ve had a couple of faceplants earlier this year, watching some of the biotechs on my short list choose a quick leap onto Nasdaq or into the arms of a buyer.

Vividion, you would have been a great pick for the Endpoints 11. I’m sorry I missed you.

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FDA au­tho­rizes Pfiz­er's vac­cine boost­er for se­niors, those at high risk for se­vere Covid-19

The Biden administration’s goal of kicking off its booster shot drive for the entire US population this week is not quite going as planned.

First, Pfizer applied for approval of a supplemental application for the booster shots, but since last Friday’s adcomm reviewing them, the plan has devolved into an EUA, which the FDA issued late Thursday evening.

The population that is now eligible for the booster, six months after receiving the first pair of Pfizer-BioNTech vaccines, also narrowed from what Pfizer applied for (everyone who’s eligible for the initial Pfizer shots) to just those who are 65 or older, or at high-risk of a Covid infection, including health care workers and others with occupational hazards.

Stéphane Bancel, AP Images

Fi­nal analy­sis of US-fund­ed Mod­er­na Covid vac­cine tri­al shows 98% ef­fi­ca­cy against se­vere dis­ease

A final look at the results of the placebo-controlled Moderna trial in the New England Journal of Medicine, published Thursday afternoon, shows how the vaccine continues to prevent Covid-19 and severe cases after more than five months following the second shot.

Of the more than 30,000 enrolled in the trial that ultimately led to the vaccine’s EUA, only two people in the vaccine group got a severe form of the disease, compared to 106 in the placebo group — leading to an efficacy of 98%.

Dave Lennon, former president of Novartis Gene Therapies

So what hap­pened with No­var­tis Gene Ther­a­pies? Here's your an­swer

Over the last couple of days it’s become clear that the gene therapy division at Novartis has quietly undergone a major reorganization. We learned on Monday that Dave Lennon, who had pursued a high-profile role as president of the unit with 1,500 people, had left the pharma giant to take over as CEO of a startup.

Like a lot of the majors, Novartis is an open highway for head hunters, or anyone looking to staff a startup. So that was news but not completely unexpected.

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Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

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

The fire un­der Glax­o­SmithK­line's Em­ma Walm­s­ley grows as an­oth­er well-known ac­tivist in­vestor grabs its pitch­fork — re­port

Bluebell Capital Partners, a proxy brawler fresh off a campaign to oust global food giant Danone’s CEO and most of its board of directors, has bought a stake in UK drugmaker GlaxoSmithKline with its eyes trained directly on Emma Walmsley, the Financial Times reported Wednesday.

The London-based hedge fund joins another notorious activist firm in Paul Singer’s Elliott Management, which earlier this year called for a shakeup in leadership at GSK to handle what the company described as a wealth of riches across the drug giant’s portfolio hindered by limited vision from top staff.

Albert Bourla, Pfizer CEO (Evan Vucci, AP Images)

Covid-19 roundup: Pfiz­er tees up 500M vac­cine dos­es for do­na­tion in ex­pand­ed US pact; Ear­ly remde­sivir helps stave off hos­pi­tal­iza­tions — study

Pfizer and BioNTech will sell 500 million doses of their Comirnaty Covid-19 vaccine to the US at cost as part of an expanded agreement to drive donations to low- and middle-income nations, the drugmaker said Wednesday.

The expanded pact doubles Pfizer/BioNTech’s commitment to the US effort, which will ship donations to COVAX, a global clearinghouse for up to 92 target nations, as well as the 55 member states of the African Union, Pfizer said. Deliveries started in August and are expected to run through September 2022.

FDA+ roundup: Bs­U­FA III ready for show­time, court tells FDA to re-work com­pound­ing plan, new guid­ance up­dates and more

The FDA has now spelled out what exactly will be included in the third iteration of Biosimilar User Fee Act (BsUFA) from 2023 through 2027, which similarly to the prescription drug deal, sets fees that industry has to pay for submitting applications, in exchange for firm timelines that the agency must meet.

This latest deal includes several sweeteners for the biosimilar industry, which has yet to make great strides in the US market, with shorter review timelines for safety labeling updates and updates to add or remove an indication that does not contain efficacy data.

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