Distribution of Moderna's Covid-19 Vaccine (Photo by Paul Sancya - Pool/Getty Images)

Opin­ion: Ado­les­cents can wait. The US needs to start do­nat­ing Covid-19 vac­cines to needy coun­tries now.

Now that the US is swim­ming in Covid-19 vac­cines and the sup­ply has of­fi­cial­ly eclipsed the de­mand, it’s time for Amer­i­ca to lead the world and start ship­ping these ex­cess dos­es to coun­tries that des­per­ate­ly need them.

Un­like the IP waiv­er at the World Trade Or­ga­ni­za­tion, which Biden now sup­ports and will like­ly take years to trans­late in­to ac­tu­al shots in arms, the US could eas­i­ly do­nate just a tiny frac­tion of the more than 60 mil­lion dos­es of Pfiz­er, Mod­er­na and J&J vac­cines sit­ting on Amer­i­can shelves right now.

Low-in­come coun­tries have re­ceived just 0.3% of all vac­cine dos­es in the world.

The sit­u­a­tion has be­come so dire in Bo­livia that its gov­ern­ment is turn­ing to a Cana­di­an com­pa­ny that doesn’t even make vac­cines, and Bo­livia will on­ly be able to ob­tain those if the com­pa­ny can ac­quire a com­pul­so­ry li­cense from the Cana­di­an gov­ern­ment.

Mean­while, the US on Thurs­day will like­ly be­gin vac­ci­nat­ing mil­lions of ado­les­cents, many of whom aren’t like­ly to get se­vere cas­es of Covid-19, or who live in ar­eas where Covid-19 in­fec­tions are wan­ing.

Texas has even gone so far as to say it will no longer track if it’s wast­ing vac­cine dos­es. The state ba­si­cal­ly ad­vised providers to waste dos­es, telling them to “vac­ci­nate any­one who wants to be vac­ci­nat­ed, even if that means open­ing a new vial for that per­son with­out know­ing whether all dos­es will be used.”

More than 150 mil­lion Amer­i­cans (or 58% of adults) have now re­ceived at least one dose of vac­cine. Dozens of neigh­bor­ing coun­tries in Cen­tral and South Amer­i­ca haven’t even ad­min­is­tered 1 mil­lion dos­es.

CO­V­AX, a world­wide ini­tia­tive fo­cused on eq­ui­table ac­cess to Covid-19 vac­cines, is do­ing its best to help, ship­ping over 58 mil­lion vac­cine dos­es to 122 par­tic­i­pants. In March, the ini­tia­tive an­nounced the de­liv­ery of 2.3 mil­lion vac­cine dos­es to Bo­livia, El Sal­vador, Guatemala, Hon­duras, Ja­maica, Nicaragua and Pe­ru.

But the US could dou­ble that fig­ure with a ship­ment to­mor­row, and nev­er even blink at the loss of 5 mil­lion vac­cine dos­es.

Biden made beat­ing the coro­n­avirus his top pri­or­i­ty, but that win won’t of­fi­cial­ly oc­cur un­til the rest of the world can con­tain their own out­breaks.

David Kessler

So far, the US has shipped just 4 mil­lion As­traZeneca Covid-19 vac­cine dos­es, in­clud­ing 2.5 mil­lion to Mex­i­co and 1.5 mil­lion to Cana­da, ac­cord­ing to tes­ti­mo­ny Tues­day from David Kessler, Biden’s Covid-19 CSO. Those dos­es aren’t au­tho­rized for use in the US, and like­ly nev­er would’ve been used in the US any­ways.

Kessler said he’s been on the phone with As­traZeneca reg­u­lar­ly over the last sev­er­al weeks to dis­cuss ship­ping about 60 mil­lion more of its dos­es out­side the US. The on­ly prob­lem — the dos­es were made at the trou­bled Emer­gent BioSo­lu­tions plant in Bal­ti­more and the FDA is still work­ing to see if they’re sal­vage­able, he said.

While the FDA con­tin­ues to re­view those dos­es, the US needs to start ship­ping our Pfiz­er, Mod­er­na and J&J dos­es to our neigh­bors.

The Fac­tors Dri­ving a Rapid Evo­lu­tion of Gene & Cell Ther­a­py and CAR-T Clin­i­cal Re­search in APAC

APAC is the fastest growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies globally, with China leading in the region. 

APAC is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022. The number of CAR-T trials initiated by Western companies has rapidly increased in recent years (current CAGR of about 60%), with multiple targets being explored including CD19, CD20, CD22, BCMA, CD30, CD123, CD33, CD38, and CD138.

The End­points 11; blue­bird's $3M gene ther­a­py; Bio­gen tout new neu­ro da­ta; Harsh re­views for can­cer drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Reading about John Carroll’s pick of biotech’s most promising startups has become a treasured tradition. If you ever get curious about previous classes of the Endpoints 11, you can find all of them (plus a number of our other regular specials) here.

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EMA warns of short­ages of two Boehringer heart drugs due to a spike in de­mand

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

The End­points 11: The top pri­vate biotechs in pur­suit of new drugs. Push­ing the en­ve­lope with pow­er­ful new tech­nolo­gies

Right around the beginning of the year, we got a close-up look at what happens after a boom ripples through biotech. The crash of life sciences stocks in Q1 was heard around the world.

In the months since, we’ve seen the natural Darwinian down cycle take effect. Reverse mergers made a comeback, with more burned out shells to go public at a time IPOs and road shows are out of favor. And no doubt some of the more recent arrivals on the investing side of the business are finding greener pastures.

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An­oth­er Cipla site lands a Form 483 over clean­ing is­sues and QC con­trols

A Cipla drug manufacturing site in India has once again landed in the crosshairs of FDA inspectors.

The facility in question is Cipla’s drug manufacturing facility in the village of Verna, in the state of Goa in India’s southwest. In a sign that foreign inspections might ramp up again, the FDA’s visit from Aug. 16 to Aug. 22 uncovered six observations.

The 11-page report noted that environmental monitoring at the site did not properly ensure that microbial contaminants were not making any impact in the aseptic filling areas. It also found that procedures meant to stop microbial contamination were not adequately conducted in aseptic areas of the facility.

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FDA ad­comm takes down Se­cu­ra Bio's leukemia drug af­ter fi­nal tri­al re­sults show po­ten­tial OS detri­ment

The FDA’s Oncologic Drugs Advisory Committee on Friday voted 8-4 against the benefit-risk profile of Secura Bio’s PI3K inhibitor Copiktra (duvelisib), which won approval in September 2018 as a third-line treatment for relapsed or refractory CLL or SLL, but updated pivotal trial results raised safety questions.

In addition to the serious and fatal toxicities of duvelisib, FDA speakers at the ODAC meeting pointed to an evolved treatment landscape for CLL and SLL, with targeted BTK or BCL2 inhibitors (front-line or second-line), and data pointing to a “potential detriment” in overall survival for duvelisib. But some ODAC members noted that the detriment was likely small and that there is some efficacy even as the data are difficult to interpret.

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Solicitor General Elizabeth Prelogar

Should SCO­TUS hear Am­gen's Repatha case? So­lic­i­tor gen­er­al says no

Back in April, Amgen said it was encouraged by the solicitor general’s anticipated review of its Supreme Court petition to rehear a Repatha patent case. They’re likely much less optimistic about the outcome now.

Solicitor General Elizabeth Prelogar wrote in a recent 27-page brief that Amgen’s arguments “lack merit and further review is not warranted.”

The case traces back to a suit filed in 2014 against Sanofi and Regeneron’s Praluent, which ended up beating Amgen’s PCSK9 blockbuster Repatha to market by a month just a year later.

FDA's out­side ex­perts vote in fa­vor of Fer­ring's fe­cal trans­plant for C. dif­fi­cile, set­ting the stage for Seres

FDA’s outside advisors voted in favor of Ferring Pharmaceuticals’ RBX2660, an experimental poop-based drug implant that the company says would be the first microbiota-based live biotherapeutic to receive an FDA green light.

That was a point repeatedly discussed during the Vaccines and Related Biological Products Advisory Committee, or VRBPAC, meeting Thursday when evaluating Ferring’s fecal microbiota transplant, or FMT, for reducing the recurrence of Clostridioides difficile infection in adults who have received antibiotics. Multiple members brought up the need for a regulated product amid a landscape of unregulated FMTs already happening in clinical care.

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Richard Pazdur, FDA's OCE director (Flatiron Health via YouTube)

FDA's OCE makes the case for ac­cel­er­at­ed ap­proval rid­er in user fee reau­tho­riza­tion

Four experts from the FDA’s Oncology Center of Excellence took to the New England Journal of Medicine yesterday to make the case for not only improving the agency’s ability to expeditiously pull dangling accelerated approvals when, on the rare occasion, confirmatory trials fail, but also better building “quality and efficiency into the AA on-ramp.”

The timely perspective arrives as Congress has exactly one week left to draft, release and sign off on the reauthorized user fee deals before layoff notices will be sent to drug reviewers. That package, which is likely to hitch a ride with the continuing resolution, may or may not include several policy riders (opposed by Republicans), including one that would allow the FDA to require confirmatory trials to be underway before an AA is granted, and would improve the process by which FDA can withdraw AAs.