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.

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; 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.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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Joe Wiley, Amryt Pharma CEO

Am­ryt Phar­ma sub­mits a for­mal dis­pute res­o­lu­tion to the FDA over re­ject­ed skin dis­ease drug

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

Sen. Thom Tillis (R-NC) (J. Scott Applewhite/AP Images)

Phar­ma-friend­ly sen­a­tor calls on FDA for a third time to show patent pro­tec­tions should­n't be blamed for high drug prices

North Carolina Republican Sen. Thom Tillis made a name for himself in the 2020 election cycle as the darling of the pharma industry, accepting hundreds of thousands in campaign contributions, even from the likes of Pfizer CEO Albert Bourla.

Those contributions have led Tillis to attempt to re-write patent laws in pharma’s favor, a move which failed to gain steam in 2019, and request for a third time since January that the FDA should help stop “the false narrative that patent protections are to blame for high drug prices.”

AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

FDA un­veils new draft guid­ance to help with oligonu­cleotide ther­a­peu­tics de­vel­op­ment

While oligonucleotides, a wide variety of synthetically modified RNA or RNA/DNA hybrids that bind to a target RNA sequence to alter RNA and/or protein expression, have been winning approvals in recent years (e.g. Novartis’ cholesterol drug Leqvio), the regulatory agency is offering new draft guidance for those looking to follow a similar path.

The non-binding guidance, titled “Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics Guidance for Industry” deals with pharmacokinetic, pharmacodynamic, and safety assessments required as part of oligonucleotide therapeutics R&D.

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Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

EMA signs off on 3 drugs re­cent­ly re­ject­ed by FDA, in­clud­ing Bio­Mar­in's new he­mo­phil­ia gene ther­a­py

The EMA’s human medicines committee on Friday recommended three new drugs for approval or conditional approval, even as their US counterparts have rejected these three for various reasons.

In a major move, CHMP offered a thumbs-up to a conditional marketing authorization for the first gene therapy to treat severe hemophilia A, although the agency cautioned that it’s so far unknown how long the effects of infusion will last.

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