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 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.

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.

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.