Fol­low­ing in the steps of Mod­er­na and Pfiz­er, the oth­er two Amer­i­can drug­mak­ers cur­rent­ly in Phase III tri­als for their Covid-19 vac­cines, As­traZeneca post­ed its own study pro­to­cols over the week­end. The move is the lat­est in a se­ries of rare peeks be­hind the cur­tain, as such blue­prints are typ­i­cal­ly shared once such tri­als are com­plet­ed.

“Giv­en the un­prece­dent­ed glob­al im­pact of the Coro­n­avirus pan­dem­ic and the need for pub­lic in­for­ma­tion, As­traZeneca has pub­lished the de­tailed pro­to­col and de­sign of our AZD1222 clin­i­cal tri­al. As with most clin­i­cal de­vel­op­ment, pro­to­cols are not typ­i­cal­ly shared pub­licly due to the im­por­tance of main­tain­ing con­fi­den­tial­i­ty and in­tegri­ty of tri­als. As­traZeneca con­tin­ues to work with in­dus­try peers to en­sure a con­sis­tent ap­proach to shar­ing time­ly clin­i­cal tri­al in­for­ma­tion,” the com­pa­ny said in a state­ment.

As­traZeneca’s tri­al, un­like the ones from coun­ter­parts, on­ly plans for one in­ter­im analy­sis that could al­low the com­pa­ny to stop the tri­al ear­ly and pe­ti­tion for an emer­gency use au­tho­riza­tion. That analy­sis is ex­pect­ed to oc­cur at 75 in­fec­tions. Mod­er­na ex­pects two analy­ses, at 53 and 106 events, while Pfiz­er pen­ciled in four — at 32, 62, 92 and 120 cas­es.

The British phar­ma al­so in­di­cat­ed that it is aim­ing for a 50% ef­fi­ca­cy rate for its can­di­date, the thresh­old that the FDA has set for in its coro­n­avirus vac­cine guide­lines, where­as Mod­er­na and Pfiz­er are both aim­ing for 60% ef­fec­tive­ness.

All three com­pa­nies al­so have dif­fer­ent cri­te­ria for symp­toms in the pri­ma­ry end­points of their tri­als, with each in­clud­ing those as­so­ci­at­ed with mild in­fec­tions. Er­ic Topol, one of the in­dus­try’s strongest ad­vo­cates for vac­cine trans­paren­cy, sum­ma­rized those dif­fer­ences in a tweet.

The all-im­por­tant pri­ma­ry end­point is dif­fer­ent for the 3 tri­als. This show how in­fec­tions are de­fined in the 3 pro­to­cols (with a pos­i­tive PCR test for virus). pic.twit­ter.com/JOPbH0SrI8

— Er­ic Topol (@Er­ic­Topol) Sep­tem­ber 19, 2020

Vac­cine mak­ers have been un­der in­tense po­lit­i­cal pres­sure through­out the Covid-19 pan­dem­ic, but that has on­ly ramped up as No­vem­ber’s pres­i­den­tial elec­tion draws near­er. Pres­i­dent Don­ald Trump has re­peat­ed­ly of­fered promis­es that a vac­cine could be ready be­fore the elec­tion, and HHS sec­re­tary Alex Azar ef­fec­tive­ly set the FDA staff on no­tice say­ing that his sig­na­ture is re­quired on all rule mak­ing.

Thus far, Pfiz­er CEO Al­bert Bourla has been the on­ly ex­ec­u­tive to say his com­pa­ny could know whether or not its vac­cine works in Oc­to­ber. Mod­er­na pres­i­dent Stephen Hoge, ap­pear­ing on CBS Evening News last week, said the drug­mak­er could know if its own vac­cine works by No­vem­ber.

De­spite a green light to re­sume in the UK, As­traZeneca’s Phase III tri­al re­mains on hold in the US af­ter a vol­un­teer in the UK de­vel­oped a con­di­tion thought to be trans­verse myelitis, a rare spinal in­flam­ma­tion dis­or­der, af­ter tak­ing their sec­ond dose of the vac­cine. The com­pa­ny has not con­firmed the di­ag­no­sis, and a doc­u­ment post­ed by Ox­ford Uni­ver­si­ty last week sug­gest­ed that the vac­cine was not linked to the con­di­tion.

That in­stance was the sec­ond time As­traZeneca’s tri­al was placed on hold fol­low­ing a case of un­di­ag­nosed mul­ti­ple scle­ro­sis oc­cur­ring in a sep­a­rate tri­al par­tic­i­pant.

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

As Congress considers whether to adopt sweeping new legislation to lower prescription drug prices across the board, the Kaiser Family Foundation is out with a new report on Monday showing how a more targeted approach on a subset of drugs might be a more efficient way to save government funds.

“This analysis shows that Medicare Part D and Part B spending is highly concentrated among a relatively small share of covered drugs, mainly those without generic or biosimilar competitors,” wrote Juliette Cubanski, deputy director of the program on Medicare policy at KFF, and Tricia Neuman, SVP of KFF. “Focusing drug price negotiation or reference pricing on a subset of drugs that account for a disproportionate share of spending would be an efficient use of administrative resources, though it would also leave some potential savings on the table.”

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.

It’s always a surprise when a court has to step in to tell the FDA that it erred in performing one of its main duties: classifying whether a medical product is drug or a device.

But that’s what the US Court of Appeals for the District of Columbia did on Friday, making clear to the world’s top drug regulator that Genus Medical Technologies’ contrast agent barium sulfate (also known as Vanilla SilQ) should not be considered a drug, as the FDA had said, but a medical device.