HHS Sec­re­tary Robert F. Kennedy Jr. claimed that mov­ing for­ward, all new vac­cines will need to be test­ed in place­bo-con­trolled tri­als be­fore they can win FDA ap­proval, call­ing it "a rad­i­cal de­par­ture from past prac­tices." In re­al­i­ty, ex­perts say, place­bo-con­trolled tri­als for new vac­cines have been stan­dard prac­tice for decades.

Kennedy's state­ment, giv­en by an HHS spokesper­son and first pub­lished in the Wash­ing­ton Post Wednes­day evening, says, “All new vac­cines will un­der­go safe­ty test­ing in place­bo-con­trolled tri­als pri­or to li­cen­sure — a rad­i­cal de­par­ture from past prac­tices."

The al­leged shift from Kennedy on place­bo-con­trolled tri­als comes as the FDA's most re­cent guid­ance from Oc­to­ber 2023 to Covid vac­cine man­u­fac­tur­ers makes clear that "lat­er phase tri­als, in­clud­ing ef­fi­ca­cy tri­als, should be ran­dom­ized, dou­ble-blind­ed, and place­bo con­trolled."

Mod­er­na tried to as­suage in­vestors Thurs­day that en­hanced scruti­ny of its vac­cines in the US wouldn’t ham­per its progress.

Ul­ti­mate­ly, though, mid­dling ex­e­cu­tion of the busi­ness may have proved to be more im­pact­ful on its stock.

The com­pa­ny re­port­ed $29 mil­lion in US sales of its Covid-19 vac­cine in the first quar­ter of this year, a frac­tion of the $229 mil­lion that Pfiz­er re­port­ed with its Covid-19 shot for the same pe­ri­od. Fi­nance chief Jamey Mock point­ed to pre­scrip­tion da­ta re­flect­ing a dif­fer­ent sto­ry, show­ing 38% mar­ket share. And he said in­ven­to­ry man­age­ment played a role in sales.

“I would al­so say that our cus­tomers are try­ing to man­age their work­ing cap­i­tal bet­ter, so their in­ven­to­ry lev­els are down,” Mock added.

Mod­er­na’s shares were down about 4.3% by 1:30 p.m. ET.

The US De­part­ment of Health and Hu­man Ser­vices rolled out a new $500 mil­lion ini­tia­tive to de­vel­op uni­ver­sal vac­cines for “pan­dem­ic-prone” virus­es such as in­fluen­za and Covid-19.

The ef­fort an­nounced Thurs­day, called Gen­er­a­tion Gold Stan­dard, will be fund­ed by BAR­DA and fo­cus on the NIH’s de­vel­op­ment of in-house uni­ver­sal vac­cine can­di­dates, in­clud­ing two dubbed BPL-1357 and BPL-24910.

The ini­tia­tive comes dur­ing en­hanced vac­cine scruti­ny un­der HHS Sec­re­tary Robert F. Kennedy Jr., a broad­er re­shap­ing of health agen­cies, and re­cent stop-work or­ders on Covid-19 vac­cine work that was fund­ed un­der a Biden-era ini­tia­tive. Vaxart, one of the com­pa­nies im­pact­ed, an­nounced ear­li­er this week that its stop-work or­der was lift­ed.