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Senate proposes $16B to fund the next wave of Covid-19 vaccines
Senate proposes $16B to fund the next wave of Covid-19 vaccines, therapeutics in 2023
Don’t call it Op­er­a­tion Warp Speed 2.0, but Sen­ate De­moc­rats on Thurs­day pro­posed $22 bil­lion in 2023 emer­gency sup­ple­men­tal fund­ing for the next phase of the pan­dem­ic, in­clud­ing $16 bil­lion to sup­port the R&D, man­u­fac­tur­ing, pur­chase, and dis­tri­b­u­tion of vac­cines, ther­a­peu­tics, di­ag­nos­tics and oth­er med­ical coun­ter­mea­sures.

The in­flux of new funds, if passed and agreed to with their House coun­ter­parts, would ar­rive as, ac­cord­ing to the US gov­ern­ment spend­ing web­site, Wash­ing­ton has al­ready spent $3.83 tril­lion in re­sponse to Covid-19.

The Sen­ate pro­pos­al al­so fol­lows the House of Rep­re­sen­ta­tives’ de­ci­sion in March to pass its own 2023 spend­ing bill, but with­out the near­ly $16 bil­lion in Covid re­lief as Re­pub­li­cans ac­cused the White House of re­quest­ing too much, and not be­ing hon­est about the gov­ern­ment’s pan­dem­ic needs.

But the Sen­ate is plot­ting to al­low for flex­i­ble fund­ing to help HHS pur­chase and dis­trib­ute Covid vac­cines, ther­a­peu­tics, and di­ag­nos­tics, as well as to fund clin­i­cal tri­als for vac­cines fo­cused on emerg­ing coro­n­avirus vari­ants, and to sup­port do­mes­tic man­u­fac­tur­ing.

Sen­ate Ap­pro­pri­a­tions Com­mit­tee Chair Patrick Leahy (D-VT) said in a state­ment, “It is my hope that by re­leas­ing these bills, and mak­ing clear what the pri­or­i­ties of Sen­ate De­moc­rats are, we can take a step clos­er to­ward reach­ing a bi­par­ti­san com­pro­mise af­ter months of stalled ne­go­ti­a­tions.”

The bill would al­so in­clude $10.5 bil­lion (a 24% in­crease) for the CDC, as well as $860 mil­lion (a 32% in­crease) to in­crease rou­tine vac­ci­na­tion rates, de­tect and re­spond to out­breaks of vac­cine-pre­ventable dis­eases, as well as to ad­dress vac­cine hes­i­tan­cy. An­oth­er $740 mil­lion would go to sup­port­ing state and lo­cal pub­lic health de­part­ments’ emer­gency pre­pared­ness while $600 mil­lion would go to tripling the fund­ing for pub­lic health in­fra­struc­ture and ca­pac­i­ty.

Sen­ate on FDA spend­ing
For the FDA, the Sen­ate com­mit­tee’s bill of­fers a lit­tle bit less than what the House al­ready passed, al­though it would still be an in­crease of $229 mil­lion in dis­cre­tionary funds over 2022. The bill al­so in­cludes $5 mil­lion to im­ple­ment the ACT for ALS, which re­quires the FDA to pub­lish and im­ple­ment a five-year plan to help de­vel­op in­ves­ti­ga­tion­al drugs for ALS and oth­er rare neu­rode­gen­er­a­tive dis­eases.

On phar­ma man­u­fac­tur­ing, the Sen­ate com­mit­tee ex­pressed con­cerns about Amer­i­cans’ ac­cess to es­sen­tial med­i­cines, and the com­mit­tee di­rects the FDA to pro­vide a re­port with­in six months on do­mes­tic and for­eign man­u­fac­tur­ing of drugs in­clud­ed on FDA’s list of es­sen­tial med­i­cines, pub­lished in Oc­to­ber 2020.

The com­mit­tee al­so raised con­cerns on “the es­ca­lat­ing cost of spe­cial­ty can­cer drugs and bi­o­log­ics,” not­ing that spon­sors com­mon­ly “pur­sue la­bels at the max­i­mum tol­er­at­ed dose, de­spite the high cost, and which of­ten re­sults in sig­nif­i­cant side ef­fects.”

The com­mit­tee notes that sev­er­al stud­ies have demon­strat­ed cost sav­ings from al­ter­nate dos­ing strate­gies for on­col­o­gy drugs, with­out im­pact­ing ef­fi­ca­cy.

“The Com­mit­tee ac­knowl­edges FDA’s re­cent pre­mar­ket dose se­lec­tion ef­forts un­der Pro­ject Op­ti­mus, led by the On­col­o­gy Cen­ter of Ex­cel­lence. The Com­mit­tee strong­ly en­cour­ages FDA to or­ga­nize clin­i­cal tri­als, in col­lab­o­ra­tion with aca­d­e­m­ic med­ical cen­ters and oth­er Fed­er­al agen­cies, of mar­ket­ed can­cer drugs and bi­o­log­ics to as­sess whether dos­ing and fre­quen­cy ad­just­ments may de­crease the cost of care and/or tox­i­c­i­ties of treat­ment with­out com­pro­mis­ing ef­fi­ca­cy,” the com­mit­tee adds in its ex­plana­to­ry state­ment.

# COVID