COVID VAC­CINE FRON­TRUN­NERS WILL SOON SEE THEIR MO­MENT OF TRUTH

BusinessMirror - - News -

Drug­mak­ers made big prom­ises for a quick turn­around on coro­n­avirus vac­cines. The mo­ment of truth for the fron­trun­ners is com­ing as soon as this month.

The first re­sults show­ing whether a vac­cine can stop peo­ple from get­ting the virus could come by mid-septem­ber from as­trazeneca Plc, ac­cord­ing to airfin­ity Ltd., an an­a­lyt­ics com­pany that tracks drug tri­als. The drug­maker has pledged as many as 30 mil­lion doses to the uk by the end of the month.

Two other con­tenders—the us’s moderna Inc. and the us.-ger­man part­ner­ship of Pfizer Inc. and Bion­tech se—may also have ini­tial data be­fore a key Food and Drug ad­min­is­tra­tion (FDA) meet­ing on virus vac­cines sched­uled for Oc­to­ber 22, airfin­ity said. The fed­eral gov­ern­ment has told states to pre­pare for a vac­cine by Novem­ber 1. a fourth can­di­date, China’s si­no­vac Biotech Ltd., could have pre­lim­i­nary re­sults shortly af­ter the FDA meet­ing.

These early re­sults will be far from the full pic­ture. They’re what’s known as in­terim read­outs—snap­shots taken be­fore a study is com­plete, with only a frac­tion of the data. The World Health Or­ga­ni­za­tion (WHO) on mon­day cau­tioned against ap­prov­ing a vac­cine be­fore its full risks and ben­e­fits are clear. But with the virus resur­gent in europe and con­tin­u­ing to spread in In­dia and the amer­i­cas, the ini­tial num­bers will be an im­por­tant early in­di­ca­tor.

The first re­sults should be enough to“give us a very good idea of where we’re head­ing,” airfin­ity Chief ex­ec­u­tive Of­fi­cer ras­mus Bech Hansen said. “They are mov­ing faster than one could have an­tic­i­pated.”

airfin­ity’s pro­jec­tions are based on pub­licly avail­able data on trial en­roll­ment and de­sign, to­gether with in­fec­tion rates in places where pa­tients are en­rolled.

each of these ex­per­i­men­tal vac­cines has al­ready shown prom­ise in smaller tri­als de­signed to flag any se­ri­ous safety con­cerns and show whether can­di­dates can spur some re­sponse from the im­mune sys­tem. early safety data is key; un­like drugs, vac­cines are typ­i­cally given to rel­a­tively healthy peo­ple and shouldn’t cre­ate se­vere risks.

The real prov­ing ground, though, is a study big enough to show with a high de­gree of cer­tainty whether a vac­cine can­di­date can work in the real world.this re­quires tens of thou­sands of par­tic­i­pants, com­pared to the few hun­dred peo­ple who took the vac­cines in early-stage tri­als.

Drug­mak­ers would usu­ally wait for fi­nal re­sults be­fore re­quest­ing reg­u­la­tory ap­proval, and the trio of fron­trun­ners are on track to get that full data by the end of the year, airfin­ity says. In the us, that might not be fast enough. Over­whelm­ingly pos­i­tive in­terim re­sults could lead to stud­ies be­ing stopped early and the vac­cines be­ing rushed to the pub­lic, an­thony Fauci, direc­tor of the Na­tional In­sti­tute of al­lergy and In­fec­tious Diseases, told the Los an­ge­les

Times ear­lier this week.

Po­lit­i­cal pres­sure will be high to ap­prove a vac­cine if even the ini­tial snap­shot of data from these tri­als is promis­ing. Pres­i­dent Don­ald Trump has said a vac­cine is pos­si­ble by the Novem­ber 3 elec­tion and ac­cused the FDA of try­ing to slow the ap­proval process.

Com­mis­sioner stephen Hahn said last week he’s open to clear­ing a vac­cine un­der an emer­gency use au­tho­riza­tion, which is based on more lim­ited data. The Cen­ters for Dis­ease Con­trol and Pre­ven­tion (CDC) asked states in a let­ter to pre­pare for vac­cine distri­bu­tion sites to be“fully op­er­a­tional”by Novem­ber 1. The agency de­clined to com­ment on the let­ter.

rus­sia and China, mean­while, have al­ready cleared ex­per­i­men­tal vac­cines for lim­ited use be­fore test­ing was com­plete.

In europe, as­trazeneca’s vac­cine may be avail­able as of Novem­ber, ac­cord­ing to a se­nior euro­pean union of­fi­cial in­volved in eu ef­forts to se­cure doses from var­i­ous drug­mak­ers, who spoke to re­porters on Thurs­day on the con­di­tion of anonymity. The eu has locked in as many as 400 mil­lion doses of the uk drug­maker’s shot. as­trazeneca said it ex­pects ef­fi­cacy read­outs be­tween Oc­to­ber and the end of the year.

Pfizer has said it’s on track to have enough data for an au­tho­riza­tion as early as Oc­to­ber. Based on how quickly and where it’s cur­rently re­cruit­ing peo­ple for its 30,000-per­son trial, it will prob­a­bly be the first us drug­maker with in­terim data—by Oc­to­ber 15—but won’t have full re­sults un­til Novem­ber 17, airfin­ity projects. a Pfizer spokes­woman de­clined to com­ment on how many virus cases it will need to see in or­der to get re­sults in the trial.

Com­pa­nies test­ing vac­cines in the us, where the virus has spread more quickly than in europe for the past sev­eral months, may have an ad­van­tage in po­ten­tial vol­un­teers and in­fec­tions. as­trazeneca said it ex­pects re­sults later this year, de­pend­ing on the rate of in­fec­tion in the com­mu­ni­ties where it’s run­ning tri­als. J&J said it still plans to start its late-stage test this month, with first batches of vac­cine avail­able for po­ten­tial emer­gency use in early 2021, pend­ing the study re­sults. si­no­vac de­clined to com­ment. moderna de­clined to com­ment on the time frame for its data read­outs.

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