Fauci: ‘No cut­ting cor­ners’ as vac­cine tests ex­pand

Trump pushes for faster time­line for ap­proval

Albuquerque Journal - - NATION - BY LAURAN NEERGAARD AND RI­CARDO ALONSO-ZALDIVAR

WASH­ING­TON — A huge in­ter­na­tional study of a COVID-19 vac­cine that aims to work with just one dose is get­ting un­der­way as top U.S. health of­fi­cials sought Wed­nes­day to as­sure a skep­ti­cal Congress and pub­lic that they can trust any shots the gov­ern­ment ul­ti­mately ap­proves.

Hopes are high that an­swers about at least one of sev­eral can­di­dates be­ing tested in the U.S. could come by year’s end, maybe sooner.

“We feel cau­tiously op­ti­mistic that we will be able to have a safe and ef­fec­tive vac­cine, al­though there is never a guar­an­tee of that,” Dr. Anthony Fauci, in­fec­tious dis­ease chief at the Na­tional In­sti­tutes of Health, told a Se­nate com­mit­tee.

As for the test­ing of vac­cine can­di­dates, Fauci added: “There is no cut­ting cor­ners.”

Pres­i­dent Don­ald Trump is push­ing for a faster time­line, which many ex­perts say is risky and may not al­low for ad­e­quate test­ing. On Wed­nes­day, he tweeted a link to news about the new John­son & John­son vac­cine study and said the Food and Drug Ad­min­is­tra­tion “must move quickly!”

“Pres­i­dent Trump is still try­ing to sab­o­tage the work of our sci­en­tists and pub­lic health ex­perts for his own political ends,” Sen. Patty Mur­ray, a Demo­crat from Wash­ing­ton state, said be­fore tick­ing off ex­am­ples of pres­sure on the FDA.

FDA Com­mis­sioner Stephen Hahn pledged that ca­reer sci­en­tists, not politi­cians, will de­cide whether any coro­n­avirus vac­cine meets clearly stated stan­dards that it works and is safe. Vac­cine de­vel­op­ment usu­ally takes years, but sci­en­tists have been rac­ing to shorten that time, partly by man­u­fac­tur­ing doses that will have to be thrown away if stud­ies find they don’t work.

“Science will guide our de­ci­sions. FDA will not per­mit any pres­sure from any­one to change that,” Hahn said. “I will put the in­ter­est of the Amer­i­can peo­ple above any­thing else.”

FDA has faced crit­i­cism for al­low­ing emer­gency use of some COVID-19 treat­ments backed by lit­tle ev­i­dence, but Hahn said if vac­cine mak­ers want that faster path to mar­ket, ad­di­tional stan­dards will be com­ing soon. Vac­cines, un­like ther­a­pies, are given to healthy peo­ple and thus usu­ally re­quire more proof.

But Trump made clear at a Wed­nes­day evening White House news con­fer­ence that he was skep­ti­cal of any reg­u­la­tory changes that might de­lay a vac­cine’s au­tho­riza­tion, even if those changes are aimed at in­creas­ing pub­lic trust.

Asked about the FDA con­sid­er­ing stricter guide­lines for emer­gency ap­proval, Trump sug­gested the ef­fort was po­lit­i­cally mo­ti­vated.

“I think that was a political move more than any­thing else,” he said, ar­gu­ing that that the com­pa­nies test­ing the vac­cines, such as Pfizer, John­son & John­son and Moderna, are ca­pa­ble of de­ter­min­ing whether they work. “I have tremen­dous trust in these mas­sive com­pa­nies,” he said.

A few vac­cines are in fi­nal test­ing in the U.S. and other coun­tries. In one of the largest stud­ies yet, John­son & John­son aims to en­roll 60,000 vol­un­teers to test its sin­gle-dose ap­proach in the U.S., South Africa, Ar­gentina, Brazil, Chile, Colom­bia, Mex­ico and Peru. Other can­di­dates in the U.S. re­quire two shots.

J&J’s vac­cine is made with slightly dif­fer­ent tech­nol­ogy than oth­ers in late-stage test­ing, mod­eled on an Ebola vac­cine the com­pany cre­ated.

Fi­nal-stage test­ing of one ex­per­i­men­tal vac­cine, made by As­traZeneca and Ox­ford Univer­sity, re­mains on hold in the U.S. as of­fi­cials ex­am­ine whether it poses a safety risk.

CH­ERYL GER­BER/COURTESY OF JOHN­SON & JOHN­SON

John­son & John­son is be­gin­ning a huge fi­nal study of a sin­gle-dose COVID-19 vac­cine in the U.S., South Africa, Ar­gentina, Brazil, Chile, Colom­bia, Mex­ico and Peru.

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