U.S. ex­perts vow ‘no cut­ting cor­ners’ as vac­cine tests ex­pand

El Dorado News-Times - - Virus Extra - By Lau­ran Neer­gaard and Richardo Alonso-Zal­divar

WASH­ING­TON — A huge in­ter­na­tional study of a COVID19 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.

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, in part 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 hand­ful of vac­cines al­ready 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.

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

Be­yond vac­cines, Trump reg­u­larly un­der­cuts con­fi­dence in his own public health agen­cies, such as falsely tweet­ing about a “deep state, or who­ever at FDA” — and in re­cent weeks, some po­lit­i­cal ap­pointees were forced out af­ter al­le­ga­tions they in­ter­fered with sci­en­tific ad­vice.

Con­spir­acy the­o­ries are sap­ping the morale of dis­ease fight­ers work­ing 24/7 at the Cen­ters for Dis­ease Con­trol and Pre­ven­tion, Dr. Robert Red­field, its direc­tor, told the Se­nate com­mit­tee on health, ed­u­ca­tion, la­bor and pen­sions.

“It’s of­fen­sive to me when I hear this type of com­ment,” said Red­field, not­ing that CDC, like the mil­i­tary, strives to be non­par­ti­san.

Yet Red­field strug­gled to de­fend against crit­i­cism that CDC bowed to po­lit­i­cal pres­sure with guide­lines that dis­cour­aged test­ing of peo­ple with­out COVID-19 symp­toms. Asymp­to­matic peo­ple do spread the virus and CDC, un­der fire, later changed the guide­lines’ word­ing. Red­field in­sisted it all amounted to mis­in­ter­pre­ta­tion and stressed Wed­nes­day: “More tests will ac­tu­ally lead to less cases.”

More than 200,000 Amer­i­cans have died from COVID-19 so far this year, and in many states, in­fec­tions still are climb­ing. The U.S. is con­firm­ing an av­er­age of 41,968 new daily cases, up 13% com­pared with the av­er­age two weeks ago.

Fauci was blunt: More lives could have been saved if ev­ery­one in the coun­try bet­ter fol­lowed rec­om­men­da­tions to wear masks, avoid crowds and keep 6 feet apart.

“We know some states did a good job. Some states did not so good a job. Some states tried to do a good job but peo­ple didn’t lis­ten,” he said, sin­gling out mask-less crowds in bars. Go­ing for­ward, “we need uni­for­mity through­out the coun­try.”

In a testy ex­change, Sen. Rand Paul of Ken­tucky in­sisted public health of­fi­cials were wrong that a lock­down could change the course of the pan­demic. A vis­i­bly an­gry Fauci ac­cused the Repub­li­can of re­peat­edly mis­con­stru­ing his state­ments.

“I don’t re­gret say­ing that the only way we could have re­ally stopped the ex­plo­sion of in­fec­tion was by es­sen­tially — I want to say shut­ting down,” he said.

Fauci dis­missed Paul’s con­tention that hard-hit New York has be­come largely im­mune be­cause so many peo­ple were in­fected: “If you be­lieve 22% is herd im­mu­nity, I be­lieve you’re alone in that.”

Fauci also called at­ten­tion to so-called “long-haulers,” COVID19 sur­vivors who con­tinue to strug­gle with a range of symp­toms such as pain, fa­tigue, even heart dam­age. He warned much re­mains un­known about the long-term ef­fects of the virus.

Democrats warned those sur­vivors are at risk of be­ing de­nied in­sur­ance if the Trump ad­min­is­tra­tion suc­ceeds in over­turn­ing an Obama-era health law that for­bids com­pa­nies from turn­ing down peo­ple with pre-ex­ist­ing health prob­lems or charg­ing them more. The death of Jus­tice Ruth Bader Gins­burg means there are no longer five jus­tices on the Supreme Court who have up­held the Af­ford­able Care Act.

“We will see rates sky­rocket for any­body who has had COVID,” pre­dicted Sen. Chris Mur­phy, D-Conn.

A vac­cine “will go a gi­ant step” in con­trol­ling in­fec­tion, but Fauci warned peo­ple still will need to take those pre­cau­tions for a while af­ter the first vac­cine ar­rives be­cause it won’t change con­di­tions overnight.

Why? It’s un­usual for a vac­cine to be 100% ef­fec­tive. There won’t be enough at first for ev­ery­one, and even once there is, it will take months to get the shots into the arms of ev­ery Amer­i­can who wants one — an ef­fort CDC’s Red­field sees stretch­ing into June or July.

Be­cause of the enor­mous lo­gis­ti­cal chal­lenges, CDC wants states to get ready now and on Wed­nes­day, an­nounced they would get $200 mil­lion to help be­gin set­ting up those op­er­a­tions.

“We want to do that the in­stant it is ap­proved. Not the fol­low­ing day but the fol­low­ing mo­ment,” Trump said.

Neer­gaard re­ported from Alexan­dria, Vir­ginia. AP Writer Linda John­son con­trib­uted from Fair­less Hills, Penn­syl­va­nia.

The As­so­ci­ated Press Health and Science Depart­ment re­ceives sup­port from the Howard Hughes Med­i­cal In­sti­tute’s Depart­ment of Science Ed­u­ca­tion. The AP is solely re­spon­si­ble for all con­tent.

(Graeme Jen­nings/Pool via AP)

Dr. Stephen Hahn, com­mis­sioner of the U.S. Food and Drug Ad­min­is­tra­tion, tes­ti­fies Wed­nes­day dur­ing a Se­nate Se­nate Health, Ed­u­ca­tion, La­bor, and Pen­sions Com­mit­tee Hear­ing on the fed­eral gov­ern­ment re­sponse to COVID-19 on Capi­tol Hill in Wash­ing­ton.

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