US ex­perts vow ‘no cut­ting cor­ners’

Drug cos work jointly to boost vac­cine con­fi­dence

Arab Times - - SCIENCE -

WASHINGTON, Sept 24, (AP): A huge in­ter­na­tional study of a COVID-19 vac­cine that aims to work with just one dose is get­ting un­der­way as top US 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 US 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.

De­ci­sions

“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 US 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 US, South Africa, Ar­gentina, Brazil, Chile, Colom­bia, Mex­ico and Peru. Other can­di­dates in the US

re­quire two shots.

J&J’s vac­cine is made with slightly dif­fer­ent tech­nol­ogy than oth­ers in lat­estage 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 US 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 amount

ed to mis­in­ter­pre­ta­tion and stressed Wed­nes­day: “More tests will ac­tu­ally lead to less cases.”

LON­DON:

Also:

Two firms de­vel­op­ing COVID-19 vac­cines say phar­ma­ceu­ti­cal com­pa­nies are try­ing to give the public as much in­for­ma­tion as pos­si­ble about their test­ing regimes as drug­mak­ers and public health of­fi­cials seek to boost con­fi­dence that any ap­proved vac­cine will be safe.

As­traZeneca CEO Pas­cal So­riot and Paul Stof­fels, chief sci­en­tific of­fi­cer of John­son & John­son, said Thurs­day that they rec­og­nize the coro­n­avirus emer­gency de­mands in­creased trans­parency from vac­cine de­vel­op­ers to en­sure the public has faith in the end prod­uct. They stressed how­ever that there are lim­its to the in­for­ma­tion they can re­lease be­cause they must pro­tect pa­tient con­fi­den­tial­ity and the in­tegrity of their sci­en­tific re­search.

Ul­ti­mately, the public will have to trust reg­u­la­tors around the world and the in­de­pen­dent ex­perts that over­see drug tri­als, So­riot said dur­ing a panel dis­cus­sion spon­sored by the World Eco­nomic Fo­rum.

“You’ve got to trust that the ex­perts whose job it is to mon­i­tor these tri­als and these de­vel­op­ments are do­ing a good job,” So­riot said. “Medicine should not be prac­ticed for the me­dia, it should be prac­ticed by ex­perts.”

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