Virus

Not very comforting news for those looking for more comfort that the drug companies actually know what they are doing.

AstraZeneca says it will likely do another study of COVID-19 vaccine after accidental lower dose shows higher efficacy | TechCrunch https://t.co/fdNil9ZwK5

— Safdar Alam (@SafdarAlam) November 26, 2020

...AstraZeneca has acknowledged a key mistake in the vaccine dosage received by some study participants, adding to questions about whether the vaccine’s apparently spectacular efficacy will hold up under additional testing.

Scientists and industry experts said the error and a series of other irregularities and omissions in the way AstraZeneca initially disclosed the data have eroded their confidence in the reliability of the results.

Officials in the United States have noted that the results were not clear. It was the head of the flagship federal vaccine initiative — not the company — who first disclosed that the vaccine’s most promising results did not reflect data from older people.

The upshot, the experts said, is that the odds of regulators in the United States and elsewhere quickly authorizing the emergency use of the AstraZeneca vaccine are declining, an unexpected setback in the global campaign to corral the devastating pandemic.

“I think that they have really damaged confidence in their whole development program,” said Geoffrey Porges, an analyst for the investment bank SVB Leerink.

Летећи Полип wrote:Dobro, jedan ogroman deo.

Летећи Полип wrote:Vlast je napravila grešku još onomad, sa prvim lokdaunom. Prvo, zamrzla je komplet ekonomiju na tri meseca, iako je imala sijaset prostora da to ne čini, a da joj mere butu približno efektivne. Drugo, nepotrebno je ljude stavila iza brave, paralelno se bahateći kako kroz Vođine komentare, tako i kroz otvoreno nepoštovanje mera od strane najgorih iz njenih redova. Sada nit ima novčanog sala, niti moralnog kredita da sprovede mere. Ima da ćute i smrde dok ovo ne prođe.

Astra Eyes Extra Global Vaccine Trial as Questions Mount

By Suzi Ring and James Paton
November 26, 2020, 10:54 AM EST Updated on November 27, 2020, 4:09 AM EST

- Additional test shouldn’t delay regulatory approvals, CEO says
- Different efficacy readouts for Oxford shot raised questions

AstraZeneca Plc’s Covid-19 vaccine looks like it’s headed for an additional global trial as the drugmaker tries to clear up uncertainty and confusion surrounding favorable results in its current study.

The company wants the new test to confirm the 90% efficacy rate that the shot showed in a portion of an existing trial, Chief Executive Officer Pascal Soriot said. It’s favoring that option rather than adding an arm to a separate study that’s already underway in the U.S.

Questions are mounting over one of the fastest-moving shots after the company acknowledged that a lower dosage level that appeared more effective resulted from a manufacturing discrepancy. The company and its partner, the University of Oxford, didn’t initially disclose the error and other key details, leading to concern over their transparency.

“Now that we’ve found what looks like a better efficacy we have to validate this, so we need to do an additional study,” Soriot said in his first interview since the data were released. It will probably be another “international study, but this one could be faster because we know the efficacy is high so we need a smaller number of patients.”

Soriot said he didn’t expect the additional trial to hold up regulatory approvals in the U.K. and European Union.

U.K. Health Secretary Matt Hancock asked the nation’s medical regulator to potentially bypass its EU counterpart and approve the supply of AstraZeneca’s vaccine to speed its deployment. Until the end of the year, when the U.K. exits a post-Brexit transition period, vaccines must be authorized by the European Medicines Agency. But on Friday, Hancock said he invoked a special rule allowing Britain’s regulator to authorize a temporary supply of the vaccine if the data is robust enough.

Clearance from the U.S. Food and Drug Administration may take longer because the regulator is unlikely to approve the vaccine on the basis of studies conducted elsewhere, especially given the questions over the results, Soriot said. Authorization in some countries is still expected before the end of the year, he said.

“The question for us was, will we need the U.S. data to get approval in the U.S. or can we get approval in the U.S. with international data, and it was never clear,” said Soriot, who is in quarantine after arriving in Australia. “Now with those results it’s more likely that we will need the U.S. data.”

Astra and its CEO are facing scrutiny as the drugmaker responds to growing confusion over the vaccine. The company’s late-stage data initially increased confidence that the world would soon have multiple shots to combat the pathogen, following positive reports from front-runners Pfizer Inc. and Moderna Inc. But scant disclosures and the manufacturing discrepancy have sparked doubts among scientists and investors.

Astra shares fell 0.8% by 8:57 a.m. in London trading Friday, bringing the decline this week to about 8% amid questions about the trial results.

Different Rates

Astra and Oxford reported Monday that a lower initial dose of the vaccine, followed by a full dose, produced a 90% efficacy rate in a smaller set of participants, compared with 62% for two full doses.

A day after the data were unveiled the head of Operation Warp Speed, the U.S. vaccine program, said that the regimen showing the higher level of effectiveness was tested in a younger population. He also said the half-dose was given to some people because of an error in the quantity of vaccine put into some vials. None of those details were disclosed in Astra or Oxford’s original statements.

Soriot disputed the idea that the half-dose regimen was an error, saying that after researchers realized the dosing discrepancy they formally changed the trial protocol with the blessing of regulators.

“I won’t tell you we expected the efficacy to be higher,” said Soriot. But “people call it a mistake -- it’s not a mistake.”

The company has previously said it might add a new arm to its U.S. trial to test the lower dosage.

Astra and researchers have declined to provide more data ahead of a peer-reviewed analysis that is expected to be published in the coming weeks. Results have been submitted to an undisclosed journal, Astra said in a statement.

bemty wrote:meni u celoj toj prici uopste nije jasno zasto svi moraju na pregled. zasto ne organizuju samo briseve, brzo, pa posle jave rezultate telefonom, a na pregled samo oni koji se osecaju bas lose. za sta trijaza moze isto telefonom da se odradi. meni se cini da su te covid ambulante potencijalno najvece zariste zaraze.

Mór Thököly wrote:Pri tom imaju skoro duplo manje na 100k stanovnika od SRB/HR

Marius Lăcătuș wrote:
Bugari su jedina država u Evropi koja je po difoltu gora od nas.

Marius Lăcătuș wrote:

Mór Thököly wrote:Pri tom imaju skoro duplo manje na 100k stanovnika od SRB/HR

Nemaju, ložiš se bezveze. Testiraju mnogo manje od nas, 2-3x manje (kad sam poslednji put gledao), haos je odavno grđi nego u Srbiji, imali su dane sa po 150 mrtvih a redovno šibaju preko 100....

Tamo gde smo mi sada oni su bili pre jedno 3 nedelje, tako da ćemo i mi ovako uskoro.

Danas su testirali oko 9,000 a imaju 151 mrtvog.

Bugari su jedina država u Evropi koja je po difoltu gora od nas.

Pa bre jasno ti je kad sevne govno u ventilator onda svako gleda svoju guzicu.

Nama su prilično pomogli, ali džaba. Doalzili i Kinezi i Talijani - mi onoliko falsifikovali stvarnost da nas pohvale. Kod Talijana upalilo, jer ga manje više boli patka, kod kineza nije - bio iskreno zgranut, toliko da su morali da otkazuju KZN da se ne bi čuo rant.

Veliki skandal je izbio letos kad su Kinezi provalili da naši prodaju donirane maske preko lažnih preduzeća.

Pa ovi naši na vlasti su ultimativne štetočine bre - one što su bili dovoljno glupi da se vrate iz inostranstva su najstrašnije ispalili, a one što su pozapošljavali na brzinu na kraju zajebali za lovu pošto je trebalo nekoliko meseci da se dogovore Ministarstvo Zdravlja i Ministarstvo za rad ko će da ih plati.

Oni mučenici koji su šest meseci proveli u COVID centrima nisu dobili prebijenu kintu od obećanih stimulacija.

Pare su počeli da dele polovinom oktobra kad nisu mogli nikog da navataju da se vrati u COVID.

Sve što je Panić rekao potpisujem od reči do reči - trenutno u COVID centrima radi sve ono što može da se navata po hodnicima bolnica - od laboranata i rentgen tehničara do šalterskih službenica i baba sera.

Medicinski radnici masovno ispadaju - sada je uvedeno pravilo da nema izolacije i samoizolacije za medicinske radnike do pojave simptoma kao i da nema kontrolnog testa za povratak - čim ti je bolje vraćaš se.



I da vam kažem još nešto - mrtve nismo ni počeli da brojimo kako ćemo ih brojati za jedno 15 dana.



I da - svi oni što se protive policijskom času neka pogledaju današnje slike iz šopinga. Nema boljeg razloga za uvodjenje.