Covid-19: Razvoj vakcine, imunitet i primena medikamenata

[fren]

3 hours ago, Milosh76 said:

Da li bilo ko u svetu radi na leku za koronu? Neka pilulica koja radi isto/slicno sto i vakcina, samo u manjoj dozi I uzima se, recimo 7 dana.

https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(20)30523-3/fulltext

[Dankan Ajdaho]

22 minutes ago, vememah said:

 

 

 

 

 

 

 

[vememah]

Neki problemi s oksfordskom vakcinom: između ostalog izgleda da je 90% efikasnost dobijena za britansku studiju kod koje su svi ispitanici mlađi od 55 godina, a i da ova druga, brazilska, sa obe pune doze ima disproporcionalno malo učesnika starijih od 55. Takođe su neželjeni efekti izgleda dosta veći nego kod Modernine i Fajzerove.

 

 

Iz drugog linkovanog teksta o ostalim vakcinama:

 

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Results for 3 inactivated virus vaccines are just around the corner: 1 from Sinovac, and 2 from Sinopharm. And it probably won’t be all that long till we start hearing more about Johnson & Johnson’s single shot vaccine.

http://hildabastian.net/index.php/100

Edited November 25, 2020 by vememah

[borris_]

Sjecate li se Remdesivir-a, magicni lijek protiv virusa. Prvo su htjeli da ga prodaju kao da smanjuje smrtnost pa kad su uvidjeli da nije tacno onda su ga prodavali kao da smanjuje broj dana provedenih u bolnici.

Cijena, prava sitnica, 390$ po dozi (treba 6 doza za jednog pacijenta pa racunajte). Proizvodnja jedne doze kosta 0,98$.

I to se naravno ispostavilo kao netacno (da smanjuje broj dana u bolnici).

 

Ipak 37 zemalja je kupilo taj "lijek" po toj cijeni, Gilead je zaradio skoro 1M€ na jednoj velikoj lazi.

 

Srecom pa je Francuska jedina zemlja iz EU koja nije kupila taj lijek (Gilead je trazio da se lijek refundira kroz socijalno osiguranje).

 

Big Farma at its best

 

Clanak:

 

Covid-19 : comment Gilead a vendu son remdésivir à l’Europe (lemonde.fr)

 

Edited November 27, 2020 by borris_

[borris_]

Ne mogu da editujem, zaradili su 900M€ a ne 1 milijardu.

[namenski]

Ostre se i avioprevoznici: prema International Air Transport Association (IATA) pred njima je do sada nevidjen izazov - za transport samo jedne doze vakcine za potrebe 7.8 milijardi ljudi koliko ih ima na Planeti, potrebno je napuniti, kazu, 8,000 Boeing 747 aviona i to onih cisto teretnih, nista putnici.

Niti ima dovoljno aviona, niti infrastrukture, a jos uvek nema ni govora o organizaciji, dakle saradnji granicnih sluzbi, carinskih vlasti i propisa, sigurnosnih mera lagerovanja, distribucije, saradnje izmedju kako drzavnih, tako i humanitarnih organizacija, farmaceutska industrija da se ne pominje...

Specificnosti poput mogucnosti da neke od vakcina budu zahtevale poseban tretman, cuvanje na niskim temperaturama, odgovarajuce cuvanje, itd, itd, da se ne pominju, sa sve eventualnim, a izglednim potrebama za hitno i pravovremeno ulaganje u potrebne instalacije i postrojenja...

Distribucija da se ne pominje, to bi bila vec politika...

 

 

[bags]

IATA i ICAO vaze kao dve najgore internacionalne organizacije u svemiru.

[Jumanji]

Izvršni direktor AstaZeneke (AstraZeneca) izjavio je da će ta farmaceutska kompanija sprovesti još jedno globalno ispitivanje efikasnosti vakcine protiv COVID-19, nakon otkrića da je efikasnija doza u postojećem kliničkom ispitivanju farmaceutskog rešenja zapravo dodeljena slučajno, piše Tech Crunch.
AstraZeneka i njen partner, Univerzitet u Oksfordu, izvestili su o privremenim rezultatima koji su pokazali efikasnost od 62 odsto za normalan režim od dve pune doze, ali i stopu efikasnosti od 90 odsto za polovinu doze praćene potpunom dozom.

[Tsai]

Zli zapadnjaci koje boli uvo za narod 

[vememah]

Pa ne, nego firma čije su akcije, za razliku od Fajzerovih i Moderninih PALE nakon objave efikasnosti. Zbog nedoslednosti i muljanja uopšte nije nemoguće da im FDA i drugi regulatori ne odobre vakcinu bez te treće studije.

 

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...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.

 

https://www.nytimes.com/2020/11/25/business/coronavirus-vaccine-astrazeneca-oxford.html

 

Datum objave prvih rezultata o efikasnosti:

 

Fajzer 9.11. (dopuna 18.11)

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-vaccine-candidate-against

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-conclude-phase-3-study-covid-19-vaccine

 

 

Moderna 16.11.

https://investors.modernatx.com/news-releases/news-release-details/modernas-covid-19-vaccine-candidate-meets-its-primary-efficacy

 

 

AstraZeneca 23.11.

https://www.astrazeneca.com/media-centre/press-releases/2020/azd1222hlr.html

 

 

 

 

 

Edited November 27, 2020 by vememah

[vememah]

 

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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.

https://www.bloomberg.com/news/articles/2020-11-26/astra-likely-to-run-fresh-global-covid-vaccine-trial-ceo-says

Edited November 27, 2020 by vememah

[Moracikus]

Mozda dobitna kombinacija bude

Stariji od 60god primaju RNA

Ostali: Astra i druge standardne vakcine

Edited November 28, 2020 by Moracikus

[borris_]

Dobitna kombinacija ce biti sto vise vakcina razlicitih dobavljaca. 

[Friend]

Vidim, vreme je za kvalitetan poll

[vememah]

Kreće distribucija Fajzerove vakcine po centrima u SAD.

Quote

 

United Airlines on Friday commenced charter flights to send doses of Pfizer and BioNTech's COVID-19 vaccine candidates to prepare for distribution, according to a report by the Wall Street Journal that cited people familiar with the matter.

In a statement to The Hill, the Federal Aviation Administration said it was "supporting the first mass air shipment of a vaccine" on Friday.

"As a result of the historic pace of vaccine development through Operation Warp Speed and careful logistics planning, the FAA today is supporting the first mass air shipment of a vaccine," the FAA statement read.
...
A United spokesperson told The Hill in a statement on Friday that the vaccine rollout was being handled by United Cargo, which established a COVID Readiness Task Team earlier this year "to help ensure we have the right people, products, services, and partnerships in place to support a vaccine distribution effort on a global scale."

 

https://thehill.com/policy/transportation/aviation/527792-united-airlines-charters-flights-to-distribute-pfizers-covid