Covid-19: Razvoj vakcine, imunitet i primena medikamenata

[ToniAdams]

djodi, sta si po struci ako nije tajna?

 

cista da ne bude zabune, ne branim rusku vakcinu.

Edited August 14, 2020 by ToniAdams

[precog]

7 minutes ago, ToniAdams said:

 

debeli, oces ti da se spricas ruskom?

ako radi i ako je bezbedna, spricao bih se i torlakovom. 

[Ayatollah]

16 minutes ago, Joe D said:

nema sta da mislis, teoretski je nemoguce dobiti odobrenu vakcinu tako brzo. mozda ona i bude delotvorna protiv koronavirusa, ali bezbedna nije. bilo ko je mogao da pusti vakcinu tako kao sto rade rusi, imali bismo ih 100 do sad. 

Ja mislim da će biti upravo obrnuto - da će ruska vakcina biti bezbedna, ali će biti potpuno nedelotvorna. Klinička istraživanja bilo kog leka, pa i vakcina, se rade tako da se pre svega utvrđuje bezbednost nekog preparata, i dok se bezbednost ne potvrdi, ne može ni da se izađe iz Faze 1 ispitivanja. Oni će da daju tu vakcinu, a to što je ona efikasna 20% neće nikog zanimati, jer teško da će neko da ide po Rusiji i ispituje da li su vakcinisani dobili koronu posle, ako uopšte bude dostupan podatak ko je vakcinisan. Veći problem bi bio ako bi krenuli da masovno imaju posledice ili da umiru zbog vakcinacije, to bi se teže sakrilo.

 

Btw, ponoviću opet (nije upućeno tebi, već generalno) - Rusija je farmaceutski patuljak, nema ni kadrove ni resurse za ozbiljna farmaceutska istraživanja. Njihov najveći domet je proizvodnja generičkih lekova, a i sa tim je Rusija imala mnogo problema u prošlosti, u toj meri da je i jedan Hemofarm imao praktično neograničen prostor za ekspanziju i mogao je tamo da proda sve što proizvede i više od toga, jer je domaća proizvodnja bila nedovoljna da podmiri potrebe. Stoga, verovati da je Rusija u stanju da napravi efikasnu i bezbednu vakcinu pre nekog J&J-a ili Sanofija je potpuno neozbiljno, jer te kompanije imaju znatno ozbiljniji kadrovski potencijal da to urade.

Edited August 14, 2020 by Ayatollah

[vememah]

Potvrdili su bezbednost za celu populaciju na 38 zdravih ispitanika starosti do 60 godina, koliko su ukupno prijavili za I i II fazu. Kako da ne.

 

https://clinicaltrials.gov/ct2/show/NCT04437875

Edited August 14, 2020 by vememah

[yabadaba]

Ovo sto kaze ayatollah ima smisla i kada se vidi tip vakcine koji su napravili. Vakcina je bazirana na ljudskom adenovirusu. Različite su procene koliki je imunitet u populaciji na te viruse, ali se on u nekim regionima za neke vste krece i do 90%. Koliko sam ja razumeo ukoliko je organizam otporan na virus vektora neće se razviti (dovoljno jak) imuni odgovor. Mislim da su zato i isli sa dva adenovirusa. Oxford recimo koristi virus šimpanze na koji nema imunitata u ljudskoj populaciji.

[vememah]

Quote

Protest developed in the international scientific community over the announcement of the vaccine registration in Russia, mainly because there has been no publication of results from clinical trials on Gam-COVID-Vac. There exists no evidence for the safety, effective dose, biomarkers of an immune response, or efficacy against COVID-19 infection. While it was announced that Gam-COVID-Vac would begin Phase III testing during 2020, no Phase I or Phase II results have been published under peer review, while six other vaccine candidates are already in interventional Phase III trials, and 26 vaccine candidates in total are in various stages of human trials. In most countries, vaccine candidates are not approved or licensed until safety and efficacy are reviewed internationally by regulators.

https://en.wikipedia.org/wiki/Gam-COVID-Vac

 

Quote

 “It's ridiculous,” says Svetlana Zavidova, a lawyer who heads the Association of Clinical Research Organizations in Russia. “I feel only shame for our country.” Zavidova, who has worked on clinical trials for 20 years and anticipated the approval, yesterday sent an appeal to the Ministry of Health to postpone registering the vaccine until proper efficacy trials are completed. “Accelerated registration will no longer make Russia a leader in this race, it will only expose end users of the vaccine, citizens of the country of the Russian Federation, to unnecessary danger,” she wrote on behalf of the clinical research group.

https://www.sciencemag.org/news/2020/08/russia-s-approval-covid-19-vaccine-less-meets-press-release

[vememah]

Quote

phase three trials continue to monitor toxicity, immunogenicity, and SAEs [serious adverse effects] on a much larger scale. The vaccine must be shown to be safe and effective in natural disease conditions before being submitted for approval and then general production

https://en.wikipedia.org/wiki/Vaccine_trial

Edited August 14, 2020 by vememah

[Amos]

Biće fine municije za anti-vaksere zbog ovoga, pa onda idemo još jedan krug šizofrenije i optuživanja. 

[ToniAdams]

a realno, sve je sem neocekivano

[vememah]

Pored instituta Gamaleja, vakcina će se proizvoditi i u fabrici Binofarm koja je u ovom trenutku u stanju da proizvede prilično skromnih 1,5 milion doza godišnje, ali je planirano proširenje kapaciteta.

 

Quote

 

It is planned to produce the product in the National Research Center of Epidemiology and Microbiology named after academician N.F. Gamaleya of the Russian Ministry of Health and in Binnopharm company (part of AFK Sistema).

 

"Fastest production of COVID-19 vaccine is one of the most urgent tasks in the fight against the pandemic. We are glad that our pharmaceutical factory in Zelenograd, having long-term experience in manufacture of vaccines and biotech preparations, participates in this project. The capacity of the Binnopharm plant currently allows us to produce about 1.5 million doses of vaccine per year. We plan to equip the plant with additional equipment, which will allow us to increase vaccine production volumes. First of all, vaccines can be provided to Russian medics who, being at the forefront of the fight against coronavirus, are now the main risk group. The first batches of vaccines are already ready to be sent to Russia's regions," Sistema President Vladimir Chirakhov said.

 

http://xn--b1agjasmlcka4m.xn--p1ai/event/minzdrav-rossii-zaregistriroval-pervuyu-v-mire-vakcinu-ot-covid-19 (translation by Deepl)

Edited August 14, 2020 by vememah

[vememah]

Zvaničan sajt ruske vakcine sa sadržajem na više jezika među kojima je i engleski:

 

https://sputnikvaccine.com/

 

Quote

Phase 3 clinical trial involving more than 2,000 people in Russia, a number of Middle Eastern (UAE and Saudi Arabia), and Latin American countries (Brazil and Mexico) will start on August 12. The vaccine has received a registration certificate from the Russian Ministry of Health on August 11 and under emergency rules adopted during the COVID-19 pandemic can be used to vaccinate the population in Russia. Mass production of the vaccine is expected to start in September 2020.

https://sputnikvaccine.com/about-vaccine/clinical-trials/

 

Quote

FREQUENTLY ASKED QUESTIONS

When will mass production of the Russian vaccine start?
Mass production of the vaccine is expected to start in September 2020.

Will the vaccine be available in other countries?
At least 20 countries had expressed interest in obtaining the Sputnik V, including UAE, Saudi Arabia, Indonesia, the Philippines, Brazil, Mexico and India.

When will Russia provide full scientific data behind the vaccine?
In August the Gamaleya Center will publish the data as part of an article in a major international scientific magazine.

 

https://sputnikvaccine.com/faq/

 

Edited August 14, 2020 by vememah

[vememah]

[vememah]

Quote

The plan is to ramp up the vaccine production to 200 million doses by the end of 2020 including 30 million doses in Russia.

https://sputnikvaccine.com/partnerships/

[namenski]

3 hours ago, Ayatollah said:

Btw, ponoviću opet (nije upućeno tebi, već generalno) - Rusija je farmaceutski patuljak, nema ni kadrove ni resurse za ozbiljna farmaceutska istraživanja. Njihov najveći domet je proizvodnja generičkih lekova, a i sa tim je Rusija imala mnogo problema u prošlosti, u toj meri da je i jedan Hemofarm imao praktično neograničen prostor za ekspanziju i mogao je tamo da proda sve što proizvede i više od toga, jer je domaća proizvodnja bila nedovoljna da podmiri potrebe. Stoga, verovati da je Rusija u stanju da napravi efikasnu i bezbednu vakcinu pre nekog J&J-a ili Sanofija je potpuno neozbiljno, jer te kompanije imaju znatno ozbiljniji kadrovski potencijal da to urade.

Ovo boldovano je tacno, ali manje poznato, dobro je da si pomenuo/podsetio: u svojevremenom socrealistickom entuzijazmu, farmaceutska industrija u okviru SEV-a, ona za siroke narodne mase da je tako nazovem, bila je u podeli rada dodeljena Madjarima, dok je CCCP prakticno bio bez pomena vredne civilne farmaceutske industrije.

I, kada si vec pomenuo Hemofarm, cini mi se da su svojevremeno jedan od ozbiljnih uzroka razvoja/bujanja ex-Yu farmaceutske industrije (treba samo pokusati nabrojati SFRJ proizvodjace lekova) bile nezasite potrebe za lekarijama pokojnog CCCP-a.

S druge strane, mozda, ali samo mozda, treba imati u vidu gomilu kapaciteta, naravno vojne namene i naravno paranoicno skrivane od ociju javnosti, koji su se u CCCP bavili svim i svacim u toj oblasti.

Kapaciteta koji su bili materijalno i kadrovski neograniceni i sigurno sposobni da urade stosta po pitanju istrazivanja i razvoja raznih hemikalija^tm...

Pa mozda i vakcina...

 

Samo ilustracije onoga sto pokusavam da kazem radi: teflon koji je prvobitno bio izmisljen^tm skoro paralelno i u CCCP i u Americi, a zarad potrebe da se necim obloze izduvi^tm raketnih motora, u SSSP/Rusiji je ostao tajna  do 90-ih, dok je u Americi i ostalom kapitalizmu u roku od odmah uskocio u tiganje i serpe.

[napadaj]

Odgledaj film Dark Waters ili pročitaj ovo https://www.business-humanrights.org/en/dupont-lawsuits-re-pfoa-pollution-in-usa

Možda je zbog toga teflon u SSSR-u ostao tajna, umesto da je korišćen za masovnu proizvodnju tiganja i šerpi.