Covid-19: Razvoj vakcine, imunitet i primena medikamenata

[vememah]

Quote

 

Moderna will charge governments between $25 and $37 per dose of its COVID-19 vaccine candidate, depending on the amount ordered, Chief Executive Stephane Bancel told German weekly Welt am Sonntag (WamS).

“Our vaccine, therefore, costs about the same as a flu shot, which is between $10 and $50,” he was quoted as saying.

 

https://indianexpress.com/article/coronavirus/moderna-covid-19-vaccine-cost-7060816/

 

Ostali:

Quote

 

The companies [Pfizer and Biontech] are reportedly charging $20 per dose for its vaccine, significantly lower than Moderna.

The AstraZeneca-Oxford vaccine, which requires two doses, is priced at approximately $3 to $4, according to the Financial Times, citing supply deals agreed through to Oct. 7.

J&J’s [= Johnson & Johnson's] vaccine requires basic refrigeration for storage and is thought to cost around $10 a dose.

 

https://www.cnbc.com/2020/11/17/covid-vaccines-how-much-they-cost-whos-bought-them-and-how-theyre-stored.html

Edited November 22, 2020 by vememah

[vememah]

Rusi kažu da će njihova vakcina biti jeftina.

 

 

[Caligula]

On 21.11.2020. at 16:59, Misko said:

Ovo nije spanska groznica, i kolik god bio zejaban i opasan, korona nije taj level, bar ga jos nije dostigla,tako da  moze biti, ne mora da znaci.

 

Nisam (samo) ja uporedio Kovid i Spansku groznicu, ozbiljni ljudi iz struke pravili su jasna poredjenja, narocito sa procentom smrtnosti i lakocom prenosa.

[dùda]

2 hours ago, Caligula said:

 

Nisam (samo) ja uporedio Kovid i Spansku groznicu, ozbiljni ljudi iz struke pravili su jasna poredjenja, narocito sa procentom smrtnosti i lakocom prenosa.

Tačno. Ja sam isto negde pročitala da je struka pravila ta poređenja .

Samo treba da zamislimo šta bi napravila korona da napadne društvo izašlo iz rata, siromašno, neuhranjeno, društvo bez antibiotika, o još novijim lekovima da ne pričam. Ne bi bilo neke razlike sa španskom groznicom.

Ko god kihne danas, hvata se silnih vitamina, hemomicina i čega sve ne. A šta da ništa od toga nemamo ?

[Tsai]

upravo to

[barrcode]

Evo ga i Oxford +AstraZeneca:

The coronavirus vaccine developed by Oxford university and AstraZeneca has shown greater than expected efficacy, a landmark finding that will boost hopes there is a way out of the pandemic for countries without access to jabs made by rival drugmakers.

On Monday, Oxford and AstraZeneca said two different dosing regimens showed different levels of efficacy in late-stage trials in the UK and Brazil.

When the vaccine was given as a half dose, followed by a full one at least one month later, efficacy was 90 per cent. When the jab was given as two full doses at least one month apart, efficacy was 62 per cent. The average efficacy was 70 per cent.

All results were statistically significant and greater than the efficacy sought by both the US Food and Drug Administration and the European Medicines Agency.

AstraZeneca said it would submit the data for regulatory approval “immediately”.

Andrew Pollard, chief investigator of the trial at Oxford, said: “These findings show that we have an effective vaccine that will save many lives.”

The jab is priced at about $3 to $4 a dose, supply deals suggest, a fraction of that of other vaccines. AstraZeneca has agreed to sell it at cost to developing nations in perpetuity. The vaccine can be stored long-term at normal fridge temperature, between 2 and 8 degrees Celsius. Others require a storage temperature as low as -70C. Astra is targeting the manufacture of up to 3bn doses next year. Depending on regulatory approval, different dosing regimens could mean more doses are available.

[Moracikus]

https://www.google.com/amp/s/amp.theguardian.com/society/2020/nov/23/astrazeneca-says-its-coronavirus-vaccine-has-70-per-cent-efficacy-covid-oxford-university

Nije mi bas jasno ovo sa pola doze. Zar od pocetka nije bila ideja o 2 cijepanje

[Moracikus]

https://www.google.com/amp/s/amp.abc.net.au/article/12912564

Odje bolje objasnjeno.

Prva doza pola

Druga doza puna. Mnogo efikasnije.

Ima logike.

[vememah]

Zvanično saopštenje:

 

Quote

AZD1222 vaccine met primary efficacy endpoint in preventing COVID-19

23 November 2020 07:00 GMT
 
Two different dosing regimens demonstrated efficacy with one showing a better profile

No hospitalisations or severe cases of COVID-19 in participants treated with AZD1222
 
Positive high-level results from an interim analysis of clinical trials of AZD1222 in the UK and Brazil showed the vaccine was highly effective in preventing COVID-19, the primary endpoint, and no hospitalisations or severe cases of the disease were reported in participants receiving the vaccine. There were a total of 131 COVID-19 cases in the interim analysis.

One dosing regimen (n=2,741) showed vaccine efficacy of 90% when AZD1222 was given as a half dose, followed by a full dose at least one month apart, and another dosing regimen (n=8,895) showed 62% efficacy when given as two full doses at least one month apart. The combined analysis from both dosing regimens (n=11,636) resulted in an average efficacy of 70%. All results were statistically significant (p<=0.0001). More data will continue to accumulate and additional analysis will be conducted, refining the efficacy reading and establishing the duration of protection.

An independent Data Safety Monitoring Board determined that the analysis met its primary endpoint showing protection from COVID-19 occurring 14 days or more after receiving two doses of the vaccine. No serious safety events related to the vaccine have been confirmed. AZD1222 was well tolerated across both dosing regimens.

 

AstraZeneca will now immediately prepare regulatory submission of the data to authorities around the world that have a framework in place for conditional or early approval. The Company will seek an Emergency Use Listing from the World Health Organization for an accelerated pathway to vaccine availability in low-income countries. In parallel, the full analysis of the interim results is being submitted for publication in a peer-reviewed journal.

Professor Andrew Pollard, Chief Investigator of the Oxford Vaccine Trial at Oxford, said: “These  findings  show  that  we  have  an  effective  vaccine  that  will  save  many  lives. Excitingly, we’ve found that one of our dosing regimens may be around 90% effective and if this dosing regime is used, more people could be vaccinated with planned vaccine supply. Today’s announcement is only possible thanks  to  the  many  volunteers  in  our  trial,  and  the  hard  working  and  talented  team  of  researchers based around the world.”

Pascal Soriot, Chief Executive Officer, said: “Today marks an important milestone in our fight against the pandemic. This vaccine’s efficacy and safety confirm that it will be highly effective against COVID-19 and will have an immediate impact on this public health emergency. Furthermore, the vaccine’s simple supply chain and our no-profit pledge and commitment to broad, equitable and timely access means it will be affordable and globally available, supplying hundreds of millions of doses on approval.”

The pooled analysis included data from the COV002 Phase II/III trial in the UK and COV003 Phase III trial in Brazil. Over 23,000 participants are being assessed following two doses of either a half-dose/full-dose regimen or a regimen of two full doses of AZD1222 or a comparator, meningococcal conjugate vaccine called MenACWY or saline. The global trials are evaluating participants aged 18 years or over from diverse racial and geographic groups who are healthy or have stable underlying medical conditions.

Clinical trials are also being conducted in the US, Japan, Russia, South Africa, Kenya and Latin America with planned trials in other European and Asian countries. In total, the Company expects to enrol up to 60,000 participants globally.

The Company is making rapid progress in manufacturing with a capacity of up to 3 billion doses of the vaccine in 2021 on a rolling basis, pending regulatory approval. The vaccine can be stored, transported and handled at normal refrigerated conditions (2-8 degrees Celsius/ 36-46 degrees Fahrenheit) for at least six months and administered within existing healthcare settings.

AstraZeneca continues to engage with governments, multilateral organisations and collaborators around the world to ensure broad and equitable access to the vaccine at no profit for the duration of the pandemic.

 

COV002

COV002 is a single-blinded, multi-centre, randomised, controlled Phase II/III trial assessing the safety, efficacy and immunogenicity of AZD1222 in 12,390 participants in the UK. Trial participants to date are aged 18 years or over, who are healthy or have medically stable chronic diseases and are at increased risk for being exposed to the SARS-CoV-2 virus. Participants receive one or two intramuscular doses of a half dose (~2.5 x1010 viral particles) or full dose (~5x1010 viral particles) of AZD1222 or comparator, meningococcal vaccine MenACWY. Participants have blood samples drawn and clinical assessments for safety as well as immunogenicity at multiple timepoints up to one year post-vaccination. Suspected cases presenting with compatible symptoms were tested for virological confirmation by COVID-19 PCR. In addition, weekly swabbing are done for detection of infection and assessment of vaccine efficacy against infection.

 

COV003

COV003 is a single-blinded, multi-centre, randomised, controlled Phase III trial assessing the safety, efficacy, and immunogenicity of AZD1222 in 10,300 participants in Brazil. Trial participants to date are aged 18 years or over, who are healthy or have medically stable chronic diseases and are at increased risk for being exposed to the SARS-CoV-2 virus. Participants are randomised to receive two intramuscular doses of a full dose (~5x1010 viral particles) of AZD1222 or comparator, meningococcal vaccine MenACWY as first dose and a saline placebo as second dose. Participants have blood samples drawn and clinical assessments for safety as well as immunogenicity at multiple timepoints up to one year post-vaccination. Suspected cases presenting with compatible symptoms were tested for virological confirmation by COVID-19 PCR.

 

AZD1222
AZD1222 was co-invented by the University of Oxford and its spin-out company, Vaccitech. It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein. After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body.

 

AstraZeneca

AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca.

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

 

Svakako odlične, čak bih rekao fantastične vesti, posebno s obzirom na jeftinoću te vakcine, činjenicu da se može skladištiti u običnom frižideru, kao i da ni oni koji su nakon vakcinisanja oboleli nisu morali da budu hospitalizovani. Vidi se da su i oni pozitivno iznenađeni pošto je manje od četvrtine stvarno vakcinisanih bilo na tom režimu 50%-100% (2700 vs 8900).

Edited November 23, 2020 by vememah

[borris_]

Odlicne vijesti. Ova vakcina je najjeftinija za sada 3-4€ po dozi.

[Tsai]

Jel ovo znaci da se zaista za nekih pola godine nazire kraj, jer ce sve tri kompanije krenuti u masovnu distribuciju odjednom? 

 

[Moracikus]

Ovo je valjda preliminarni nalaz na 24k ispitanih. Zarazilo se 131 od kojih je po mome proracunu 20 primilo vakcinu a 111 placebo. Od ovih 20 niko nije hospitalizovan a ogromna vecina je dobila prvu punu dozu dok je samo par njih dobilo pola prve doze.

[Moracikus]

Cekaju se rezultati jos 36k.

 

[vememah]

@Tsai

 

Malo je preoptimistično za pola godine.

 

Vidiš da ovi u zvaničnom saopštenju kažu da za oksfordsku mogu maks. 3 mlrd doza do kraja godine, to je u ovom režimu 50%-100% dovoljno za 2 milijarde ljudi pod pretpostavkom da proizvodnju ne usporava bitno deljenje jedne doze na dve ambalaže. Pritom je AstraZeneka najbolja s proizvodnim kapacitetima.

 

Fajzer je objavio da u 2011. može da proizvede najviše 1,3 G doza, tj. da vakcinišu najviše 650 miliona ljudi.

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

 

Moderna je objavila da u 2011. mogu da proizvedu između 500 M i 1 G doza, tj. da vakcinišu najviše 500 miliona ljudi.

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

 

Dakle, sve zajedno je to oko 3,15 milijardi vakcinisanih pod pretpostavkom da će i najskuplje vakcine ići kao alva. Sa svim drugim vakcinama koje će se pojaviti i ruskim i kineskim koje već postoje, možda 4-5 milijardi. Svetska populacija je 7,8 milijardi.

Edited November 23, 2020 by vememah

[borris_]

Pa ne moraju se svi vakcinistai da bi se usporio virus. Govorili su nam da se kolektivni imunitate stice kada se zarazi 60% populacije. Posto neke indicije da je virus usporio tamo gdje se dosta ljudi vec zarazilo a to je mnogo ispod tih 60%.

 

Najveci problem ce biti logistika.