Results Sputnik phase III trials

[cormanr7]

After new pre-print data on the AZ vaccine were published (referenced in another topic), results of phase III trials of the Sputnik vaccine have just appeared in the Lancet.

https://www.thelancet.com/action/showPdf?pii=S0140-6736(21)00234-8

The Sputnik is a viral vector (DNA) vaccine a la AZ but with a clever twist: it uses a different viral vector for the 2nd shot. Data pertain to about 15,000 vaccinated and 5,000 in the placebo group, with a heavy emphasis on males. Virtually all participants were white and the higher age group -listed just as above 60- made up only 11% of participants (in the AZ trials the group of over 70 was 6% overall in all trials combined). There was an exclusion period of three weeks after first shot. The three weeks coincide with the timing of the second shot. A symptomatic infection was defined as  PCR+ and a respiratory infection. There were 16 in the vaccinated and 62 symptomatic cases in the placebo group, resulting in an efficacy of 91.6%. These data were independent of the age group but the actual number of infections in the above 60 group is low (10 in total) with a corresponding high CI (also observed in the AZ trials with the over 70 group). It was claimed that there were no severe cases in the vaccinated group and 20 in the placebo group. However, it was noted that in the limited number of persons screened for 'immune responses' a few participants in the vaccinated group did not show any increase.

You can read the rest for yourself.  

 

Interesting: after the vaccine debacles in Europe, Germany among others has said that it is 'open' to using vaccines from Russia and China subject to EU approval. 

https://www.dw.com/en/coronavirus-germany-open-to-chinese-and-russian-vaccines-amid-delays/a-56396510.  We'll have to see whether this is just a snub/warning to Western manufacturers or whether this will actually occur (I can see all the comments already: 'a vaccine from Russia or China? Over my dead body!' Well without any vaccine you might end just like that).

Edited February 3, 2021 by cormanr7
modify last sentence

[Kiujunn]

The study was done in Moscow.

 

[internationalism]

sputnik is already approved in hungary (which is EU). They also have approved one of chinese one.

So now it's open door to the other EU countries, and declaration of importing might be very real.

Russia is doing mass vax program since november, so far with success.

 

also to note:

"In an unprecedented move in the coronavirus vaccine field, the Gamaleya Institute joined forces in December with the drugmaker AstraZeneca, which makes a vaccine with human adenoviruses. The two teams will combine their vaccines to see if the mixture can increase the efficacy of the AstraZeneca vaccine. AstraZeneca registered a Phase 1 trial for the combination on Dec. 24. In January, Gamaleya researchers also started a trial on a single-dose version of the vaccine, which they dubbed “Sputnik Light.” 

https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html

[rabas]

I have no reason to doubt Russia's vaccine but I'm always a little hesitant to believe numbers out of Russia.

 

On November 11, immediately after Pfizer suggested their vaccine could be 'more than'' 90% effective, Russia announced their vaccine was 92% effective. I think it was the next day.  Pfizer later announced 95%.  However, the 92% was based on just 20 volunteers who contracted the virus. Now I'm asked to believe the real number is 91.6% based on a larger but still not sizeable trial.

 

In a way, it reminds me of Sinovac's vaccine's 50.4% efficacy, just 0.4% above the approval rating.

 

https://www.reuters.com/article/health-coronavirus-russia-vaccine-idUSKBN27R0ZA

 

Edited February 3, 2021 by rabas

[cormanr7]

3 hours ago, internationalism said:

sputnik is already approved in hungary (which is EU). They also have approved one of chinese one.

Russia is doing mass vax program since november, so far with success

Yes, I am well aware of that. However, Hungary has virtually been at war with the EU for some time this mainly to do with the policies of Orban cs (independent of COVID) and their approval for the Sputnik and Sinopharm vaccines without green light from the EMA has upset quite a few   https://www.ft.com/content/20bfa7ba-4df9-4422-9dbf-06811da1294c. I don't think Germany will just proceed like this.

And about the successful vaccination in program: Russia has just vaccinated 0.7% of its population (ourworldindata) and it appears that most Russians are very suspicious of Sputnik (maybe of other vaccines too). It appears that they have an oversupply of vaccines but with many of the vaccination centers largely empty. A recent article (not sure how reliable this is, but many western correspondents mention the lack of enthusiasm regarding vaccination, they could get it for free though they were not high on the list as few Russians turned up)    https://theprint.in/world/oversupply-of-covid-shot-in-russia-but-skepticism-dogs-sputnik-v-vaccine-drive/595878/ 

[Kiujunn]

4 hours ago, internationalism said:

AstraZeneca, which makes a vaccine with human adenoviruses

Wrong.

AZ uses chimpanzee adenovirus. Chadox = chimpanzee adenovirus Oxford. I hardly dare to write that chimpanzees are not human, afraid to get banned...

BTW i checked your source,  NYT really writes this. 

[cormanr7]

13 hours ago, Kiujunn said:

Wrong.

AZ uses chimpanzee adenovirus. Chadox = chimpanzee adenovirus Oxford. I hardly dare to write that chimpanzees are not human, afraid to get banned...

BTW i checked your source,  NYT really writes this. 

Indeed. If you want to know why AZ has chosen a chimp cold virus you can check this article:

• https://doi.org/10.1080/21645515.2017.1419108

In contrast, Sputnik uses human cold adenoviruses (Ad26 for the first shot and Ad5 for the second), whereas the one shot Janssen vaccine (from Johnson & Johnson) uses one (Ad26). The Ad26 platform is fairly common for viral vector vaccines (i.e. against Ebola, Zika, HPV, malaria, etc).

 

https://doi.org/10.1016/j.vaccine.2020.09.018