9 ms·

Gam-COVID-Vac phase 3 trial results: 91·6% efficacy and well tolerated

102 points by zhan_eg 6y ago

deleted 6y ago
[deleted]
inglor 6y ago
91.6% seems like a very good result for this vaccine and a big confidence boost to the companies that bought it. I'm waiting for the J&J results after two-dose immunisation given this vaccine takes a similar (non mRNA) approach and appears to be very effective. (Not ignoring that 66% efficiency is still significant but much less so than 91.6%)
- lode 6y ago
  > I'm waiting for the J&J results after two-dose immunisation given this vaccine takes a similar (non mRNA) approach and appears to be very effective. Given the J&J two dose trial (ENSEMBLE 2) only started just recently, and takes 60 days between two doses, this is going to take a while though. (I'm a volunteer. My second those is scheduled for mid-march.)
  - inglor 6y ago
    Thanks! 60 days would still be very interesting to get results for if-only to understand the technology (mRNA vaccines) better for future viruses. A lot of claims were made about how mRNA vaccination was revolutionizing how we approach these problems - but the Sputnik V results show similar gains with the traditional method.
    - bluGill 6y ago
      Sputnik V is not a traditional method either. It is different form mRNA, but both are relatively new on the vaccine scene. No traditional vaccine has finished phase-3 trials anywhere. Everything is something fairly new.
      - cesarb 6y ago
        > No traditional vaccine has finished phase-3 trials anywhere. Everything is something fairly new. According to the table at https://en.wikipedia.org/wiki/COVID-19_vaccine https://en.wikipedia.org/wiki/COVID-19_vaccine both CoronaVac and Covaxin are traditional "inactivated virus" vaccines, and both have finished Phase 3 trials; CoronaVac is already being applied by the government here (started last month, so far only health workers and elderly above 90 years old), and IIRC there have been talks of bringing Covaxin to be applied by private clinics.
        bluGill 6y ago
        I stand corrected.
- tinyhouse 6y ago
  What's important is hospitalization and death. Ideally you want the vaccine to protect you against infection, but where we are today, having a vaccine with "only" 66% efficiency against infection but that protects you with > 85% from severe reaction is very promising. I'd take the J&J one shot vaccine in a heartbeat.
  - bluGill 6y ago
    Short term yes, but long term I want to get rid of this virus and ensure my children don't get it. Since kids cannot get a vaccine that means elimination, and 95% gets us there a lot faster. I'm not even sure if we can eliminate with a 66% vaccine without covering kids - even 95% is questionable but we can get a lot closer.
    - postalrat 6y ago
      As far as I know it's impossible to eliminate this virus. The science we have so far says the virus is safer for children than the vaccine.
      - JumpCrisscross 6y ago
        > As far as I know it's impossible to eliminate this virus Almost no virus is impossible to eliminate or eradicate. It’s a question of cost (and reservoirs). > The science we have so far says the virus is safer for children than the vaccine Source? We haven’t tested the vaccine on children. We have had children die from Covid. This sounds like bunk.
        postalrat 6y ago
        My only source is the logically conclusion when we don't have the data how the vaccine will affect children yet we do have data on how many children are suffering serious side effects from the virus.
        JumpCrisscross 6y ago
- tzs 6y ago
  According to an article I read recently, the difference between 66% and 90% isn't actually very important when it comes to ending the pandemic. The 66% vaccines and the 90+% vaccines were about equally as effective at preventing severe COVID cases. More people get it on the 66% vaccine, but their cases were like a mild to medium flu. Most experts seem to believe that COVID is not going to be one of those viruses like smallpox or polio that we can for all practical purposes eliminate. They believe COVID is going to like cold and flu viruses. The long term goal then is to get it so that when we do get it, which most of us inevitably will at some point, it is no worse than a mild flu. The 66% vaccines are as good as the 90+% vaccines for that.
  - sudosysgen 6y ago
    We could probably eradicate a single cold virus if we wanted. The reason why we didn't is that there are a great many. SARS-CoV-2 is nothing like influenza. Technically, we could certainly eradicate this virus. It would take years, but it would be possible. It's just that it seems many countries just don't want to.
bhaavan 6y ago
91.6% is a good efficacy. Do they have plans to test it against other variants (E501Y mutation)? Ideally this + the adenovirus based AZD122 seems to be the best combination of (efficacy, affordablility, and logistically feasibility) end for the pandemic. https://www.gavi.org/vaccineswork/coronavirus-why-combining-oxford-vaccine-russias-sputnik-v-vaccine-could-make-it https://www.gavi.org/vaccineswork/coronavirus-why-combining-... is another such article which talks about it.
puzzlingcaptcha 6y ago
I wonder how much the heterologous approach (different viral vectors for first and second doses) contributed to its high efficiency compared to a similar Astra Zeneca vaccine. Conversely, why did Astra Zeneca opted not to do it this way.
- timr 6y ago
  > Conversely, why did Astra Zeneca opted not to do it this way. Because it's far more complicated (to manufacture and to distribute), and it isn't clear that it's necessary.
mrtksn 6y ago
I have been asking this the last week, only to receive downvotes and no proper answers: Why EU/UK/USA did not even consider the Russian and Chinese vaccines? They all can go "realpolitik" but have their economies crushed and citizens lost for the sake of political rivalry then fight with each other who gets the Western vaccines first? I'm sorry for asking it, I get that you don't like the question but I feel like it is a fair question. I'm not deleting this.
- manojlds 6y ago
  AZ are working with Sputnik to improve efficacy
  - mrtksn 6y ago
    Thanks, I know that but that's not what I am asking.
- Ulrich2 6y ago
  Of course EU/UK/USA consider it. But none of these vaccines have provided any trustworthy data of their efficacy and safety. And none of the makers of these vaccines even applied to be used in EU/UK/USA. If today's publication changes that status for Sputnik V remains to be seen. Still many open questions.
  - mrtksn 6y ago
    Any sources on that? AFAIK EU/UK/USA signed deals way before the western vaccines had any data too. Actually the Sanofi one even tanked.
    - Ulrich2 6y ago
      Sources for what? Of course EU/UK/USA signed deals with their local companies first, just like China and Russia. And in the case of China we have long history of problems with medical products.
Ulrich2 6y ago
Can this phase3 data be trusted? Is the raw data available for screening/checking, or do we have only the publication?
- repsilat 6y ago
  It's worth something that it passed peer review and was published in The Lancet.
- rzzzt 6y ago
  These seem to be preliminary results; it is mentioned in the paragraph at the top and throughout the report. The estimated completion date is May 1st, according to the clinicaltrials.gov link.
mchusma 6y ago
I doubt the US will see much of this, but this is now one of at least 4 high quality vaccines with great, public data banned from use in the US: Astrazeneca, J&J, Novavax, and Sputnik V.
- zaphod12 6y ago
  J&J only announced phase 3 results a few days ago and will be up for approval shortly. the Astrazenaca vaccine's results were a mess of p-hacking and mixing methods (they reported a result on a half-size first dose which occurred by accident and in a non-representative population because it looked good). Personally it makes me more confident in the FDA that they have yet to approve that vaccine.
- ls612 6y ago
  The AZ vaccine has had data issues in its trial and the FDA is waiting on the US trial arm to finish (likely a month from now) before making a decision. The J&J vaccine has just released data and will likely be authorized in a couple weeks, but manufacturing issues mean that we won’t see tens of millions of doses until April. Novavax is in a similar boat, they won’t have much manufacturing available until late spring and their US trial only started in December so it will run until April.
sradman 6y ago
The Russian Sputnik V vaccine [1] distinguishes itself from other two-dose Adenovirus vector vaccines [2] (Oxford–AstraZeneca and Chinese CanSino) by using different vectors (Ad26 and Ad5) for each dose. The Johnson & Johnson vaccine [3] is an Ad26 single-vector single-dose vaccine. In my opinion, the outstanding question is production capacity. Given the supply chains and geopolitics involved, I think the rational choice is to get whatever approved vaccine is available to you as soon as possible. [1] https://en.wikipedia.org/wiki/Sputnik_V_COVID-19_vaccine https://en.wikipedia.org/wiki/Sputnik_V_COVID-19_vaccine [2] https://en.wikipedia.org/wiki/COVID-19_vaccine#Adenovirus_vector_vaccines https://en.wikipedia.org/wiki/COVID-19_vaccine#Adenovirus_ve... [3] https://en.wikipedia.org/wiki/Ad26.COV2.S https://en.wikipedia.org/wiki/Ad26.COV2.S
nullifidian 6y ago
It's all nice and good, but Putin made this vaccine's effectiveness a political issue. If it's significantly less effective than its western counterparts it would result in a severe loss of face for Putin's propagandists and the regime in general. Considering the historical record of Putin's regime love for truth and integrity, it wouldn't be surprising if many people would choose to take these results with a grain of salt.
- myth_drannon 6y ago
  Unfortunately everything became political in this pandemic. Nothing wrong with a bit of national price. Russia inherited a very good scientific base for vaccine research and didn't squander it all, so I think they had a good case to be so risky.
  - nullifidian 6y ago
    >Unfortunately everything became political in this pandemic. Western leaders don't call vaccines developed in their countries as "the best Covid vaccine in the world". More so before any statistically relevant studies (faked or not) even ready. >Nothing wrong with a bit of national price. I think there is a difference (at least there shoudl be) between national pride and a fact distortion field.
throwaway4good 6y ago
European authorities need to approve this ASAP.
boringg 6y ago
Does the funding source have some bias impacts in this kind of thing? (i.e.: Moscow City Health Department, Russian Direct Investment Fund, Sberbank, and RUSAL.)

102 points by zhan_eg 6y ago

deleted 6y ago

[deleted]

91.6% seems like a very good result for this vaccine and a big confidence boost to the companies that bought it. I'm waiting for the J&J results after two-dose immunisation given this vaccine takes a similar (non mRNA) approach and appears to be very effective. (Not ignoring that 66% efficiency is still significant but much less so than 91.6%)

lode 6y ago
> I'm waiting for the J&J results after two-dose immunisation given this vaccine takes a similar (non mRNA) approach and appears to be very effective. Given the J&J two dose trial (ENSEMBLE 2) only started just recently, and takes 60 days between two doses, this is going to take a while though. (I'm a volunteer. My second those is scheduled for mid-march.)
- inglor 6y ago
  Thanks! 60 days would still be very interesting to get results for if-only to understand the technology (mRNA vaccines) better for future viruses. A lot of claims were made about how mRNA vaccination was revolutionizing how we approach these problems - but the Sputnik V results show similar gains with the traditional method.
  - bluGill 6y ago
    Sputnik V is not a traditional method either. It is different form mRNA, but both are relatively new on the vaccine scene. No traditional vaccine has finished phase-3 trials anywhere. Everything is something fairly new.
    - cesarb 6y ago
      > No traditional vaccine has finished phase-3 trials anywhere. Everything is something fairly new. According to the table at https://en.wikipedia.org/wiki/COVID-19_vaccine https://en.wikipedia.org/wiki/COVID-19_vaccine both CoronaVac and Covaxin are traditional "inactivated virus" vaccines, and both have finished Phase 3 trials; CoronaVac is already being applied by the government here (started last month, so far only health workers and elderly above 90 years old), and IIRC there have been talks of bringing Covaxin to be applied by private clinics.
      - bluGill 6y ago
        I stand corrected.
tinyhouse 6y ago
What's important is hospitalization and death. Ideally you want the vaccine to protect you against infection, but where we are today, having a vaccine with "only" 66% efficiency against infection but that protects you with > 85% from severe reaction is very promising. I'd take the J&J one shot vaccine in a heartbeat.
- bluGill 6y ago
  Short term yes, but long term I want to get rid of this virus and ensure my children don't get it. Since kids cannot get a vaccine that means elimination, and 95% gets us there a lot faster. I'm not even sure if we can eliminate with a 66% vaccine without covering kids - even 95% is questionable but we can get a lot closer.
  - postalrat 6y ago
    As far as I know it's impossible to eliminate this virus. The science we have so far says the virus is safer for children than the vaccine.
    - JumpCrisscross 6y ago
      > As far as I know it's impossible to eliminate this virus Almost no virus is impossible to eliminate or eradicate. It’s a question of cost (and reservoirs). > The science we have so far says the virus is safer for children than the vaccine Source? We haven’t tested the vaccine on children. We have had children die from Covid. This sounds like bunk.
      - postalrat 6y ago
        My only source is the logically conclusion when we don't have the data how the vaccine will affect children yet we do have data on how many children are suffering serious side effects from the virus.
        JumpCrisscross 6y ago
tzs 6y ago
According to an article I read recently, the difference between 66% and 90% isn't actually very important when it comes to ending the pandemic. The 66% vaccines and the 90+% vaccines were about equally as effective at preventing severe COVID cases. More people get it on the 66% vaccine, but their cases were like a mild to medium flu. Most experts seem to believe that COVID is not going to be one of those viruses like smallpox or polio that we can for all practical purposes eliminate. They believe COVID is going to like cold and flu viruses. The long term goal then is to get it so that when we do get it, which most of us inevitably will at some point, it is no worse than a mild flu. The 66% vaccines are as good as the 90+% vaccines for that.
- sudosysgen 6y ago
  We could probably eradicate a single cold virus if we wanted. The reason why we didn't is that there are a great many. SARS-CoV-2 is nothing like influenza. Technically, we could certainly eradicate this virus. It would take years, but it would be possible. It's just that it seems many countries just don't want to.

bhaavan 6y ago

91.6% is a good efficacy. Do they have plans to test it against other variants (E501Y mutation)? Ideally this + the adenovirus based AZD122 seems to be the best combination of (efficacy, affordablility, and logistically feasibility) end for the pandemic. https://www.gavi.org/vaccineswork/coronavirus-why-combining-oxford-vaccine-russias-sputnik-v-vaccine-could-make-it https://www.gavi.org/vaccineswork/coronavirus-why-combining-... is another such article which talks about it.

puzzlingcaptcha 6y ago

I wonder how much the heterologous approach (different viral vectors for first and second doses) contributed to its high efficiency compared to a similar Astra Zeneca vaccine. Conversely, why did Astra Zeneca opted not to do it this way.

timr 6y ago
> Conversely, why did Astra Zeneca opted not to do it this way. Because it's far more complicated (to manufacture and to distribute), and it isn't clear that it's necessary.

mrtksn 6y ago

I have been asking this the last week, only to receive downvotes and no proper answers: Why EU/UK/USA did not even consider the Russian and Chinese vaccines? They all can go "realpolitik" but have their economies crushed and citizens lost for the sake of political rivalry then fight with each other who gets the Western vaccines first? I'm sorry for asking it, I get that you don't like the question but I feel like it is a fair question. I'm not deleting this.

manojlds 6y ago
AZ are working with Sputnik to improve efficacy
- mrtksn 6y ago
  Thanks, I know that but that's not what I am asking.
Ulrich2 6y ago
Of course EU/UK/USA consider it. But none of these vaccines have provided any trustworthy data of their efficacy and safety. And none of the makers of these vaccines even applied to be used in EU/UK/USA. If today's publication changes that status for Sputnik V remains to be seen. Still many open questions.
- mrtksn 6y ago
  Any sources on that? AFAIK EU/UK/USA signed deals way before the western vaccines had any data too. Actually the Sanofi one even tanked.
  - Ulrich2 6y ago
    Sources for what? Of course EU/UK/USA signed deals with their local companies first, just like China and Russia. And in the case of China we have long history of problems with medical products.

Ulrich2 6y ago

Can this phase3 data be trusted? Is the raw data available for screening/checking, or do we have only the publication?

repsilat 6y ago
It's worth something that it passed peer review and was published in The Lancet.
rzzzt 6y ago
These seem to be preliminary results; it is mentioned in the paragraph at the top and throughout the report. The estimated completion date is May 1st, according to the clinicaltrials.gov link.

mchusma 6y ago

I doubt the US will see much of this, but this is now one of at least 4 high quality vaccines with great, public data banned from use in the US: Astrazeneca, J&J, Novavax, and Sputnik V.

zaphod12 6y ago
J&J only announced phase 3 results a few days ago and will be up for approval shortly. the Astrazenaca vaccine's results were a mess of p-hacking and mixing methods (they reported a result on a half-size first dose which occurred by accident and in a non-representative population because it looked good). Personally it makes me more confident in the FDA that they have yet to approve that vaccine.
ls612 6y ago
The AZ vaccine has had data issues in its trial and the FDA is waiting on the US trial arm to finish (likely a month from now) before making a decision. The J&J vaccine has just released data and will likely be authorized in a couple weeks, but manufacturing issues mean that we won’t see tens of millions of doses until April. Novavax is in a similar boat, they won’t have much manufacturing available until late spring and their US trial only started in December so it will run until April.

sradman 6y ago

The Russian Sputnik V vaccine [1] distinguishes itself from other two-dose Adenovirus vector vaccines [2] (Oxford–AstraZeneca and Chinese CanSino) by using different vectors (Ad26 and Ad5) for each dose. The Johnson & Johnson vaccine [3] is an Ad26 single-vector single-dose vaccine. In my opinion, the outstanding question is production capacity. Given the supply chains and geopolitics involved, I think the rational choice is to get whatever approved vaccine is available to you as soon as possible. [1] https://en.wikipedia.org/wiki/Sputnik_V_COVID-19_vaccine https://en.wikipedia.org/wiki/Sputnik_V_COVID-19_vaccine [2] https://en.wikipedia.org/wiki/COVID-19_vaccine#Adenovirus_vector_vaccines https://en.wikipedia.org/wiki/COVID-19_vaccine#Adenovirus_ve... [3] https://en.wikipedia.org/wiki/Ad26.COV2.S https://en.wikipedia.org/wiki/Ad26.COV2.S

nullifidian 6y ago

It's all nice and good, but Putin made this vaccine's effectiveness a political issue. If it's significantly less effective than its western counterparts it would result in a severe loss of face for Putin's propagandists and the regime in general. Considering the historical record of Putin's regime love for truth and integrity, it wouldn't be surprising if many people would choose to take these results with a grain of salt.

myth_drannon 6y ago
Unfortunately everything became political in this pandemic. Nothing wrong with a bit of national price. Russia inherited a very good scientific base for vaccine research and didn't squander it all, so I think they had a good case to be so risky.
- nullifidian 6y ago
  >Unfortunately everything became political in this pandemic. Western leaders don't call vaccines developed in their countries as "the best Covid vaccine in the world". More so before any statistically relevant studies (faked or not) even ready. >Nothing wrong with a bit of national price. I think there is a difference (at least there shoudl be) between national pride and a fact distortion field.

throwaway4good 6y ago

European authorities need to approve this ASAP.

boringg 6y ago

Does the funding source have some bias impacts in this kind of thing? (i.e.: Moscow City Health Department, Russian Direct Investment Fund, Sberbank, and RUSAL.)