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> Because the change is small, an updated vaccine doesn’t need Phase III trials and/or regularity approval. So, this whole process should take a max of 6 weeks.

> Because the change is small, an updated vaccine doesn’t need Phase III trials and/or regularity approval. So, this whole process should take a max of 6 weeks. This appears to be incorrect, Moderna says it needs 60 days to just get into trials (https://twitter.com/megtirrell/status/1464225637590310938 https://twitter.com/megtirrell/status/1464225637590310938) . The FDA has not said what the approval process will look like, but its safe to say it will be non-zero

Anon84 5y ago
Yes, you need to show that the new vaccine works against the new variant but not that it’s safe. So it will be much faster
- refurb 5y ago
  Why would you not need to show it’s safe? A new mRNA vaccine would be introducing different mRNA, which produces new antigen proteins and elicits a different immune response.
  - johnchristopher 5y ago
    If it elicited the same immune response it wouldn't be much of a use though, right ? Anyway, how do they know the usual but new seasonal flu vaccine is safe ? Can't the same framework apply ?
    - refurb 5y ago
      They run clinical trials on them to make sure they are safe and effective. https://www.cdc.gov/flu/vaccines-work/effectivenessqa.htm https://www.cdc.gov/flu/vaccines-work/effectivenessqa.htm Manufacturers guess which flu strain will predominate and start working 9-12 months early to capture the data for approval. There is no way a new Covid mRNA vaccine will be approved with safety and efficacy data from a clinical trial. That will be take months to complete.
      - ed_balls 5y ago
        It's possible that mRNA would reduce the time to the market, which would give use more time to gather data and have better predictions of dominant strains.
      - tempestn 5y ago
        > There is no way a new Covid mRNA vaccine will be approved with safety and efficacy data from a clinical trial. You meant 'without', right?
        pbaka 5y ago
        tbf to OC, I think he got it right ;-) /s
      - johnchristopher 5y ago
        Wow, thanks. I didn't know that they had an extensive clinical trial program and that the whole thing started so soon.
  - weaksauce 5y ago
    Yeah i'm pretty pro vaccine but it seems like safety should be evaluated because it's creating a different antigen. maybe this is some relic from the flu-shots being made yearly without any real safety testing to my knowlege(which, to be fair for the flu, I haven't really followed so i don't know how accurate that is but i don't think much meaningful safety testing can be done every year)
  - ralusek 5y ago
    You would think software engineers would understand this. It's like approving subsequent pull requests on any and all code changes because the integration tests already passed once.
- nojito 5y ago
  They still need to do Phase 2...I don't where you got your info from, but it's very misleading.
johnchristopher 5y ago
https://www.pbs.org/newshour/health/covid-19-vaccines-can-adapt-to-new-variants-heres-what-it-will- https://www.pbs.org/newshour/health/covid-19-vaccines-can-ad... COVID-19 vaccines can adapt to new variants. Here’s what it will take Health Feb 9, 2021 6:37 PM EST > It would take six weeks for researchers to go from “plugging new variants into the vaccine” to “make a new vaccine ready to go into people,” he said, but that does not account for the time it would take to have a drug approved. Weissman compared the process to the way the vaccines for the seasonal influenza are modified each time it circumnavigates the globe. https://www.theguardian.com/society/2021/nov/26/biontech-says-it-could-tweak-covid-vaccine-in-100-days-if-needed https://www.theguardian.com/society/2021/nov/26/biontech-say... BioNTech says it could tweak Covid vaccine in 100 days if needed > BioNTech says it could produce and ship an updated version of its vaccine within 100 days if the new Covid variant detected in southern Africa is found to evade existing immunity.
- ralusek 5y ago
  The question has never been about how long it would take to adjust the vaccine. mRNA has been a platform capable of rapid alterations since the beginning. The question is regarding ensuring that the changes are safe and efficacious.
  - johnchristopher 5y ago
    Sorry for misleading, I just wanted to post moderna and pfizer estimates to add to authorization time.
gladinovax 5y ago
Doesn't need phase 3 trials? That's gonna be great! How soon will other people be able to get it?

Anon84 5y ago

Yes, you need to show that the new vaccine works against the new variant but not that it’s safe. So it will be much faster

refurb 5y ago
Why would you not need to show it’s safe? A new mRNA vaccine would be introducing different mRNA, which produces new antigen proteins and elicits a different immune response.
- johnchristopher 5y ago
  If it elicited the same immune response it wouldn't be much of a use though, right ? Anyway, how do they know the usual but new seasonal flu vaccine is safe ? Can't the same framework apply ?
  - refurb 5y ago
    They run clinical trials on them to make sure they are safe and effective. https://www.cdc.gov/flu/vaccines-work/effectivenessqa.htm https://www.cdc.gov/flu/vaccines-work/effectivenessqa.htm Manufacturers guess which flu strain will predominate and start working 9-12 months early to capture the data for approval. There is no way a new Covid mRNA vaccine will be approved with safety and efficacy data from a clinical trial. That will be take months to complete.
    - ed_balls 5y ago
      It's possible that mRNA would reduce the time to the market, which would give use more time to gather data and have better predictions of dominant strains.
    - tempestn 5y ago
      > There is no way a new Covid mRNA vaccine will be approved with safety and efficacy data from a clinical trial. You meant 'without', right?
      - pbaka 5y ago
        tbf to OC, I think he got it right ;-) /s
    - johnchristopher 5y ago
      Wow, thanks. I didn't know that they had an extensive clinical trial program and that the whole thing started so soon.
- weaksauce 5y ago
  Yeah i'm pretty pro vaccine but it seems like safety should be evaluated because it's creating a different antigen. maybe this is some relic from the flu-shots being made yearly without any real safety testing to my knowlege(which, to be fair for the flu, I haven't really followed so i don't know how accurate that is but i don't think much meaningful safety testing can be done every year)
- ralusek 5y ago
  You would think software engineers would understand this. It's like approving subsequent pull requests on any and all code changes because the integration tests already passed once.
nojito 5y ago
They still need to do Phase 2...I don't where you got your info from, but it's very misleading.

johnchristopher 5y ago

https://www.pbs.org/newshour/health/covid-19-vaccines-can-adapt-to-new-variants-heres-what-it-will- https://www.pbs.org/newshour/health/covid-19-vaccines-can-ad... COVID-19 vaccines can adapt to new variants. Here’s what it will take Health Feb 9, 2021 6:37 PM EST > It would take six weeks for researchers to go from “plugging new variants into the vaccine” to “make a new vaccine ready to go into people,” he said, but that does not account for the time it would take to have a drug approved. Weissman compared the process to the way the vaccines for the seasonal influenza are modified each time it circumnavigates the globe. https://www.theguardian.com/society/2021/nov/26/biontech-says-it-could-tweak-covid-vaccine-in-100-days-if-needed https://www.theguardian.com/society/2021/nov/26/biontech-say... BioNTech says it could tweak Covid vaccine in 100 days if needed > BioNTech says it could produce and ship an updated version of its vaccine within 100 days if the new Covid variant detected in southern Africa is found to evade existing immunity.

ralusek 5y ago
The question has never been about how long it would take to adjust the vaccine. mRNA has been a platform capable of rapid alterations since the beginning. The question is regarding ensuring that the changes are safe and efficacious.
- johnchristopher 5y ago
  Sorry for misleading, I just wanted to post moderna and pfizer estimates to add to authorization time.

gladinovax 5y ago

Doesn't need phase 3 trials? That's gonna be great! How soon will other people be able to get it?