3 ms·

This probably explains why only 5M doses of J&J vaccine were allocated for the week of April 5 as opposed to the 11+M that were anticipated. Emergent was also

This probably explains why only 5M doses of J&J vaccine were allocated for the week of April 5 as opposed to the 11+M that were anticipated. Emergent was also supposed to be approved to ramp up the full supply chain but that hasn’t happened yet, could be related.

jschwartzi 6y ago
In the article it says that these doses were produced in a facility that wasn't approved by the FDA yet, so this has no impact on the availability of doses now. It might have an impact on the availability of doses in the future though.
- bitcharmer 6y ago
  Honest question: if the facility wasn't approved by the FDA then why was it manufacturing the vaccines at all? And how could such vaccines be used anywhere if they were produced by an unapproved facility?
  - maxerickson 6y ago
    FDA is likely reviewing their processes and controls more than running a white glove inside of anything. So those things would be the same for a batch that was in production as they would be for a batch started tomorrow.
  - hn8788 6y ago
    Maybe the approval process includes a "must have met X criteria for the past Y months", so once you get approved, everything you've done in the past Y months counts as having been created in an approved facility. I'm just guessing though, I have no idea what the process is.
    - markus92 6y ago
      Basically this. You need four consecutive batches with consistent quality in a row for approval.
  - zacharycohn 6y ago
    Everyone has been gearing up production before approvals with the assumption they'll get approved for expediency sake. You get approved? Great - We can immediately ship these 30 million doses while we start the next 30 million. We don't get approved? Write off the produced doses, fix your process, and try again.
  - cortesoft 6y ago
    Maybe making them for another country?
  - mulmen 6y ago
    Because that's how good we are as a society at efficiently allocating capital and operating supply chains. Regulators have to sign off before you can administer it to anyone but you can ramp up your production in parallel with the approval process. It's actually an incredible achievement.

jschwartzi 6y ago

In the article it says that these doses were produced in a facility that wasn't approved by the FDA yet, so this has no impact on the availability of doses now. It might have an impact on the availability of doses in the future though.

bitcharmer 6y ago
Honest question: if the facility wasn't approved by the FDA then why was it manufacturing the vaccines at all? And how could such vaccines be used anywhere if they were produced by an unapproved facility?
- maxerickson 6y ago
  FDA is likely reviewing their processes and controls more than running a white glove inside of anything. So those things would be the same for a batch that was in production as they would be for a batch started tomorrow.
- hn8788 6y ago
  Maybe the approval process includes a "must have met X criteria for the past Y months", so once you get approved, everything you've done in the past Y months counts as having been created in an approved facility. I'm just guessing though, I have no idea what the process is.
  - markus92 6y ago
    Basically this. You need four consecutive batches with consistent quality in a row for approval.
- zacharycohn 6y ago
  Everyone has been gearing up production before approvals with the assumption they'll get approved for expediency sake. You get approved? Great - We can immediately ship these 30 million doses while we start the next 30 million. We don't get approved? Write off the produced doses, fix your process, and try again.
- cortesoft 6y ago
  Maybe making them for another country?
- mulmen 6y ago
  Because that's how good we are as a society at efficiently allocating capital and operating supply chains. Regulators have to sign off before you can administer it to anyone but you can ramp up your production in parallel with the approval process. It's actually an incredible achievement.