4 ms·

It hasn't been approved esp faster than anywhere else - it's just the first out the gate. The regulators have had the data for a while now, you'll see steady ap

It hasn't been approved esp faster than anywhere else - it's just the first out the gate. The regulators have had the data for a while now, you'll see steady approvals over the next couple weeks. The only danger sign I would foresee that would indicate a rush is if some regulator declines to approve emergency use - but given the data that seems highly unlikely.

refurb 6y ago
The regulators have had the data for a while now They've had some of the data for a while. Pfizer didn't finish their analysis of the Phase 3 data until close to their EUA submission on Nov 20th.
- Kliment 6y ago
  To be clear, the complete dataset and approval application was not delivered to the EMA by Pfizer until Monday. You can't expect a regulatory approval in two days - it takes longer to even read the complete application.
  - refurb 6y ago
    I have zero insight into what was shared when, but I'm assuming if Pfizer completed their primary analysis in time for the Nov 20th FDA submission, they could have shared that with the EMA at that point. So somewhat of a rolling review (submit data to regulator as it becomes available). But yes, you are correct, the EMA has specific requirements for it's submission and if they haven't received it until Monday, it's going to take a while to review it, even on an expedited basis.
    - bluGill 6y ago
      I would assume the EMA has different forms, and wants the data in a different format. Pfizer as a US company presumably has more experience with FDA formats as well, and more FDA experienced people on staff (this is one of the advantages of the revolving door between industry and regulators - there are disadvantages as well). I'm not sure why the UK got things sooner unless it is because they accepted data sooner there was time to figure out how to submit it while not even knowing if they would submit to the FDA.

refurb 6y ago

The regulators have had the data for a while now They've had some of the data for a while. Pfizer didn't finish their analysis of the Phase 3 data until close to their EUA submission on Nov 20th.

Kliment 6y ago
To be clear, the complete dataset and approval application was not delivered to the EMA by Pfizer until Monday. You can't expect a regulatory approval in two days - it takes longer to even read the complete application.
- refurb 6y ago
  I have zero insight into what was shared when, but I'm assuming if Pfizer completed their primary analysis in time for the Nov 20th FDA submission, they could have shared that with the EMA at that point. So somewhat of a rolling review (submit data to regulator as it becomes available). But yes, you are correct, the EMA has specific requirements for it's submission and if they haven't received it until Monday, it's going to take a while to review it, even on an expedited basis.
  - bluGill 6y ago
    I would assume the EMA has different forms, and wants the data in a different format. Pfizer as a US company presumably has more experience with FDA formats as well, and more FDA experienced people on staff (this is one of the advantages of the revolving door between industry and regulators - there are disadvantages as well). I'm not sure why the UK got things sooner unless it is because they accepted data sooner there was time to figure out how to submit it while not even knowing if they would submit to the FDA.