The documents appear to be a fairly standard drug evaluation.
They've raised concerns about the different quality in 2 batches of testing doses, especially the deterioration of the RNA used to carry the drug.
They have not received commercial doses (versus lab quality doses) for testing yet.
They have concerns about one of the proposed drug manufacturing sites (no data provided to them about the process proposed).
They are also concerned about the storage of the source material (biological material) in case it gets destroyed in a catastrophic event.
They conclude that as of the time of writing the vaccine is not cleared for use until the MO (Major Objections) are addressed. Some of which can be addressed after production has started.
The documents appear to be a fairly standard drug evaluation.
They've raised concerns about the different quality in 2 batches of testing doses, especially the deterioration of the RNA used to carry the drug.
They have not received commercial doses (versus lab quality doses) for testing yet.
They have concerns about one of the proposed drug manufacturing sites (no data provided to them about the process proposed).
They are also concerned about the storage of the source material (biological material) in case it gets destroyed in a catastrophic event.
They conclude that as of the time of writing the vaccine is not cleared for use until the MO (Major Objections) are addressed. Some of which can be addressed after production has started.