Q: Can you confirm that the Solution will be distributed first to health workers (I realize the testing is being primarily in high risk environments).
A: Yes, it is our goal to have antibodies available for front line workers first, including healthcare workers, service members, and those with the most medical need.
Q: Is it repeatable? Once it wears off in weeks or months, can said subject repeat the dose and get relief again? (This would be an excellent universal Solution to get everybody back to work again - and to vote, while we are all waiting for a vaccine to be developed.)
A: One advantage of the gene-based platform capability is that it can be re-administered (no vector-based immune response). As a reminder, these are for near immediate, non-permanent protection and are not meant to be a replacement for vaccines.
Q: Following on from my assumption above, can this Solution be a stop-gap measure to get us to the vaccine? If so, how would that work?
A: Correct. The gene-encoded medical countermeasure provides protection in less than three days, but lasts only for months not days, and is not meant to be a replacement for vaccines. It's a prophylactic for temporary protection before a vaccine is available or an immune response [is elicited].
Q: Assuming the tests go well, how long will it take for FDA approval? Will that process be accelerated? And what is the target date for actual public access to the antibody regimen solution?
A: We have no way of knowing how long it will take for FDA review. That process and timeline are up to the FDA, and DARPA -- nor any other government agency -- does not have the ability to request accelerated review.
Probably the most important Answer above is DARPA's indication that the antibody treatment, though it stays in the bloodstream for only months, is re-administrable. It is an apparently solid "prophylactic" means of getting the masses to a vaccine. (Good way of making some money, too.)
Though DARPA claims that no accelerated review of data can be had -- it would require breaking long-established clinical testing protocols -- in a separate 'miracle' program run by DHHS, Operation Warp Speed, AstraZeneca is claiming it will have a vaccine available by October. The announcement, released back in May to little fanfare in the MSM, starts:
Responding to President Trump's call to develop 300 million doses of SARS-CoV-2 vaccine by January under Operation Warp Speed, the U.S. Department of Health and Human Services (HHS) and AstraZeneca are collaborating to make available at least 300 million doses of a coronavirus vaccine called AZD1222, with the first doses delivered as early as October 2020.
Just in time for the election, one hopes. You know, a feel-good October Surprise for a change.
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