shootformoon
Member
So in the best case scenario, how long does p1 take? i.e. the minimum time span we need to observe the vaccinated to have no serious side effects?
Correct, it only needed a Phase 2 trial which could be modified for efficacy testing because the overall process of an influenza vaccine was well established.
Phase 1 trials always look at both safety and efficacy. Both are included.
Safety - any adverse reactions, specifically looking for allergic reactions or unexpected side effects (i.e. the old Polio vaccine gave some kids a life-threatening condition called Guillain Barre Syndrome).
Efficacy - in this case, we have to wait about 2 weeks (my guess) and then draw blood from the candidates given the vaccine and check antibody titers to the virus.
Longer term, likely Phase 2, we will have to see what the infection rate is in people that got vaccinated. But that takes a lot of people to tease out (i.e. how efficacious is the vaccine).
I read this morning, but for the life of me cannot find the source now, that there were over 300 Phase 1 candidates that are in the pipeline for approval. That is reassuring and I hope that we can get 3-4 really good candidates to push into Phase 2 trials from that large a number.