Coronavirus vaccine not the end-all-be-all. We must have a plan for reopening without one.
Dr. Anthony Fauci and other experts have touted vaccines as the ultimate solution to dealing with the threat of COVID-19. There are strong reasons to doubt this. The eight vaccine candidates Dr. Fauci described to the Senate face daunting obstacles on the road from laboratory to final Food and Drug Administration (FDA) approval and mass manufacturing. If one or two vaccines do make it through, it will be a year or more before they are widely available. Even then, the vaccines may not be effective enough or sufficiently utilized to defeat the new illness.
The approval process for vaccines follows the same general FDA pathway as for drugs, including pre-clinical discovery and development and three phases of clinical trials in humans. The process can take over 10 years and cost billions of dollars with less than one in ten candidates making it to market, although vaccines for acute infectious diseases and prophylaxis often do better.
We’re making progress, but not as much as many might like
The speed of pre-clinical development for COVID-19 vaccines has been unprecedented — Moderna’s innovative m-RNA platform moved from receiving the coronavirus genome to having a testable vaccine in 44 days. But as Dr. Fauci emphasized, even if everything goes perfectly during clinical trials, there are another 6-12 months to go until approval, and additional time will be needed to ramp up production.
Read the full article on USA Today.