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.
Approval is just the first hurdle. No vaccine is 100% effective at reducing the risk of becoming ill. Effectiveness rates often vary by age group, particularly for the elderly who are most vulnerable to COVID-19 and may not mount as good an immune response to make antibodies as younger people. Over the past 15 years, vaccine effectiveness for another familiar respiratory illness — seasonal influenza — has ranged between 10 and 60%. The vaccine that was specifically created for the 2009 influenza pandemic was 62% effective for people under 65 and 43% effective for people 65 and older.
And regardless of how effective a vaccine is, it can only work if people get vaccinated. In recent seasonal influenza seasons, only 45% of the U.S. population was vaccinated. Only 27% of Americans were was vaccinated during the 2009 influenza pandemic even though that virus was new and different from the seasonal virus and posed a larger potential threat.
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