Of all the great tension both doctors and patients have faced in the COVID-19 crisis is the lack of assurances on long-term safety of COVID-19 vaccines.
Americans were told these genetic products were brought through testing at “warp speed.” While that may be wonderful for the Starship Enterprise, warp speed should not be viewed as favorable in drug or vaccine development.
Observation time in research is very important to evaluate the emergence of problems, particularly for the long-lasting mRNA vaccines and their biologic product, the coronavirus spike protein. For a typical live-attenuated, killed, or antigen-based vaccine, the minimum period for safety observation in clinical development is two years. For genetic products which includes mRNA and adenoviral DNA, the minimum time is five years.
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