- Oct 22, 1999
Aren't the lipids used in several already approved drugs?One reasons other vaccines take longer for FDA approval is disease prevalence. The lower the incidence of a disease, the longer the trial takes before enough 'events' have accumulated to determine if you have efficacy or not. And also, there is a pandemic - it would not be ethical to continue to monitor people for a 2 year time period to compare the outcomes of active vaccination vs placebo to see the long-term effects.
As for the mRNA vaccines - it might be new to market, but they have been researched for a very long time. Consider also that mRNA is not exactly known for it's biological stability - it's extremely prone to degradation. With pretty much any vaccine, at the end of the day, side effects are going to arise from immunogenicity against the vaccine components and the products that are generated. In the case of the mRNA vaccines - mRNA isn't stable enough to generate any antibodies against; the lipids nanoparticles are largely just generic lipids, which your body probably won't react to in a meaningful way, and the spike protein that the mRNA tells some cells to make. So unless there is some human protein that easily cross-reacts with the antibodies generated against the spike protein, you're not likely to see some latent, long-term side effect.