The FDA is (rightly) requiring SIX MONTHS of safety follow up for 3000 subjects before any COVID-19 vaccine can even get an EUA (Emergency Use Authorization), let alone a full approval. If you think we’re getting a vaccine before mid-2021 EARLIEST you are trrrippin.
Also the FDA has cautioned that longer term safety data may be needed for more novel platforms including the mRNA- and DNA-based platforms that are currently in Phase 1 trials
There have been concerns that the population in clinical trials won’t be representative of the real-world use of the vaccine so sponsors are being encouraged to enroll a diverse population in the trials to facilitate generalizability of the data
Recall that this disease disproportionately affects the elderly and communities of color, especially Black and Latino communities, so it is imperative that the typically majority white and young clinical trial population is expanded to include these heavily affected populations
This is another reason why it’s important to have multiple vaccine candidates and extensive safety data for new platforms/adjuvants - it’s likely that certain vaccines will be more safe and efficacious in certain populations
The real challenge will be vaccine compliance. Our country is increasingly anti-science and the botched response by our “leaders” will make it hard for people who are already wary of vaccines to feel comfortable taking one that is approved/pushed by the govt.
We also don’t know what the ideal vaccine compliance rate is in order to successfully prevent community spread, which makes not mandating vaccination extremely challenging. But you know, individual liberty, freedom of choice, blah blah fucking blah.
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