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The @pfizer BNT162b2 vaccine data released today as part of the upcoming @US_FDA meeting are simply incredible. Still open questions, but this really is as good as it gets for early-stage data. A few thoughts 
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https://www.fda.gov/media/144246/download
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.https://www.fda.gov/media/144246/download
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The most important things first - both efficacy and safety data look very good. Efficacy ~95% across all demographics and no concerning safety events. I for one did not dare to hope the early data would look this good, nor did I think we'd have it this fast. I was wrong. 
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However, a few unknowns of critical importance:
1. We do not know if the vaccine protects against infection or just disease. Animal studies are promising, but it's incredibly important to know if it leads to sterilizing immunity (and for how long).
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1. We do not know if the vaccine protects against infection or just disease. Animal studies are promising, but it's incredibly important to know if it leads to sterilizing immunity (and for how long).
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Knowing whether the vaccine prevents against infection (sterilizing immunity) or disease (asymptomatic+infectious) is very important as it will dictate our vax strategies. E.g. do you vaccinate HCWs in nursing homes or residents? Sterilizing immunity key for the former.
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2. We do not know longevity of immunity - what we know from the trial is that it protects if people get exposed within ~1 month after booster, but we don't have any data past that. Longevity of neutralizing antibodies in vaccine arm has been studied longer and is promising.
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3. No data for pregnant women - safety and efficacy data here will be important, although I'm optimistic both will be fine.
4. No data for kids younger than 16 years old - the EUA is also limited to 16+ year age group. We need data here, but probably also fine.
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4. No data for kids younger than 16 years old - the EUA is also limited to 16+ year age group. We need data here, but probably also fine.
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5. Similar to long-term efficacy data, we also don't have long-term safety data for this vaccine. This is still something I'm slightly concerned about, but e.g., small-scale cancer trials with similar mRNA vaccine platforms have run longer with no concerning events reported.
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6. While there are no concerning adverse (safety) events reported from the trial, it's important to understand that this is a pretty unpleasant vaccine to receive - you'll likely feel pretty crappy after receiving your shots (the second shot is worse), BUT all temporary.
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7. We don't know if / how fast SARS-CoV-2 may evolve vaccine resistance, however, given how modular the mRNA platform is (a total revolution in vax design!), updates can likely be done quickly, if necessary. Also, further shots likely no issue unlike e.g., adeno platforms.
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Despite these gaps, overall very promising data. With good data, but the vax still many months away for most, now is a great time to double down on COVID-19 precaution measures. As Ed Yong said, there's light at the end of the tunnel, but the tunnel has never been darker.
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