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1/Just finished reading the NEJM paper on the Pfizer mRNA vaccine. I've always maintained that seeing clinical trial data published in a peer reviewed journal of significance would be my yardstick for taking any vaccine. Bottom line, this is an impressive, rigorous study.
2/Over 43,000 patients were enrolled across 152 trial sites in 6 countries. Roughly half got the vaccine and the other half received placebo. Impressive demographics included 49% women, 9% Black and 28% Hispanic or Latinx.
3/Two doses given 21 days apart proved to be 95% effective in preventing COVID-19 with high confidence. Interesting that the first dose gives some measure of protection with a 52% efficacy rate in as soon as 21 days.
4/The weakness in the publication is the limited safety data. There was a safety "data cut" of nearly 38,000 participants who had an average of 2 months of safety data. Long term safety is being assessed, but the safety signals from the intermediate assessment were favorable.
5/ The most typical safety issues were mild to moderate pain at the injection site fatigue, headache, and muscle pain. Fever of over 100 deg was rare and more prevalent in participants 16 - 55 years old vs. those over 55.
6/Other limitations are that the study does not assess (1) prevention of asymptomatic infection (2) establishment of immunity (3) safety or efficacy in children, adolescents, pregnant women and the immunocompromised.
7/ I will take this vaccine when it is available despite the newness of mRNA technology. I will look at some of the paper citations but what I read is good enough for me.
Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2034577
Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2034577
