With nearly 3,000 people a day dying of COVID-19, our country faces a renewed, full-blown medical emergency. And yet, the Food and Drug Administration (FDA) has fallen behind the United Kingdom in approving distribution of life-saving vaccines developed here in the United States. Every day that the FDA delays the obvious is a day that thousands of lives may be lost. This delay is inconceivable and, to the extent it may be due to political or public relations concerns, it is unconscionable.
Let’s review the data released on Nov. 18 by Pfizer, which waited to meet an additional wait-and-see period set by the FDA and requiring at least a two-month median period since follow-up with test subjects. The minimum vaccine requirement was 50 percent effective. The two vaccine candidates have blown through that requirement, with no cases of documented severe adverse reaction: 162 subjects who took a placebo got the disease, compared to eight who received the vaccine. Ten severe cases occurred, nine of them among the placebo group. Nearly 4 percent felt fatigue and 2 percent got a headache. These are impressive numbers, far exceeding minimum thresholds.
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