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License the damned vaccines


It’s becoming increasingly odd that the historically effective mRNA vaccines still only have conditional approval:

Here’s a paradox: A new drug for Alzheimer’s disease, aducanumab, gets approved by the Food and Drug Administration through an accelerated process without sufficient data, although there was limited evidence that it works, leading three advisory board members to resign in protest. Meanwhile, mRNA coronavirus vaccines are not yet fully licensed despite massive evidence of their benefits.

In December 2020, the F.D.A. approved the distribution of mRNA coronavirus vaccines made by Pfizer and Moderna under the agency’s emergency use authorization provision, which permits an accelerated approval process for medications and treatments during a public health emergency. The approvals were granted after the agency reviewed the results of clinical trials that involved more than 70,000 participants. Until the coronavirus pandemic, the agency had never given an E.U.A. to a new vaccine.

Now more than 180 million doses of the Pfizer vaccine and 133 million of Moderna’s have been administered in the United States, with millions more doses distributed worldwide. In the history of medicine, few if any biologics (vaccines, antibodies, molecules) have had their safety and efficacy scrutinized to this degree. First, clinical trials showed the vaccines were 95 percent effective at preventing symptomatic illness. Since then, a number of peer-reviewed reports in leading journals have substantiated the vaccines’ safety and efficacy, using data collected in Israel, Qatar, the United Kingdom, the United States and other countries.

In other words, the mRNA vaccines have overwhelmingly been proved safe and effective by clinical trials, independent research and the experience of millions of people around the world who received them.

But the vaccines’ approvals remain conditional, and the urgency of full approvals cannot be overstated.


Still, that leaves almost half of Americans without protection. Some people who understand that the “E” in “E.U.A.” stands for “emergency” are waiting for full F.D.A. approval before they receive a shot. Others may not get immunized unless their employers require it, and many organizations — including, reportedly, the military — are waiting for the vaccines to be fully approved before instituting such mandates.

We need absolutely every viable carrot and stick thrown at this, and the FDA moving slowly on this — while they approve much more dubious medications — is not helping at all. Hopefully this will happen sooner rather than later.

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