As Remdesivir Wins FDA “Emergency Use”, Moderna Begins Prep For July “On Spec” Mass Vaccine Production

To be sure, “emergency use” authorization is well-short of full FDA approval. Under it, the FDA evaluates available clinical data, and considers potential risks of an otherwise unproven therapy — against potential benefits of making the therapy available during this COVID-19 emergency. So, given the data we highlighted earlier this week, this was to be expected — just not this quickly.

Meanwhile, also today, Moderna signed a ten year deal to mass produce its potential recombinant vaccine, called mRNA-1273, assuming the ongoing trials prove it safe — and effective, against COVID-19 — as early as July.

But clearly the Gilead news is the bigger story. So here we go, from FDA’s web announcement:

. . .“FDA’s emergency authorization of remdesivir, two days after the National Institutes of Health’s clinical trial showed promising results, is a significant step forward in battling COVID-19 and another example of the Trump Administration moving as quickly as possible to use science to save lives. . . . NIH, FDA, and scientists across America and around the world have worked tirelessly with patients to get us this new potential treatment for COVID-19. The seamless cooperation between government and private industry under the President’s all-of-America approach to COVID-19 is getting treatment options to patients in record time.”

The emergency use authorization allows for remdesivir to be distributed in the U.S. and administered intravenously by health care providers, as appropriate, to treat suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease. Severe disease is defined as patients with low blood oxygen levels or needing oxygen therapy or more intensive breathing support such as a mechanical ventilator.

“From day one, the FDA has been committed to expediting the development and availability of potential COVID-19 treatments. Today’s action is an important step in our efforts to collaborate with innovators and researchers to provide sick patients timely access to new therapies where appropriate, while at the same time supporting research to further evaluate whether they are safe and effective,” said FDA Commissioner Stephen M. Hahn, M.D. “There’s tremendous interest among all parties to identify and arm ourselves with medicines to combat COVID-19. . . .

Onward, smiling. . . . We shall conquer this virus — with real science, much sweat and. . . steadfast patience. Not photo ops — and not. . . fly-overs.


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