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Moderna’s Covid-19 Vaccine Likely to Get Backing From FDA Panel, Chairman Says

Another vaccine nears approval.
(Ascannio)
(Ascannio)
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The independent committee advising the FDA on Moderna’s Covid-19 vaccine is likely to recommend emergency-use approval for the shot, WSJ reports.

Why It Matters: With the FDA’s blessing, Moderna would become the second provisionally available Covid-19 vaccine in the U.S., joining the Pfizer-BioNTech shot. With vaccination efforts underway and supply limited, the more safe and highly-effective vaccines available, the better.

“The Moderna vaccine would be the first of several after Pfizer’s vaccine that are expected to build up the nation’s vaccine supply against the coronavirus pandemic, which has killed more than 305,000 Americans and 1.6 million people worldwide, according to Johns Hopkins University.”

Other Key Details:

  1. Data from Moderna’s roughly 30,000-person late-stage trials showed the vaccine was highly effective, with a 94%.1 efficacy rate. Pfizer’s data showed 95% effectiveness.
  2. Moderna’s vaccine is expected to be approved for individuals 18 or older, whereas Pfizer’s shot was “more extensively tested in younger patients and can be used in people 16 and older.”
  3. Severe adverse reactions from Moderna’s shot were rare but did occur more frequently after the second does than the first. Common side effects found in the study “included injection-site pain, fatigue, headache and chills.”

What’s Left To Sort Out: What happens to the placebo patients from the Moderna and Pfizer trials? Do they automatically get the vaccine?

  • “There are ethical considerations arguing that these study participants should, having sacrificed for the public.”
  • “But a countervailing force is that researchers need to follow those patients as long as possible to be a comparison group to assess side effects of the vaccines.”
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