More Good Vaccine News

There's more good news on the vaccine front. The FDA Finds Moderna Covid-19 Vaccine Highly Effective.

The Food and Drug Administration said Tuesday that the Covid-19 vaccine developed by Moderna Inc. MRNA  was “highly effective,” setting the stage for an emergency authorization later this week that would add a second vaccine to the arsenal against the pandemic.

Barring complications, the FDA is aiming to authorize emergency use of the Moderna vaccine Friday, following the same timetable as last week with the first Covid-19 vaccine from Pfizer Inc. and BioNTech SE.

Moderna’s analysis, posted by the FDA, also included new data suggesting that the first dose of its vaccine can reduce infections that don’t cause symptoms. If this finding holds up in further analysis—including after the second of the two-dose regimen—it could mean that the vaccine not only protects individuals from disease, but also curbs transmission of the virus from person to person.

Moderna has said it expects to have 20 million doses available for the U.S. to ship by the end of 2020, enough to inoculate 10 million people with the two-shot regimen. Moderna, with its own manufacturing plant and working with contract manufacturers, expects to produce between 500 million and 1 billion doses in 2021 for global use.

FDA Analysis

There is no excuse for failure to link to the study, but unfortunately that is typical. 

Here is the FDA Report

Moderna Efficiency

Moderna Efficiency

Moderna Efficiency Final Analysis

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Moderna Efficiency Final Analysis

Key Points

  • All 11 cases of severe COVID-19 at least 14 days after second dose as assessed by the  adjudication committee were in the placebo group.
  • Of these 11 participants, 5 had risk factors for severe COVID-19 and 6 did not. 
  • In the primary efficacy analysis, there were an additional 19 cases of severe COVID-19 (one of which resulted in death from COVID-19), for a total of 30 severe COVID-19 cases starting 14 days after dose 2, per adjudication committee assessment. 
  • All 30 cases were in the placebo group. Nine of the total 30 severe COVID-19 cases resulted in hospitalization. 

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Competition Is a Good Thing

The problem with the Pfizer vaccine was the extreme cold storage and handling conditions it required. 

Moderna is much less sensitive. 

In addition, two sources will provide competition, increase supplies,  and help keep costs down.

Mish

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