Advisory panel recommend FDA approval of Modern COVID-19 vaccine

The FDA released an analysis of the data for the Moderna COVID-19 vaccine that supports the approval of the vaccine for emergency use. The next step of the approval process is a group of experts who will be meeting to advise the FDA whether the vaccine would be approved for emergency authorization for use.

The report shows positive results that have a favorable safety profile with no concerns that would hinder the distribution of the vaccine under the emergency authorization for use. Though the vaccine was deemed safe to use there are some common side effects that should be considered including headaches, pain at the injection site, and fatigue.

The United States Food and Drug Administration has decided to approve #Moderna's coronavirus vaccine on an emergency basis. pic.twitter.com/88A0duwHvt

— ANews (@anewscomtr) December 18, 2020

Early studies proved the vaccine was 95% effective but was proven to be 94% effective after assessed at least two weeks after the second dose of the vaccine. The Moderna vaccine requires two doses that are to be taken 28 days apart for each patient.

Moderna will also be participating in an advisory group meeting that will be open to the public, similar to the approval process Pfizer and Bio’N’Tech faced last week for vaccine approval. The Vaccines and Related Biological Products Advisory Committee (VRBPAC) reviewed the data of the Moderna vaccine that was live-streamed for public access.

The VRBPAC panel voted 20-0 (including one absentee vote) in favor of the FDA to move forward authorizing the Moderna vaccine for emergency use. The FDA is now working rapidly to finalize and issue the emergency use authorization for the Moderna vaccine that will initiate the distribution process.

The coronavirus vaccine made by Moderna is heading for broad use: Expert advisors just voted that the F.D.A. should authorize it. Millions of doses could be shipped this weekend.  https://t.co/f269gx0V4j

— NYT Science (@NYTScience) December 18, 2020

The Moderna vaccine has an edge over the competition because the medicine is more accessible with easier required shipping and storage than Pfizer. The Pfizer vaccine needs to kept in extremely cold conditions at -76 °F that isn’t common in most medical facilities.

Moderna’s vaccine is required to be frozen at -4°F during shipping and storage that can be stored in a common household freezer. The vaccine is thawed for use that can be stored at 36-46 °F for up to 30 days in a standard household fridge.

The leading pandemic specialist in the U.S. working closely with the CDC and FDA, Dr. Anothy Fauci, predicts the Moderna vaccine should be available for use by early next week. Fauci predicts the vaccine should be delivered to medical facilities over the next couple of days and will be ready to administer doses by Monday or Tuesday.

Dr. Fauci also predicts that a majority of Americans should have access to the vaccine by April or May 2021. This vaccine approval will bring Americas one step closer to combat COVID-19.