FDA Announces EUA for Second COVID-19 Vaccine


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FDA Announces EUA for Second COVID-19 Vaccine
On Friday, December 18, 2020 the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for a second vaccine for the prevention of COVID-19 to Moderna. This follows the FDA’s earlier EUA for Pfizer/BioNTech’s vaccine, known as BNT162b2, which has shown 95% effectiveness in preventing the contraction of COVID-19. This latest EUA allows the Moderna COVID-19 Vaccine to be distributed in the U.S. for use in individuals 18 years of age and older. “With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day,” said FDA Commissioner1 The Moderna COVID-19 Vaccine, just like the Pfizer/BioNTech vaccine, contains messenger RNA (mRNA), which is genetic material. Messenger RNA (mRNA) vaccines like these two vaccines use newer technology and, more significantly, are the first commercially available vaccines of this type for an infectious disease. For a number of years now, there has been ongoing research using this technology for various cancers and also for numerous infectious diseases. Messenger RNA (mRNA) is faster to develop and manufacture in large quantities, which is why this type of vaccines are the first vaccines available for use. Both the Moderna COVID-19 Vaccine and the Pfizer/BioNTech vaccine are two step vaccines which require people to get two shots 30 days apart. Based on FDA approved clinical trials these vaccines are safe, easy to make and they produce a robust immune response in the human body. This is because your body uses mRNA to tell a specific structure in your cells what kind of proteins to make. The mRNA sequence in these vaccines instructs your cells to make the spike protein found on the outside of the Sars-COV-2 virus. Your body then will learn to recognize this protein (an antigen) and know how to make an antibody for it.2 “Guided by science and data, the agency’s career staff determined that the vaccine’s known and potential benefits clearly outweigh its known and potential risks, and although not an FDA approval,  the FDA’s expectations described in our June and October guidance documents have been met,” said Director of the FDA’s Center for Biologics Evaluation and Research. “3 The really good news for the American people is that millions of these vaccines from Pfizer/BioNTech and from Moderna have already been produced through “Operation Warp Speed.” This means that they will be shipped out and administered very quickly to high-risk groups (i.e., hospital patients, the elderly, healthcare workers, first responders, etc.) now that they are approved.4 The target from the FDA for a COVID-19 vaccine’s effectiveness was 50% with a hope of 60-75%. The effectiveness reported by both Moderna and Pfizer/BioNTech is over 90% which is excellent news. These are also safe vaccines because our body uses this same protein making ability all the time and should not alter the cell’s DNA in any way. These vaccines use no actual virus, and the mRNA strand degrades quickly in the human body and becomes inactive.5 “Moderna has submitted a pharmacovigilance plan to the FDA to monitor the safety of Moderna COVID-19 Vaccine.”6  While clearly not the end of the fight against COVID-19, the EUAs for these two vaccines certainly marks the beginning of the end of the fight against this deadly virus. The speed with which these two vaccines were developed and approved represents a major victory for all those involved in this amazing effort!   1 https://www.fda.gov/news-events/press-announcements/fda-takes-additional-action-fight-against-covid-19-issuing-emergency-use-authorization-second-covid 2 Novo blog #128 ‘‘Breaking News’ on COVID-19 Vaccines” November 21, 2020 3 Ibid “FDA” 4 Health and Human Services https://www.hhs.gov/coronavirus/explaining-operation-warp-speed/index.htmlRNA vaccines: an introduction https://www.phgfoundation.org/briefing/rna-vaccines    6 Ibid “FDA”
December 21, 2020
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