COVID-19: FDA Authorization of ModernaTX,Inc. Vaccine December 18, 2020

#COVID-19, #Moderna, #modernavaccine

FDA Emergency Use Authorization—Another milestone to combat the COVID-19 pandemic: FDA gave the green light by granting an Emergency Use Authorization (EUA) to ModernaTX, Inc. (Moderna) for its vaccine. Here is the link to the official FDA Press release: https://www.fda.gov/news-events/press-announcements/fda-takes-additional-action-fight-against-covid-19-issuing-emergency-use-authorization-second-covid

Letter of Authorization: https://www.fda.gov/media/144636/download

Why Emergency Use? This is because of the declaration under the PREP Act, which back in the winter of 2020, Health and Human Secretary Alex Azar II officially declared the COVID-19 a pandemic. The FDA grant of emergency use is critical because it allows the use of the unapproved yet authorized vaccine to travel in interstate commerce in essence as an unapproved drug.

Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19 Health and Human Secretary Azar declared a public health emergency pursuant to section 319 of the PHS Act,  for the entire United States to aid in the nation’s health care community response to the COVID-19 outbreak. Azar issued a Declaration pursuant to section 319F-3 of the Public Health Service Act (codified above) to provide liability immunity for activities related to medical countermeasures against COVID-19. See 85 FR 15198 (March 17, 2020) retroactive and renewed effective date Oct. 23, 2020. (U.S.Department of Health and Human Services, Determination of a Public Health Emergency and Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3. February 4, 2020).

This is the second vaccine (Pfizer BioNTech the first) authorized for the prevention of COVID-19, which is a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The emergency use authorization allows the Moderna COVID-19 Vaccine to be distributed in the U.S. for use in individuals 18 years of age and older.

Vaccine Adverse Event Reporting System (VAERS) for Moderna COVID-19 Vaccine: According to FDA Moderna is required to report serious adverse events, cases of Multisystem Inflammatory Syndrome (MIS), and cases of COVID-19 that result in hospitalization or death.

https://vaers.hhs.gov

COVID-19 VACCINE RESISTANCE

Does public safety justify mandatory vaccination?

Over 100 years ago, in the early 1900s the United States Supreme Court was faced with the issue of “police power” or the power of state government to protect public health and the Constitution’s protection of personal liberty. In the United States Supreme Court case of Jacobson v Massachusetts 197 US 11 (1905), the Supreme Court upheld the Cambridge Massachusetts Board of Health authority to require vaccination of healthy adults against smallpox due to the epidemic which could compromise the community. The plaintiff, Henning Jacobson, had refused the vaccination and was fined $5.00.

Unlike today, where chronic diseases account for most deaths, at that time, infectious disease was the leading cause of death and states administered public health initiatives. The FDA did not even exist at that time. Yet today, globalization, has essentially required immunizations from infectious diseases. COVID-19 is an example of a pandemic perhaps reminiscent of earlier time periods in history.