The US takes additional steps against coronavirus, clears Moderna’s vaccine for emergency use
New Delhi: The US Food and Drug Administration (FDA) on Friday late night issued an emergency use authorization (EUA) for the second vaccine for the prevention of coronavirus disease.
The emergency use authorization allowed the Moderna COVID-19 Vaccine to be distributed in the US for use in individuals 18 years of age and older.
The FDA Commissioner Stephen M. Hahn said that “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.”
“Through the FDA’s open and transparent scientific review process, two COVID-19 vaccines have been authorized in an expedited time frame while adhering to the rigorous standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization that the American people have come to expect from the FDA. These standards and our review process, which are the same we have used in reviewing the first COVID-19 vaccine and intend to use for any other COVID-19 vaccines, included input from independent scientific and public health experts as well as a thorough analysis of the data by the agency’s career staff,” M. Hahn said.
The FDA has determined that the Moderna COVID-19 Vaccine has met the statutory criteria for issuance of an EUA. The totality of the available data provides clear evidence that the Moderna COVID-19 Vaccine may be effective in preventing COVID-19.
According to health and medicines experts “The Moderna COVID-19 Vaccine contains messenger RNA (mRNA), which is genetic material. The vaccine contains a small piece of the SARS-CoV-2 virus’s mRNA that instructs cells in the body to make the virus’s distinctive “spike” protein. After a person receives this vaccine, their body produces copies of the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2.”
The director of the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (M.D, and Ph.D) Peter Marks said that “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,”
“Today’s authorization demonstrates our steadfast commitment to the health of the American people, with the assurance that our scientific standards and the integrity of our review process have been maintained. This achievement is yet another testament to the dedication of FDA’s career scientists and physicians, who have been working urgently to conduct comprehensive and rigorous evaluations of the data submitted for vaccines to prevent COVID-19.” Peter Marks said.
_Vinayak.Barot
