Pamela Cruz. Peninsula 360 Press [P360P].
The Food and Drug Administration (FDA) has issued an emergency use authorization for the second vaccine for the prevention of COVID-19 disease caused by SARS-CoV-2 respiratory syndrome.
The emergency use authorization allows Modern COVID-19 vaccine to be distributed in the U.S. for use in people 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 pandemic that is causing a large number of hospitalizations and deaths in the U.S. every day," said FDA Commissioner Stephen M. Hahn.
In a statement, the FDA said that through the open and transparent scientific review process, two vaccines have been licensed on an accelerated timeline while adhering to the rigorous safety, efficacy and manufacturing quality standards necessary to support emergency use authorization.
"These standards, and our review process, are the same ones we used in reviewing the first COVID-19 vaccine and intend to use for any other vaccine," the commissioner said.
The DA determined that the vaccine against the virus meets the legal criteria for release in the U.S., since the totality of available data provides evidence that it may be effective in preventing COVID-19.
In turn, the data show that the known and potential benefits outweigh the known and potential risks, which supports the company's application for use of the vaccine in persons 18 years of age and older. With this determination, the FDA can assure the public that it has conducted a thorough evaluation of safety, efficacy, and manufacturing quality.
How does Moderna's COVID-19 vaccine work?
The vaccine contains a small part of the SARS-CoV-2 virus mRNA that instructs cells in the body to produce the virus's signature spike protein.
After a person receives the vaccine, their body produces copies of the spike protein, which does not cause disease, but causes the immune system to learn to react defensively, producing an immune response against SARS-CoV-2.
It should be noted that this vaccine is administered in two doses, one month apart.
Safety data available to support it in the U.S. include an analysis of 30,351 participants enrolled in an ongoing U.S. randomized placebo-controlled study.
The FDA said the most commonly reported side effects, which usually lasted several days, were pain at the injection site, tiredness, headache, muscle pain, chills, joint pain, swollen lymph nodes in the same arm as the injection, nausea, vomiting and fever, which occurred after the second dose.
The approval comes a week after the FDA gave the green light to the vaccine against COVID-19 of the U.S. pharmaceutical company Pfizer in collaboration with the German BioNTech, which is already distributed and applied in several states of the country.
