USA- The U.S. Food and Drug Administration (FDA) has given an emergency use authorization (EUA) for the Novavax COVID-19 Vaccine.
The aim of the approval is to prevent COVID-19 caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in people who are 18 years of age and older.
The Advisory Committee on Immunization Practices (ACIP) of the U.S. Centers for Disease Control and Prevention (CDC) made a favorable recommendation, and the CDC endorsed the FDA’s approval of the EUA for a two-dose primary series in adults 18 and older in July.
In the United States, doses of the Novavax COVID-19 Vaccine, Adjuvanted, have been accessible since July.
This vaccination may be helpful in preventing COVID-19 and the known and prospective benefits of receiving it exceed the known and possible dangers in adults 18 years of age and older.
The FDA anticipates Novavax Inc. to carry forward with its clinical trials in order to gather more information about safety and efficacy and pursue approval (licensure).
The FDA reassures the general public and the medical community that it has made this decision after carefully analyzing and evaluating the safety, efficacy, and manufacturing facts that are now available.
Two doses of the major series of the adjuvanted COVID-19 vaccine from Novavax are given, three weeks apart.
The SARS-CoV-2 spike protein and Matrix-M adjuvant are both present in the vaccination.
Some vaccinations contain adjuvants to improve the immunological response in the recipient of the vaccination.
The Matrix M-adjuvant contains saponin extracts from the bark of the native Chilean soapbark tree, and the spike protein in this vaccine is made in insect cells.
The company, Novavax Inc., and vaccination providers are required by this authorization to report major adverse events to the Vaccine Adverse Event Reporting System (VAERS).
They are also to report cases of Multisystem Inflammatory Syndrome, and instances of COVID-19 that result in hospitalization or death from the vaccine.
Additionally, the FDA anticipates Novavax Inc. to carry forward with its clinical trials in order to gather more information about safety and efficacy and pursue approval (licensure).
The permission will be in effect until it is determined that it no longer warrants the emergency use of medications and biologics for the prevention and treatment of COVID-19.
If it is discovered that the EUA no longer satisfies the legal requirements for issuance, it may be changed or canceled.
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