US FDA Grants Emergency Use Authorization for Novavax COVID-19 Vaccine
Pfizer, Moderna, Janssen Followed by Fourth US Approval
CDC Expected to Hold Meeting Next Week to Discuss Vaccination Targets
[Asia Economy Reporter Kim Hyunjung] The U.S. Food and Drug Administration (FDA) on the 13th (local time) granted emergency use authorization for Novavax's COVID-19 vaccine for adults aged 18 and older. With this, Novavax became the fourth COVID-19 vaccine approved in the United States, following Pfizer, Moderna, and Janssen.
The FDA stated in a press release that adults aged 18 and older can receive the Novavax vaccine. It is administered in two doses, 21 days apart, and has not been approved for use as a booster shot.
The U.S. Centers for Disease Control and Prevention (CDC) plans to hold a meeting next week to discuss and announce the specific vaccination targets for the Novavax vaccine.
Robert Califf, FDA Commissioner, explained, "This approval provides another option that meets the FDA's rigorous standards for safety, efficacy, and manufacturing quality for U.S. adults who have not yet been vaccinated against COVID-19." He added, "Vaccination remains the best measure to prevent severe illness," and encouraged those eligible who have not yet been vaccinated to consider getting the vaccine.
Unlike Pfizer and Moderna vaccines, which use messenger RNA (mRNA) technology, Novavax, already approved and administered domestically, is manufactured using nanoparticles made from coronavirus surface proteins. It contains the COVID-19 spike protein and the Matrix-M immune adjuvant and has undergone clinical trials involving approximately 26,000 participants.
The Biden administration recently announced plans to purchase 3.2 million doses of the Novavax vaccine, enough to vaccinate 1.6 million adults.
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According to the CDC, about 67% of the U.S. population has completed vaccination, where "fully vaccinated" is defined as receiving two doses of an mRNA vaccine or one dose of the Johnson & Johnson vaccine. Among those fully vaccinated, approximately 48% have received their first booster dose.
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