The U.S. Food and Drug Administration on Tuesday approved two prescription forms of an anti-viral flu vaccine designed to protect against the newly minted Middle East Respiratory Syndrome Coronavirus (MERS-CoV), or coronavirus.
The FDA granted priority review status to Certynx and an expedited 180-day review of its application with an approval expected by August 2.
Certynx contains a synthetic, dead virus called simvastatin, a drug that has been shown to neutralize coronaviruses. In the May announcement of the approval of Certynx, the FDA said it would study the safety and effectiveness of the vaccine in people in Asia and the Middle East.
Both Certynx and the MMRV vaccine, made by the Merck & Co. and TriVax Sciences, provide immediate immunity to the coronavirus. Both will only be available in August and will be required to be administered via needle or injector during three to six weeks, after vaccination with a conventional flu vaccine.
The FDA’s decision was announced one day after the Centers for Disease Control and Prevention issued a revised guidance about vaccines. The CDC update noted that none of the coronavirus infections reported in the United States so far have been fatal.