by Photo courtesy of Novavax

The U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices(ACIP) unanimously recommended a two-dose Novavax COVID-19 Vaccine, Adjuvanted for adults. 

The recommendation follows the Emergency Use Authorization granted by the Food and Drug Administration last week. The ACIP’s recommendation will be submitted to CDC Director Dr. Rochelle Walensky for review and endorsement. 

“We think vaccine choice is important, particularly as we expect to see ongoing surges of COVID-19 and work to increase vaccination rates," said Stanley C. Erck, President, and Chief Executive Officer, Novavax. "With demonstrated efficacy and a reassuring safety profile, our vaccine is the country's first protein-based option."

The Department of Defense announced an agreement last week to secure 3.2 million doses of Novavax’s two-dose COVID-19 vaccine. Novavax said these vaccine doses will be free to states, jurisdictions, federal pharmacy partners, and federally qualified health centers.

Novavax’s coronavirus vaccine also recieved conditional authorization for use in individuals aged 18 and older from multiple regulatory agencies worldwide, including the European Commission (EC), and Emergency Use Listing from the World Health Organization, the company announced Tuesday. 

The committee’s recommendation was based on data from the pivotal Phase 3 clinical trial, PREVENT-19, which enrolled 29,960 participants aged ages 18 – 64 years of age in the U.S. and Mexico. 

The vaccine showed 90.4 percent efficacy. Common side effects of the vaccine include pain or tenderness at the injection site, fatigue, pain, and headaches. A small percentage of people experienced fevers. 

The protein-based vaccine is engineered from the genetic sequence of the first strain of COVID-19 and was formulated to enhance the immune response and stimulate high levels of neutralizing antibodies with an ingredient called an adjuvant. According to Novavax, the vaccine contains purified protein antigen and can neither replicate nor can it cause COVID-19. 

The vaccination regimen calls for two 0.5 ml doses administered 21 days apart. The vaccines are packaged as ready-to-use liquid formation in a vial containing 10 doses that can be stored at approximately 35 to 46 degrees Fahrenheit. 

The company announced Tuesday that it will produce its Omicron-containing vaccine in single-dose, pre-filled syringes.

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