After months of delay, drugmaker Novavax submitted its request to the U.S. Food and Drug Administration to grant its COVID-19 vaccine an emergency use authorization (EUA), the biotechnical company said in a statement on Monday.
“The request for EUA is based on the totality of pre-clinical, clinical and manufacturing-related (CMC) data provided to the agency, including results of two large pivotal clinical trials that demonstrated an overall efficacy of approximately 90 percent and a reassuring safety profile,” the company said.
The vaccines are intended for those 18 years and above.
Last month, the company said its two-dose, protein-based COVID-19 vaccine is effective against Omicron, the latest variant of the coronavirus that is accounting for most of the cases in the United States and across many parts of the world.
Marathon County Health Department Spokesperson Aaron Ruff said the vaccine approval is still in an early stage.
“There are a number of important steps that need to occur prior to the FDA’s EUA for any vaccine,” Ruff told Wausau Pilot & Review. “We need to respect that process, wait for guidance from the FDA, (the) Centers for Disease Control and Prevention (CDC), and the Wisconsin Department of Health Services.”
Ruff said the department is continuing to emphasize and share the science related to vaccines “and what we know is that vaccines continue to work remarkably well.”He added that the county still has plenty of vaccines in supply through various sources and outlets.
The county’s vaccination rate is behind state and national figures. Additionally, health officials say people who are not fully vaccinated are far ahead in cases, hospitalizations and deaths in the Wausau area.
The department blames politicization and misinformation for the current vaccination rate.
“We are also acutely aware of the politicization and misinformation that occurs around vaccination,” Ruff said. “Those two aspects are certainly contributors to our community’s vaccination efforts and they are very different barriers to overcome.”
So far the FDA has granted EUA to the two-dose shots of Pfizer-BioNTech and Moderns and a single dose from Johnson & Johnson.
Novavax’s request for EUA comes after the company faced production-related problems and quality concerns, delaying the rollout of a vaccine that aims to meet the needs of developing countries.
The vaccine has already received authorizations from the European Union regulators, India, Indonesia, the Philippines and the World Health Organization.The WHO has partnered with the GAVI vaccine alliance and the Coalition for Epidemic Preparedness Innovations (CEPI) to create COVAX, a global vaccine distribution coalition.
The U.S. government has invested $1.6 billion in Novavax for the vaccines.