It is also mandatory for vaccination providers to report all vaccine administration errors to VAERS for which they become aware and for Novavax Inc. to include a summary and analysis of all identified vaccine administration errors in monthly safety reports submitted to the FDA. The FDA has evaluated the pharmacovigilance plan submitted by the company to monitor the safety of Novavax COVID-19 Vaccine, Adjuvanted as it will be used under EUA to ensure that any safety concerns are identified and evaluated in a timely manner. As a condition of authorization, the company will conduct studies to further assess its safety, including studies to further assess the risks of myocarditis and pericarditis.