Novavax Operational phase

• Please see the section Pfizer Operational phase for detailed information • Ensure the appropriate processes are in place to prevent vaccination of people under 12 years– this is a never event. • Ensure the appropriate processes are in place to prevent second dose vaccinations earlier than 21 days – this is a never event. Note: A prescription from an authorised prescriber is required when using the Novavax vaccine as a second primary dose (i.e., following a non-Novavax COVID-19 vaccine for dose 1), in accordance with Section 25 of The Medicines Act 1981, as it is considered off-label use. This must be documented clearly including the rationale and the informed consent process. A CARM report does not need to be completed if the vaccine has been prescribed by an authorised prescriber. Written consent is required for all consumers receiving an ‘off-label’ dose of the Novavax vaccine.