Common use of EUA Clause in Contracts

EUA. Pre-approval, Post-approval vaccination points with 2-8oC refrigerator Attachment D – Delivery Specification Exhibit 1 – Unpacking and Re-icing: Thermal Shipper A Attachment D – Delivery Specification Exhibit 2 – Unpacking and Re-icing: Thermal Shipper B Vaccine Preparation & Administration Instructions Removing the Vials to Thaw • From storage, remove 1 vial for every 6 recipients according to planned vaccinations schedule. • Vials may be stored in the refrigerator for 5 days (120 hours). Diluting the Vaccine • Obtain 0.9% Sodium Chloride Injection, for use as a diluent. Do not use any alternate diluents. • Dilute the thawed vial by adding 1.8 mL of 0.9% Sodium Chloride Injection into the vial. • Ensure vial pressure is equalized by withdrawing 1.8 mL air into the empty diluent syringe before removing the needle from the vial. Preparing the Dose • Draw up 0.3 mL of the diluted dosing solution into a new sterile dosing syringe with a needle appropriate for intramuscular injection. • For each additional dose, use a new sterile syringe and needle and ensure the vial stopper is cleansed with antiseptic before each withdrawal. Vaccine Administration • Diluted vials must be used within 6 hours from the time of dilution and stored between 2-25 °C (35-77°F). • A single 30 mcg/0.3 mL dose is followed by a second dose 21 days later.

EUA. Pre-approval, Post-approval vaccination points with 2-8oC 8 C refrigerator Attachment D – Delivery Specification Exhibit 1 – Unpacking and Re-icing: Thermal Shipper A Attachment D – Delivery Specification Exhibit 2 – Unpacking and Re-icing: Thermal Shipper B Vaccine Preparation & Administration Instructions Removing the Vials to Thaw • From storage, remove 1 vial for every 6 recipients according to planned vaccinations schedule. • Vials may be stored in the refrigerator for 5 days (120 hours). Diluting the Vaccine • Obtain 0.9% Sodium Chloride Injection, for use as a diluent. Do not use any alternate diluents. • Dilute the thawed vial by adding 1.8 mL of 0.9% Sodium Chloride Injection into the vial. • Ensure vial pressure is equalized by withdrawing 1.8 mL air into the empty diluent syringe before removing the needle from the vial. Preparing the Dose • Draw up 0.3 mL of the diluted dosing solution into a new sterile dosing syringe with a needle appropriate for intramuscular injection. • For each additional dose, use a new sterile syringe and needle and ensure the vial stopper is cleansed with antiseptic before each withdrawal. Vaccine Administration • Diluted vials must be used within 6 hours from the time of dilution and stored between 2-25 °C (35-77°F). • A single 30 mcg/0.3 mL dose is followed by a second dose 21 days later.