Administration information for Pfizer-BioNTech COVID-19 Vaccine

Anna Bischler, Lead Medicines Information Pharmacist, Midlands and East Medicines Advice Service (East Anglia site)Published

Information on batch specific dosing and withdrawing an additional dose from an individual vial is given.

Batch specific doses

It is not necessary for the same patient to receive both doses of vaccine from the same batch.

The conditions for authorisation state that in light of the batch specific-nature of this approval, and the high demand for this product, providers administering this vaccine should ensure that they have provision for two doses for each patient treated. This advice is not related to batch variation but rather to ensure that there are two doses of the same product available for each vaccinated individual.

See further information if the same brand of vaccine is unavailable for the second dose

Withdrawing a sixth dose

On 24th December 2020 the MHRA Information for Healthcare Professionals was updated to reflect the potential for 6 doses being extracted from the diluted vial.

This now states that the vial volume was optimised to reliably obtain 5 doses regardless of syringe type used as most syringe and needle combinations require withdrawal of excess volume in order to ensure the full 0.3 mL dose of vaccine can be administered. After correct dilution of the product and when low dead-volume syringes and/or needles are used, the amount remaining in the vial after 5 doses have been extracted may be sufficient for an additional (sixth) dose. The Patient Group Direction (PGD) was updated on the 5th January 2021 and the National Protocol was updated on the 10th January 2021 to allow for the sixth dose to be administered from a vial under this mechanism if a full 0.3ml dose can be extracted.

Care should be taken to ensure a full 0.3 mL is administered to the individual and that all doses from a single prepared vial are administered within 6 hours of the time of dilution. Any unused vaccine should be discarded 6 hours after dilution.