Fact sheet for interim authorization of the Pfizer-BionTech Covid-19 Vaccine

FACT SHEET FOR HEALTHCARE PROVIDERS ADMINISTERING VACCINE (VACCINATION PROVIDERS)
INTERIM AUTHORIZATION OF THE PFIZER-BIONTECH COVID-19 VACCINE
TO PREVENT CORONAVIRUS DISEASE 2019 (COVID-19)

The Health Sciences Authority (HSA) has granted an interim authorization to permit the emergency use of the therapeutic product, Pfizer-BioNTech COVID-19 Vaccine, for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) in individuals 12 years of age and older.

SUMMARY OF INSTRUCTIONS FOR COVID-19 VACCINATION PROVIDERS
Vaccination providers must report all vaccine administration errors, all serious adverse events, cases of Multisystem Inflammatory Syndrome (MIS) in adults and children, and cases of COVID-19 that result in hospitalization or death following administration of Pfizer-BioNTech COVID-19 Vaccine.

See “MANDATORY REQUIREMENTS FOR PFIZER-BIONTECH COVID-19 VACCINE ADMINISTRATION UNDER INTERIM AUTHORIZATION” for reporting requirements.

The Pfizer-BioNTech COVID-19 Vaccine is a suspension for intramuscular injection administered as a primary series of two doses (0.3 mL each) 3 weeks apart.

A booster dose (third dose) of Pfizer-BioNTech COVID-19 Vaccine may be administered intramuscularly after the second dose. The decision when and for whom to implement a booster (third dose) of Pfizer-BioNTech COVID-19 Vaccine should be made based on available vaccine safety and effectiveness data, in accordance with official recommendations.
See this Fact Sheet for instructions for preparation and administration.

This Fact Sheet may have been updated. For the most recent Fact Sheet, please see http://www.cvdvaccine.com.
For information on clinical trials that are testing the use of the Pfizer-BioNTech COVID-19 Vaccine for active immunization against COVID-19, please see http://www.clinicaltrials.gov.

Source: Pfizer Inc – PDF 52 pages – Revised: 13 December 2021

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