Safety of BNT162b2 COVID-19 Vaccine in Adolescent Patients of UP-PGH

Abstract

Background. In response to the pandemic brought about by COVID-19, vaccines were developed immediately.
Together with adhering to safety protocols, vaccines are needed to help decrease the mortality and morbidity. As with any other, COVID-19 vaccines are evaluated based on efficacy and safety. Real world data is important in the recommendation of vaccines.

Objectives. This study aims to assess the short-term safety of BNT162b2 COVID-19 vaccines administered to Filipino adolescents from October 15, 2021 to December 15, 2021 at the Philippine General Hospital. The number and typeof local and systemic reaction within 7 days of vaccination were determined.

Methods. This is a  retrospective cohort study. The review of the recorded events was done through an electronic diary that was accessed from the official Electronic Medical Records of University of the Philippines-Philippine General Hospital (UP-PGH). This included solicited and prespecified local and systemic reactions that occurred within 7 day  of receipt of vaccine dose. Descriptive statistics was used to present the data.

Results. Out of the 1,756 BNT162b2 vaccines administered (Dose 1- 890; Dose 2- 866), 13% (N=221) indicated
having adverse reaction. Injection site pain was the overall most common reaction with majority (81%) experiencing it within 7 days of vaccination. Systemic reactions made up 60% of the reactions after Dose 1 and 85% of thereactions after Dose 2. This includes tiredness, headache and fever. None of the reactions required hospitalization or further workup.

Conclusion. BNT162b2 vaccine has a good safety profile among adolescents vaccinated at UP-PGH, since most of the reported adverse events within 7 days of vaccination were local and systemic reactogenic reactions that did not necessitate hospitalization or work-up. No serious adverse events were reported. Further follow-up is suggested to assess longer term safety