Pfizer-BioNTech Vaccine for COVID-19 Gains Approval for Use in Patients Aged > 12 Years of Age
Author: Kyra Browne, PharmD – PGY-1 Resident Howard University Hospital
Last week, the Pfizer-BioNTech vaccine for the prevention of COVID-19 became the first out of the three currently available FDA-authorized vaccines in the U.S. to receive Emergency-Use Authorization in patients aged 12 to 15 years of age. Initial EUA recommendations were made for patients aged 18 and older, which was extended to patients aged 16 and older in December. This update comes amongst news of easing restrictions across the country—last week the Centers for Disease Control and Prevention announced that those who are fully vaccinated no longer need to socially distance or wear masks unless otherwise required by law or regulations, and can refrain from testing after exposure under certain circumstances.1 Both of these updates mark enormous strides towards normalcy as we continue into year 2 of the pandemic.
News of the Emergency-Use Authorization in the pediatric population is very timely. The American Academy of Pediatrics reports that since the beginning of the pandemic, over 3.85 million children have tested positive for COVID-19.2 While the incidence of cases is decreasing, there is still an estimated 72,000 pediatric cases of COVID-19 each week, correlating to 24% of new cases. While severe illness is uncommon amongst the pediatric population, the risk of transmission remains elevated and data is still being collected on the long-term effects of infection.
Pfizer-BioNTech initially released the results of their phase 3 trial on March 31st, 2021. The press release announced that the trial, which enrolled 2,260 patients aged 12 to 15, showed that the vaccine elicited a significant immune response and showed 100% efficacy in individuals with and without prior exposure to the COVID-19 virus.3 In addition, the vaccine was generally well tolerated with similar side effects reported in other age groups. Amongst the exciting news, CEO and co-founder of BioNTech Ugur Sahin, M.D. expressed that the collaborating companies have no plans to stop yet.4 Trials evaluating vaccine safety and efficacy amongst children aged 6 months to 11 years old are underway, with hopes of releasing positive data by September—just in time for schools to resume sessions. The results of the study have also been submitted to other global regulating bodies, and additional approvals are expected in the upcoming weeks.5
As more of the general population gains access to vaccines, the world is getting closer and closer to the end of the pandemic, but there is still work to be done. In westernized countries, large trials are underway to gain approval in wider populations such as pregnancy and infancy, but poorer and more populated countries in the East are experiencing spikes in transmission amongst the general population. If these high-transmission areas do not gain access to the vaccines widely available in the West, we risk virus mutation and losing the global progress made towards eradicating COVID-19 thus far
Pfizer-BioNTech Covid-19 Vaccine for Emergency Use Authorization (6)
- Age Indications: 12 years of age and older
- Dosing Schedule: 2 doses, separated by 21 days
- Administration: Intramuscular (IM) into the deltoid muscle
- Dosing information: 0.3 mL per injection
- Co-administration with other vaccines: Can be given with other vaccines on the same day6
- "COVID-19 Vaccination". Centers For Disease Control And Prevention, 2021, https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated-guidance.html.
- "Children And COVID-19: State-Level Data Report". Services.Aap.Org, 2021, https://services.aap.org/en/pages/2019-novel-coronavirus-covid-19-infections/children-and-covid-19-state-level-data-report/.
- "Pfizer-Biontech Announce Positive Topline Results Of Pivotal COVID-19 Vaccine Study In Adolescents | Pfpfizeruscom". Pfizer.Com, 2021, https://www.pfizer.com/news/press-release/press-release-detail/pfizer-biontech-announce-positive-topline-results-pivotal.
- "Pfizer And Biontech Receive First U.S. Authorization For Emergency Use Of COVID-19 Vaccine In Adolescents | Pfpfizeruscom". Pfizer.Com, 2021, https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-receive-first-us-authorization.
- "Coronavirus (COVID-19) Update: FDA Authorizes Pfizer-Biontech COVID-19 Vaccine For Emergency Use In Adolescents In Another Important Action In Fight Against Pandemic". U.S. Food And Drug Administration, 2021, https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-pfizer-biontech-covid-19-vaccine-emergency-use.
- "Interim Clinical Considerations For Use Of COVID-19 Vaccines | CDC". Cdc.Gov, 2021, https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html#Coadministration.