Health Alert
EXPANDED PFIZER-BIONTECH EUA FOR 12-15-YEAR-OLDS, MODIFICATION OF CO-ADMINISTRATION GUIDANCE

The Delaware Division of Public Health (DPH) is issuing this health alert to advise the medical community that on May 10, 2021, the U.S. Food and Drug Administration (FDA) expanded the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) to include adolescents 12 to 15 years of age. The FDA amended the EUA originally issued on Dec. 11, 2020 for administration to individuals 16 years of age and older. Additionally, on May 12, 2021, the Centers For Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP), voted to recommend Pfizer-BioNTech COVID-19 vaccine for persons 12 to 15 years of age in the U.S. population under the FDA’s EUA.

Summary

In Delaware, providers may administer the Pfizer-BioNTech vaccine for COVID-19 to those 12 and older effective immediately, or as soon as they are in a position to do so.

Furthermore, ACIP also revised guidance on the co-administration of routine vaccines with COVID-19 vaccine, removing the 14-day minimum interval for administration of any other vaccine before, or after, a COVID-19 vaccine.

Background

Safety Data:

The available safety data to support the EUA in adolescents as young as 12 years of age include 2,260 participants ages 12 to 15 years old enrolled in an ongoing randomized, placebo-controlled clinical trial in the United States. Of these, 1,131 adolescent participants received the vaccine and 1,129 received a saline placebo. More than half of the participants were followed for safety for at least two months following the second dose.

The most commonly reported side effects in the adolescent clinical trial participants, which typically lasted one to three days, were pain at the injection site, tiredness, headache, chills, muscle pain, fever, and joint pain. With the exception of pain at the injection site, more adolescents reported these side effects after the second dose than after the first dose, so it is important for vaccination providers and recipients to expect that there may be some side effects after either dose, but more so after the second dose. The side effects in adolescents were consistent with those reported in clinical trial participants 16 years of age and older. It is important to note that as a general matter, while some individuals experience side effects following any vaccination, not every individual’s experience will be the same and some people may not experience side effects.

Effectiveness Data:

The effectiveness data to support the EUA in adolescents as young as 12 years of age is based on immunogenicity and an analysis of COVID-19 cases. The immune response to the vaccine in 190 participants, 12 to 15 years of age, was compared to the immune response of 170 participants, 16 to 25 years of age. In this analysis, the immune response of adolescents was non-inferior to the immune response of the older participants. An analysis of cases of COVID-19 occurring among participants, 12 to 15 years of age, seven days after the second dose was also conducted. In this analysis, among participants without evidence of prior infection with SARS-CoV-2, no cases of COVID-19 occurred among 1,005 vaccine recipients and 16 cases of COVID-19 occurred among 978 placebo recipients; the vaccine was 100% effective in preventing COVID-19.

Co-administration:

COVID-19 and other vaccines may now be administered without regard to timing with respect to other vaccines. This includes simultaneous administration of COVID-19 and other vaccines on the same day, as well as co-administration within 14 days.

COVID-19 vaccines were previously recommended to be administered alone, with a minimum interval of 14 days before or after administration of any other vaccines. This was out of an abundance of caution and not due to any known safety or immunogenicity concerns. However, substantial data have now been collected regarding the safety of COVID-19 vaccine currently authorized by FDA for use under EUA. Although data are not available for COVID-19 vaccines administered simultaneously with other vaccines, extensive experience with non-COVID-19 vaccines has demonstrated that immunogenicity and adverse event profiles are generally similar when vaccines are administered simultaneously as when they are administered alone.

Recommendations

When deciding to co-administer with COVID-19 vaccines, providers could consider whether the patient is behind, or at risk of becoming behind, on recommended vaccines and the reactogenicity profile of the vaccines.

Additional Information

• Pfizer COVID-19 Vaccine EUA Fact Sheet for Recipients and Caregivers: https://coronavirus.delaware.gov/wp-content/uploads/sites/177/2021/05/Fact-Sheet-for-Vaccination-Recipients-and-Caregivers-Pfizer_5.10.2021.pdf
• Pfizer COVID-19 Vaccine EUA Fact Sheet for Vaccination Providers:  https://coronavirus.delaware.gov/wp-content/uploads/sites/177/2021/05/Fact-Sheet-for-Vaccination-Providers-Pfizer_5.10.2021.pdf

• Pfizer COVID-19 Vaccine EUA Letter of Authorization: https://coronavirus.delaware.gov/wp-content/uploads/sites/177/2021/05/Pzifer-Vaccine-EUA_5.10.21.pdf

• ACIP Presentation Slides: May 12, 2021 Meeting: https://www.cdc.gov/vaccines/acip/meetings/slides-2021-05-12.html
• DPH Webpage: Information for Ages 12-15: https://coronavirus.delaware.gov/vaccine/vaccine-information-for-ages-12-15/