FDA Extends Emergency Use Authorization for Pfizer COVID-19 Vaccine to Adolescents: What it Means for Allergic Kids

Important note: This article is intended for those who understand vaccines as critical to maintaining their health and that of their families. It is NOT intended for those who are anti-vaccine and as such is NOT intended to foster a discussion on the merits of vaccines in this forum. It is also NOT intended to foster a discussion of the lethality of COVID-19 or the need for civic action to limit the spread of the disease.

Yesterday, the US Food and Drug Administration expanded the emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine to include adolescents 12 through 15 years of age. The FDA amended the EUA originally issued on December 11, 2020 for administration in individuals 16 years of age and older.

Said Dr Janet Woodcock, Acting FDA Commissioner:

The FDA’s expansion of the emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine to include adolescents 12 through 15 years of age is a significant step in the fight against the COVID-19 pandemic. Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic. Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations.

Children 12-15 years of age can now be vaccinated to protect against COVID-19 infection, but what about kids coping with severe food allergies?

The FDA’s Fact Sheet for Recipients and Caregivers is clear and concise on the matter:

WHO SHOULD GET THE PFIZER-BIONTECH COVID-19 VACCINE?
FDA has authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine in
individuals 12 years of age and older.

WHO SHOULD NOT GET THE PFIZER-BIONTECH COVID-19 VACCINE?
You should not get the Pfizer-BioNTech COVID-19 Vaccine if you:
• had a severe allergic reaction after a previous dose of this vaccine
• had a severe allergic reaction to any ingredient of this vaccine.

After hundreds of millions of doses of the Pfizer vaccine have been administered, the FDA maintains that allergies to specific foods and insect venoms are not a concern for individuals including adolescents for receiving the vaccine.

Only those that have had a reaction to the first dose of the vaccine and those that have suffered a reaction to any of the following ingredients should not get the vaccine:

• mRNA
• lipids:
  • (4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate)
  • 2 [(polyethylene glycol)-2000]-N,N-ditetradecylacetamide
  • 1,2-Distearoyl-sn-glycero-3 phosphocholine
  • cholesterol
• potassium chloride
• monobasic potassium phosphate
• sodium chloride
• dibasic sodium phosphate dihydrate
• sucrose.

If you are concerned about the potential for anaphylaxis, the Centers for Disease Control (CDC) issued the following update in a report on January 15, 2021 on anaphylactic reactions:

During December 14–23, 2020, monitoring by the Vaccine Adverse Event Reporting System detected 21 cases of anaphylaxis after administration of a reported 1,893,360 first doses of the Pfizer-BioNTech COVID-19 vaccine (11.1 cases per million doses); 71% of these occurred within 15 minutes of vaccination.

To learn more, the FDA recommends you:

• Ask the vaccination provider;
• Visit CDC at https://www.cdc.gov/coronavirus/2019-ncov/index.html;
• Visit FDA at https://www.fda.gov/emergency-preparedness-and-response/mcmlegal-regulatory-and-policy-framework/emergency-use-authorization;
• Contact your local or state public health department.

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