The U.S. Food and Drug Administration (FDA) has recently issued an Emergency Use Authorization (EUA) for 2 highly effective coronavirus disease 2019 (COVID-19) vaccines from Pfizer-BioNTech and Moderna. This has brought hope to millions of Americans in the midst of an ongoing global pandemic. The FDA EUA guidance for both vaccines is to not administer the vaccine to individuals with a known history of a severe allergic reaction (eg, anaphylaxis) to any component of the COVID-19 vaccine. The Centers for Disease Control and Prevention (CDC) additionally advises individuals with a history of an immediate allergic reaction to a vaccine or injectable or any history of anaphylaxis be observed for 30 minutes after COVID-19 vaccination. All other individuals should be observed for 15 minutes after COVID-19 vaccination. Staff at vaccine clinics must be able to identify and manage anaphylaxis. Post–FDA EUA, despite very strong safety signals in both phase 3 trials, reports of possible allergic reactions have raised public concern. To provide reassurance and support during widespread global vaccination, allergists must offer clear guidance to individuals based on the best information available, but also in accordance with the broader recommendations of regulatory agencies. This review summarizes vaccine allergy epidemiology and proposes drug and vaccine allergy expert opinion informed risk stratification for Allergy specialist use in conjunction with guidance of public health and regulatory authorities. The risk stratification schema guide care for (1) individuals with different allergy histories to safely receive their first mRNA COVID-19 vaccine and (2) individuals who develop a reaction to their first dose of mRNA COVID-19 vaccine.

No abstract

38.3%) were tested on days 9 to 14. Of the 134 student contacts tested on day 3, 14 (10.4%) were positive for SARS-CoV-2 infection. Of the 839 student contacts tested on days 9 to 14, 40 (4.8%) were positive for SARS-CoV-2 infection. Of the 388 student contacts in high school who were tested, 32 (8.2%) were positive for SARS-CoV-2 infection on days 9 to 14 compared with 8 (1.8%) of 451 student contacts in elementar y and middle school who tested positive (P < .001; Table ).Among 799 student contacts of confirmed COVID-19 cases with a negative test result on days 9 to 14, only 1 student became symptomatic after returning to school and had a positive SARS-CoV-2 test result on day 14 after an initial negative test result on day 9. The virus from this student was genetically distinct from the virus isolated from the confirmed COVID-19 case to which the student had been exposed (GenBank confirmed case: MW307809; GenBank 9-day student contact: MW308137). Loss of instruction decreased by 3649 days with the 9-day testing protocol (8097 days missed) compared with a theoretical 14-day quarantine without testing (11 746 days missed).Discussion | In this study of a 9-day testing protocol for student contacts of confirmed COVID-19 cases in 1 Florida county, a reduction in loss of instructional time was found that was less than what would have occurred with a 14-day quarantine. There was no evidence that an earlier return to school with a negative test result was linked with subsequent symptomatic illness. Had students returned to school before day 14 without testing on day 9 or thereafter, 8.2% of high school contacts would have returned to school with SARS-CoV-2 infection. These findings should be considered when evaluating the December 2020 CDC recommendation for a 10-day quarantine without testing or a 7-day quarantine with testing. 5 Limitations of this study include (1) contact testing ranging from days 9 to 14; (2) lack of testing for students who quarantined for 14 days; and (3) use of symptomatic illness alone for follow-up of negative test results.

Background CDC states that a severe or immediate allergic reaction to the first dose of an mRNA COVID-19 vaccine is a contraindication for the second dose. Objective To assess outcomes associated with excipient skin testing after a reported allergic reaction to mRNA COVID-19 vaccine dose one. Methods We identified a consecutive sample of patients with reported allergic reactions after the first dose of mRNA COVID-19 vaccine who underwent allergy assessment with skin testing to polyethylene glycol (PEG) and, if appropriate, polysorbate 80. Skin testing results in conjunction with clinical phenotyping of the first dose mRNA COVID-19 vaccine reaction guided second dose vaccination recommendation. Second dose mRNA COVID-19 vaccine reactions were assessed. Results 80 patients with reported first dose mRNA COVID-19 vaccine allergic reactions (n=65, 81% immediate onset) underwent excipient skin testing. 14 (18%) had positive skin tests to PEG (n=5) and/or polysorbate 80 (n=12). Skin testing result did not impact tolerance of second dose in patients with immediate or delayed reactions. Of 70 (88%) patients who received their second mRNA COVID-19 vaccine dose, 62 (89%) had either no reaction or a mild reaction managed with antihistamines, but two patients required epinephrine. Three patients with positive PEG-3350 intradermal (methylprednisolone) testing tolerated second dose mRNA COVID-19 vaccination. Refresh Tears caused non-specific irritation. Conclusion Most individuals with a reported allergic reaction to dose one of the mRNA COVID-19 vaccines, regardless of skin test result, received the second dose safely. More data are needed on the value of skin prick testing to PEG (Miralax) in evaluating patients with mRNA COVID-19 vaccine anaphylaxis. Refresh Tears should not be used for skin testing.