Allergy to PEG (polyethylene glycol) – sensitivity of basophil activation test with COVID-19 mRNA-vaccine BNT162B2

Figures & data

Table 1. Characteristics and results of basophil activation test in PEG allergic patients.

Patient No. (age, sex)	Pat. 1 (73 y, male)	Pat. 2 (77 y, female)	Pat. 3 (59 y, female)	Pat. 4 (28 y, female)	Pat. 5 (59 y, female)	Pat. 6 (43 y, female)	Pat. 7 (66 y, female)	Pat. 8 (47 y, male)	Pat. 9 (79 y, female)	Pat. 10 (40 y, female)
History Skin test results	Year 2018: 30 min after taking a colon cleansing solution (contains PEG 3350) palmar and plantar itching and erythema, generalized itch, dizziness	Year 2013: Anaphylactic reaction to Multinorm® Husten-Brauseta-bletten® (contain macrogol)	February 2021: Minutes after Moviprep® (contains PEG 3350) swelling of back of hands, generalized rash, vomiting, nausea, diarrhea	Year 2015: After intake of WickMediNait® (contains PEG 6000) respiratory distress, generalized rash Year 2016: After intake of Movicol® (contains PEG 3350) generalized swelling and rash, loss of consciousness	Year 2002: Traumeel® and Zeel® ➔ unconscious-ness Year 2005: Triamcinolone, prednisolone ➔ anaphylactic reaction grade III-IV Year 2008: Wick MediNait® (contains PEG 6000) ➔ anaphylactic reaction	May 2021: Immediately after intake (150 ml) of PLENVU® (contains PEG 3350) before colonoscopy feeling of heat, tingling, constriction of food, trachea, shortness of breath, palpitations, dizziness, vomiting	July 2004: Mecaine and triamcinolone: After 10 min urticaria, dizziness, loss of consciousness June 2005: Klean-Prep® (contains PEG 3350): After 15 min dizziness, nausea, circulation problems	Several weeks before (2021): Intake of Moviprep® (contains PEG 3350): After 30 min severe agitation, flushing, repeated vomiting, itching	April 2015: Paclitaxel (contains PEG): Problems with circulation, clouding of conscious-ness, abdominal cramps, skin rash. Year 2015: After intake of Moviprep® (contains PEG 3350): urticaria Year 2016: Triamhexal®: hypertension, itching, heat sensation	Year 2013: After intake of Moviprep® (contains PEG 3350): Urticaria, rhinitis
	Positive: Spt: PEG 3350, 4000 IDT: PEG 3350, 4000, 6000, Comirnaty®; after IDT palmar and plantar erythema, generalized itch	Positive in the year 2013: Macrogol (PEG 3350) (Negative in the year 2021: All tested PEGs and PEG-containing vaccines)	Positive: SPT: PEG 4000 1%, PEG 4000 10%, PEG 6000 10%, dizziness 15 minutes after skin test	Positive in the year 2017: Macrogol (PEG 3350) Year 2021: IDT: Comirnaty® (SPT: Negative: All tested PEGs and PEG-containing vaccines)	Positive before year 2021: PEG 6000 Positive in the year 2021: IDT: Comirnaty®, Spikevax® (SPT: Negative: All tested PEGs and PEG-containing vaccines)	Positive: IDT: PEG 6000 0.01% and 0.1% (SPT: Negative: All tested PEGs and PEG-containing vaccines)	Positive: SPT: PEG 2000	Positive: IDT: Comirnaty® 10%, Spikevax® 10% (SPT: Negative: All tested PEGs and PEG-containing vaccines)	Positive: IDT: Comirnaty® 0.1%, 0.01% (SPT: Negative: All tested PEGs and PEG-containing vaccines)	Positive: IDT: Comirnaty® 10%, Spikevax® 10% (SPT: Negative: All tested PEGs and PEG-containing vaccines)
Provocation tests	Provocation test not performed	Provocation test not performed	Provocation test not performed	Provocation test not performed	Provocation test not performed	Provocation test not performed	35 min after intake of PEG 2000 generalized itching, urticaria	Provocation test not performed	After intake of PEG 4000: Generalized itching After intake of PEG 3350: Tingling of fingertips, urticaria, abdominal cramps	Provocation test not performed
COVID-19 vaccination	1^st (fractio-nated) and 2^nd vaccination with Vaxzevria® (contains no PEG) tolerated	unknown	Vaccination with COVID-19 Vaccine Janssen® (contains no PEG) tolerated	Fractionated vaccination with Vaxzevria® (contains no PEG) tolerated	Vaccination with COVID-19 Vaccine Janssen® (contains no PEG) tolerated	Vaccination with Spikevax® (contains PEG) and Vaxzevria® (contains no PEG) tolerated	Fractionated vaccination with Spikevax® (contains PEG) tolerated	Vaccination with Spikevax® (contains PEG) tolerated	Vaccination with Vaxzevria® (contains no PEG) tolerated	unknown
Basophil activation test (% CD63^+ basophils)
Negative control	1.6	4.5	3.2	0.2	0.8	1.8	0.6	1.6	2.4	0
Positive control 1 (anti-FcεRI)	90.0	90.4	16.0	90.2	80.6	96.4	61.8	89.2	91.8	34.8
Positive control 2 (fMLP)	23.2	29.2	14.4	43.7	73.5	42.0	22.5	2.2	43.8	15.8
Comirnaty®, BNT162B2
22.5 µg/ml	20.0	9.4	5.6	17.4	4.2	1.3	1.4	2.8	30.2	0.3
4.5 µg/ml	34.4	16.9	7.8	37.4	9.8	4.1	1.3	3.0	37.6	0.6
0.9 µg/ml	18.4	21.3	7.4	6.6	4.0	2.5	0.3	5.0	37.6	0.7
0.18 µg/ml	2.2	n.d.	3.6	2.0	2.0	2.2	0.3	2.0	34.8	0.6

IDT, intradermal test; n.d. = not done; SPT, skin prick test.

Table 2. Characteristics and results of basophil activation test in controls.

Control No. (age, sex)	Control 1 (61 y, female)	Control 2 (30 y, male)	Control 3 (29 y, male)	Control 4 (29 y, female)	Control 5 (59 y, female)	Control 6 (26 y, female)	Control 7 (23 y, male)	Control 8 (26 y, male)	Control 9 (62 y, female)	Control 10 (56 y, female)
History	Vaccinated with Comirnaty®, COVID-19 infection	No vaccination, COVID-19 infection	Vaccinated with Comirnaty®, COVID-19 infection	Vaccinated with Comirnaty®, COVID-19 infection	Vaccinated with Comirnaty®, COVID-19 infection	No vaccination, COVID-19 infection	Vaccinated with Comirnaty®, COVID-19 infection	Vaccinated with Comirnaty®, COVID-19 infection	Vaccinated with Comirnaty®, no COVID-19 infection	Vaccinated with Comirnaty®, no COVID-19 infection
Basophil activation test (% CD63^+ basophils)
Negative control	0.4	3.9	0.4	0.6	2.9	0.2	0.7	0.7	2.2	1.0
Positive control 1 (anti-FcεRI)	91.2	50.8	73.7	15.8	91.0	78.0	83.3	93.2	90.8	82.2
Positive control 2 (fMLP)	47.7	68.7	44.9	9.5	20.6	2.0	9.7	92.2	4.5	11.8
Comirnaty®, BNT162B2
22.5 µg/ml	1.0	4.4	1.3	1.3	5.8	0.0	0	0.9	2.0	0.6
4.5 µg/ml	1.1	3.8	0.9	0.3	4.8	0.2	0.3	0.5	1.6	1.0
0.9 µg/ml	1.0	3.4	1.4	0.7	4.0	2.4	0.5	0.2	0.3	1.3
0.18 µg/ml	0	4.4	0.3	0.9	4.2	0.4	1.2	0.3	n.d.	3.2

n.d. = not done

Figure 1. Basophil activation with different concentrations of BNT vaccine in PEG allergic patients and controls (*p < .01).

Figure 2. Receiver operator characteristic curve of BNT vaccine (4.5 µg/ml).