COVID-19 vaccine counseling and safety assessment in children and teenagers with underlying medical conditions in China: a single center study

Figures & data

Table 1. Authorization for use in children and teens of COVID-19 vaccines validated for use by the WHO as of January 12, 2022.

No	Developer	Vaccine Name	Vaccine Platform	Intended Use	Authorization Date	Booster
1	Pfizer-BioNTech	BNT162b2/Comirnaty	RNA-based	≥5 y*	11 December 2020 by FDA for ≥16 y 10 May 2021 by FDA for 12–15 y 29 October 2021 by FDA for 5–11 y	At least 5 months after the completion of the primary series for ≥12 y; Not determined for 5–11 y
2	Sinovac	CoronaVac	Inactivated virus	≥3 y	5 June 2021 by NMPA for 3–17 y	At least 6 months after the completion of the primary series for ≥18 y
3	Beijing Institute of Biological Products, Sinopharm	BBIBP-CorV	Inactivated virus	≥3 y	Around June 2021 by NMPA for 3–17 y	At least 6 months after the completion of the primary series for ≥18 y
4	Bharat Biotech	BBV152 COVAXIN	Inactivated virus	≥12 y	25 December 2021 by DGCI for 12–17 y	To be determined
5	Moderna	mRNA-1273/Spikevax	RNA-based	≥12 y	23 July 2021 by EMA for 12–17 y	At least 5 months after the completion of the primary series for ≥18 y
6	AstraZeneca	AZD1222 Vaxzevria/SII COVISHIELD	Viral vector	≥18 y	30 December 2020 by MHRA	To be determined
7	Janssen	Ad26.COV2.S	Viral vector	≥18 y	27 February 2021 by FDA	At least 2 months after receiving Janssen COVID-19 vaccination
8	Novavax/Covovax	NVX-CoV2373	Protein subunit	≥18 y	17 November 2021 by EMA	To be determined

*FDA Advisory Committee Meeting discussed the request for authorization of Pfizer-BioNTech COVID-19 Vaccine for children 6 months through 4 y of age on February 1, 2022.

Figure 1. Flow chart of the study.

Table 2. Contraindications and precautions to COVID-19 vaccination for children aged 3–17 y with underlying medical conditions.

Contraindications History of a known diagnosed allergy to a component of the COVID-19 vaccine History of an allergic reaction after a previous dose of the COVID-19 vaccine History of a severe allergic reaction (e.g., anaphylaxis, any angioedema affecting the airway, diffuse rash involving mucosal surfaces) to any other vaccine Uncontrolled epilepsy or other serious neurological diseases (e.g., transverse myelitis, Guillain-Barré syndrome, demyelinating diseases) Precautions Moderate or severe acute illness or unstable chronic illness, with or without fever*

*Children with above-mentioned conditions are recommended to defer vaccination until the acute illness has improved or the unstable chronic illness has been stable for two weeks.

Table 3. Demographics and medical conditions between the two groups recommended to start or defer CIVID-19 vaccination in the 324 subjects.

Characteristics	Total n = 324 (%)	Starting vaccination n = 242 (%)	Deferring vaccination n = 82 (%)	p-value
Sex				.53
Male	188 (58.0)	138 (57.0)	50 (61.0)
Female	136 (42.0)	104 (43.0)	32 (39.0)
Age, years				.62
3-5	25 (7.7)	19 (7.9)	6 (7.3)
6-11	221 (68.2)	168 (69.4)	53 (64.6)
12-17	78 (24.1)	55 (22.7)	23 (28.0)
Underlying medical conditions
Allergy	108 (33.6)	71 (29.3)	37 (45.1)	.01*
Having a preexisting atopic disease	58 (17.9)	29 (12.0)	29 (35.4)
Allergy to a prior dose of a COVID-19 vaccine	6 (1.9)	3 (1.2)	3 (3.7)
Allergy to an unrelated vaccine or medication	2 (0.6)	0 (0)	2 (2.4)
Allergy to a non-medication	42 (13.9)	39 (16.1)	3 (3.7)
Neurological diseases	101 (31.2)	80 (33.1)	21 (25.6)	.21
Epilepsy	36 (11.1)	26 (10.7)	10 (12.2)
Febrile seizure	24 (7.4)	21 (8.7)	3 (3.7)
Tic disorders	16 (4.9)	12 (5.0)	4 (4.9)
Attention deficit hyperactivity disorder	11 (3.4)	11 (4.5)	0 (0)
Hereditary disorders	4 (1.2)	2 (0.8)	2 (2.4)
Immuno-related encephalopathy	2 (0.6)	0 (0)	2 (2.4)
Other neurological diseases	8 (2.5)	8 (3.3)	0 (0)
Rheumatic diseases	27 (8.3)	20 (8.3)	7 (8.5)	.94
Hematological diseases	21 (6.5)	19 (7.9)	2 (2.4)	.14
Endocrine disease	17 (5.2)	15 (6.2)	2 (2.4)	.31
Non-allergic reaction AEFI history	11 (3.4)	7 (2.9)	4 (4.9)	.61
Cardiovascular diseases	11 (3.4)	10 (4.1)	1 (1.2)	.36
Others^#	10 (3.1)	6 (2.5)	4 (4.9)	.47
Solid tumors	9 (2.8)	8 (3.3)	1 (1.2)	.55
Kidney diseases	6 (1.9)	4 (1.7)	2 (2.4)	.99
Skin diseases	3 (0.9)	2 (0.8)	1 (1.2)	.73

AEFI: adverse events following immunization.

^#Others included Epstein-Barr virus infection history, acute respiratory tract infection, acute otitis media, malnutrition, history of syncope of unknown reason, history of fracture, history of neonatal asphyxia.

*The p value of comparison between two groups is significant for the number of children recommended to start COVID-19 vaccination (p = .01).

Table 4. Adverse reactions reported within 28 d after vaccination in the 180 children receiving 340 doses of inactivated COVID-19 vaccines.

	Total	Cases after the first dose	Cases after the second dose
	n (%)	n (%)	n (%)	p-value
Systemic adverse reactions within 72 hours
Any	29 (15.6)	24 (13.3)	5 (3.1)	.00
Fever	13 (7.2)	11 (6.1)	2 (1.3)	.02
Rash	5 (2.8)	4 (2.2)	1 (0.6)	.38
Fatigue	3 (1.7)	2 (1.1)	1 (0.6)	1.00
Dizziness	2 (1.1)	2 (1.1)	0 (0)	-
Myalgia	2 (1.1)	1 (0.6)	1 (0.6)	1.00
Sore throat	2 (1.1)	2 (1.1)	0 (0)	-
Cough	1 (0.6)	1 (0.6)	0 (0)	-
Headache	1 (0.6)	1 (0.6)	0 (0)	-
Vomiting	1 (0.6)	1 (0.6)	0 (0)	-
Nausea	1 (0.6)	1 (0.6)	0 (0)	-
Unsolicited adverse reactions within 28 d
Any	37 (20.6)	28 (15.6)	9 (8.8)	.00
Respiratory infections	28 (15.6)	20 (11.1)	8 (5)	.04
Flare of atopic dermatitis	4 (2.2)	3 (1.7)	1 (0.6)	.36
Flare of tics	2 (1.1)	2 (1.1)	0 (0)	-
New onset of atopic dermatitis	2 (1.1)	2 (1.1)	0 (0)	-
Vision loss	1 (0.6)	1 (0.6)	0 (0)	-
Overall adverse reactions within 28 d	39 (21.6)	29 (16.1)	10 (6.3)	.00

The data in number represented the total number of participants who had adverse events following immunization. There were 160 children received two doses and 20 received one dose vaccine. A total of 29 children reported 31 episodes of systemic adverse reactions within 72 hours, including one case had fever with sore throat (counted two adverse events), and another case had rash with muscle soreness (counted two adverse events). And 37 children reported 37 episodes of unsolicited adverse reactions within 28 d.

Table 5. Demographics and medical conditions between the two groups of reported adverse reactions and not reported adverse reactions within 28 d after vaccination.

Characteristics	Total n = 180 (%)	Cases reported adverse reactions n = 29 (%)	Cases not reported adverse reactions n = 151 (%)	p-value
Sex				.05
Male	104 (57.8)	12 (41.4)	92 (60.9)
Female	76 (42.2)	17 (58.6)	59 (39.1)
Age, years				.84
3-5	7 (3.9)	1 (3.4)	6 (4.0)
6-11	125 (69.4)	19 (65.5)	106 (70.2)
12-17	48 (26.7)	9 (31.0)	39 (25.8)
Underlying medical conditions
Allergy	52 (28.9)	13 (44.8)	39 (25.8)	.04*
Neurological diseases	57 (31.7)	5 (17.2)	52 (34.4)	.07
Rheumatic diseases	14 (7.8)	2 (6.9)	12 (7.9)	.85
Hematological diseases	17 (9.4)	3 (10.3)	14 (9.3)	.86
Endocrine disease	13 (7.2)	1 (3.4)	12 (7.9)	.39
Non-allergic reaction AEFI history	5 (2.8)	1 (3.4)	4 (2.6)	.60
Cardiovascular diseases	8 (4.4)	2 (6.9)	6 (4.0)	.48
Others^#	4 (2.2)	2 (6.9)	2 (1.3)	.12
Solid tumors	7 (3.9)	0 (0)	7 (4.6)	-
Kidney diseases	3 (1.7)	0 (0)	3 (2.0)	-
Skin diseases	0 (0)	0 (0)	0 (0)	-

AEFI: adverse events following immunization.

^#Others included Epstein-Barr virus infection history, acute respiratory tract infection, acute otitis media, malnutrition, history of syncope of unknown reason, history of fracture, history of neonatal asphyxia.

*The p value of comparison between two groups is significant for the number of children reported adverse reactions (p = .04).