Post-marketing surveillance for the safety of the 9-valent human papillomavirus vaccine: a retrospective real-world study in China

Figures & data

Table 1. Characteristics of women who received the 9vHPV vaccine between 25 January 2019 and 31 March 2021 in Ningbo.

Characteristics	Only 9vHPV vaccine (n = 41,609)	Mixed regimen (n = 16)
Age at first dose (years), mean±SD	22.81 ± 2.44	23.75 ± 1.53
16–20 years, n (%)	8,972 (21.56)	2 (12.50)
21–26 years, n (%)	32,637 (78.44)	14 (87.50)
Residence region, n (%)
Urban	15,183 (36.49)	8 (50.00)
Rural	18,691 (44.92)	8 (50.00)
Unknown	7,735 (18.59)	0 (0)
Year of first dose, n (%)
2019	10,615 (25.51)	7 (43.75)
2020	23,258 (55.90)	7 (43.75)
2021	7,736 (18.59)	2 (12.50)
Number of doses received, mean±SD	2.47 ± 0.72	3.44 ± 0.73
1 dose, n (%)	5,678 (13.65)	2 (12.50)
2 doses, n (%)	10,801 (25.96)	5 (31.25)
3 doses, n (%)	25,130 (60.40)	9 (56.25)
Time interval between doses (months), mean±SD
Dose 1 and dose 2	2.20 ± 0.45	2.28 ± 0.54
Dose 2 and dose 3	4.31 ± 0.66	4.25 ± 1.06
Dose 3 and the last dose	–	6.70 ± 6.33

Figure 1. Flowchart of new-onset cases of pre-specified autoimmune diseases among women who received the 9vHPV vaccine.

Table 2. Characteristics of women who received with the 9vHPV vaccine only and had new-onset Graves’ disease or Hashimoto’s thyroiditis between 25 January 2019 and 31 March 2021 in Ningbo.

Characteristics	Graves’ disease (n = 11)	Hashimoto’s thyroiditis (n = 21)
Age at first dose (years), mean±SD	23.33 ± 2.20	23.82 ± 1.81
16–20 years, n (%)	3 (27.27)	2 (9.52)
20–26 years, n (%)	8 (72.73)	19 (90.48)
Residence region, n (%)
Urban	6 (54.55)	9 (42.86)
Rural	4 (36.36)	8 (38.10)
Unknown	1 (9.09)	4 (19.05)
Year at first dose, n (%)
2019	3 (27.27)	7 (33.33)
2020	8 (72.73)	13 (61.90)
2021	0 (0)	1 (4.76)
Number of doses received, mean±SD	2.91 ± 0.30	2.90 ± 0.30
Only 1 dose, n (%)	0 (0)	0 (0)
2 doses, n (%)	1 (9.09)	2 (9.52)
3 doses, n (%)	10 (90.91)	19 (90.48)
Diagnosis time, n (%)
After dose 1	6 (54.55)	9 (42.86)
After dose 2	5 (45.45)	12 (57.14)
After dose 3	0 (0)	0 (0)
Time interval between the last dose of vaccination before diagnosis and diagnosis (days)	57.91 ± 33.67	59.29 ± 37.17

Figure 2. Flowchart of adverse pregnancy outcomes among women who received the 9vHPV vaccine.

Table 3. Characteristics of women with maternal exposure to only the 9vHPV vaccine between 25 January 2019 and 31 March 2021 in Ningbo.

Characteristics	9vHPV vaccine (n = 50)
Age at first dose (years), mean±SD	24.56 ± 0.93
16–20 years, n (%)	0 (0.00)
20–26 years, n (%)	50 (100.00)
Residence region, n (%)
Urban	14 (28.00)
Rural	25 (50.00)
Unknown	11 (22.00)
Education, n (%)
University and above	43 (86.00)
Senior high school	6 (12.00)
Junior school and below	1 (2.00)
Occupation, n (%)
Factory worker	9 (18.00)
Agriculture worker	5 (10.00)
Administrator/manager/professional/technical	10 (20.00)
Service worker	3 (6.00)
Other	22 (44.00)
Unknown	1 (2.00)
Cigarette smoking status, n (%)
Non-smoker	50 (100.00)
Smoker	0 (0.00)
Alcohol drinking status, n (%)
Non-drinker	50 (100.00)
Drinker	0 (0.00)
Gravidity, mean±SD	1.28 ± 0.73
1, n (%)	42 (84.00)
2, n (%)	4 (8.00)
≥3, n (%)	4 (8.00)
Parity, mean±SD	0.02 ± 0.14
0, n (%)	49 (98.00)
1, n (%)	1 (2.00)
≥2, n (%)	0 (0.00)
Year at first dose, n (%)
2019	40 (80.00)
2020	10 (20.00)
2021	0 (0.00)
Number of doses received, mean±SD	2.34 ± 0.82
1 dose, n (%)	11 (22.00)
2 doses, n (%)	11 (22.00)
3 doses, n (%)	28 (56.00)
Conception time, n (%)
Before dose 1	15 (30.00)
After dose 1	12 (24.00)
After dose 2	13 (26.00)
After dose 3	10 (20.00)
Vaccination time of the first dose in risk windows, n (%)
Within 30 days prior to conception	18 (36.00)
In the 1^st trimester (0–12 weeks)	28 (56.00)
In the 2^nd trimester (13–28 weeks)	3 (6.00)
In the 3^rd trimester (29–40 weeks or above)	1 (2.00)

Data availability statement

The data that supports the findings of this study is available from the Ningbo Center for Disease Control and Prevention, but restrictions apply to the availability of these data, which was used under license for the current study, and so is not publicly available. Data is however available from the authors upon reasonable request and with permission of the Ningbo Center for Disease Control and Prevention.