Coronavirus Disease Vaccination In Patients With Pulmonary Hypertension: A National Prospective Cohort Study

X.-H. Wu; J.-Y. Li; J.-L. Ma; Q.-Q. Liu; L. Wang; Y.-J. Zhu; Y. Cui; J.-X. Lu; A.-Y. Wang; C.-J. Wen; L.-H. Qiu; Y.-J. Yang; D. Lu; X.-Q. Xu; X.-J. Zhu; C.-Y. Cheng; Duolao Wang; Z.-C. Jing

doi:10.1164/ajrccm-conference.2023.207.1_meetingabstracts.a3801

Abstract

Rationale:

COVID-19 has potential risks for both the clinical course and mortality among patients with pulmonary hypertension(PH), with vaccines play an important role in preventing this pandemic. The PH patients are mostly ruled out from vaccine trials, so data still lacking regarding the protective role of vaccination among this population. This study aimed to assess the safety of approved vaccination for patients with PH.

Methods:

In this national prospective cohort study, patients diagnosed with PH (World Health Organization [WHO] groups 1 and 4) from 3 national referral centers in China were included between October 2021and March 2022.Patients were asked vaccination status and stratified into vaccinated (VAC) and un-vaccinated (unVAC) groups. unVAC group was followed up for 4 months while VAC group were followed up for 3 months after vaccination completion. The primary outcome was the composite of PH-related major adverse events. Inverse probability weighting (IPW) approach was used to control for possible confounding factors in the baseline patient characteristics.

Results:

Totally 706 patients participated(mean age, 40.3 years; mean duration after diagnosis, 8.2 years). All patients underwent standardized treatment for PH in accordance with guidelines. 278 patients did not receive vaccination, whereas 428 patients completed the vaccination series. Overall, 398 patients received inactivated vaccines (CoronaVac), whereas 30 received protein subunit vaccines (ZF2001). None of the participants were infected with COVID-19 during our study. After adjusting for baseline covariates using IPW approach, the odds of having any adverse events due to PH in VAC group did not increase (6.3% versus 8.5%, odds ratio=0.72, p=0.3).Approximately half of the vaccinated patients reported at least one post-vaccination side effect, most of which were mild, including pain at the injection site (37·1%), fever (2·6%), and fatigue (6·1%).

Conclusions:

COVID-19 vaccination did not augment the PH-related major adverse events for patients with WHO groups 1 and 4 PH, although there were some tolerable side effects. A large-scale randomized controlled trial is warranted to confirm this finding. The final approval of the COVID-19 vaccination for patients with PH as a public health strategy is promising.

Original language	English
Article number	eA3801
Journal	American Journal of Respiratory and Critical Care Medicine
Volume	2023
Issue number	207
DOIs	https://doi.org/10.1164/ajrccm-conference.2023.207.1_meetingabstracts.a3801
Publication status	Published - 1 May 2023
Event	American Thoracic Society International Conference 2023 - Washington DC, United States Duration: 19 May 2023 → 24 May 2023

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Wu, X.-H., Li, J.-Y., Ma, J.-L., Liu, Q.-Q., Wang, L., Zhu, Y.-J., Cui, Y., Lu, J.-X., Wang, A.-Y., Wen, C.-J., Qiu, L.-H., Yang, Y.-J., Lu, D., Xu, X.-Q., Zhu, X.-J., Cheng, C.-Y., Wang, D., & Jing, Z.-C. (2023). Coronavirus Disease Vaccination In Patients With Pulmonary Hypertension: A National Prospective Cohort Study. American Journal of Respiratory and Critical Care Medicine, 2023(207), Article eA3801. https://doi.org/10.1164/ajrccm-conference.2023.207.1_meetingabstracts.a3801

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title = "Coronavirus Disease Vaccination In Patients With Pulmonary Hypertension: A National Prospective Cohort Study",

abstract = "Rationale:COVID-19 has potential risks for both the clinical course and mortality among patients with pulmonary hypertension(PH), with vaccines play an important role in preventing this pandemic. The PH patients are mostly ruled out from vaccine trials, so data still lacking regarding the protective role of vaccination among this population. This study aimed to assess the safety of approved vaccination for patients with PH. Methods:In this national prospective cohort study, patients diagnosed with PH (World Health Organization [WHO] groups 1 and 4) from 3 national referral centers in China were included between October 2021and March 2022.Patients were asked vaccination status and stratified into vaccinated (VAC) and un-vaccinated (unVAC) groups. unVAC group was followed up for 4 months while VAC group were followed up for 3 months after vaccination completion. The primary outcome was the composite of PH-related major adverse events. Inverse probability weighting (IPW) approach was used to control for possible confounding factors in the baseline patient characteristics. Results:Totally 706 patients participated(mean age, 40.3 years; mean duration after diagnosis, 8.2 years). All patients underwent standardized treatment for PH in accordance with guidelines. 278 patients did not receive vaccination, whereas 428 patients completed the vaccination series. Overall, 398 patients received inactivated vaccines (CoronaVac), whereas 30 received protein subunit vaccines (ZF2001). None of the participants were infected with COVID-19 during our study. After adjusting for baseline covariates using IPW approach, the odds of having any adverse events due to PH in VAC group did not increase (6.3\% versus 8.5\%, odds ratio=0.72, p=0.3).Approximately half of the vaccinated patients reported at least one post-vaccination side effect, most of which were mild, including pain at the injection site (37·1\%), fever (2·6\%), and fatigue (6·1\%). Conclusions: COVID-19 vaccination did not augment the PH-related major adverse events for patients with WHO groups 1 and 4 PH, although there were some tolerable side effects. A large-scale randomized controlled trial is warranted to confirm this finding. The final approval of the COVID-19 vaccination for patients with PH as a public health strategy is promising.",

author = "X.-H. Wu and J.-Y. Li and J.-L. Ma and Q.-Q. Liu and L. Wang and Y.-J. Zhu and Y. Cui and J.-X. Lu and A.-Y. Wang and C.-J. Wen and L.-H. Qiu and Y.-J. Yang and D. Lu and X.-Q. Xu and X.-J. Zhu and C.-Y. Cheng and Duolao Wang and Z.-C. Jing",

year = "2023",

month = may,

day = "1",

doi = "10.1164/ajrccm-conference.2023.207.1\_meetingabstracts.a3801",

language = "English",

volume = "2023",

journal = "American Journal of Respiratory and Critical Care Medicine",

issn = "1073-449X",

publisher = "American Thoracic Society",

number = "207",

note = "American Thoracic Society International Conference 2023 ; Conference date: 19-05-2023 Through 24-05-2023",

}

Wu, X-H, Li, J-Y, Ma, J-L, Liu, Q-Q, Wang, L, Zhu, Y-J, Cui, Y, Lu, J-X, Wang, A-Y, Wen, C-J, Qiu, L-H, Yang, Y-J, Lu, D, Xu, X-Q, Zhu, X-J, Cheng, C-Y, Wang, D & Jing, Z-C 2023, 'Coronavirus Disease Vaccination In Patients With Pulmonary Hypertension: A National Prospective Cohort Study', American Journal of Respiratory and Critical Care Medicine, vol. 2023, no. 207, eA3801. https://doi.org/10.1164/ajrccm-conference.2023.207.1_meetingabstracts.a3801

TY - JOUR

T1 - Coronavirus Disease Vaccination In Patients With Pulmonary Hypertension: A National Prospective Cohort Study

AU - Wu, X.-H.

AU - Li, J.-Y.

AU - Ma, J.-L.

AU - Liu, Q.-Q.

AU - Wang, L.

AU - Zhu, Y.-J.

AU - Cui, Y.

AU - Lu, J.-X.

AU - Wang, A.-Y.

AU - Wen, C.-J.

AU - Qiu, L.-H.

AU - Yang, Y.-J.

AU - Lu, D.

AU - Xu, X.-Q.

AU - Zhu, X.-J.

AU - Cheng, C.-Y.

AU - Wang, Duolao

AU - Jing, Z.-C.

PY - 2023/5/1

Y1 - 2023/5/1

N2 - Rationale:COVID-19 has potential risks for both the clinical course and mortality among patients with pulmonary hypertension(PH), with vaccines play an important role in preventing this pandemic. The PH patients are mostly ruled out from vaccine trials, so data still lacking regarding the protective role of vaccination among this population. This study aimed to assess the safety of approved vaccination for patients with PH. Methods:In this national prospective cohort study, patients diagnosed with PH (World Health Organization [WHO] groups 1 and 4) from 3 national referral centers in China were included between October 2021and March 2022.Patients were asked vaccination status and stratified into vaccinated (VAC) and un-vaccinated (unVAC) groups. unVAC group was followed up for 4 months while VAC group were followed up for 3 months after vaccination completion. The primary outcome was the composite of PH-related major adverse events. Inverse probability weighting (IPW) approach was used to control for possible confounding factors in the baseline patient characteristics. Results:Totally 706 patients participated(mean age, 40.3 years; mean duration after diagnosis, 8.2 years). All patients underwent standardized treatment for PH in accordance with guidelines. 278 patients did not receive vaccination, whereas 428 patients completed the vaccination series. Overall, 398 patients received inactivated vaccines (CoronaVac), whereas 30 received protein subunit vaccines (ZF2001). None of the participants were infected with COVID-19 during our study. After adjusting for baseline covariates using IPW approach, the odds of having any adverse events due to PH in VAC group did not increase (6.3% versus 8.5%, odds ratio=0.72, p=0.3).Approximately half of the vaccinated patients reported at least one post-vaccination side effect, most of which were mild, including pain at the injection site (37·1%), fever (2·6%), and fatigue (6·1%). Conclusions: COVID-19 vaccination did not augment the PH-related major adverse events for patients with WHO groups 1 and 4 PH, although there were some tolerable side effects. A large-scale randomized controlled trial is warranted to confirm this finding. The final approval of the COVID-19 vaccination for patients with PH as a public health strategy is promising.

AB - Rationale:COVID-19 has potential risks for both the clinical course and mortality among patients with pulmonary hypertension(PH), with vaccines play an important role in preventing this pandemic. The PH patients are mostly ruled out from vaccine trials, so data still lacking regarding the protective role of vaccination among this population. This study aimed to assess the safety of approved vaccination for patients with PH. Methods:In this national prospective cohort study, patients diagnosed with PH (World Health Organization [WHO] groups 1 and 4) from 3 national referral centers in China were included between October 2021and March 2022.Patients were asked vaccination status and stratified into vaccinated (VAC) and un-vaccinated (unVAC) groups. unVAC group was followed up for 4 months while VAC group were followed up for 3 months after vaccination completion. The primary outcome was the composite of PH-related major adverse events. Inverse probability weighting (IPW) approach was used to control for possible confounding factors in the baseline patient characteristics. Results:Totally 706 patients participated(mean age, 40.3 years; mean duration after diagnosis, 8.2 years). All patients underwent standardized treatment for PH in accordance with guidelines. 278 patients did not receive vaccination, whereas 428 patients completed the vaccination series. Overall, 398 patients received inactivated vaccines (CoronaVac), whereas 30 received protein subunit vaccines (ZF2001). None of the participants were infected with COVID-19 during our study. After adjusting for baseline covariates using IPW approach, the odds of having any adverse events due to PH in VAC group did not increase (6.3% versus 8.5%, odds ratio=0.72, p=0.3).Approximately half of the vaccinated patients reported at least one post-vaccination side effect, most of which were mild, including pain at the injection site (37·1%), fever (2·6%), and fatigue (6·1%). Conclusions: COVID-19 vaccination did not augment the PH-related major adverse events for patients with WHO groups 1 and 4 PH, although there were some tolerable side effects. A large-scale randomized controlled trial is warranted to confirm this finding. The final approval of the COVID-19 vaccination for patients with PH as a public health strategy is promising.

U2 - 10.1164/ajrccm-conference.2023.207.1_meetingabstracts.a3801

DO - 10.1164/ajrccm-conference.2023.207.1_meetingabstracts.a3801

M3 - Meeting Abstract

SN - 1073-449X

VL - 2023

JO - American Journal of Respiratory and Critical Care Medicine

JF - American Journal of Respiratory and Critical Care Medicine

IS - 207

M1 - eA3801

T2 - American Thoracic Society International Conference 2023

Y2 - 19 May 2023 through 24 May 2023

ER -

Coronavirus Disease Vaccination In Patients With Pulmonary Hypertension: A National Prospective Cohort Study

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