tetano
Editor, Senior Moderator
J R Soc Med
. 2023 Nov 3:1410768231205430.
doi: 10.1177/01410768231205430. Online ahead of print. Adverse events after first and second doses of COVID-19 vaccination in England: a national vaccine surveillance platform self-controlled case series study
Ruby Sm Tsang[SUP] 1 [/SUP], Utkarsh Agrawal[SUP] 1 [/SUP], Mark Joy[SUP] 1 [/SUP], Rachel Byford[SUP] 1 [/SUP], Chris Robertson[SUP] 2 3 [/SUP], Sneha N Anand[SUP] 1 [/SUP], William Hinton[SUP] 1 [/SUP], Nikhil Mayor[SUP] 4 [/SUP], Debasish Kar[SUP] 1 [/SUP], John Williams[SUP] 1 [/SUP], William Victor[SUP] 5 [/SUP], Ashley Akbari[SUP] 6 [/SUP], Declan T Bradley[SUP] 7 8 [/SUP], Siobhan Murphy[SUP] 7 [/SUP], Dermot O'Reilly[SUP] 7 [/SUP], Rhiannon K Owen[SUP] 6 [/SUP], Antony Chuter[SUP] 9 [/SUP], Jillian Beggs[SUP] 9 [/SUP], Gary Howsam[SUP] 5 [/SUP], Aziz Sheikh[SUP] 10 [/SUP], F D Richard Hobbs[SUP] 1 [/SUP], Simon de Lusignan[SUP] 1 2 [/SUP]
Affiliations
Objectives: To estimate the incidence of adverse events of interest (AEIs) after receiving their first and second doses of coronavirus disease 2019 (COVID-19) vaccinations, and to report the safety profile differences between the different COVID-19 vaccines.
Design: We used a self-controlled case series design to estimate the relative incidence (RI) of AEIs reported to the Oxford-Royal College of General Practitioners national sentinel network. We compared the AEIs that occurred seven days before and after receiving the COVID-19 vaccinations to background levels between 1 October 2020 and 12 September 2021.
Setting: England, UK.
Participants: Individuals experiencing AEIs after receiving first and second doses of COVID-19 vaccines.
Main outcome measures: AEIs determined based on events reported in clinical trials and in primary care during post-license surveillance.
Results: A total of 7,952,861 individuals were vaccinated with COVID-19 vaccines within the study period. Among them, 781,200 individuals (9.82%) presented to general practice with 1,482,273 AEIs. Within the first seven days post-vaccination, 4.85% of all the AEIs were reported. There was a 3-7% decrease in the overall RI of AEIs in the seven days after receiving both doses of Pfizer-BioNTech BNT162b2 (RI = 0.93; 95% CI: 0.91-0.94) and 0.96; 95% CI: 0.94-0.98), respectively) and Oxford-AstraZeneca ChAdOx1 (RI = 0.97; 95% CI: 0.95-0.98) for both doses), but a 20% increase after receiving the first dose of Moderna mRNA-1273 (RI = 1.20; 95% CI: 1.00-1.44)).
Conclusions: COVID-19 vaccines are associated with a small decrease in the incidence of medically attended AEIs. Sentinel networks could routinely report common AEI rates, which could contribute to reporting vaccine safety.
Keywords: Epidemiology; public health; vaccination programmes.
. 2023 Nov 3:1410768231205430.
doi: 10.1177/01410768231205430. Online ahead of print. Adverse events after first and second doses of COVID-19 vaccination in England: a national vaccine surveillance platform self-controlled case series study
Ruby Sm Tsang[SUP] 1 [/SUP], Utkarsh Agrawal[SUP] 1 [/SUP], Mark Joy[SUP] 1 [/SUP], Rachel Byford[SUP] 1 [/SUP], Chris Robertson[SUP] 2 3 [/SUP], Sneha N Anand[SUP] 1 [/SUP], William Hinton[SUP] 1 [/SUP], Nikhil Mayor[SUP] 4 [/SUP], Debasish Kar[SUP] 1 [/SUP], John Williams[SUP] 1 [/SUP], William Victor[SUP] 5 [/SUP], Ashley Akbari[SUP] 6 [/SUP], Declan T Bradley[SUP] 7 8 [/SUP], Siobhan Murphy[SUP] 7 [/SUP], Dermot O'Reilly[SUP] 7 [/SUP], Rhiannon K Owen[SUP] 6 [/SUP], Antony Chuter[SUP] 9 [/SUP], Jillian Beggs[SUP] 9 [/SUP], Gary Howsam[SUP] 5 [/SUP], Aziz Sheikh[SUP] 10 [/SUP], F D Richard Hobbs[SUP] 1 [/SUP], Simon de Lusignan[SUP] 1 2 [/SUP]
Affiliations
- PMID: 37921538
- DOI: 10.1177/01410768231205430
Objectives: To estimate the incidence of adverse events of interest (AEIs) after receiving their first and second doses of coronavirus disease 2019 (COVID-19) vaccinations, and to report the safety profile differences between the different COVID-19 vaccines.
Design: We used a self-controlled case series design to estimate the relative incidence (RI) of AEIs reported to the Oxford-Royal College of General Practitioners national sentinel network. We compared the AEIs that occurred seven days before and after receiving the COVID-19 vaccinations to background levels between 1 October 2020 and 12 September 2021.
Setting: England, UK.
Participants: Individuals experiencing AEIs after receiving first and second doses of COVID-19 vaccines.
Main outcome measures: AEIs determined based on events reported in clinical trials and in primary care during post-license surveillance.
Results: A total of 7,952,861 individuals were vaccinated with COVID-19 vaccines within the study period. Among them, 781,200 individuals (9.82%) presented to general practice with 1,482,273 AEIs. Within the first seven days post-vaccination, 4.85% of all the AEIs were reported. There was a 3-7% decrease in the overall RI of AEIs in the seven days after receiving both doses of Pfizer-BioNTech BNT162b2 (RI = 0.93; 95% CI: 0.91-0.94) and 0.96; 95% CI: 0.94-0.98), respectively) and Oxford-AstraZeneca ChAdOx1 (RI = 0.97; 95% CI: 0.95-0.98) for both doses), but a 20% increase after receiving the first dose of Moderna mRNA-1273 (RI = 1.20; 95% CI: 1.00-1.44)).
Conclusions: COVID-19 vaccines are associated with a small decrease in the incidence of medically attended AEIs. Sentinel networks could routinely report common AEI rates, which could contribute to reporting vaccine safety.
Keywords: Epidemiology; public health; vaccination programmes.