June 23, 2022
2 min read
Disclosures: Chan reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.
Immunization with the Pfizer/BioNTech or Sinovac COVID-19 vaccines is not associated with an increased risk for major adverse CV events in people with established CVD, according to data published in Cardiovascular Research.
“Preexisting CVD should not prevent individuals from receiving BNT162b2 or CoronaVac COVID-19 vaccines,” Esther Wai Yin Chan, PhD, FSHP, associate professor in the department of pharmacology and pharmacy and research lead at the Centre for Safe Medication Practice and Research at The University of Hong Kong, told Healio. “It is important that clinical practice and public vaccination programs provide real-world evidence and easy-to-access health information about the potential risks following COVID-19 vaccination and establish the safety profile for each type of vaccine. Our research findings can guide clinicians and members of the general public in their decision-making, especially patients with certain disease history, to weigh the risks and benefits of receiving the vaccine.”
Chan and colleagues analyzed EHR data from 229,235 adults with a history of CVD before February 2021 and a diagnosis of a major adverse CV event between Feb. 23, 2021, and Jan. 31, 2022, with all data linked with vaccine records from the Hong Kong department of health. Major adverse CV events were defined as a composite of MI, stroke, revascularization and CV death. Researchers used a self-controlled case-series method to evaluate risk for major adverse CV events for 0 to 13 and 14 to 27 days after two doses of the COVID-19 vaccine. Researchers estimated incidence rate ratios (IRRs) to compare the risk for major adverse CV events between each risk period and the baseline period.
Within the cohort, 8,529 adults developed a major adverse CV event during the observation period, of which 1,764 received a Pfizer (n = 662) or Sinovac (n = 1,102) COVID-19 vaccine. Researchers observed 82 major adverse CV events within 28 days after the first two doses for the Pfizer vaccine and 115 events after the first two doses for the Sinovac vaccine.
The event-dependent model detected no evidence of an increased risk for major adverse CV events during the 28 days after both doses of the Pfizer or Sinovac vaccines, according to the researchers. For the Pfizer vaccine, IRRs were 0.48 (95% CI, 0.23-1.02) for the first vaccine dose and 0.87 (95%, CI 0.5-1.52) for the second dose during the 0 to 13-day risk period, and 0.4 (95%, CI 0.18-0.93) for the first dose and 1.13 (95%, CI 0.7-1.84) for the second dose during the 14 to 27-day risk period. For the Sinovac vaccine, IRRs were 0.43 (95% CI, 0.24-0.75) for the first dose and 0.73 (95% CI, 0.46-1.16) for the second dose during the 0 to 13-day risk period, and 0.54 (95% CI, 0.33-0.9) for the first dose and 0.83 (95% CI, 0.54-1.29) for the second dose during the 14 to 27-day risk period.
Results persisted in subgroup analyses stratified by sex, age and underlying CV conditions.
“Future research is required to monitor the risk after the third and subsequent doses of vaccination and assess other COVID-19 vaccines,” Chan told Healio.
Other research has also shown that COVID-19 vaccination is safe for people with a history of myocarditis. As Healio previously reported, SARS-CoV-2 vaccination in patients with a history of acute myocarditis was not associated with risk for recurrent myocarditis or other serious side effects.
For more information:
Esther Wai Yin Chan, PhD, FSHP, can be reached at email@example.com; Twitter: @Esther_CSMPRHKU.