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Risk of serious adverse events after the BNT162b2, CoronaVac, and ChAdOx1 vaccines in Malaysia: A self-controlled case series study.
Ab Rahman, Norazida; Lim, Ming Tsuey; Lee, Fei Yee; Lee, Sing Chet; Ramli, Azuana; Saharudin, Siti Nurhafizah; King, Teck Long; Anak Jam, Emelyne Bani; Ayub, Nor Aliya; Sevalingam, Raj Kumar; Bahari, Rashidah; Ibrahim, Nor Nadziroh; Mahmud, Fatihah; Sivasampu, Sheamini; Peariasamy, Kalaiarasu M.
  • Ab Rahman N; Institute for Clinical Research, National Institutes of Health, Selangor, Malaysia. Electronic address: norazida@crc.gov.my.
  • Lim MT; Institute for Clinical Research, National Institutes of Health, Selangor, Malaysia.
  • Lee FY; Institute for Clinical Research, National Institutes of Health, Selangor, Malaysia.
  • Lee SC; National Pharmaceutical Regulatory Agency, Selangor, Malaysia.
  • Ramli A; National Pharmaceutical Regulatory Agency, Selangor, Malaysia.
  • Saharudin SN; Clinical Research Centre, Shah Alam Hospital, Selangor, Malaysia.
  • King TL; Clinical Research Centre, Sarawak General Hospital, Sarawak, Malaysia.
  • Anak Jam EB; Clinical Research Centre, Queen Elizabeth II Hospital, Sabah, Malaysia.
  • Ayub NA; Clinical Research Centre, Kuala Lumpur Hospital, Kuala Lumpur, Malaysia.
  • Sevalingam RK; Clinical Research Centre, Kuala Lumpur Hospital, Kuala Lumpur, Malaysia.
  • Bahari R; Clinical Research Centre, Putrajaya Hospital, Putrajaya, Malaysia.
  • Ibrahim NN; Clinical Research Centre, Putrajaya Hospital, Putrajaya, Malaysia.
  • Mahmud F; Clinical Research Centre, Tengku Ampuan Afzan Hospital, Pahang, Malaysia.
  • Sivasampu S; Institute for Clinical Research, National Institutes of Health, Selangor, Malaysia.
  • Peariasamy KM; Institute for Clinical Research, National Institutes of Health, Selangor, Malaysia.
Vaccine ; 40(32): 4394-4402, 2022 07 30.
Статья в английский | MEDLINE | ID: covidwho-1946788
ABSTRACT

BACKGROUND:

Rapid deployment of COVID-19 vaccines is challenging for safety surveillance, especially on adverse events of special interest (AESIs) that were not identified during the pre-licensure studies. This study evaluated the risk of hospitalisations for predefined diagnoses among the vaccinated population in Malaysia.

METHODS:

Hospital admissions for selected diagnoses between 1 February 2021 and 30 September 2021 were linked to the national COVID-19 immunisation register. We conducted self-controlled case-series study by identifying individuals who received COVID-19 vaccine and diagnosis of thrombocytopenia, venous thromboembolism, myocardial infarction, myocarditis/pericarditis, arrhythmia, stroke, Bell's Palsy, and convulsion/seizure. The incidence of events was assessed in risk period of 21 days postvaccination relative to the control period. We used conditional Poisson regression to calculate the incidence rate ratio (IRR) and 95% confidence interval (CI) with adjustment for calendar period.

RESULTS:

There was no increase in the risk for myocarditis/pericarditis, Bell's Palsy, stroke, and myocardial infarction in the 21 days following either dose of BNT162b2, CoronaVac, and ChAdOx1 vaccines. A small increased risk of venous thromboembolism (IRR 1.24; 95% CI 1.02, 1.49), arrhythmia (IRR 1.16, 95% CI 1.07, 1.26), and convulsion/seizure (IRR 1.26; 95% CI 1.07, 1.48) was observed among BNT162b2 recipients. No association between CoronaVac vaccine was found with all events except arrhythmia (IRR 1.15; 95% CI 1.01, 1.30). ChAdOx1 vaccine was associated with an increased risk of thrombocytopenia (IRR 2.67; 95% CI 1.21, 5.89) and venous thromboembolism (IRR 2.22; 95% CI 1.17, 4.21).

CONCLUSION:

This study shows acceptable safety profiles of COVID-19 vaccines among recipients of BNT162b2, CoronaVac, and ChAdOx1 vaccines. This information can be used together with effectiveness data for risk-benefit analysis of the vaccination program. Further surveillance with more data is required to assess AESIs following COVID-19 vaccination in short- and long-term.
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Полный текст: Имеется в наличии Коллекция: Международные базы данных база данных: MEDLINE Основная тема: COVID-19 Vaccines / COVID-19 Тип исследования: Экспериментальные исследования / Наблюдательное исследование / Прогностическое исследование Темы: Вакцина Пределы темы: Люди Страна как тема: Азия Язык: английский Журнал: Vaccine Год: 2022 Тип: Статья

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Полный текст: Имеется в наличии Коллекция: Международные базы данных база данных: MEDLINE Основная тема: COVID-19 Vaccines / COVID-19 Тип исследования: Экспериментальные исследования / Наблюдательное исследование / Прогностическое исследование Темы: Вакцина Пределы темы: Люди Страна как тема: Азия Язык: английский Журнал: Vaccine Год: 2022 Тип: Статья