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KUALA LUMPUR – Between February and September last year, the Health Ministry has identified 25 cases of myocarditis that took place within 21 days of the patients getting their Covid-19 vaccination shots.
The cases were detected based on 433,674 admissions to 216 public and private hospitals that were analysed.
Of the 25 myocarditis cases, 14 were reportedly linked to the Pfizer-BioNTech vaccine, Sinovac (9) and AstraZeneca (2).
The study found that the actual incidence rate of myocarditis per million doses given was 0.9 for among recipients of the Comirnaty (Pfizer-BioNTech) vaccine, 0.5 for CoronaVac (Sinovac) and 0.7 for the Oxford-AstraZeneca vaccine.
Among those under the age of 30, the actual incidence rate of myocarditis was 0.87 per million doses given for Comirnarty and 0.49 for CoronaVac.
Whereas, for individuals aged 30 and above, the actual rate of myocarditis is 1.0 per million doses for Comirnaty and 0.6 for CoronaVac.
It concluded that there was no significant link based on the relative incidence rate of myocarditis during the observation period for all vaccine and age groups.
The Case-Based Monitoring of Adverse Events Following Covid-19 Vaccination (Safecovac) study was carried out by the Institute of Clinical Research, National Institute of Health and the Health Ministry.
The findings of this study are consistent with the continuous AEFI (adverse event following immunisation) pharmacovigilance system by the National Pharmaceutical Regulatory Agency (NPRA) that reported a myocarditis rate of 1.5 incidents per million doses – 0.5 incidence per million doses for ages 18 and older, 0.9 incidence per million doses for ages under 18.
Based on the results of the Safecovac study, data from the AEFI NPRA system and real-world data from the Recovam study, the ministry said the vast majority of reported cases of myocarditis are rare, mild and self-limited.
Meanwhile, the statement issued by the ministry said the Recovam study found that the case rate of Covid-19 per 1,000 population among the unvaccinated group was significantly higher at 36.2 compared to Oxford-AstraZeneca (7.1), Pfizer-BioNTech (6.6) and CoronaVac (11.6) vaccine recipients.
During the observation period from April 1, 2021 to January 9, 2022, Malaysia has reported 2,440,873 Covid-19 cases. This includes 628,627 cases that have been reported to occur among individuals under the age of 20, and of which, 331,991 cases are men.
Concerns of myocarditis following vaccine jabs were raised last year, especially when approvals are given for children between ages five and 11 to receive jabs.
The US FDA said the Comirnarty vaccine would prevent far more hospitalisations from Covid-19 than they might cause from myocarditis.
Recently, Malaysia gave conditional approval to inoculate children between 5 and 11 years old with the Comirnaty vaccine.
Health Director-General Tan Sri Dr Noor Hisham Abdullah said this group of children would be given 10mcg, which is a smaller dose compared with the same vaccine given to those aged 12 and above.
He added that the 30mcg of Comirnaty solution for injection is a new formulation that does not require dilution before it is given to those aged 12 and above.
“This new formulation has a longer shelf life – 10 weeks – compared with the existing formulation (one month) when stored at 2ºC to 8ºC after thawing.” – The Vibes, January 15, 2022