10 cases of serious adverse events reported in children aged 5 to 11 after COVID-19 vaccine jab: HSA
A girl holding on to her mother while getting a vaccine shot on Dec 27, 2021. (Photo: CNA/Hanidah Amin)
SINGAPORE: Ten cases of serious adverse events have been reported in
children aged five to 11 who have taken their COVID-19 vaccine as of end-January, said the Health Sciences Authority (HSA) on Wednesday (Feb 23).
These reports included seizures, appendicitis, drop in blood pressure, allergic reaction, abnormal renal function and swelling of small blood vessels, said HSA. So far, no cases of myocarditis or pericarditis have been reported in this age group.
The COVID-19 vaccination programme was rolled out to children aged five to 11
on Dec 27 and the Pfizer-BioNTech/Comirnaty dose is the only approved vaccine for this age group.
As of end-January, 238,253 doses have been administered to children in this age group. The reporting rate of serious adverse events in this age group is at 0.004 per cent of the administered doses, said HSA.
The authority added, however, that the reports do not "necessarily mean that the vaccine has caused these serious (adverse events) as they may be related to an underlying or undiagnosed disease or it may be coincidental that they occurred around the same time that the vaccine was given".
"HSA is closely monitoring the (adverse events) reported in children and is assessing them in the context of background incidence rates," it added.
In all, 280 adverse events have been reported in this age group, representing 0.12 per cent of the doses that were administered. Common side effects include swelling of eyelids, face or lips, dizziness, fever and shortness of breath.
This is the 10th such COVID-19 vaccine safety update, covering the period since the roll-out of the national programme on Dec 30, 2020 to Jan 31, 2022.
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MRNA VACCINES
As of end-January, Singapore has administered 12,755,259 doses of the Pfizer-BioNTech/Comirnaty and Moderna/Spikevax mRNA vaccines, out of which 15,655 suspected adverse events reports were received.
The most common side effects included allergic reactions such as rash or swelling of eyelids, face and lips, dizziness, shortness of breath and fever.
There were also 820 serious adverse events reported, including 88 cases of anaphylaxis and other reactions such as rheumatoid arthritis, severe skin reactions and low platelets and blood clots.
"HSA has assessed that the reporting rate of AEs and serious AEs of 0.12 per cent and 0.006 per cent of administered doses, respectively have remained stable since the roll-out of the COVID-19 vaccines and the overall benefits of the COVID-19 vaccines in preventing COVID-19 and serious complications associated with COVID-19 far outweigh any currently known AEs," said the authority.
(Image: HSA)
NON-MRNA VACCINES
As of Jan 31, a total of 369,083 doses of the Sinovac-CoronaVac vaccine have been administered, with 299 suspected adverse events and 22 serious adverse events reported.
For Sinopharm, 89,350 doses have been administered, with 41 suspected adverse events and six serious adverse events reported.
"The type and number of reports received for different COVID-19 vaccines are not directly comparable as the vaccines have been used in the vaccination programme for different durations of time," said HSA.
(Image: HSA)
BOOSTER DOSES
Since the booster programme was rolled out on Sep 15, a total of 3,194,494 have received these jabs as of Jan 31, said HSA.
In this category, there were 553 adverse events reports (0.03 per cent of doses administered) associated with the use of the PfizerBioNTech/Comirnaty vaccine and 289 such reports (0.03 per cent of doses administered) with the Moderna/Spikevax vaccine.
There were also 73 serious adverse event reports (0.002 per cent of administered doses), of which 15 cases were myocarditis and pericarditis - inflammation of the heart muscles and outer lining of the heart respectively.
ADVERSE EVENTS OF SPECIAL INTEREST
HSA said that it is closely monitoring several adverse events of special interest, including anaphylaxis, myocarditis, pericarditis and cerebral venous thrombosis.
So far, the incidence rate of anaphylaxis reported locally with the vaccines has remained "low and stable" at about 0.89 per 100,000 doses administered, said HSA.
Of the 88 cases of anaphylaxis reported with the mRNA vaccines, all the patients recovered after medical treatment, said the authority.
It added that the number of cases of anaphylaxis associated with the second dose was lower than with the first dose of mRNA vaccines. To date, HSA has not received any cases of anaphylaxis associated with the booster dose.
For myocarditis and pericarditis, HSA said that it has as of end-January received 115 reports following the administration of mRNA vaccines. These cases happen more frequently in younger males below 30 years old, and more often with the second dose, said HSA.
One case of myocarditis with Sinovac-Coronavac vaccine has also been reported.
"Most cases are mild, with individuals reported to have recovered or are recovering," said the authority.
"It should be noted that COVID-19 infection is also known to be associated with myocarditis," HSA added.
There have been rare cases of cerebral venous thrombosis (CVT), or blood clots occurring in the veins of the brain, reported with the mRNA vaccines.
As of end-January, HSA has received 13 suspected reports of cerebral venous thrombosis with such vaccines.
"Vaccines are the best way to protect people from COVID-19 and have already saved many lives," said HSA.
"HSA’s current assessment is that the overall benefits of the Pfizer-BioNTech/Comirnaty, Moderna/Spikevax and Sinovac-CoronaVac COVID-19 vaccines in preventing COVID-19 and serious complications associated with COVID-19 far outweigh any currently known adverse events," it added.
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