6 cases of 'non-serious' side effects reported among children aged 5 to 11 who received Covid-19 jab: HSA

SINGAPORE — Six cases of "non-serious" side effects due to Covid-19 vaccination have been reported among children aged five to 11, out of 20,327 doses administered as of Dec 31 last year, said the Health Sciences Authority (HSA).

The six reports comprised of three cases of allergic reactions — namely hives and swelling of the eyelids, face and lips — and one case each of dizziness, fever and fast breathing.

However, no serious suspected adverse events have been reported among children in this age group since vaccinations were extended to them on Dec 27 last year, the authority said in its latest vaccine safety report released on Wednesday (Jan 19).

This is in line with what Senior Minister of State for Health Janil Puthucheary had said earlier this month in Parliament, that the Ministry of Health (MOH) has not received any report of serious adverse events or myocarditis from vaccination in children aged five to 11 as of Jan 7.

He added that most side effects experienced by children after vaccination have been mild, and resolved themselves within days.

Among children between 12 and 18 years old who took messenger ribonucleic acid (mRNA) vaccines, HSA received 1,170 reports of suspected adverse events, which made up 0.18 per cent of the doses administered to them since the rollout of the programme to students on June 3.

Commonly reported cases, which generally resolved within a few days, included shortness of breath, palpitations, chest discomfort and syncope, or fainting and brief episodes of loss of consciousness, the authority added.

There were also 83 serious adverse events reported in this age group, which included allergic reactions, skin conditions, seizures, dizziness, syncope, myocarditis, pericarditis and tachycardia, the authority added. 

HSA’s safety report on Wednesday was its ninth update since Singapore's Covid-19 vaccination exercise began on Dec 30, 2020.

An adverse event in this context is any undesirable medical condition that occurs after vaccination and does not necessarily mean that the vaccine caused it. These have to be reported by healthcare providers to HSA.

Serious adverse events result in hospitalisations, a significant reduction in functioning level, a life-threatening illness, a birth defect or death.

The following are some key points from the latest report.

COMMON ADVERSE EVENTS 

As of Dec 31, a total of 11,490,023 doses of the Pfizer-BioNTech and Moderna mRNA vaccines have been administered, of which 14,729, or 0.13 per cent, resulted in suspected adverse events.

Rash and angioedema, or swelling of eyelids, face and lips, made up almost half of the adverse events reported. 

Other commonly reported adverse events included allergic reactions, dizziness, shortness of breath, chest discomfort, palpitations, fever and pain or swelling at the injection sites, which usually resolve in a few days, HSA said.

There were 747 serious adverse events — or 0.007 per cent of doses administered. Anaphylaxis was the most common serious adverse event, with 87 cases reported. 

Close to 80 per cent of the adverse events were reported in those younger than 60 years old.

HSA attributed this to the more active immune responses of younger people, adding that this is in line with clinical trials of both vaccines.

ADVERSE EVENTS WITH BOOSTER DOSES

Since the national roll-out of the Covid-19 booster vaccination programme on Sept 15 last year, 2,217,161 individuals have received a booster dose as of end-2021.

HSA received 401 adverse event reports — or 0.03 per cent of doses administered — with the Pfizer-BioNTech booster dose, and 172 of such reports, or 0.03 per cent, of Moderna doses.

“Overall, the adverse event reports with the booster doses described similar adverse events associated with Dose 1 and Dose 2 of the mRNA vaccines and there was no observed increase in frequency,” HSA said.

There were 10 cases of myocarditis and pericarditis reported, all of which occurred with the Pfizer-BioNTech/Comirnaty vaccine. HSA noted that a higher proportion of individuals (about 70 per cent) received this vaccine as their booster dose.

“HSA continues to closely monitor the adverse events and will inform the public on any significant events and take relevant regulatory actions as required,” the authority added.

SINOVAC AND SINOPHARM

Out of the 332,379 doses of the Sinovac vaccine administered here so far, there have been 271 reports of adverse events, or about 0.08 per cent of the doses administered.

The commonly reported ones were rash, hives, shortness of breath, chest discomfort, dizziness and the swelling of the eyelids, face and lips.

There were 20 serious adverse events reported, equivalent to 0.006 per cent of the administered doses.

There were 11 reports of anaphylaxis, all occurring in people who had previous allergic reactions with mRNA vaccines or had multiple drug allergies.

The remaining nine serious reports included myocarditis, Bell’s palsy, blood clots, numbness, muscle spasm, vertigo with tinnitus (ringing of the ears) and serious allergic reactions.

Since the Sinopharm vaccine was made available here from Aug 30, there have been 35 suspected adverse event reports. This is 0.05 per cent of the 75,440 doses administered.

The non-serious adverse events included rash, shortness of breath, numbness, syncope, chest discomfort, tinnitus and the swelling of the eyelids, face and lips.

There were four serious adverse event reports of low platelet count and chest pain with visual disturbance, making up 0.005 per cent of doses administered.