Three suspected ‘adverse events’ reported out of 17,630 Sinopharm Covid-19 vaccine doses, says Singapore Health Sciences Authority

Boxes of Covid-19 vaccine developed by China's Sinopharm company. ― AFP pic
Boxes of Covid-19 vaccine developed by China's Sinopharm company. ― AFP pic

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SINGAPORE, Oct 16 — As of September30, there were a total of three reports of suspected “adverse events” experienced by people who received the Sinopharm Covid-19 vaccine, the Health Sciences Authority (HSA) said.

In its sixth safety report, HSA said yesterday (October 15) that the three reports were out of a total of 17,630 doses of the China-made vaccine administered here since August 30, when the first dose was given. It was approved under HSA’s special access route.

There were also no serious adverse events reported for the vaccine so far, it added.

An adverse event for vaccination is any undesirable medical condition that occurs after taking the vaccine, which does not necessarily have a direct link to it. It may be coincidental or related to an underlying or undiagnosed disease.

These have to be reported by healthcare providers to HSA.

As for the Sinovac-CoronaVac vaccine, HSA said it has received 111 reports of suspected adverse events, including nine serious ones, out of a total of 180,903 doses of the vaccine being administered here since Sept 30.

The 111 reports is an increase from the 90 suspected adverse events stated in HSA’s fifth safety report about a month ago.

Even so, HSA noted that the type and number of reports received for the different Covid-19 vaccines administered here “are not directly comparable” as the vaccines have been rolled out for different durations of time.

“In addition, these vaccines have been administered to a very small proportion, less than 2 per cent, of the population compared to the much larger scale of deployment for the messenger ribonucleic acid (mRNA) vaccines.” 

Safety update for mRNA vaccines

As for the mRNA vaccines from Pfizer-BioNTech and Moderna, which are part of Singapore's national voluntary vaccination programme, HSA said it has received 12,589 reports of suspected adverse events.

This is 0.14 per cent of the more than 8.9 million doses administered as of Sept 30, just marginally more than the 0.13 per cent in the update last month.

About 79 per cent of the suspected adverse events were among people younger than 60 and 67 per cent were women.

Suspected serious adverse events made up 581 or 0.006 per cent of all doses of the mRNA vaccines, the same percentage as stated in the last update.

Reactions in children aged 12 and older

Among children between 12 and 18 years old who took the mRNA vaccines, HSA received 616 reports of suspected adverse events, which make up 0.1 per cent of the doses administered to them since June 3.

This is a slight increase on the 0.08 per cent reported in the previous safety update.

Separately, since booster shots were rolled out to some in the population on Sept 15, 237,746 people have received their third shots.

Of these, HSA received 14 reports of suspected adverse events, including two serious ones.

The serious adverse events described blood clots in the veins of the legs and anaphylaxis, HSA said.

“As the booster dose programme was recently rolled out, HSA continues to closely monitor the adverse events and will inform the public on any significant events that are observed as well as take relevant regulatory actions as required.”

Reactions in serious cases

Out of the 581 serious suspected adverse events related to the mRNA vaccines, the most frequently reported serious reactions were anaphylaxis and other severe allergic reactions.

Other serious suspected adverse events include nerve inflammation, limb numbness, blood clots, chest discomfort and menstrual disorder, among others.

Adverse events of special interest

Anaphylaxis, Bell’s palsy, myocarditis and pericarditis are examples of what HSA terms “adverse events of special interest”, which is a “medically significant event that has been observed historically with other vaccines”.

Anaphylaxis

There were 77 cases of anaphylaxis reported with the Pfizer-BioNTech and Moderna vaccines, and all the patients were reported to have recovered after medical treatment.

The incidence rate of anaphylaxis reported here with the vaccines is about 0.87 for every 100,000 doses administered and this is similar to the incidence rates reported overseas.

Myocarditis and pericarditis

There were 81 cases of myocarditis and pericarditis, which refer to an inflammation of the heart muscle and outer lining of the heart respectively, following more than 8.9 million doses of vaccines administered.

The incidence rate is:

― 5.9 per 100,000 doses for those aged 12 to 19

― 1.8 per 100,000 doses for those aged 20 to 29

― 0,59 per 100,000 doses for those aged 30 and above

HSA said the risk is observed to be higher in younger men than women.

Of the 47 cases observed in those below 30 years old, 43, or 91 per cent, occurred in males.

“There is also a small observed increase in risk for males aged 30 to 49,” HSA said, adding that of the 12 cases observed in those between the ages of 30 and 39, seven occurred in men.

Cerebral venous thrombosis

Cerebral venous thrombosis is a rare type of blood clot that occurs in the veins of the brain.

There were 10 suspected cases of cerebral venous thrombosis reported with the Pfizer-BioNTech and Moderna vaccines.

None of the cases had a fatal outcome, HSA said.

It added that the adverse events reported to be associated with Covid-19 showed an incidence rate of 8.4 per 100,000 in a study here.

Bell’s palsy

There were 103 cases of Bell’s palsy, an inflammation of the facial nerve, reported with the Pfizer-BioNTech and Moderna vaccines, with most reports not being serious.

The local incidence rate is estimated to be 2.4 per 100,000 persons per month, HSA said. ― TODAY

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