Incidence rate for side effects of Novavax higher than other COVID vaccines: HSA data

As of May 31, four adverse events were reported from the 2,792 doses of Nuvaxovid administered here, with an incidence of 0.14%. (Reuter file photo)

SINGAPORE — The incidence of suspected adverse events of: Novavax COVID-19 Vaccine According to a report from the Health Sciences Authority (HSA), doses given in Singapore are higher than the other three vaccines under the national vaccination program.

As of May 31, four cases of side effects were reported from the 2,792 doses of Nuvaxovid administered here, with an incidence of 0.14 percent, according to the report published Monday (June 27).

All four were not serious and had reported rash, chest pain, dizziness and vasculitis (inflammation of the blood vessel). “These are largely consistent with what was reported in the clinical trials and are known side effects associated with vaccines,” HSA said.

An adverse reaction is considered serious if it leads to hospitalization, significant impairment of function, life-threatening illness, or death.

Apart from Novavax’s protein-based Nuvaxovid, the other vaccines under the national vaccination program are Sinovac’s inactivated CoronaVac and one of the mRNA vaccines developed by Pfizer-BioNTech and Moderna.

Of the 11,168,800 doses of Pfizer administered, 14,236 cases reported adverse events, with an incidence of 0.13%, of which 841 were severe. In comparison, of the 3,261,656 Moderna doses, 3,077 cases reported side effects, with an incidence of 0.09 percent, of which 191 were serious.

There was no comparative data for the CoronaVac vaccine in the latest HSA report, its 12th in the rollout of COVID-19 vaccines in Singapore

The incidence of adverse events with the CoronaVac vaccine was about 0.08 percent, or 312, of the 392,122 doses administered, according to an earlier HSA report in March. Of these events, 24 were serious.

No reports of myocarditis

While there have been no local reports of myocarditis — or inflammation of the heart muscle — due to Nuvaxovid doses, a small number of such cases have been observed during ongoing global clinical trials, HSA said.

As such, HSA will monitor the incidence of pericarditis — or inflammation of the outer layer of the heart — and myocarditis.

“HSA’s assessment is that while the potential risk of myocarditis with the Nuvaxovid COVID-19 vaccine cannot be ruled out, the benefits of the vaccine in the Singapore context continue to outweigh the risks,” it said.

COVID-19 infection is also known to be associated with myocarditis, with an additional 40 myocarditis events per million people observed in those infected with the virus based on published data, HSA said.

As a precaution, those vaccinated with Nuvaxovid should avoid strenuous physical activity or exercise for two weeks after the dose to reduce the risk of myocarditis, such as running, lifting weights and competitive sports.

The incidence rates of side effects such as anaphylaxis, myocarditis, pericarditis and cerebral venous thrombosis – blood clotting in the brain – with the mRNA vaccines have stabilizedsaid HSA.

But of the more than 11 million doses of Pfizer administered here, 21 cases of appendicitis — inflammation of the appendix — have been reported, HSA added. All cases with appendicitis were discharged after hospitalization.

A small increase in incidences of appendicitis – two additional cases per 100,000 doses administered – was observed within 21 days of the primary vaccination course of Pfizer vaccine, mainly at 12 to 17 years of age.

According to HSA, no increased incidence of appendicitis has been observed with the booster dose of the vaccine.

The background incidence of appendicitis is estimated to be about 100 per 100,000 people per year. Rare cases of appendicitis have been reported worldwide following vaccination with COVID-19 vaccines.

On Sunday, 92 percent of Singapore’s total population completed their full COVID-19 vaccine regimen, while 78 percent received their booster shots.

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