PETALING JAYA: The National Pharmaceutical Regulatory Agency (NPRA) has only recorded two serious reports involving adverse events following immunisation (AEFI) among children aged between five and 11 years old as of Feb 28.

       NPRA director Dr Roshayati Mohamad Sani said these two cases, both aged 10 years old, involved a girl who had existing asthma and a boy with Bell's Palsy or facial paralysis.

       “The asthma case needed immediate hospitalisation and treatment and was subsequently discharged. The boy is also said to be recovering well,” she told a press briefing earlier Wednesday (March 2).

       She also said that a total of 1,763 cases were categorised as serious AEFI as of Feb 25, out of which 596 deaths were reported.

       “An additional death has been recorded since Feb 18 from the 596 cases.

       “The death, however, is not that of the 13-year-old boy who is said to have died weeks after receiving a dose of a Covid-19 vaccine. We have not received any report on this,” Dr Roshayati said.

       She added that NPRA AEFI Reporting System has received a total of 25,445 reports involving 1,275 booster jabs while 94 reports involved children aged five to 11 years old under the vaccination programme.

       The majority of the AEFI or 93% (23,692 reports) were not serious and cases recovered within one to two days. These included those with fever, pain around the injection site, headache, muscle pains and tiredness.

       “We are also monitoring Covid-19 vaccine safety issues, which is identified globally as Adverse Events of Special Interest (AESI).

       “Apart from monitoring reports related to myocarditis/pericarditis and venous thromboembolism with thrombocytopenia, NPRA also monitors other AESI such as anaphylaxis and acute facial paralysis/Bell’s Palsy reported to occur in stages after receiving the Covid-19 vaccine globally.

       “However, based on our monitoring, we have found that these effects were extremely rare, consistent with those reported globally,” she said.

       According to NPRA, as of Feb 25, a total of 751,928 doses of Pfizer-BioNTech (Comirnaty 10mcg) were given to children aged five to 11 years old.

       A total of 94 AEFI reports (0.1 report rate per 1,000 doses, which is lower than the overall AEFI reporting rate of 0.4 per 1,000 doses) were received. The majority, some 97.9 %, involved non-serious side effects.

       As of Feb 25, a total of 14,369,227 booster doses have been administered, as well.