KUALA LUMPUR, March 2 – The National Pharmaceutical Regulatory Agency (NPRA) today reported a Bell’s palsy case in the paediatric Covid-19 vaccination programme (PICKids) out of 751,928 Pfizer vaccine doses administered.
Facial paralysis was reported in a 10-year-old boy after he received a Pfizer Covid-19 vaccine dose, the only approved coronavirus shot for children aged five to 11 years in Malaysia.
“He has been reported to be recovering well from the episode,” NPRA pharmacovigilance division head Dr Azuana Ramli told a media briefing on adverse events following immunisation (AEFI) with Covid-19 vaccines today, adding that the boy was hospitalised for just one day to do scans.
She stressed that although Bell’s palsy was found in clinical trials of Pfizer’s mNRA vaccine, the condition could also happen spontaneously in the general population.
When CodeBlue asked if this case was part of the usual incidence rate for Bell’s palsy in Malaysia or if it was linked to the Covid-19 vaccine, Dr Azuana acknowledged the possibility that the case was caused by the vaccine.
“We cannot exclude that it can be related to the vaccine in this case.”
Bell’s palsy – facial muscle weakness or paralysis that usually occurs on one side of the face – is not considered permanent, though it doesn’t disappear in rare cases. Recovery for the condition, which has no known cure, usually begins two weeks to six months from the onset of symptoms. Most people with Bell’s palsy regain full facial strength and expression, according to Johns Hopkins Medicine.
Last August, Canada updated the label on Pfizer’s Covid-19 vaccine to highlight possible Bell’s palsy, but maintained that such cases after vaccination are few and very rare.
Besides the new Bell’s palsy case that is categorised as serious AEFI, NPRA previously reported another serious AEFI in the children’s Covid-19 inoculation programme of exacerbated asthma in a 10-year-old girl who recovered after a few days of hospitalisation.
Overall, the NPRA received 94 AEFI reports in PICKids as of February 25, including the two asthma and Bell’s palsy cases of serious side effects, with the remaining cases comprising mild side effects.
The 94 reports are equivalent to 0.1 reports for every 1,000 doses, lower than the AEFI rate for the overall Covid-19 vaccination programme at 0.4 reports per 1,000 doses.
“The most common side effects reported were fever, stress over injections or the vaccination process, and reactions like skin itchiness, headache, and head pain.”
NPRA received 1,763 reports of serious AEFI in the overall Covid-19 vaccination programme as of February 25, including 596 suspected AEFI deaths.
The 1,763 reports of serious AEFI are equivalent to 26 reports per million doses. Nearly 66.8 million coronavirus vaccine doses have been administered in Malaysia as of February 25.