KUALA LUMPUR , Jan 19 – The Health Ministry has assured that it is committed to ensuring the quality, safety and effectiveness of vaccines and registered medicines via the quality product monitoring programme and pharmacovigilance.
Health Minister Datuk Seri Dr Adham Baba said in a statement that the ministry would notify the public of the latest developments on the registered vaccines, from time to time.
“Those who experience adverse effects after receiving a vaccine can lodge reports to any healthcare facilities that administer vaccines or submit them to NPRA (the National Pharmaceutical Regulatory Division) through its website,” he said.
He was commenting on a report by the Norwegian Medicines Agency (NMA) on deaths associated with the Pfizer-BioNTech Covid-19 vaccine in Norway.
Dr Adham said NPRA is seeking detailed information from Pfizer (M) Sdn Bhd as the product registration holder and closely monitoring the development of the issue, including actions taken by other international regulatory bodies such as the European Medicines Agency (EMA).
“Based on the initial report issued by the NMA, the deaths were among the elderly with illnesses and had a history of chronic disease.
“Autopsies showed that the recipients (of the vaccine) had suffered fever, nausea and diarrhoea which are normal adverse effects after receiving immunisation and following that vaccination information updates are being carried out to take into account the recipient’s age and health condition,” he said.
Dr Adham said the Covid-19 vaccine produced by Pfizer-BioNTech, COMIRNATY Concentrate For Dispersion For Injection received conditional registration from the Drug Control Authority (PBKD) on January 8, this year.
“The efficacy and safety data for this vaccine was obtained from its third phase clinical trials conducted on 44,000 volunteers, including those aged above 75.
“The trials have shown a 95% success rate of the vaccine in preventing symptomatic Covid-19 infection when it is given in two complete doses within 21 days. Clinical research shows that the adverse effects are tolerable and only temporary,” he added.