The Health Ministry today stressed that no expired vaccines were supplied to vaccine storage (PSV) and vaccination centres (PPV).
Senior director of Pharmaceutical Services Norhaliza A Halim said the Ministry is continuously monitoring supplies and expiry dates of Covid-19 vaccines sent to PSVs and PPVs through the vaccine management system (VMS).
She said, the VMS, was an addition to the existing inventory system at facilities where the Covid-19 National Immunisation Programme was being conducted.
“The Health Ministry is aware of several postings and videos that had gone viral on social media claiming that Covid-19 vaccines given to recipients had or were about to expire.
“In some cases, investigations were unable to be carried out as the location, date and the vaccines used were not properly mentioned,” she said in a statement today.
Norhaliza explained that the shelf life of all pharmaceutical products, including Covid-19 vaccines, was set based on the product stability tests conducted by manufacturers.
“Covid-19 vaccines were developed in a short period of time, less than two years, due to that, a test period to determine the vaccine shelf life was limited.
“Hence, manufacturers were only allowed to put an expiraty date based on how long the stability of the vaccine had been tested in real-time and not by extrapolation,” she said.
She said if the manufacturers have additional data after further testing is carried out, the application to extend the shelf life of the vaccines would be submitted to the National Pharmaceutical Regulatory Agency (NPRA) for evaluation.
“The extension of the vaccine shelf life will only be approved after the evaluation results confirm that it meets the regulatory requirements.
“This also applies to all other pharmaceutical products that are already registered,” she said.
Meanwhile, Norhaliza said NPRA has approved applications to extend the shelf life of Comirnaty (Pfizer) from six to nine months, CoronaVac (Sinovac) that manufactured in China from nine to 12 months, and those manufactured by Pharmaniaga Lifescience Sdn Bhd in Malaysia from six to 12 months.
“Lists of batch numbers involved in extending the shelf life of vaccines have been notified to all health facilities.”
She added that the Ministry is committed to ensuring all pharmaceutical products, including the Covid-19 vaccines, have been evaluated in terms of quality, safety and effectiveness by the NPRA and approved by the Drug Control Authority.
“Benefit-risk evaluations of Covid-19 vaccines that has been granted conditional registration approval is also being carried out from time to time in accordance with latest dates,” she said.