PETALING JAYA: No expired vaccines have been supplied to vaccine storage centres and vaccination centres (PPVs), the health ministry said.
Senior director of pharmaceutical services Norhaliza Halim said the ministry was continuously monitoring the supply and expiry dates of all Covid-19 vaccines.
This was being done using the vaccine management system, in addition to the existing inventory at facilities involved in the national Covid-19 immunisation programme (PICK).
“The health ministry would like to refer to several postings and videos that have spread on social media regarding allegations that the Covid-19 vaccine given to recipients has or is about to expire.
“Some allegations could not be properly investigated because the location and date of the incident, as well as the product information involved, were not disclosed,” she said in a statement.
Norhaliza also said the National Pharmaceutical Regulatory Agency (NPRA) had approved applications to extend the shelf life of the Pfizer vaccine from six to nine months, Sinovac (manufactured in China) from nine to 12 months, and those manufactured by Pharmaniaga Lifescience Sdn Bhd from six to 12 months.
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She said the list of batch numbers involved in extending the shelf life of vaccines had been notified to all health facilities.
“The health ministry is committed to ensuring that 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 assessment of the Covid-19 vaccines granted conditional registration approval is also carried out on an ongoing basis based on the latest data from time to time,” she said.
She said the shelf life of all pharmaceutical products, including the Covid-19 vaccine, was determined by a product stability test conducted by the manufacturers.
The manufacturer was only allowed to put an expiration date based on how long the stability of the vaccine had been tested in real-time and not by extrapolation.
“If the manufacturer has additional data after further testing is carried out, the application to extend the shelf life of the vaccine will be submitted to the 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.
Norhaliza also said that the shelf life of Covid-19 vaccine products would differ if there was a change in storage temperature.
“Therefore, a new expiration date will be assigned to the product. It will still be safe to administer as long as it has not passed the new expiration date,” she said.
