KUCHING, Jan 10: The Ministry of Health (MOH) gives assurance that no expired vaccines are supplied to vaccine storage centres (PSVs) or vaccination centres (PPVs).
Its pharmaceutical services senior director Norhaliza A Halim said the ministry is continuously monitoring the supplies and expiration dates of Covid-19 vaccines received by PSVs and PPVs using the Vaccine Management System (VMS), apart from the existing inventory system at the facilities involved in the Covid-19 National Immunisation program (Pick).
“The ministry is aware of the posts and videos that has gone viral on social media regarding the allegation that Covid-19 vaccines given to recipients had or are about to expire.
“However, some allegations could not be properly investigated because information about the location and date of the incident as well as the product information involved were not disclosed,” she said in a statement today.
Norhaliza noted the determination of the shelf life of pharmaceutical products including Covid-19 vaccines is prescribed based on the stability test conducted by the vaccine manufacturer.
She explained that the test is performed in real-time for storage at a specific temperature.
According to her, Covid-19 vaccines were developed over a shorter period of time (less than two years) in response to the outbreak compared to the typical development period of a pharmaceutical product.
“Therefore, the duration of tests conducted to determine the shelf life of the vaccine is limited.
“The manufacturer is only allowed to put an expiration date based on how long the stability of the vaccine has been tested in real time and not by extrapolation,” she explained.
Norhaliza said 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 National Pharmaceutical Regulatory Division (NPRA) for evaluation.
She also said the extension of the shelf life of the vaccine product will only be approved after the evaluation results confirm that it meets the regulatory requirements.
“In fact, this also applies to all other pharmaceutical products that are already registered,” she added.
Meanwhile, Norhaliza pointed out that NPRA has approved the application for shelf life extension for the Comirnaty vaccine (from 6 months to 9 months), CoronaVac vaccine manufactured by Sinovac, China (from 9 months to 12 months) and CoronaVac vaccine manufactured by Pharmaniaga Lifescience, Malaysia (from 6 months to 12 months).
She said the list of cluster numbers involved in extending the shelf life of the vaccine has been communicated to all health facilities and also through a press statement issued by the MOH on Nov 16, 2021.
“The NPRA has also approved an extension of the shelf life of Convidecia vaccine products from 6 months to 12 months on 17 December 2021,” she said.
Norhaliza also gave assurance that MOH is always committed to ensuring that all pharmaceutical products including Covid-19 vaccines supplied to the people of Malaysia have been evaluated in terms of quality, safety and effectiveness by the NPRA and approved by the Drug Control Authority (DCA).
“Evaluation of the benefits-risks of Covid-19 vaccines granted conditional registration approval is carried out on an ongoing basis based on the latest data from time to time,” she said. — DayakDaily
