by NURUL SUHAIDI / pic by MUHD AMIN NAHARUL
THE Health Ministry (MoH) is committed to monitoring the supply and expiry dates of Covid-19 vaccines received by the Vaccine Storage Centre (PSV) and Vaccine Delivery Centre (PPV) through the Vaccine Management System.
MoH’s senior director of pharmacy services Norhaliza A Halim was responding to posts and videos circulating social media claiming that the public is being given Covid-19 vaccines that have or are about to expire.
She said some allegations could not be properly investigated since the location and date of the incident, as well as the product information involved, were not disclosed.
“Based on the ministry’s review, no expired vaccine stocks were supplied to the PSV or PPV,” she said in the statement yesterday, adding that MoH also has an additional existing inventory system available at the facilities involved in the National Covid-19 Immunisation Programme.
“The shelf life of pharmaceutical items, like the Covid-19 vaccine, is determined based on the vaccine’s stability test undertaken by the manufacturer in a specified storage temperature, and run in real-time,” Norhaliza said.
In comparison to the standard development duration of a pharmaceutical product, the Covid-19 vaccine was produced in less than two years to respond to the outbreak.
“Therefore, the period of testing to evaluate the vaccine’s shelf life is limited. The producer can only place an expiration date on the vaccination based on how long the vaccine’s stability has been assessed in real-time, not by extrapolation,” she explained in the statement.
Additionally, in the event that the manufacturer has more information after additional testing, the application to prolong the vaccine’s shelf life will be sent to the National Pharmaceutical Regulatory Agency (NPRA) for review.
This means that the vaccine’s shelf life extension will only be permitted if the evaluation results show that it fits regulatory standards.
“This applies to all already-registered pharmaceutical products, not just vaccines,” Norhaliza said.
It is also important to understand that the shelf life of Covid-19 vaccine products will change if there is a change in storage temperature.
Therefore, a new expiration date will be assigned to the product and it is still safe to administer as long as it has not passed the new expiration date.
Commenting further, she clarified that NPRA has approved the life extension of the Comirnaty vaccine from six to nine months; the CoronaVac vaccine manufactured by Sinovac Biotech Ltd in China from nine to 12 months; and the CoronaVac vaccine manufactured by Pharmaniaga Lifescience Sdn Bhd in Malaysia from six and nine months to 12 months.
“All the list of batch numbers involved for the extension has been distributed to health facilities and notified by MoH on Nov 16, 2021,” she said.
In this regard, MoH reiterated that it remained cautious that each and all pharmaceutical products including the Covid-19 vaccine supplied to Malaysia have been evaluated in terms of quality, safety and effectiveness by the NPRA and approved by the Drug Control Authority.
Any evaluation of the benefits and 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.