KUALA LUMPUR, Jan 10 – The National Pharmaceutical Regulatory Agency (NPRA) has authorised applications from Covid-19 vaccine developers to extend the shelf life of their shots by three to six months.
Local regulators explained that the expiration period will be extended for the Pfizer-BioNTech vaccine (from six months to nine months), CoronaVac vaccine manufactured by Sinovac, China (from nine months to 12 months), CoronaVac vaccine manufactured by Pharmaniaga Berhad (from six months to 12 months), and CanSino’s Convidecia vaccine (from six months to 12 months).
Norhaliza Halim, the senior director of pharmacy services, said the Ministry of Health (MOH) continuously monitors the supply and expiry dates of Covid-19 vaccines received by vaccine storage centres (PSV) and vaccination centres (PPV) by using the Vaccine Management System (VMS), in addition to the existing inventory system available at the facilities involved in the National Covid-19 Immunisation Programme (PICK).
“Based on the review, no expired vaccine stocks were supplied to PSV or PPV,” Norhaliza said in a statement today.
The shelf life of pharmaceutical products, including Covid-19 vaccine, is set based on the stability test of the vaccine conducted by the manufacturer. The test is performed in real-time for a specific storage temperature, MOH explained.
Covid-19 vaccines were developed in a shorter period of time — less than two years — in response to the outbreak compared to the normal development period of a pharmaceutical product.
Therefore, the MOH noted that the duration of tests conducted to determine the shelf life of the vaccine was limited.
“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 NPRA for evaluation.”
Norhaliza also clarified that the extension of the shelf life of a 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 registered pharmaceutical products.
“The shelf life of Covid-19 vaccine products will also be changed if there is a change in storage temperature. Therefore, a new expiration date will be assigned to the product. The product is still safe to administer as long as it has not passed the new expiration date.”
Norhaliza also highlighted that the MOH is investigating allegations on how some recipients were supposedly given expired Covid-19 vaccines as posted on social media.
“However, some allegations could not be properly investigated because the location and date of the incident, as well as information on the product involved, were not disclosed.”
