PUTRAJAYA, Nov 16 — The National Pharmaceutical Regulatory Agency (NPRA) has approved the shelf life extension for two COVID-19 vaccines, namely ‘CoronaVac Suspension for Injection COVID-19 Vaccine (Vero Cell), Inactivated’ (CoronaVac) and ‘Comirnaty Concentrate for Dispersion for Injection’ (COMIRNATY).
Health director-general Tan Sri Dr Noor Hisham Abdullah said NPRA had approved the respective applications from Pharmaniaga Lifescience Sdn Bhd and Pfizer (Malaysia) Sdn Bhd.
“The shelf life extension for the products have been given based on the latest stability data submitted by the respective manufacturers,” he said in a statement today.
He said an additional six months was given from the original date printed on the label of the CoronaVac vaccine with the registration number MAL21046125ACSZ.
“The extension of shelf life from six to 12 months is for vaccine vials stored at temperatures of between 2 to 8 degrees Celsius,” he said.
Meanwhile, for the COMIRNATY vaccine, he said a three-month extension was given from the original date printed on the vial.
This involves the variant with the registration number MAL21046125ACSZ from Pfizer Manufacturing Belgium NV, Belgium, and MAL21036039ASZ from manufacturer BioNTech Manufacturing GmbH, Germany.
“The extension of shelf life from six to nine months is for vaccine vials stored at a temperature of between -90 to -60 degrees Celsius,” he said.
He said the shelf life extension also applied retrospectively to all previous stocks.
“The manufacturer has been given six months from the date of approval of the variation application to update the expiry date printed on the vial label for the vaccine product to be manufactured,” he said.
In this regard, Dr Noor Hisham said the Ministry of Health (MOH) would extend the shelf life of vaccine stocks that were still in the ministry’s stockpile.
“This extension also applies to stocks that will be received from manufacturers in the near future,” he said, adding that information on the batch numbers involved can be browsed on the NPRA website at www.npra.gov.my.
