Npra Approves Shelf Life Extensions For Several Covid 19 Vaccines

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The National Pharmaceutical Regulatory Agency (NPRA) has approved shelf-life extensions for several Covid-19 vaccine products in light of new data submitted by their respective manufacturers.
This gives a new shelf life of 15 to 24 months, depending on the vaccine in question, for the vaccines produced by Pfizer, Sinovac, and Cansino Biologics – a move that could help reduce vaccine wastage.
“The approval for the shelf-life extension is retrospective, meaning it is also applicable to all stocks before the shelf-life variation is approved,” said Health Ministry pharmaceutical services senior director Norhaliza A Halim.
She explained that the approved shelf life of pharmaceutical products, including vaccines, must be backed by data from stability studies conducted by its manufacturers.
This meant keeping samples of the product under certain storage conditions for years while testing it to ensure it still meets the required standards for physical characteristics, potency, purity, and stability, despite the passage of time.
Normally, such studies would be conducted for two to three years.
“Since there is an immediate need for Covid-19 vaccines to tackle the spread of Covid-19 that is affecting the world, conditional approval was given for these vaccine products, and manufacturers are allowed to make rolling submissions of stability test data from time to time.
“The latest data will be submitted to the NPRA in the form of a variation application. This data will be evaluated to ensure the quality of the vaccine is still the same as when it was first approved,” she said.
For the most widely used version of the Pfizer vaccine Comirnaty, the new shelf life is 15 months when stored at -90°C to -60°C.
The shelf life for the child formulation of the vaccine is longer at 18 months, and for the ready-to-use “Tris/Sucrose” formulation is 12 months, when stored under the same ultra-cold conditions.
For the CoronaVac vaccine, the new shelf life is 24 months whether it is manufactured by Sinovac in China or Pharmaniaga in Malaysia. This is if it is kept within 2°C to 8°C.
For CanSino Biologics’ Convidecia vaccine, the shelf life is 15 months when kept within 2°C to 8°C. This is applicable to both the single-dose vial version as well as the three-dose vial version.
Due to the retrospective nature of the shelf-life extension, Norhaliza said some vaccines still in use will carry labels indicating an expiry date that has already passed. She said members of the public can consult an NPRA webpage for updated expiry dates for each vaccine batch.
“The products are still safe to use as long as it has not passed the new expiry dates,” she said. - Mkini

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