KUCHING, April 24: The Sarawak Health Department today assured that the expired Pfizer-BioNTech Covid-19 vaccine (Comirnaty) being administered was safe and effective for use as this batch of vaccine’s shelf life has been extended for another three months.
State Health director Dr Ooi Choo Huck clarified this following a video describing the use of Covid-19 vaccines that have passed its expiration date going viral on social media recently.
He said the the National Pharmaceutical Regulatory Division (NPRA) has approved and authorised the extension of the expiration date of the Covid-19 Comirnaty vaccine produced by Pfizer-BioNTech with the batch number FK9414 from the original six months to nine months at the storage condition of -90 to -60 degrees Celsius.
“It is extended for an additional three months from the original date printed on the vial label.
“The expiration date printed on the vial numbered FK9414 was 02/2022. The original expiration date was 28 Feb, 2022, and the new expiration date is 31 May, 2022. With that, the vaccine is safe for use until 31 May, 2022,” he explained in a statement issued.
Dr Ooi added that the shelf life of pharmaceutical products including Covid-19 vaccine is determined after manufacturers carried out research on the vaccine’s stability in real-time for a specific storage temperature to ensure its quality.
“The Covid-19 vaccine was developed in less than two years in response to the outbreak compared to the normal development period of a pharmaceutical product.
“Therefore, the duration of the 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.
“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 NPRA for evaluation, which will only approve the extension after evaluation results confirm that it meets the regulatory requirements,” he said.
With that, he added that the shelf life of Covid-19 vaccine products will also change 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.
“This also applies to all other pharmaceutical products that are already registered,” he said.
The public can access the NPRA official website at https://www.npra.gov.my to get detailed information on the batch of vaccines involved (Consumers> Vaccine Lot Release: Lot Release Certificate).
Dr Ooi urged the public not to doubt the safety of the vaccines being administered.
The Sarawak Health Department, he reassured, is always committed in ensuring that the Covid-19 vaccine is of quality as well as safe and effective for use, and most importantly, does not compromise the safety of the public. — DayakDaily