KUALA LUMPUR, Jan 6 – The National Pharmaceutical Regulatory Agency (NPRA) has again extended the shelf life of potentially millions of unused Pfizer-BioNTech adult and paediatric Covid-19 vaccine doses.
The NPRA, in two separate announcements published in November and December last year, listed 76 Covid vaccine lots or batches in total comprising Pfizer’s adult and paediatric doses, where the expiration dates were extended by an additional three to six months, respectively.
Last December 20, the NPRA extended the shelf life of Pfizer’s Covid vaccine doses for children ages 5 to 11 years from 12 months to 18 months. Local health regulators approved the extension of shelf life for Pfizer’s adult Covid vaccines last September 13 from 12 months to 15 months, according to a November 16, 2022 announcement.
The extension applies to vaccine doses stored at ultra-low temperatures of -90°C to -60°C.
It is the third time the NPRA has extended the shelf life on Pfizer’s adult Covid-19 vaccines, and the second time for the paediatric vaccines.
In an August 5 announcement last year, the NPRA said both the adult and paediatric doses of the mRNA vaccine were extended from nine to 12 months.
Prior to that, the shelf life on Pfizer’s adult Covid vaccine doses were extended from six to nine months.
Out of the 72 Pfizer Covid adult vaccine lots affected by the latest September 2022 extension, only 15 lots can be used within the next two months – with 13 lots expiring at the end of this month, leaving just two lots unexpired by the end of February.
Most of the other lots had new expiry dates listed from February to December 2022. These vaccine doses were likely already taken before expiry or destroyed upon expiration.
A search on NPRA’s website for individual vaccine lot release certificates of Pfizer’s adult vaccine doses failed to produce any results, making it unclear how many doses each lot contains.
For paediatric vaccines, the NPRA’s December 2022 announcement listed four lots – FP9643, FN4075, FP8290 and FW0201 – that can be used until end April or end June 2023. Each lot is divided into smaller batches that have been distributed to public health facilities nationwide.
Each batch contains a range of about 6,000 doses (for smaller facilities), up to 24,000 doses (for larger facilities such as Tengku Ampuan Rahimah Hospital in Klang, Selangor).
The NPRA has been reviewing expiration dates on all Covid vaccines, including those manufactured by Pfizer and Sinovac, with extensions to certain lots made based on information from drugmakers on how long the shots stay at the right strength.
Last June 23, the NPRA approved an application from Pharmaniaga Lifescience Sdn Bhd, the product registration holder for Sinovac’s Covid-19 vaccines, to extend the shelf life of its vaccine doses from 18 months to 24 months.
The extension of the expiration dates suggests there are 247 Sinovac vaccine lots, each containing between 50,000 to over 650,000 doses, that can be administered as either primary or booster doses between February and September 2023.
The extensions give health providers more time to use the remaining shots as booster doses, amid concerns over a potential wave of infections leading to new coronavirus mutations. The nation is expected to receive stocks of Pfizer’s bivalent Covid-19 vaccines later this month.
The first Covid-19 booster is recommended for those aged 12 years and above, regardless of health status. It can be taken six months after the second dose.
The MOH also recommends second booster jabs for adults aged 18 and above regardless of their health status, as well as pregnant women and health care workers. The second Covid booster dose can be taken six months after the first booster.
The World Health Organization (WHO) had previously appealed to African countries not to destroy Covid-19 vaccines that may have passed their expiry date, the BBC reported.
WHO Africa regional director Matshidiso Moeti urged countries to “store the vaccines safely as we continue to study and try to get definitive advice on whether the vaccines can be used for longer”.
Global vaccine alliance Gavi said manufacturers were extremely cautious of their estimate on how long the Covid vaccines would last. Vaccines were labelled with an expiry date of only three to six months, although most vaccines have an expiry date of around three years.
Several manufacturers have since requested extensions on the shelf life of their vaccines but must provide robust stability data to support their request.
Prime Minister Anwar Ibrahim yesterday said that only five to six million Covid-19 vaccine doses are left in stock in Malaysia, after expired doses were destroyed due to poor demand.
According to KKMNow data, only about half of Malaysia’s total population have received their first Covid booster jab, or about 16.28 million people.
With only five to six million vaccine doses remaining in stock, that will only be sufficient to give a third dose to another 15 to 18 per cent of the population, or 65 per cent to 68 per cent in total.
The first booster coverage will be less should more people take up their second booster. Only 2 per cent of the population, or more than 640,000 people, have received their second booster jab or fourth Covid-19 vaccine dose.
The Ministry of Health (MOH) had previously admitted to Covid-19 vaccine wastage at vaccine centres (PPVs) and at storage facilities due to accidental thawing of vaccines following a cold chain breach. However, the amount of batches affected was not disclosed.
Other Covid-19 vaccines that were months away from expiry were redirected and donated to other countries such as Bangladesh and Laos.