21 February 2021
Pharmaceutical company Pfizer Malaysia Sdn Bhd will have to submit data to verify that its Covid-19 vaccine can be stored at standard freezer temperatures (-20 degrees Celsius) for two weeks.
Science, Technology and Innovation Minister Khairy Jamaluddin said the latest approval by the United States Food and Drug Authority on the matter needs to verified by the National Pharmaceutical Regulatory Authority (NPRA) for further action.
“Although this would help with our logistics management, the conditional license given to (Pfizer) is based on -80 degrees Celsius storage conditions.”
“Pfizer has to submit new data that the vaccine is stable after being stored at -20 degrees Celsius over two weeks.”
The US Food and Drug Administration reviewed data submitted by the developers on the stability of the doses at normal freezer temperatures (-25 degrees Celsius to -15 degrees Celsius), and on Feb 25, the agency issued new guidance that says the vaccine can be safely shipped and stored for up to two weeks at these relatively higher temperatures.
On the 182,250 Pfizer-BioNTech vaccine doses which were initially scheduled to arrive this Wednesday, Khairy said that updates on the vaccine’s arrival schedule would be provided next week.
Meanwhile, on the Johnson & Johnson Covid-19 vaccine, Khairy said the Health Ministry is looking at the developer’s terms sheet, to study the legalities of the procurements among others.
“I have asked that it be sped-up so that it can be signed by the Health Minister.”
On Sinovac’s vaccine (CoronaVac), Khairy said that NPRA will not conduct human trials as part of the regulatory approval for the vaccine.
He said in the case of Pfizer, it was approved very quickly because the data was given quickly and published in peer-reviewed journals
Khairy said the data provided was also transparent and widely available.
“If you publish your data in internationally recognised peer-review journals and it is transparent, the process is faster.”
Khairy said this after witnessing the delivery of CoronaVac, the Covid-19 vaccine manufactured by China-based Sinovac Life Sciences Co Ltd at the Kuala Lumpur International Airport (KLIA).
The envirotainer – a temperature-controlled container – with 200 litres of the vaccine arrived at 9am at KLIA from Beijing in a Malaysia Airlines Airbus 330-300 aircraft, Flight MH319, bearing the livery of the Jalur Gemilang (national flag).
Present were Foreign Minister Datuk Seri Hishammuddin Hussein; Senior Minister (Security Cluster) Datuk Seri Ismail Sabri Yaakob; and Transport Minister Datuk Seri Dr Wee Ka Siong.