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NPRA1985
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Posted by NPRA1985 > 2020-11-28 20:39 | Report Abuse
Malaysia’s agreement with Pfizer void if Covid-19 vaccine fails to be registered with FDA, NPRA — health DG
Malaysia’s preliminary purchasing agreement with pharmaceutical company Pfizer will be void if the latter’s Covid-19 vaccine fails to be registered with the US Food and Drug Administration (FDA) and Malaysia’s National Pharmaceutical Regulatory Agency (NPRA), health director-general (DG) Tan Sri Dr Noor Hisham Abdullah said today.
Azrul said Galen is also concerned about the logistical burden to be shouldered by the MoH because the vaccine requires ultra-cold storage of -70°C, a capacity beyond most existing primary care healthcare facilities.
Therefore, the MoH would be reliant on the availability of suitable storage units at the state level to ensure that the vaccines' cold chain is not interrupted, according to him.
"We expect the most challenging part of the process to be the delivery of vaccines to rural areas. Due to limitations and pragmatic concerns, will urban areas end up being prioritised over rural areas?” Azrul asked.
Azrul said Malaysia needs to review its Budget 2021 allocations, especially those related to Covid-19 vaccination because the scheme involves more than just the cost of the vaccine but also supporting infrastructure expenses.
He said the country needs to ensure that the MoH gets the necessary funds and manpower needed to hit the ground running when the vaccine becomes available in 2021, especially since this vaccine has specific logistical and storage requirements which require investing in related infrastructure and training.
"Are we going to acquire Pfizer's special ice boxes? Have we allocated for the record-keeping system? As it stands, we do not believe that the existing allocations are adequate for the purpose. The health allocations need to be reviewed and increased," Azrul said.
https://www.theedgemarkets.com/article/health-dg-malaysias-agreement-pfizer-will-be-void-if-covid19-vaccine-fails-be-registered-fda