Malaysia’s agreement with Pfizer void if Covid-19 vaccine fails to be registered with FDA, NPRA — health DG

Malaysia’s agreement with Pfizer void if Covid-19 vaccine fails to be registered with FDA, NPRA — health DG
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KUALA LUMPUR (Nov 28): 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.

Noor Hisham said this via Twitter today following news reports yesterday that the Malaysian government, through the Ministry of Health (MoH), had signed the agreement with Pfizer to obtain 12.8 million doses of its Covid-19 vaccine to meet immunisation needs of 20% or 6.4 million Malaysians.

Bernama, quoting Prime Minister Tan Sri Muhyiddin Yassin, reported that the agreement, signed on Tuesday, aimed to ensure the government had access to data to assess the vaccine’s quality, safety and effectiveness, while also ensuring access once it is ready for distribution.

It was reported that Muhyiddin, however, said Pfizer would still need approval from the FDA and regulatory approval from the producing country, besides approval from the NPRA for the vaccine to be used in Malaysia.

"Pfizer on Nov 9 stated that the first interim data analysis showed that the vaccine's efficacy was at 95%. Through this agreement, Pfizer has pledged to deliver one million doses, 1.7 million doses, 5.8 million doses and 4.3 million doses of Covid-19 vaccines in the first, second, third and fourth quarters of 2021.

“The government also wants to assure the people that the vaccine to be used in Malaysia must pass strict conditions set by the NPRA. The government will never compromise on this matter,” he told a virtual media conference in Putrajaya yesterday.

Today, Azrul Mohd Khalib, the chief executive officer (CEO) of the Galen Centre for Health and Social Policy, said news of Malaysia’s agreement with Pfizer represents a major leap forward in the race towards improving management of the coronavirus epidemic among the Malaysian population.

However, the fight against Covid-19 is a marathon and the Malaysia-Pfizer deal is only the first leg of the race, according to Azrul.

"The Covid-19 vaccine by Pfizer and BioNTech, a two-dose regimen like most of the leading vaccine candidates, is expected to be priced at US$19.50 (about RM79.36) per dose. This would mean that Malaysia has committed to paying an estimated US$249.6 million (over RM1 billion) for 12.8 million doses. 

"However, the investment is worth it if we are able to prioritise and quickly assure protection of our personnel working in essential public services, such as in the health, law enforcement, sanitation and utilities sectors, as well as those vulnerable, such as the elderly and patients with non-communicable diseases,” he said.

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.

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