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

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 (pictured) said today.

Dr 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.

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