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PUTRAJAYA (Nov 27): The Malaysian government, through the Health Ministry, has signed a preliminary purchasing agreement with pharmaceutical company Pfizer to obtain 12.8 million doses of Covid-19 vaccines to meet the immunisation needs of 20% or 6.4 million Malaysians.

Prime Minister Tan Sri Muhyiddin Yassin said the agreement, signed on Tuesday (Nov 24), aimed to ensure the government had access to data to assess the vaccine’s quality, safety and effectiveness while also ensuring access once it was ready for distribution.

"Pfizer on Nov 9 stated that the first interim data analysis showed that vaccine 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 vaccine in the first, second, third and fourth quarters of 2021,” he told a virtual media conference here today.  

Also present were Health Minister Datuk Seri Dr Adham Baba and Science, Technology and Innovation Minister Khairy Jamaluddin.

Muhyiddin, however, said Pfizer would still need approval from the United States' Food and Drug Administration (FDA) and regulatory approval from the producing country, this besides approval from the Health Ministry's National Pharmaceutical Regulatory Agency (NPRA) for the vaccine to be used in Malaysia.

The prime minister said the government had also inked a deal with the Covid-19 vaccine global access (COVAX) facility for 10% of Malaysians, adding that with the signing of the two agreements, Malaysia now expects to guarantee Covid-19 vaccine access for 30% of Malaysians.

Meanwhile, Muhyiddin said once in hand, the vaccination process will be done in stages, with priority for high-risk groups prone to Covid-19 infection.

"They include frontliners, senior citizens and patients with non-communicable diseases (NCD) such as heart disease, diabetes, chronic respiratory disease and so on," he said.

The prime minister went on to say that the Health Ministry (MoH) and the Ministry of Science, Technology and Innovation (MOSTI) were still actively negotiating with developers globally for adequate access to the vaccine.

Muhyiddin also announced that the MoH would begin Phase 3 clinical research of the Covid-19 vaccine developed by the Institute of Medical Biology Chinese Academy of Medical Sciences (IMBCAMS) via a government-to-government initiative with China.

The study will involve 3,000 participants and will evaluate the vaccine’s safety and effectiveness, he said.

He said the study, which is expected to begin next month, will be conducted by the local clinical studies organisation (CRO) and has been registered in the National Medical Research Register (NMRR).

"The vaccine safety profile will first be reviewed by NPRA to obtain the Clinical Trial Import License (CTIL) and the research protocol will be reviewed by the Medical Research and Ethics Committee (MREC) to ensure that the study will be conducted in accordance with guidelines set by the MoH," he said.

Muhyiddin said the study would also involve eight clinical research centres under the supervision of the MoH.

“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 said.

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