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PUTRAJAYA: The Malaysian government, through the Ministry of Health, has signed a preliminary purchase agreement with the pharmaceutical company Pfizer to obtain 12.8 million doses of Covid-19 vaccines to meet the immunization needs of 20 percent or 6, 4 million Malaysians.
Prime Minister Tan Sri Muhyiddin Yassin said that the agreement, signed on Tuesday (November 24), was aimed at ensuring that the government had access to data to assess the quality, safety and efficacy of the vaccine, while ensuring the access once it was ready for distribution.
“Pfizer stated on November 9 that the first interim data analysis showed that the efficacy of the vaccine was 95 percent.”
“Through this agreement, Pfizer has committed to deliver one million doses, 1.7 million doses, 5.8 million doses, and 4.3 million doses of the Covid-19 vaccine in the first, second, third and fourth quarters of 2021, “he said in a virtual press conference. Here today.
Also present were the Minister of Health, Datuk Seri, Dr. Adham Baba, and the Minister of Science, Technology and Innovation, Khairy Jamaluddin.
However, Muhyiddin said that Pfizer would still need approval from the US Food and Drug Administration (FDA) and regulatory approval from the producing country. These approvals must be obtained in addition to obtaining approval from the National Drug Regulatory Agency (NPRA) of the Ministry of Health for the vaccine to be used in Malaysia.
The prime minister said the government had also signed an agreement with the Covid-19 Vaccine Global Access Facility (COVAX) for 10 percent of Malaysians, adding that with the signing of the two agreements, Malaysia now hopes guarantee access to the Covid-19 vaccine. for 30 percent of Malaysians.
Meanwhile, Muhyiddin said that once in hand, the vaccination process will take place in stages, with priority for high-risk groups prone to Covid-19 infection.
“They include front-line people, the elderly, and patients with non-communicable diseases (NCDs) like heart disease, diabetes, chronic respiratory disease, etc.,” he said.
The prime minister went on to say that the Ministry of Health (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 Ministry of Health would begin phase 3 clinical research of the Covid-19 vaccine developed by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (IMBCAMS) through a government-to-government initiative with China.
The study will involve 3,000 participants and evaluate the safety and efficacy of the vaccine, he said.
He said the study, which is expected to begin next month, will be conducted by the local clinical trials organization (CRO) and has been registered with the National Medical Research Registry (NMRR).
“The safety profile of the vaccine will first be reviewed by NPRA to obtain the Clinical Trials 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 carried out carried out according to the guidelines established by the Ministry of Health, ”he said.
Muhyiddin also said that the study would involve eight clinical research centers under the supervision of the Ministry of Health.
“The government wants to assure people that for the vaccine to be used in Malaysia, it must pass the strict conditions set by the NPRA. The government will never compromise on this matter, ”he said.
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