PUTRAJAYA – The government has signed the advance purchase agreement for Covid-19 vaccine with Pfizer to get 12.8 million doses of supply to support the immunisation needs for 6.4 million or 20 percent of Malaysians.
Prime Minister, Tan Sri Muhyiddin Yassin said that the deal will ensure that the government has access to data in evaluating the quality, safety and efficacy besides having the guarantee of access to the vaccine once it is ready to be distributed by the company.
He said, on 9 November, Pfizer stated that its first interim data showed a 95 percent of vaccine efficacy.
“Through this agreement, Pfizer also promised to supply one million doses for the first quarter of 2021, followed by 1.7 million doses in the second quarter, 5.8 million doses in the third quarter and 4.3 million doses in the fourth quarter of 2021,” he said in a news conference on the Covid-19 vaccine today.
However, Muhyiddin said that Pfizer still requires the approval of the US Food and Drug Administration (FDA) and other regulatory agencies besides getting the approval of National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health Malaysia before the vaccine could be used in Malaysia.
He said, on 22 November, Malaysia, through the Ministry of Health had signed the Covax Facility Agreement to get Covid-19 vaccine to support the immunisation needs of 10 percent of Malaysians.
Therefore, he said that the two agreements are expected to guarantee the access of the Covid-19 vaccine for 30 percent of the people in the country.
After obtaining the vaccine, it would be given in stages by prioritising on high risk groups.
He said, the high risk groups also include frontliners, senior citizens and patients who suffer from non-communicable disease (NCD) such as heart diseases, diabetes, chronic respiratory diseases and such. After that, the vaccine will be extended to other target groups.
Meanwhile, Muhyiddin also said that the Ministry of Health (MOH) and the Ministry of Science, Technology and Innovation (MOSTI) are still actively engaging with other vaccine producers to gain sufficient access to Covid-19 vaccine for Malaysians.
In a relevant development, he said that the MOH will be starting the third phase of clinical trial on the vaccine through the government’s initiative (G2G) with the government of the People’s Republic of China (PRC).
He said, the vaccine s developed by the Institute of Medical Biology Chinese Academy of Medical Sciences (IMBCAMS).
“The third phase clinical trial will involve 3,000 participants and it would evaluate the safety and efficacy of that Covid-19 vaccine.
“The research is expected to begin in December 2020 and it will be managed by the local Clinical Research Organisation (CRO) and it has been registered under the National Medical Research Registry (NMRR),”
He further shared that the safety profile of the vaccine will be studied by the NPRA to obtain the Clinical Trial Import License (CTIL) and the research protocols will be evaluated by the Medical Review & Ethics Committee (MREC) to ensure that the research concurs to the guidelines set by the MOH.
The third phase of studies will involve eight clinical research centres under the MOH.
“The government would like to extend our highest appreciation to IMBCAMS which will be collaborating to run the third phase of clinical trial in Malaysia.
“The government also wish to give its guarantee to all Malaysians that the vaccines used in Malaysia would pass stringent regulations set by the NPRA. The government will never compromise on that,” he said. –MalaysiaGazette