PRESS STATEMENT (IN REPLY TO RONNIE LIU)
I refer to the press statement from the State Assemblyman of Sungai Pelek, titled “Muhyiddin must come clean on the COVID-19 vaccine.” The State Assemblyman has claimed several inaccuracies, allegations, and misrepresentations that require answering in this statement.
I will answer them one by one.
1. The State Assemblyman has alleged that the mRNA vaccine will alter the DNA of a person. He has also questioned whether it will be approved by JAKIM based on the same premise.
Briefly, in our cells, mRNAs (messenger RNAs) are temporary molecules that are made from our genomic DNA before it is translated to make a protein. It is essentially a short-term, temporary message.
In this case, the temporary message instructs the body to produce one of the proteins on the surface of the coronavirus. The immune system will then learn to recognise the virus protein and produce antibodies against it. That’s all the mRNA vaccine does. It does not alter your DNA.
In response to State Assemblyman’s query if JAKIM will approve the vaccine since “it is capable of altering the DNA of a person?” The DNA issue has been addressed above. In addition, I have already stated that JAKIM is part of the Jawatankuasa Khas Jaminan Akses Bekalan Vaksin COVID-19 (JKJAV) which assesses COVID-19 vaccines. Furthermore, Minister in the Prime Minister's Department (Religious Affairs) YB Datuk Seri Dr Zulkifli Mohamad Al-Bakri clarified in Parliament, the Muzakarah (Conference) of the National Fatwa Council will study and deliberate on the matter.
2. The State Assemblyman has also questioned who will be paying for the vaccine. If he read beyond the headlines of the announcement, he would have seen that the Prime Minister has pledged that the Government will fund the public COVID-19 vaccination programme for Malaysians with an initial target of 70% of our population to reach herd immunity. The Malaysian Government has set aside at least RM 3 billion solely for this purpose.
3. The pricing of the Pfizer vaccine is covered by a non-disclosure agreement as each country negotiates directly with the pharmaceutical company. Suffice it to say we are satisfied with the terms and pricing that we have agreed upon. The terms we have reached protect Malaysia’s interests both financially and with regards to the safety of the vaccine.
I can categorically confirm that it is definitely less than the RM100 per dose as assumed by the State Assemblyman.
4. The State Assemblyman also claimed that we are rushing to sign deals with vaccine manufacturers. I can categorically say that this is false. We have been negotiating with vaccine manufacturers since April 2020 when we announced our Science Diplomacy strategy. We are considering all data provided by the companies we are negotiating with in order to make the best, most informed decision. This is just the first of many deals that we are considering. Negotiations are ongoing including with vaccine manufacturers from China (including the manufacturer which the State Assemblyman strongly champions). I would like to emphasise that the vaccines must be deemed safe and efficacious by the National Pharmaceutical Regulatory Agency (NPRA) under MOH before we execute the agreements and begin the vaccination process.
It is important to note that not any one pharmaceutical company will be able to supply vaccines for the entire Malaysian population. This is why the multi-pronged approach to procure a portfolio of vaccines is significant in order to obtain enough doses to meet our herd immunity target of 70% of the population.
5. With regards to the ultra-cold supply chain required; the shipment will be handled and delivered by Pfizer directly.
As for ultra-cold storage, we have ultra-low temperature freezers in universities and research institutes in the country which can be redeployed, if necessary. Pfizer has also shown that the vaccines are stable at 2-8 degree Celsius for five days.
We are also not getting the 12.8 million doses in one shot. They will be staggered throughout the year. Our planning for storage will take the delivery schedule into consideration.
6. MOH’s efforts during the crisis have not only been domestically praised but also internationally recognised. They have been working constantly and consistently to ensure that Malaysians have among the best standards of healthcare in the world. All of us will help where we can.
We are taking a whole-of-government approach to the COVID-19 crisis. It is all hands-on deck. Every one of my Cabinet colleagues is involved in this effort to get us through this pandemic.
On the question as to why I am involved, I co-chair the JKJAV with Health Minister, YB Dato’ Seri Dr Adham Baba. MOSTI is also involved in vaccine negotiations as the ministry in charge of biotechnology. The Malaysia Genome Institute under MOSTI is producing whole genome sequencing and bioinformatics analysis to detect mutations in the genome from COVID-19 samples.
MOSTI is also in the midst of developing a National Vaccine Roadmap. The National Institutes of Biotechnology (NIBM), Malaysia under MOSTI is collaborating with multiple foreign research institutes in vaccine development R&D as well.
I continue to welcome questions and queries on this important national endeavour.
KHAIRY JAMALUDDIN
30 NOVEMBER 2020
https://www.khairykj.com/statements/press-statement-in-reply-to-ronnie-liu
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safety analysis set 在 台灣光鹽生物科技學苑 Facebook 的最佳貼文
【International Live Webinar Series】Strategies for Applying Clinical Trials in Europe歐洲臨床試驗申請策略與佈局
🌍此次學苑特別推出國際線上同步遠距課程,並與德國講師合作,提供學員最新的國際臨床試驗實務課程!
此次課程為系列課程,首堂為”歐洲臨床試驗申請策略與佈局”。對於想往歐洲發展、合作或與歐洲從事臨床試驗的相關公司廠商有很大的幫助!
Date:
Part 1: 2020/12/01 (Tues) 16:30 ~ 18:00 (GMT+8)
Part 2: 2020/12/03 (Thurs) 16:30 ~ 18:00 (GMT+8)
Location:Online Webinar Training
Instructor:Anika Staack, Founder of ARC-TRAICOA / EU-QPPV
【Course Outline】
Part 1 2020/12/01 (Tues) 16:30 ~ 18:00 (GMT+8)
A. Europe – One Union with differences
B. European Clinical Trial Directive
1.Role of national competent authorities
2.Role of ethics committees (central / local)
3.Role of investigator
4.Role of sponsor
5.Role of EMA
C. Planning clinical trials in Europe
1.Analysis of product
a.Indication
b.Patient group
2.Analysis of end points
3 .Analysis of protocol
4.Preparing feasibility
5.Choosing Key Opinion Leaders
6.Sponsor or IIT?
7.Similar studies already running?
Part 2 2020/12/03 (Thurs) 16:30 ~ 18:00 (GMT+8)
A. Applying clinical trial
1.Collecting information you need
2.Establishing study team
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D. Required fulfilment of national data protection laws
E. Considerations
1.Doing it by yourselves
2.Contracting CRO
3.Auditing
F. Upcoming issues: Site and patient recruitment, site resources, patients withdrawal, protocol amendments
G. Final presentation of study reports
Online Course Fees include 2 Webinars, 90 minutes each:
Special Price $160 USD per Person; Original Price $180 USD
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(*2) Certificate of Completed Assessment will be issued only if participant pass the assessment
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Organizer:ARC-TRAICOA
Co-Organizer:Salt and Light Institute
【Target Audience】
(1.) Anyone who is interested in clinical trials in Europe
(2.) Anyone who has experience in working in clinical trials related field such as PI,PM,RA,RD,MA,DM,ST,CRA, CRC,QC,QA, etc)
【Instructor CV】
Anika Staack
Current Position:
Founder of ARC-TRAICOA
EU-Qualified Person for Pharmacovigilance (EU-QPPV)
Local German QPPV Consultant and Speaker
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EU-QPPV / Stufenplanbeauftragte & Group Leader PV at Medice
Senior Drug Safety Manager at ICON
Lead Site Management Associate at PRA
Clinical Research Associate at SKM Oncology
Expertise:
Expertise Databases: European Medicine Agency EudraVigilance and xEVMPD
Quality Assurance: Audits & Inspections, SOP Writing and QA documentation, recalls and product quality
Clinical Trial Management: Feasibility, monitoring, eCRF set-up, database reconciliation, site selection, contract management, patient recruitment, study reports
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Master of Science (Biology)
Email: bioschool@biotech-edu.com Tel: (+886) 02-2545-9721 ext.18
safety analysis set 在 玳瑚師父 Master Dai Hu Facebook 的最佳解答
【玳瑚師父玄學論】 《萬水千山總是情》
Harmonious Love In The Enchanting Mountains & Rivers (English version below)
先以禪宗五祖,弘忍大師,的一首偈,來掀開這文章的序幕。
有情來下種,
因地果還生;
無情亦無種,
無性亦無生。
當吾最初見到這首佛偈時,深深被這首佛偈所吸引。吾也不由自主地當場進入深思維,果真用在勘輿一道裡,對於所有欲學堪輿者,是一種很大的加持。吾能在這一世,再見到這首佛偈,除了自己的因緣以外,還得感恩吾的根本上師,因為吾是從祂的著作中,觀讀到這首佛偈的。如今再寫這首佛偈,依然如此甘甜。但願普天下,所有欲參禪者,欲學勘輿者,能有機緣觀讀到,並心領神會,後再造福一切眾生。
一間旺宅,它本身一定是「有情」的。為什麼一定要「有情」呢?因為陰陽互配有序,才能結穴蔭後代及自己。而且,真學過陰陽五行之人,必知之甚詳,孤陰孤陽皆不生也。此理用於四柱論命,及待人處世之道上,是相通的。就好比一個孤陰或孤陽的八字,是青燈自守的。那麼,一個人若是極端,不懂變通,鶴立雞群,此類人物,也是不生不旺的格局。
堪輿指的「有情」,不是指男對女,女對男產了好感,又或者產生了情愫,就叫有情。不是的,絕對不是這樣的。我們要想學會如何確認陰陽宅「有情」或「無情」,除了師父的傳授,我們本身也必需積累實地考察的經驗,才能夠完全掌握「有情」與「無情」。
總而言之,統而言之,有情則旺,無情則衰。堪輿學就是山川流水的大智慧,官人掌權柄、道人得長安、健康富貴平安均包含。學堪輿者,心中要有萬水千山總是情的概念。
--------------------
Allow me to quote this verse from the Fifth Patriarch of Zen Buddhism tradition, Master Hong Ren, as the curtain raiser for this article:
When sentient beings sow their karmic seeds,
they shall reap the fruits of their efforts;
Inanimate objects, lacking seeds,
have neither Buddha-essence nor life force.
When I first read this Dharma verse, I was deeply attracted to it, and at that very moment, it inevitably set me into a deep contemplation. In truth, this verse, when applied to the field of Feng Shui, is a great empowerment to all who are keen to learn this art. Besides my own affinity, I am extremely grateful to my Root Guru Master that I was able to read this verse from His books. The same feeling of sweetness from the nectar of Truth remains, even as I wrote this verse here. I pray that all practitioners of the Zen Buddhism as well as the art of Feng Shui would have the affinity to read and fully understand the essence of this verse, and in doing so, bring benefits to all sentient beings.
An auspicious residence must be endearing and harmonious. Why must this be so? Because when the Yin and the Yang are in complementary alignment, a meridian point will form, which facilitates the prosperity of yourself and your descendants. Also, for those who have truly learned the principles of the Yin and Yang and the Five Elements, you ought to know that an absolute Yin or absolute Yang does not induce growth. You can apply this principle in Bazi (birth chart) analysis, your interpersonal relationships and the way you treat others. Take for an example, a person with an absolute Yin or absolute Yang Bazi will live a life of solitude. On the same thread, if a person is extreme in his or her character, and not flexible to change, sticking out like a sore thumb, he or she will not prosper either.
The love and endearment that I am talking about here do not refer to the love between a man and a woman, where they develop feelings for each other and romance ensues. No, that is definitely not the case here. What we want to learn is how to determine if a Yin or Yang premises has energies of harmony and affection to prosper the occupants. Besides receiving teachings from Master, we need to get out there and accumulate real-life experience through field studies, in order to achieve mastery in this area.
All in all, you will prosper in a house with affection and harmony, and flounder in one without. The art of Feng Shui is the great wisdom hidden in the mountains, valleys, lakes and rivers. It can empower a office-holder with authority, and bring lasting bliss to a spiritual practitioner. That is not all. Health, wealth, prosperity and safety are all part of the immense benefits Feng Shui can bring you. For those who are learning Feng Shui, please hold dear to this mantra: Affection and harmony lies in the alluring mountains and rivers.
www.masterdaihu.com/love-in-the-enchanting-mountains-rivers/
Photo credit: Charles Vicky, Google