STATEMENT/ KENYATAAN
By: 20 scientists, doctors, and concerned individuals
Now more than ever, get vaccinated.
One of the increasingly disturbing things about misinformation on Covid-19 vaccines, particularly in the Malaysian context, is the way it is disguised with a veneer of legitimacy through medical credentials and official-sounding sources.
Those questioning the safety of Covid-19 vaccines claim they are not anti-vaxxers. However, the tone of their messages – containing the implicit call to avoid Covid-19 vaccines, even those approved by regulators – is disturbingly similar to vaccine-hesitant people across the board who oppose shots like the measles, mumps and rubella (MMR)vaccine for their children.
Persistent misinformation about the MMR vaccine causing autism (it does not) had originated from a scientific study published by Dr Andrew Wakefield in 1998 in the renowned medical journal, the Lancet. It has since been retracted because the claim was deemed fraudulent. Accuracy of information about Covid-19 vaccines depends on the science and proven data.
Let us be clear. Any approved Covid-19 vaccine is given the greenlight because regulators determine, based on review of clinical trial evidence and data, that it is safe and effective, and carries significantly more benefits than risks. Arguably, it is far more harmful to one’s health to contract Covid-19 than to take an approved vaccine for the disease.
Although the majority of Covid-19 patients in Malaysia experience no or mild symptoms, the Ministry of Health notes that the percentage of people in the moderate to severe stages 3 to 5 has increased from 7 per cent to 11 per cent. For this group of patients, the risk of ventilation and death is very real.
According to the Institute for Clinical Research, 87 per cent of reported Covid-19 deaths in Malaysia had at least one underlying health condition, based on 335 Covid-19 deaths analysed as of November 22. Nearly two-thirds of Covid-19 victims were aged 60 years and above. The mortality rate for people aged 70 years and above is about 9 to 10 per cent, which is substantial.
About 61 per cent of Covid-19 fatalities in Malaysia had high blood pressure, followed by diabetes (41 percent), heart disease (24 per cent), and high cholesterol (19 per cent). There is high prevalence of non-communicable diseases in the adult population: diabetes (18 per cent), hypertension (30 per cent), and high cholesterol (38 per cent), according to the National Health and Morbidity Survey 2019.This means that a large number of young and middle-aged people in Malaysia are at risk of developing severe Covid-19 disease and potentially dying from it.
Immunisation is even more important for these vulnerable groups.
Covid-19 is not a simple flu or respiratory illness. While most people who are infected recover quickly, some patients can have symptoms lasting for weeks, or even months after recovery from acute illness, according to the United States’ Centers for Disease Control and Prevention (CDC). Even people with mild Covid-19 can experience persistent or late symptoms. The most commonly reported long-term symptoms are fatigue, cough, joint and chest pain, among others. Other reported long-term symptoms include difficulty with thinking and concentration (known as “brain fog”), depression, and muscle pain.
Yet more serious long-term complications have also been reported, though these appear to be less common. These include inflammation of the heart muscle, lung function abnormalities, acute kidney injury, dermatologic conditions like rash and hair loss, and neurological conditions like smell and taste problems and sleep issues. Even severe psychotic symptoms have been reported in a small number of Covid-19 patients in the US, UK, and Spain, who had not previously experienced mental health problems.
Prevention is better than cure.
Statements propagating fear-mongering and pseudoscience that attack Covid-19 vaccines’ mRNA (messenger RNA) technologies – which have now been approved by the US’ Food and Drug Administration, the UK’s Medicines and Healthcare Products Regulatory Agency, the European Medicines Agency, and the regulatory bodies of at least seven other countries – risk turning Malaysians off all Covid-19 vaccines entirely, as some may not differentiate between one type of Covid-19 vaccine with another. mRNA and vector-based therapies have actually been used for nearly a decade to treat people with cancer, inherited immunodeficiencies, and metabolic, eye, and neuro-muscular diseases.
While the speed of the development of Covid-19 vaccines is unprecedented, mRNA technology has been around since the early 2000s, while the early proof-of-concept of using gene-based therapeutics to produce the proteins necessary to combat disease was published back in 1990.
Scientists started work as soon as the Covid-19 pandemic hit the world. Large-scale clinical trials were conducted through global collaborative efforts by governments, international institutions, the private sector, research institutions, and non-profits. These Covid-19 vaccine studies have been run with the same scientific rigour as for any other vaccines.
mRNA vaccines do not affect human DNA. The mRNA never enters the nucleus of the cell, where our DNA (genetic material)is kept. The vaccine simply contains instructions to the cell to make a harmless piece of the spike protein on the virus that causes Covid-19. The immune system then attacks this new protein; more importantly, our immune system will remember how it looks like. The vaccine’s mRNA instructions are broken down and later disposed of. When the coronavirus enters our body, our immune system now recognises the spike protein and launches an attack like it did previously, destroying the virus before it can take hold, replicate, and make us sick.
A safe vaccine does not mean it is completely free from side effects or adverse events.
The H1N1 vaccine, for example, was linked with an extremely small risk of Guillain-Barré syndrome (a rare autoimmune disorder causing nerve damage), affecting 1.6 cases among every one million people vaccinated. Natural influenza causes 17 cases of the Guillain-Barré syndrome per million people.
However, vaccination produces overwhelmingly greater benefits to individuals and society than the risks due to adverse reactions. It is because of vaccines that infectious diseases such as polio and measles have been largely eliminated in many countries, or totally eradicated as is the case with smallpox.
This pandemic has ground the global economy to a halt and cost the lives of more than 1.8 million people worldwide. In Malaysia, Covid-19 has killed nearly 500 people. Cases continue to increase and are expected to surge right through 2021 – a vaccine is one possible solution to end the acute phase of the Malaysian epidemic.
Repeated doubts about the government’s procurement of Covid-19 vaccines may contribute to vaccine hesitancy.
Concerns about vaccine procurement and the immunisation programme should be addressed with full transparency and public accountability through Executive oversight by Parliament’s Public Accounts Committee and the Parliamentary Select Committee on Health, Science and Innovation. Persistent suspicion shifts the national discourse away from the more important issues of planning and implementing the inoculation campaign.
The US and the UK are struggling with various challenges in administering the Covid-19 vaccines they have already received. It is highly likely that Malaysia will also encounter similar obstacles rolling out its vaccination programme after we receive the doses ordered.
Critics are free to call for more data and transparency related to all aspects of Covid-19 vaccines. However, such criticism should not be clouded with anti-capitalist sentiment and political ideology.
The National Pharmaceutical Regulatory Agency (NPRA) uses a rigorous and thorough process in evaluating all vaccines and medicines for use in Malaysia.
The critical aspects of a vaccine that we should be concerned with, which have been entrusted to the NPRA, are its efficacy and safety.
There are still many unknowns where the vaccines are concerned. Will the efficacy seen in clinical trials be translated into real-world effectiveness? Many factors affect the effectiveness of a vaccine in the community setting, the largest being the sheer logistics of vaccinating an entire adult population. We hope these vaccines will be the beginning of the end to the Covid-19 nightmare, but more monitoring and data will be required to show this as they are rolled out in our and other nations.
It is important to impress on all of us that receiving the vaccine does not give us the liberty to disregard all the current SOPs.
Caution will still be required and SOPs will need to be maintained as control of Covid-19 is achieved not just locally but also globally.
Malaysia’s national Covid-19 vaccination programme requires an “all-of-society” approach. We must work together to overcome serious immunisation hurdles when the vaccines finally arrive in our country. Fire-fighting constant misinformation and doubt distracts from the work that lies ahead.
Oleh: 20 saintis, doktor dan individu prihatin
Di saat gentir ini, kita perlu mengambil vaksin.
Antara perkara yang membimbangkan adalah keabsahan maklumat mengenai vaksin Covid-19 yang berselindung disebalik tauliah perubatan dan rujukan yang seakan-akan rasmi.
Golongan yang mempersoalkan keselamatan vaksin-vaksin Covid-19 mendakwa mereka bukan ahli anti vaksin. Walaubagaimanapun, kenyataan dan suara mereka membimbangkan kerana mirip kepada golongan yang menentang penggunaan vaksin campak, beguk dan rubella (MMR). Adakah vaksin Covid-19 perlu dihindar walaupun sudah diluluskan oleh pihak berkuasa?
Maklumat menyeleweng kononnya vaksin MMR menyebabkan autisme merujuk kepada hasil kajian Dr Andrew Wakefield yang diterbit jurnal perubatan terkenal Lancet pada tahun 1998. Artikel tersebut terpaksa ditarik balik apabila kajian itu didedahkan sebagai sebuah penipuan. Ketepatan maklumat mengenai vaksin Covid-19 bergantung kepada sains dan data yang telah dibuktikan.
Sebarang vaksin Covid-19 yang diluluskan pihak berkuasa perlu berlandaskan penilaian data dan bukti kajian klinikal yang menunjukkan ianya selamat, berkesan dan membawa lebih banyak faedah daripada risiko. Kesihatan seseorang lebih terjejas akibat dijangkiti COVID-19 daripada menggunakan vaksin yang telah diluluskan.
Walaupun kebanyakan pesakit Covid-19 di Malaysia mengalami samada simptom ringan atau tidak menunjukkan sebarang simptom, Kementerian Kesihatan mendapati peratusan pesakit dalam kelompok sederhana (tahap 3) ke kritikal (tahap 5) meningkat daripada 7 ke 11 peratus. Untuk kumpulan pesakit ini, risiko menghadapi masalah pernafasan dan kematian adalah tinggi.
Menurut Institut Penyelidikan Klinikal, Kementerian Kesihatan Malaysia, 87 peratus kematian Covid-19 di Malaysia yang dianalisa daripada 335 kes kematian COVID-19 sehingga 22 November, mempunyai sekurang-kurangnya satu masalah kesihatan sediada. Hampir dua pertiga daripada mangsa Covid-19 berusia 60 tahun ke atas. Kadar kematian mereka yang berusia 70 tahun dan ke atas adalah ketara, iaitu sebanyak sembilan ke 10 peratus.
Kira-kira 61 peratus daripada mereka yang meninggal akibat Covid-19 di Malaysia menghidapi penyakit darah tinggi, diikuti diabetes (41 peratus), penyakit jantung (24 peratus) dan kolestrol tinggi (38 peratus). Menurut Tinjauan Kebangsaan Kesihatan dan Morbiditi (NHMS) 2019, populasi dewasa di negara ini mempunyai prevalens penyakit tidak berjangkit (NCD) yang tinggi. 18 peratus daripada mereka menghidapi diabetes, hipertensi (30 peratus) dan kolesterol tinggi (38 peratus). Ini bermakna ramai di kalangan golongan muda dan pertengahan umur di Malaysia berisiko dijangkiti Covid-19 dan meninggal dunia.
Imunisasi menjadi lebih penting bagi golongan-golongan rentan ini.
Menurut Pusat Kawalan dan Pencegahan Penyakit Amerika Syarikat, walaupun kebanyakan pesakit yang dijangkiti sembuh dengan cepat, sesetengah daripada mereka mengalami simptom yang berterusan selama berminggu-minggu, malah beberapa bulan selepas dianggap sembuh. Pesakit dengan jangkitan COVID-19 yang ringan juga boleh mengalami simptom yang lewat atau yang berterusan. Simptom jangka panjang yang sering dilaporkan termasuklah keletihan, batuk, sakit pada sendi dan dada. Simptom lain yang juga dilaporkan termasuk kesukaran berfikir dan memberi tumpuan, kemurungan dan sakit otot.
Banyak komplikasi serius jangka masa panjang lain turut dilaporkan. Ini termasuk radang otot jantung, masalah paru-paru, sakit buah pinggang, sakit kulit seperti ruam dan keguguran rambut, masalah saraf seperti gangguan deria rasa dan bau, serta tidak dapat tidur. Malah simptom psikosis yang teruk turut dialami oleh sebilangan kecil pesakit Covid-19, yang sebelum ini tidak mengalami masalah kesihatan mental, di Amerika Syarikat, United Kingdom dan Sepanyol.
Mencegah lebih baik daripada mengubati.
Kenyataan-kenyataan yang menakut-nakutan dan berbau pseudosains serta serangan terhadap teknologi messenger RNA (mRNA) yang digunapakai oleh salah satu daripada vaksin-vaksin tersebut, mampu memberikan kesan negatif kepada masyarakat mengenai vaksin COVID-19 secara amnya. Salah satu daripada vaksin jenis ini telahpun diluluskan oleh Pentadbiran Makanan dan Ubat-ubatan Amerika Syarikat (FDA), Agensi Kawalan Produk Ubat-Ubatan dan Penjagaan Kesihatan United Kingdom (MHRA), Agensi Perubatan Eropah (EMA) dan badan kawal selia daripada sekurang-kurangnya tujuh negara.
Sudah hampir sedekad, terapi mRNA dan penggunaan vektor digunakan bagi merawat pesakit barah, golongan yang mewarisi masalah metabolisme dan kurang daya tahan penyakit, mata, dan penyakit saraf.
Walaupun pembuatan vaksin-vaksin Covid-19 berlaku dalam masa yang begitu singkat, penggunaan teknologi mRNA sudah berlangsung sejak awal 2000. Pembuktian konsep awal penggunaan terapi gen bagi penghasilan protein untuk melawan penyakit pula diterbitkan pada tahun 1990.
Usaha saintifik bermula sejurus pandemic Covid-19 melanda dunia. Ujian klinikal secara besar-besaran dijalankan melalui kerjasama global antara kerajaan, institusi-institusi antarabangsa, sektor swasta, institusi penyelidikan dan badan bukan kerajaan. Penyelidikan keatas vaksin Covid-19 dilakukan dengan perhatian dan penelitian yang sama seperti vaksin-vaksin lain.
Vaksin mRNA tidak memberi kesan kepada DNA manusia. mRNA tidak menembusi nukleus sel di mana DNA (bahan genetik) disimpan. Vaksin jenis ini hanya mengandungi arahan untuk penghasilan sejenis protein yang merupakan sebahagian daripada struktur virus yang menyebabkan Covid-19. Penghasilan komponen ini oleh sel bukan sahaja menyebabkan sistem imun melawan protein tersebut, malah ianya akan membolehkan sistem imun kita mengingati rupa bentuk strukturnya. Ini akan membolehkan serangan dilakukan dengan serta merta apabila kehadiran virus COVID-19 dikesan dalam badan, dan memusnahkannya sebelum ia dapat membiak, dan menjadikan kita sakit. Arahan asal daripada vaksin mRNA akan dilupuskan secara semula jadi.
Vaksin yang selamat tidak bermakna ianya bebas sepenuhnya daripada kemudaratan dan kesan sampingan. Contohnya, vaksin H1N1 mempunyai risiko yang sangat kecil menyebabkan berlakunya sindrom Guillain-Barré (gangguan autoimun yang jarang dijumpa mengakibatkan kerosakan saraf) kepada 1.6 kes dalam setiap satu juta penerima vaksin. Influenza secara semulajadi menyebabkan 17 kes sindrom Guillain-Barré dalam sejuta orang.
Walaubagaimanapun, vaksin memberikan faedah yang lebih besar kepada individu dan masyarakat daripada risiko akibat kesan sampingan. Vaksin adalah sebab penyakit berjangkit seperti polio dan demam campak di kebanyakan negara sudah hampir lenyap, atau sudahpun pupus dalam kes penyakit cacar atau small pox.
Pandemik ini sudah melumpuhkan ekonomi global dan meragut nyawa lebih 1.8 juta orang di seluruh dunia. Di Malaysia, Covid-19 sudah meragut nyawa hampir 500 orang. Kes-kes baru semakin meningkat dan dijangka melonjak pada tahun 2021. Penggunaan vaksin merupakan salah satu penyelesaian kepada epidemik yang melanda Malaysia.
Keraguan melampau dan berterusan mengenai perolehan vaksin Covid-19 oleh kerajaan mungkin menyumbang kepada keraguan masyarakat terhadap vaksin, atau vaccine hesitancy. Kebimbangan mengenai perolehan dan program imunisasi perlu dikemukakan dan ditangani secara telus dan bertanggungjawab oleh pihak Eksekutif kepada Jawatankuasa Kira-Kira Wang Negara dan Jawatankuasa Pilihan Khas Kesihatan, Sains dan Inovasi. Syak wasangka yang berterusan mampu mengalihkan perbincangan nasional daripada isu-isu penting mengenai perancangan dan implementasi kempen vaksin yang akan datang. Negara Amerika Syarikat dan United Kingdom kini bergelut dengan pelbagai cabaran mengurus vaksin Covid-19 yang sudah diterima. Malaysia tidak akan terkecuali dan juga sudah pasti bakal berhadapan dengan halangan-halangan yang sama dalam melaksanakan program vaksinnya.
Para pengkritik perlu bebas meminta untuk ketelusan dan lebih banyak data dikongsi secara terbuka mengenai semua aspek vaksin Covid-19. Walaubagaimanapun, ia perlu bebas daripada sentimen anti-kapitalis dan ideologi politik. Agensi Regulatori Farmasi Negara (NPRA) menggunakan pendekatan yang tegas dan terperinci dalam penilaian semua vaksin dan ubat-ubatan yang digunapakai di Malaysia. Aspek kritikal sebuah vaksin yang perlu kita mengambil berat adalah keselamatan dan keberkesanannya. Penilaian aspek ini telah diamanahkan kepada NPRA.
Masih banyak lagi yang tidak diketahui mengenai vaksin-vaksin tersebut. Adakah keberkesanan yang dilihat dalam ujian klinikal mampu diperolehi apabila vaksin tersebut digunakan secara meluas? Banyak faktor memberi kesan kepada keberkesanan vaksin dalam masyarakat. Yang paling ketara adalah beban logistik yang terlibat dalam usaha memberikan vaksin tersebut kepada seluruh populasi dewasa. Kami berharap berharap vaksin-vaksin ini menjadi titik permulaan kepada penghujung mimpi ngeri Covid-19. Walaubagaimanapun, pemantauan dan pengumpulan data yang berterusan perlu dilakukan ketika vaksinasi dilakukan di negara kita dan negara lain.
Kita perlu beringat bahawa penerimaan sebarang vaksin bukanlah lesen untuk mengabaikan segala prosedur operasi standard (SOP). Kita perlu terus mengambil langkah berjaga-jaga dan sentiasa mengamalkan SOPs. Ini adalah sebahagian daripada langkah kawalan Covid-19 bukan sahaja di Malaysia malah seluruh dunia.
Program vaksinasi Covid-19 kebangsaan memerlukan pendekatan “seluruh rakyat” (“all-of-society”). Kita mesti bersama-sama serius menangani cabaran-cabaran ini apabila vaksin-vaksin tersebut tiba di negara kita. Melawan salah faham maklumat dan kecurigaan yang berterusan mampu mengganggu usaha dan tugas yang akan datang.
- Tan Sri Dr Abu Bakar Suleiman (bekas ketua pengarah kesihatan)
- Prof Datuk Dr Adeeba Kamarulzaman (pakar penyakit berjangkit; Profesor, Jabatan Perubatan, Fakulti Perubatan, Universiti Malaya)
- Datuk Dr Amar-Singh HSS (perunding kanan pediatrik)
- Prof Dr April Camilla Roslani (Dekan, Fakulti Perubatan, Universiti Malaya)
- Mr Azrul Mohd Khalib (Ketua Eksekutif, Pusat Kesihatan dan Polisi Sosial Galen)
- Ms Boo Su-Lyn (Ketua Pengarang CodeBlue)
- Dr John Chew (bekas ahli Majlis Perubatan Malaysia)
- Dr Steven Chow (Presiden, Persatuan Pengamal Perubatan Swasta)
- Ms Daphne Iking (pengamal media sosial dan aktivis kanak-kanak)
- Tan Sri Dr Ismail Merican (bekas ketua pengarah kesihatan)
- Datuk Dr Christopher Lee (bekas timbalan ketua pengarah kesihatan [penyelidikan dan sokongan teknikal]; pakar penyakit berjangkit)
- Dr Lim Teck Onn (bekas pengarah Pusat Penyelidikan Klinikal, Kementerian Kesihatan)
- Prof Datuk Dr Lokman Hakim Sulaiman (Timbalan Naib Canselor (Penyelidikan), Universiti Perubatan Antarabangsa, bekas timbalan ketua pengarah kesihatan [kesihatan awam])
- Dr Milton Lum (bekas presiden Persatuan Perubatan Malaysia)
- Datin Paduka Marina Mahathir (aktivis sosial)
- Datuk Dr Musa Mohd Nordin (pakar pediatrik)
- Assoc Prof Dr Nirmala Bhoo Pathy (Profesor Madya di klinik epidemiologi, Universiti Malaya)
- Prof Dr Rosmawati Mohamed (Sarjana, Akademi Perubatan Malaysia)
- Prof Datuk Dr Subramaniam Muniandy (Presiden, Persatuan Perubatan Malaysia)
- Prof Dr Woo Yin Ling (Profesor, Jabatan Obstretrik dan Ginekologi, Fakulti Perubatan, Universiti Malaya)
— TAMAT —
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English
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By: 20 scientists, doctors, and concerned individuals
Now more than ever, get vaccinated.
One of the increasingly disturbing things about misinformation on Covid-19 vaccines, particularly in the Malaysian context, is the way it is disguised with a veneer of legitimacy through medical credentials and official-sounding sources.
Those questioning the safety of Covid-19 vaccines claim they are not anti-vaxxers. However, the tone of their messages – containing the implicit call to avoid Covid-19 vaccines, even those approved by regulators – is disturbingly similar to vaccine-hesitant people across the board who oppose shots like the measles, mumps and rubella (MMR)vaccine for their children.
Persistent misinformation about the MMR vaccine causing autism (it does not) had originated from a scientific study published by Dr Andrew Wakefield in 1998 in the renowned medical journal, the Lancet. It has since been retracted because the claim was deemed fraudulent. Accuracy of information about Covid-19 vaccines depends on the science and proven data.
Let us be clear. Any approved Covid-19 vaccine is given the greenlight because regulators determine, based on review of clinical trial evidence and data, that it is safe and effective, and carries significantly more benefits than risks. Arguably, it is far more harmful to one’s health to contract Covid-19 than to take an approved vaccine for the disease.
Although the majority of Covid-19 patients in Malaysia experience no or mild symptoms, the Ministry of Health notes that the percentage of people in the moderate to severe stages 3 to 5 has increased from 7 per cent to 11 per cent. For this group of patients, the risk of ventilation and death is very real.
According to the Institute for Clinical Research, 87 per cent of reported Covid-19 deaths in Malaysia had at least one underlying health condition, based on 335 Covid-19 deaths analysed as of November 22. Nearly two-thirds of Covid-19 victims were aged 60 years and above. The mortality rate for people aged 70 years and above is about 9 to 10 per cent, which is substantial.
About 61 per cent of Covid-19 fatalities in Malaysia had high blood pressure, followed by diabetes (41 percent), heart disease (24 per cent), and high cholesterol (19 per cent). There is high prevalence of non-communicable diseases in the adult population: diabetes (18 per cent), hypertension (30 per cent), and high cholesterol (38 per cent), according to the National Health and Morbidity Survey 2019.This means that a large number of young and middle-aged people in Malaysia are at risk of developing severe Covid-19 disease and potentially dying from it.
Immunisation is even more important for these vulnerable groups.
Covid-19 is not a simple flu or respiratory illness. While most people who are infected recover quickly, some patients can have symptoms lasting for weeks, or even months after recovery from acute illness, according to the United States’ Centers for Disease Control and Prevention (CDC). Even people with mild Covid-19 can experience persistent or late symptoms. The most commonly reported long-term symptoms are fatigue, cough, joint and chest pain, among others. Other reported long-term symptoms include difficulty with thinking and concentration (known as “brain fog”), depression, and muscle pain.
Yet more serious long-term complications have also been reported, though these appear to be less common. These include inflammation of the heart muscle, lung function abnormalities, acute kidney injury, dermatologic conditions like rash and hair loss, and neurological conditions like smell and taste problems and sleep issues. Even severe psychotic symptoms have been reported in a small number of Covid-19 patients in the US, UK, and Spain, who had not previously experienced mental health problems.
Prevention is better than cure.
Statements propagating fear-mongering and pseudoscience that attack Covid-19 vaccines’ mRNA (messenger RNA) technologies – which have now been approved by the US’ Food and Drug Administration, the UK’s Medicines and Healthcare Products Regulatory Agency, the European Medicines Agency, and the regulatory bodies of at least seven other countries – risk turning Malaysians off all Covid-19 vaccines entirely, as some may not differentiate between one type of Covid-19 vaccine with another. mRNA and vector-based therapies have actually been used for nearly a decade to treat people with cancer, inherited immunodeficiencies, and metabolic, eye, and neuro-muscular diseases.
While the speed of the development of Covid-19 vaccines is unprecedented, mRNA technology has been around since the early 2000s, while the early proof-of-concept of using gene-based therapeutics to produce the proteins necessary to combat disease was published back in 1990.
Scientists started work as soon as the Covid-19 pandemic hit the world. Large-scale clinical trials were conducted through global collaborative efforts by governments, international institutions, the private sector, research institutions, and non-profits. These Covid-19 vaccine studies have been run with the same scientific rigour as for any other vaccines.
mRNA vaccines do not affect human DNA. The mRNA never enters the nucleus of the cell, where our DNA (genetic material)is kept. The vaccine simply contains instructions to the cell to make a harmless piece of the spike protein on the virus that causes Covid-19. The immune system then attacks this new protein; more importantly, our immune system will remember how it looks like. The vaccine’s mRNA instructions are broken down and later disposed of. When the coronavirus enters our body, our immune system now recognises the spike protein and launches an attack like it did previously, destroying the virus before it can take hold, replicate, and make us sick.
A safe vaccine does not mean it is completely free from side effects or adverse events.
The H1N1 vaccine, for example, was linked with an extremely small risk of Guillain-Barré syndrome (a rare autoimmune disorder causing nerve damage), affecting 1.6 cases among every one million people vaccinated. Natural influenza causes 17 cases of the Guillain-Barré syndrome per million people.
However, vaccination produces overwhelmingly greater benefits to individuals and society than the risks due to adverse reactions. It is because of vaccines that infectious diseases such as polio and measles have been largely eliminated in many countries, or totally eradicated as is the case with smallpox.
This pandemic has ground the global economy to a halt and cost the lives of more than 1.8 million people worldwide. In Malaysia, Covid-19 has killed nearly 500 people. Cases continue to increase and are expected to surge right through 2021 – a vaccine is one possible solution to end the acute phase of the Malaysian epidemic.
Repeated doubts about the government’s procurement of Covid-19 vaccines may contribute to vaccine hesitancy.
Concerns about vaccine procurement and the immunisation programme should be addressed with full transparency and public accountability through Executive oversight by Parliament’s Public Accounts Committee and the Parliamentary Select Committee on Health, Science and Innovation. Persistent suspicion shifts the national discourse away from the more important issues of planning and implementing the inoculation campaign.
The US and the UK are struggling with various challenges in administering the Covid-19 vaccines they have already received. It is highly likely that Malaysia will also encounter similar obstacles rolling out its vaccination programme after we receive the doses ordered.
Critics are free to call for more data and transparency related to all aspects of Covid-19 vaccines. However, such criticism should not be clouded with anti-capitalist sentiment and political ideology.
The National Pharmaceutical Regulatory Agency (NPRA) uses a rigorous and thorough process in evaluating all vaccines and medicines for use in Malaysia.
The critical aspects of a vaccine that we should be concerned with, which have been entrusted to the NPRA, are its efficacy and safety.
There are still many unknowns where the vaccines are concerned. Will the efficacy seen in clinical trials be translated into real-world effectiveness? Many factors affect the effectiveness of a vaccine in the community setting, the largest being the sheer logistics of vaccinating an entire adult population. We hope these vaccines will be the beginning of the end to the Covid-19 nightmare, but more monitoring and data will be required to show this as they are rolled out in our and other nations.
It is important to impress on all of us that receiving the vaccine does not give us the liberty to disregard all the current SOPs.
Caution will still be required and SOPs will need to be maintained as control of Covid-19 is achieved not just locally but also globally.
Malaysia’s national Covid-19 vaccination programme requires an “all-of-society” approach. We must work together to overcome serious immunisation hurdles when the vaccines finally arrive in our country. Fire-fighting constant misinformation and doubt distracts from the work that lies ahead.
4 January, 2021 -
BM
-
Oleh: 20 saintis, doktor dan individu prihatin
Di saat gentir ini, kita perlu mengambil vaksin.
Antara perkara yang membimbangkan adalah keabsahan maklumat mengenai vaksin Covid-19 yang berselindung disebalik tauliah perubatan dan rujukan yang seakan-akan rasmi.
Golongan yang mempersoalkan keselamatan vaksin-vaksin Covid-19 mendakwa mereka bukan ahli anti vaksin. Walaubagaimanapun, kenyataan dan suara mereka membimbangkan kerana mirip kepada golongan yang menentang penggunaan vaksin campak, beguk dan rubella (MMR). Adakah vaksin Covid-19 perlu dihindar walaupun sudah diluluskan oleh pihak berkuasa?
Maklumat menyeleweng kononnya vaksin MMR menyebabkan autisme merujuk kepada hasil kajian Dr Andrew Wakefield yang diterbit jurnal perubatan terkenal Lancet pada tahun 1998. Artikel tersebut terpaksa ditarik balik apabila kajian itu didedahkan sebagai sebuah penipuan. Ketepatan maklumat mengenai vaksin Covid-19 bergantung kepada sains dan data yang telah dibuktikan.
Sebarang vaksin Covid-19 yang diluluskan pihak berkuasa perlu berlandaskan penilaian data dan bukti kajian klinikal yang menunjukkan ianya selamat, berkesan dan membawa lebih banyak faedah daripada risiko. Kesihatan seseorang lebih terjejas akibat dijangkiti COVID-19 daripada menggunakan vaksin yang telah diluluskan.
Walaupun kebanyakan pesakit Covid-19 di Malaysia mengalami samada simptom ringan atau tidak menunjukkan sebarang simptom, Kementerian Kesihatan mendapati peratusan pesakit dalam kelompok sederhana (tahap 3) ke kritikal (tahap 5) meningkat daripada 7 ke 11 peratus. Untuk kumpulan pesakit ini, risiko menghadapi masalah pernafasan dan kematian adalah tinggi.
Menurut Institut Penyelidikan Klinikal, Kementerian Kesihatan Malaysia, 87 peratus kematian Covid-19 di Malaysia yang dianalisa daripada 335 kes kematian COVID-19 sehingga 22 November, mempunyai sekurang-kurangnya satu masalah kesihatan sediada. Hampir dua pertiga daripada mangsa Covid-19 berusia 60 tahun ke atas. Kadar kematian mereka yang berusia 70 tahun dan ke atas adalah ketara, iaitu sebanyak sembilan ke 10 peratus.
Kira-kira 61 peratus daripada mereka yang meninggal akibat Covid-19 di Malaysia menghidapi penyakit darah tinggi, diikuti diabetes (41 peratus), penyakit jantung (24 peratus) dan kolestrol tinggi (38 peratus). Menurut Tinjauan Kebangsaan Kesihatan dan Morbiditi (NHMS) 2019, populasi dewasa di negara ini mempunyai prevalens penyakit tidak berjangkit (NCD) yang tinggi. 18 peratus daripada mereka menghidapi diabetes, hipertensi (30 peratus) dan kolesterol tinggi (38 peratus). Ini bermakna ramai di kalangan golongan muda dan pertengahan umur di Malaysia berisiko dijangkiti Covid-19 dan meninggal dunia.
Imunisasi menjadi lebih penting bagi golongan-golongan rentan ini.
Menurut Pusat Kawalan dan Pencegahan Penyakit Amerika Syarikat, walaupun kebanyakan pesakit yang dijangkiti sembuh dengan cepat, sesetengah daripada mereka mengalami simptom yang berterusan selama berminggu-minggu, malah beberapa bulan selepas dianggap sembuh. Pesakit dengan jangkitan COVID-19 yang ringan juga boleh mengalami simptom yang lewat atau yang berterusan. Simptom jangka panjang yang sering dilaporkan termasuklah keletihan, batuk, sakit pada sendi dan dada. Simptom lain yang juga dilaporkan termasuk kesukaran berfikir dan memberi tumpuan, kemurungan dan sakit otot.
Banyak komplikasi serius jangka masa panjang lain turut dilaporkan. Ini termasuk radang otot jantung, masalah paru-paru, sakit buah pinggang, sakit kulit seperti ruam dan keguguran rambut, masalah saraf seperti gangguan deria rasa dan bau, serta tidak dapat tidur. Malah simptom psikosis yang teruk turut dialami oleh sebilangan kecil pesakit Covid-19, yang sebelum ini tidak mengalami masalah kesihatan mental, di Amerika Syarikat, United Kingdom dan Sepanyol.
Mencegah lebih baik daripada mengubati.
Kenyataan-kenyataan yang menakut-nakutan dan berbau pseudosains serta serangan terhadap teknologi messenger RNA (mRNA) yang digunapakai oleh salah satu daripada vaksin-vaksin tersebut, mampu memberikan kesan negatif kepada masyarakat mengenai vaksin COVID-19 secara amnya. Salah satu daripada vaksin jenis ini telahpun diluluskan oleh Pentadbiran Makanan dan Ubat-ubatan Amerika Syarikat (FDA), Agensi Kawalan Produk Ubat-Ubatan dan Penjagaan Kesihatan United Kingdom (MHRA), Agensi Perubatan Eropah (EMA) dan badan kawal selia daripada sekurang-kurangnya tujuh negara.
Sudah hampir sedekad, terapi mRNA dan penggunaan vektor digunakan bagi merawat pesakit barah, golongan yang mewarisi masalah metabolisme dan kurang daya tahan penyakit, mata, dan penyakit saraf.
Walaupun pembuatan vaksin-vaksin Covid-19 berlaku dalam masa yang begitu singkat, penggunaan teknologi mRNA sudah berlangsung sejak awal 2000. Pembuktian konsep awal penggunaan terapi gen bagi penghasilan protein untuk melawan penyakit pula diterbitkan pada tahun 1990.
Usaha saintifik bermula sejurus pandemic Covid-19 melanda dunia. Ujian klinikal secara besar-besaran dijalankan melalui kerjasama global antara kerajaan, institusi-institusi antarabangsa, sektor swasta, institusi penyelidikan dan badan bukan kerajaan. Penyelidikan keatas vaksin Covid-19 dilakukan dengan perhatian dan penelitian yang sama seperti vaksin-vaksin lain.
Vaksin mRNA tidak memberi kesan kepada DNA manusia. mRNA tidak menembusi nukleus sel di mana DNA (bahan genetik) disimpan. Vaksin jenis ini hanya mengandungi arahan untuk penghasilan sejenis protein yang merupakan sebahagian daripada struktur virus yang menyebabkan Covid-19. Penghasilan komponen ini oleh sel bukan sahaja menyebabkan sistem imun melawan protein tersebut, malah ianya akan membolehkan sistem imun kita mengingati rupa bentuk strukturnya. Ini akan membolehkan serangan dilakukan dengan serta merta apabila kehadiran virus COVID-19 dikesan dalam badan, dan memusnahkannya sebelum ia dapat membiak, dan menjadikan kita sakit. Arahan asal daripada vaksin mRNA akan dilupuskan secara semula jadi.
Vaksin yang selamat tidak bermakna ianya bebas sepenuhnya daripada kemudaratan dan kesan sampingan. Contohnya, vaksin H1N1 mempunyai risiko yang sangat kecil menyebabkan berlakunya sindrom Guillain-Barré (gangguan autoimun yang jarang dijumpa mengakibatkan kerosakan saraf) kepada 1.6 kes dalam setiap satu juta penerima vaksin. Influenza secara semulajadi menyebabkan 17 kes sindrom Guillain-Barré dalam sejuta orang.
Walaubagaimanapun, vaksin memberikan faedah yang lebih besar kepada individu dan masyarakat daripada risiko akibat kesan sampingan. Vaksin adalah sebab penyakit berjangkit seperti polio dan demam campak di kebanyakan negara sudah hampir lenyap, atau sudahpun pupus dalam kes penyakit cacar atau small pox.
Pandemik ini sudah melumpuhkan ekonomi global dan meragut nyawa lebih 1.8 juta orang di seluruh dunia. Di Malaysia, Covid-19 sudah meragut nyawa hampir 500 orang. Kes-kes baru semakin meningkat dan dijangka melonjak pada tahun 2021. Penggunaan vaksin merupakan salah satu penyelesaian kepada epidemik yang melanda Malaysia.
Keraguan melampau dan berterusan mengenai perolehan vaksin Covid-19 oleh kerajaan mungkin menyumbang kepada keraguan masyarakat terhadap vaksin, atau vaccine hesitancy. Kebimbangan mengenai perolehan dan program imunisasi perlu dikemukakan dan ditangani secara telus dan bertanggungjawab oleh pihak Eksekutif kepada Jawatankuasa Kira-Kira Wang Negara dan Jawatankuasa Pilihan Khas Kesihatan, Sains dan Inovasi. Syak wasangka yang berterusan mampu mengalihkan perbincangan nasional daripada isu-isu penting mengenai perancangan dan implementasi kempen vaksin yang akan datang. Negara Amerika Syarikat dan United Kingdom kini bergelut dengan pelbagai cabaran mengurus vaksin Covid-19 yang sudah diterima. Malaysia tidak akan terkecuali dan juga sudah pasti bakal berhadapan dengan halangan-halangan yang sama dalam melaksanakan program vaksinnya.
Para pengkritik perlu bebas meminta untuk ketelusan dan lebih banyak data dikongsi secara terbuka mengenai semua aspek vaksin Covid-19. Walaubagaimanapun, ia perlu bebas daripada sentimen anti-kapitalis dan ideologi politik. Agensi Regulatori Farmasi Negara (NPRA) menggunakan pendekatan yang tegas dan terperinci dalam penilaian semua vaksin dan ubat-ubatan yang digunapakai di Malaysia. Aspek kritikal sebuah vaksin yang perlu kita mengambil berat adalah keselamatan dan keberkesanannya. Penilaian aspek ini telah diamanahkan kepada NPRA.
Masih banyak lagi yang tidak diketahui mengenai vaksin-vaksin tersebut. Adakah keberkesanan yang dilihat dalam ujian klinikal mampu diperolehi apabila vaksin tersebut digunakan secara meluas? Banyak faktor memberi kesan kepada keberkesanan vaksin dalam masyarakat. Yang paling ketara adalah beban logistik yang terlibat dalam usaha memberikan vaksin tersebut kepada seluruh populasi dewasa. Kami berharap berharap vaksin-vaksin ini menjadi titik permulaan kepada penghujung mimpi ngeri Covid-19. Walaubagaimanapun, pemantauan dan pengumpulan data yang berterusan perlu dilakukan ketika vaksinasi dilakukan di negara kita dan negara lain.
Kita perlu beringat bahawa penerimaan sebarang vaksin bukanlah lesen untuk mengabaikan segala prosedur operasi standard (SOP). Kita perlu terus mengambil langkah berjaga-jaga dan sentiasa mengamalkan SOPs. Ini adalah sebahagian daripada langkah kawalan Covid-19 bukan sahaja di Malaysia malah seluruh dunia.
Program vaksinasi Covid-19 kebangsaan memerlukan pendekatan “seluruh rakyat” (“all-of-society”). Kita mesti bersama-sama serius menangani cabaran-cabaran ini apabila vaksin-vaksin tersebut tiba di negara kita. Melawan salah faham maklumat dan kecurigaan yang berterusan mampu mengganggu usaha dan tugas yang akan datang.
4 Januari, 2021Kenyataan ini ditandatangani oleh 20 individu di bawah:- Tan Sri Dr Abu Bakar Suleiman (bekas ketua pengarah kesihatan)
- Prof Datuk Dr Adeeba Kamarulzaman (pakar penyakit berjangkit; Profesor, Jabatan Perubatan, Fakulti Perubatan, Universiti Malaya)
- Datuk Dr Amar-Singh HSS (perunding kanan pediatrik)
- Prof Dr April Camilla Roslani (Dekan, Fakulti Perubatan, Universiti Malaya)
- Mr Azrul Mohd Khalib (Ketua Eksekutif, Pusat Kesihatan dan Polisi Sosial Galen)
- Ms Boo Su-Lyn (Ketua Pengarang CodeBlue)
- Dr John Chew (bekas ahli Majlis Perubatan Malaysia)
- Dr Steven Chow (Presiden, Persatuan Pengamal Perubatan Swasta)
- Ms Daphne Iking (pengamal media sosial dan aktivis kanak-kanak)
- Tan Sri Dr Ismail Merican (bekas ketua pengarah kesihatan)
- Datuk Dr Christopher Lee (bekas timbalan ketua pengarah kesihatan [penyelidikan dan sokongan teknikal]; pakar penyakit berjangkit)
- Dr Lim Teck Onn (bekas pengarah Pusat Penyelidikan Klinikal, Kementerian Kesihatan)
- Prof Datuk Dr Lokman Hakim Sulaiman (Timbalan Naib Canselor (Penyelidikan), Universiti Perubatan Antarabangsa, bekas timbalan ketua pengarah kesihatan [kesihatan awam])
- Dr Milton Lum (bekas presiden Persatuan Perubatan Malaysia)
- Datin Paduka Marina Mahathir (aktivis sosial)
- Datuk Dr Musa Mohd Nordin (pakar pediatrik)
- Assoc Prof Dr Nirmala Bhoo Pathy (Profesor Madya di klinik epidemiologi, Universiti Malaya)
- Prof Dr Rosmawati Mohamed (Sarjana, Akademi Perubatan Malaysia)
- Prof Datuk Dr Subramaniam Muniandy (Presiden, Persatuan Perubatan Malaysia)
- Prof Dr Woo Yin Ling (Profesor, Jabatan Obstretrik dan Ginekologi, Fakulti Perubatan, Universiti Malaya)
— TAMAT —
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