Q
: How is a COVID-19 vaccine declared safe ?
A
: All vaccines must go through the regulatory approval process in countries where they are intended for use . That process is based on accepted international scientific standards .
In Malaysia , any vaccine that enters the market will first have to get approval from the regulator . The process is very clear . First the National Pharmaceutical Regulatory Agency will look into the dossier provided by the drug manufacturer and assess its vaccine for quality , safety , and efficacy , meaning its effectiveness .
The process being followed for the COVID-19 vaccines is exceptional because nothing like this has ever happened before . The Pfizer-BioNTech vaccine , for example , which will be the first to be put to use by the Malaysian government , has been given fast track , or conditional , registration for two years . This is because the situation is somewhat of an emergency .
As a result of this fast-tracking , we will still need to monitor the efficacy and safety of the vaccines following immunisation of the population in phase four of the clinical trials .
Authorities only need phase 3 data for approval , and this fourth phase of the study will be done later . Phase 4 is not a requirement for approval of the vaccine . What happens after phase 4 are the post-marketing studies , but these are not needed for the registration , approval , or marketing authorisation of vaccines and medicines .
Q
: How will the vaccines be rolled out ?
A
: The government has its own COVID-19 immunisation plan . Under this exercise , the main objective is to get herd immunity . This is a big challenge because we are talking about a Malaysian population of about 32 million , and , in addition , there are a few million more foreign and undocumented workers who are the most challenging to vaccinate .
The vaccination roll-out plan will be implemented over three phases , with the first going to frontliners and the second to those aged 60 years and above and people at risk of severe COVID-19 . The third phase is for everyone else . The plan is there .
Malaysia takes a free-market approach to pharmaceuticals . Anyone can bring their product in , and it will go through the same regulatory process . This means that vaccines other than the ones the government has bought for mass vaccination can also be used as long as they gain regulatory approval first .
Q
: Is there any cause for concern ?
A
: There has been much discussion about the new genetic technology behind the mRNA vaccines developed by Pfizer and others that have been bought widely by governments . The study of mRNA is not new , though ; it ’ s been going on for three decades already . At the end of the day , it will produce a spike protein , the cell wall will give out antibodies , and when an invader comes , they will be able to detect it . The mRNA is like a big “ Wanted ” poster for the body .
As a nation , we are carrying out pharmacovigilance , so we are watching out for any unexpected events like adverse reactions and deaths .
No two bodies are the same , so people may react differently to their vaccination , based on what is underlying in an individual . According to figures we have been seeing around the world , allergy to COVID-19 drugs stands at around 10 in one million vaccinations , while anaphylaxis is one in a million .
We have to base our findings on science and data . Safety is our concern and all governments are alert to make sure that , once a drug is given to the public , it will be safe .
Amrahi Buang
Amrahi Buang is president of the Malaysian Pharmacists Society and former chief pharmacist at the University Malaya Medical Centre .
GlobalHealthAsiaPacific . com APRIL 2021
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